deliversvipragen.com.bh-in-14.webhostbox.net/wp2/wp-content/[email protected] mumbai...

Enterpreneurship

Idea2PoC

Grand Challenges

Access to Early Funding

Bioventure Funding (Kitven III)

Department of IT, BT and S&T, Government of Karnataka

www.uhsbagalkot.edu.in

www.cftri.com

http://www.iabt.in

www.bioinnovationcentre.com www.ibab.ac.in; www.chg.res.in

Aqua - Marine BT

IC & CIF

Soon to Initiate TBI in collaborationwith KVAFSU, to explore Marine Ecosystem to develop products

relevant to Bio-energy, Pharma &Nutrition

Convergence of Science & Technology

Being developed in associationwith UHS - Bagalkot to establish

a R & and incubationfacilities at Bagalkot

Centre for Biotechnology at Bagalkot

Stable Cell lineDevelopment

Biosimilar ProductDevelopment

Recombinant ProteinProduction

HybridomaDevelopment

Cell BasedAssays

Drug DiscoveryScreening

ELISA kitDevelopment

“We provide wide range of services executed by experienced team of scientists for research and

therapeutic applications”

Our marketing partner

Email: [email protected]: www.abgenex.com

IMGENEX India

E S I G N SEVELOPSELIVERSD

to accelerate your research

IMGENEX India Pvt. Ltd.E-5, Infocity, Bhubaneswar

Odisha - 751024, INDIA

: +91-674-6544311/6544312: [email protected]: www.imgenexindia.com

COVERDESIGN BY: Neha Metha

BioSpectrum | October 2017 | www.biospectrumindia.comBIOContent4

COVERSTORY .................................................................................................................................................................................22

INDIA TO BOUNCE BACKAS CLINICAL RESEARCH HUBIndia was considered as an all-time favoured destination for clinical trials. Most of the outsourced studies are phase III studies where India has a diverse pool of patients. After 2010 there was major setback in the CRO industry in India. Drug Controller General of India (DCGI) approvals were delayed and multinational sponsors stepped back outsourcing studies to India. But slowly post 2016 DCGI has been generous enough in proving approvals and online application system has brought a lot of difference. Indian Clinical Trial market and clinical trial services is expected to grow significantly along with trends.

BIOPOLICY

21“We have streamlined the whole process of reviewing and approval”Dr Soumya SwaminathanDirector General, ICMR & Secretary,Department of Health Research (DHR)

32Hike in ANDA processing fees

Pharma exportersto US under pressure

29“Creating a more conducive environment will go a long way in encouraging more clinical research”Dr Chirag TrivediPresident, Indian Society forClinical Research (ISCR)

34Draft Pharmaceutical Policy – 2017

Aims at providing a longerterm stable policy environment

30“CROs need to be faster, smarter and more responsive to accommodate”

Dr Sujay SinghCEO, IMGENEX India Pvt Ltd.

38The generic drug push needs further clarity

Utkarsh PalnitkarPartner and Head, Infrastructure, Government and Healthcare, Life Sciences, KPMG in India

42“Biosciences studentshave excellent opportunitiesin traditional segments”Amitava SahaSr. Vice President & Head, Human Resources, Biocon Limited

43BIOTECHNOLOGY: Where is it heading?

TOPVIDEO

5www.biospectrumindia.com | October 2017 | BioSpectrum BIOContent

BIOTALK

50CLINICA -2017

“Data sharing, post study access totrial medication are emerging frontiers”

BIOEVENT

REGULARS

BioEdit ............................................................. 07BioMail ............................................................ 08Policy and Regulatory News ..................... 09Finance News ................................................. 10Start-up News ................................................. 12WHO News ....................................................... 14Company News .............................................. 16World News ..................................................... 18People News ................................................... 44Academic News ............................................. 45Science News ................................................. 46Supplier News ................................................. 48

40“India accounts for 60% ofvaccine supplies made to UNICEF”Dr K Anand KumarManaging Director, Indian Immunologicals Ltd

BIOCAREERSDr Soumya Swaminathan, Director-General, Indian Council of Medical Research (ICMR) talks on measures taken by ICMR to improve clinical research in India

Harish Pillai, COO, Indus Health Plus shares his views on preventive healthcare

Dr Sandeep Dewan, Director and HOD, Critical Care, Fortis Research Institute talks about the role of ECMO

Scan the QR Code »

Scan the QR Code »

Scan the QR Code »

7BIOEditwww.biospectrumindia.com | October 2017 | BioSpectrum

Some recent reports and news about healthcare sector are alarming as they bring into focus two important angles –

growing disease burden on one hand and sharply contrasted inadequate healthcare facilities, particularly at the grass root level on the other.

World Health Organisation (WHO) in its recent report highlighted that 61% of deaths in India are attributed to non-communicable diseases (NCDs). Almost 23% are at risk of premature death due to such diseases. NCDs caused over six million deaths in India in 2016 as per the Global Burden of Disease (GBD) study published in Lancet last year. India is at the 127th position among 188 countries in achieving UN’s health related sustainable development goals (SDGs).

India’s poor performance on healthcare front gets exposed by frequent news about deaths of patients due to inadequate facilities in hospitals. It is also due to the failure of the authorities to reach the healthcare facilities to the sick people in remote areas. A recent report pointed out that while the government is setting up new All India Institutes of Medical Sciences (AIIMS) at different places, five major projects in a campus of AIIMS in Delhi, which started in 2014, are delayed due to lack of funds. First the beginning of the work on implementation of these projects delayed by a decade after they were proposed and even after the work began it got further delayed.

The failures of authorities on various such counts are no more restricted only to the publication of news, but the Comptroller and Auditor General (CAG) has now officially nailed them in its recent performance audit report, leaving no scope for any counter argument.

The most interesting part of this report is that paucity of financial resources is generally cited as the cause for inadequate infrastructure in the government sector but that is not the case here. A massive Rs 9,509 crore remain unspent in the National Rural Health Mission in 2015-16. It is not a case of a single year. This amount has

steadily increased from Rs 7,375 crore in 2011-12.While the funds on such a large scale remain

unutilised, healthcare infrastructure in various forms, including sub-centres, primary and community health centres remain inadequate. The shortfall ranged between 24% and 38% and in case of five states the facilities are only half of the requirement. In over 1200 cases the constructions have been done but the facilities are not operational.

Same is the situation of equipment, drugs, and human resources. Equipment is in short supply at some places and where equipment exit they lie unutilised due to non-availability of the required human resources. Average shortfall of five types of specialists ranged from 77% to 87%. Shortage of nurses in 236 Contributory Health Services Scheme (CHSs) is over 1000. Drugs are not only in short supply, but where they are available they are given to patients without conducting quality checks and without observing expiry dates. The performance report points out to the inadequacies in the rural healthcare in detail.

The CAG has shown the total neglect of the existing facilities and infrastructure in the healthcare. As a result of this the ministry curtailed the cost estimates of National Health Mission 2020 following the criticism of the inadequacies by NITI Aayog and finance ministry. The estimates are curtailed when the rural areas require much more healthcare facilities with more spending.

The report is certainly an eye opener for all. But more than that, it can be also looked at by the union and state governments as an opportunity to take corrective steps on an urgent basis for speedy improvement. Otherwise, it will continue to remain as one more report like many previous ones, gathering dust.

Milind KokjeChief Editor

[email protected]

Urgent measuresrequired in rural healthcare

Vol 15; Issue 10; October 2017

Publisher and Managing Editor: Vijay ThombreEditorial:Chief Editor: Milind Kokje [email protected] Editor: Srinivas Rasoor [email protected] Manager Content Creation and Coordination: Narayan KulkarniContent Team:Bengaluru: Dr Manbeena Chawla Delhi: Nitin Konde, Kalyani Sharma Mumbai: Prapti ShahChief Financial Officer: Manasee KurlekarProduction & Design:MM Activ Sci-Tech CommunicationsAnil WalunjSales and Marketing:General Manager- Sales: Delhi: Vikas Monga [email protected] Sr. Executive, Digital Marketing: Sayali Damle [email protected], Global Market Development: Kavita Pote [email protected] Creation and Coordination:Priyanka [email protected], Subscription and Media Enquiry:Asmita [email protected]

Bengaluru Alok Srivastava Regional Sales Manager (South)#9, UNI Building, Thimmaiah Road, Millers Tank Bund, Vasanthnagar, Bengaluru - 560 052Tel.: +91-80-41131912/13 [email protected]

Mumbai Sayali DamleSr. Executive, Digital Marketing 133, Kaliandas Udyog Bhavan, Babasaheb Woralikar Marg, Near Century Bazaar, Mumbai - 400 025Tel. No: +91 22 2438 5007/8/[email protected]

Pune Ankit Kankar Senior ExecutiveAshirwad, 36/A/2, S.No. 270, Pallod Farms, Near Bank of Baroda, Baner Road, Pune- 411045Tel. No: +91 20 2729 1769 [email protected]

New DelhiRajeev Ranjan Assistant Manager- Sales (North)103-104, Rohit House3, Tolstoy Marg, Connaught Place, New Delhi - 110 001Tel. No: +91 11 4354 2737 [email protected]

Hyderabad Y V L N MurthyFlat 205, Sai Sharmistha Residency, Springfields Colony, Jeedimetla Village, Hyderabad-500055, Telangana State Mob: +91 9246577114

Chennai & Kerala Krishna Kumar VMagattuparampil House, 1st Floor, Lakshmi Nivas, Kannankulangara Kidangu Road, Thrippunithura, Eranakulam, Kerala, Pin:682301Tel: +91 484 2777997Mob: +91 9526 44 3331

INTERNATIONAL

Singapore MM Activ Singapore Pte. Ltd.Saradha Mani Manager Admin & Sales Support #14-06, High Street Centre, 1 North Bridge Road, Singapore - 179094Tel: +65-63369142Fax:+65-63369145 [email protected]

USA Leslie Hallanan Media Representative Avani Media Inc.,80 Liberty Ship Way, Suite 25, Sausalito, CA 94965 USATel.: +1-415-3312150 E-mail: [email protected]

Europe Stuart Smith Media Representative Global Media Sales Limited 1 Cobden Court, Wimpole Close,Bromley, BR2 9JF, United KingdomTel: +44-(0)20-8464-5577E-mail: [email protected]

Printed and published by Vijay Thombre on behalf of MM Activ Sci-Tech Communications Pvt LtdPrinted at Spectrum Offset, D 2/4 Satyam EstateBehind CDSS, Pandurang Colony, Erandwane, Pune - 411004. Tel : +91 20 2543 6556

TIN No: 09565712431Published from Ashirwad, 36/A/2, S.No. 270, Pallod Farms, Near Bank of Baroda, Baner Road, Pune- 411045.Tel. No: +91 20 2729 1769 Website: www.biospectrumindia.com

Nagpur Manisha Boratkar402, Govind Apartments, Shankar Nagar Square, Nagpur - 440 010Tel. +91-712-2555 249

MM Activ Sci-Tech Communications

Vol 15; Issue 09; September 2017

Rapid growth in HealthcareA well written article on India’s life sciences and healthcare industry with respect to the challenges faced by the biosuppliers. More resources are definitely required to drive their market growth.

- Krishna Arora, Aurangabad

Biopharma CompetitionThere is definitely a lot of competition in the market these days. An interesting article covered on the benefits of process cost-modeling tools.

- Ravi Sinha, Bengaluru

Technological advancementsA good article published highlighting the need of marketing and development strategies for the entire biosupplier industry.

- Shreya Adhikari, Pune

A march of ScienceI have been reading a lot about the protest put forward by scientists in our country. Please write more on the scientific developments taking place in India in order to give our scientists a boost.

- Ananya Nath, Mumbai

BIOMail8 BioSpectrum | October 2017 | www.biospectrumindia.com

9www.biospectrumindia.com | October 2017 | BioSpectrum l POLICY AND REGULATORY NEWS

The Centre has fixed a price range between Rs 54,000 and Rs 1.14 lakh for knee implants. Also, the price of specialised implants in cancer and tumour cases has been cut to Rs 1,13,950 from the current price of Rs 4 lakh to Rs 9 lakh. The order also specified that no healthcare institutions such as hospitals, nursing homes and clinics performing orthopaedic surgical procedures shall solicit any patient to purchase knee implants from them in case the patient wishes to procure these from a third party.

The National Pharmaceutical Pricing Authority (NPPA) had maintained that the average trade margin on orthopaedic knee implants were found to be as high as 313 per cent. The move is expected to save an estimated Rs 1,500 crore annually. There are 1.5 crore to 2 crore patients who need knee implants. Each year, 1.2 lakh to 1.5 lakh knee surgeries take place in India.

According to the order, the ceiling price will apply to all stocks of knee implants available for sale from the date of publication of the notification. Under the new price regime, the MRP of the most widely used complete knee implant (cobalt-chromium) has been fixed at Rs 54,720 plus GST, which is a reduction of 65 per cent from the earlier average MRP of Rs 1,58,324. This knee implant enjoys 80 per cent of the market share.

The Indian Council of Medical Research (ICMR) has entered into an agreement to collaborate on vaccine research and development with international vaccine development organisation International Vaccine Institute (IVI). Through this partnership, India will commit $5,00,000 (Rs 3.20 crore) annually for a stake in IVI—an amount approved during a cabinet meeting in January.

Under its latest Memorandum of Understanding (MoU), ICMR will be focused on research and development of vaccines combatting various infectious diseases. Under ICMR’s latest partnership, vaccine candidates developed in IVI labs could be brought to India and given to one of the companies here for further development. IVI may also facilitate further global testing of vaccine candidates developed in Indian labs by linking developers here with global partners.

The partnership is further expected to help with capacity building for clinical trials within India as well. The MoU is also expected to help support companies like Bharat Biotech, which has completed phase I clinical trials of its chikungunya vaccine and has expressed the need for support in conducting phase II and III trials for the candidate.

Gujarat expedites pharma licensingGujarat government has reduced the duration for granting licenses for new pharmaceutical units by 60 days. Similarly, the government has also reduced the time taken for granting new permission and renewing exiting ones for sale of medicines in the state. New permission for sale of medicines have also been reduced to 30 days from the earlier 45 days and the renewal of existing permission for sale have been reduced to 30 days from the earlier 70 days.

This decision from the state government comes as more and more pharmaceutical units are approaching the state government to open new units.

The number of project proposals submitted to Gujarat’s Food and Drugs Control Administration for green-field projects or expansions of existing ones have risen three fold post-GST. The move is also expected to help the state government promote itself as a pharma hub during the upcoming Pharmac India 2017 event that is scheduled to be held on November 7-9, 2017.

In 2016, Gujarat had slipped to third spot behind Andhra Pradesh and Telangana in the ease-of-doing-business ranking prepared by the World Bank and Department of Industrial Policy and Promotion (DIPP).

Knee implants become more affordable

ICMR invests intovaccine research

BioSpectrum | October 2017 | www.biospectrumindia.com10 FINANCE NEWS l

Strides Shasun acquires Amneal Pharma operationsDrug firm Strides Shasun’s arm Arrow Pharmaceuticals has acquired Australian operations of Amneal Pharmaceuticals for a total consideration of Australian dollar (AUD) 17 million (over Rs 85 crore). The acquisition would accelerate Arrow’s market reach and will help in attaining a leadership position in the Australian generics market. Under the terms of the agreement, Arrow Pharmaceuticals will acquire 100 per cent of the issued capital of Amneal Pharmaceutical Australia. Arrow will incur an amount of AUD 17 million towards consideration, working capital and other estimated acquisition and integration related costs. Bringing Amneal’s customer base into the network of supporting pharmacies further accelerates the current growth and strengthens the offering the company bring to all its customers.

Sweden-based healthcare and diagnostics services provider Medicover AB has decided to expand its operations in India by picking up a 22 per cent stake in Sahrudaya Healthcare Pvt. Ltd, which runs a hospital chain under the MaxCure brand, for 13.2 million Euros ($15.5 million).

The company will look to further increase its ownership in MaxCure, which operates nine hospitals in Andhra Pradesh and Telangana, across two stages within the next two years. MaxCure will be considered as an associate

company of Medicover AB.The company, which had

entered the Indian healthcare space in 2016 by agreeing to manage the operations of Medicover Fertility India, is also looking to

acquire the company from the principal shareholder, Delhi-based Medicover Healthcare Pvt. Ltd, for $7.4 million (Rs 47 crore).

The European company has presence across Poland, Germany, Romania, Ukraine, and Central and Eastern Europe and offers both outpatient and inpatient healthcare services. In 2016, the company had generated revenue of 497.3 million euros. Sahrudaya, which was incorporated in January 2011, had registered a total income of Rs 166.3 crore and net loss of Rs 6.54 crore in 2015-16.

Private equity firm IDFC Alternatives has invested Rs 75 crore ($11 million) for a minority stake in ASG Eye Hospitals Pvt Ltd. This is the second investment from the PE firm’s fourth fund.

IDFC Alternatives – IV marked its first close at $100 million in January this year. Its first investment was a Rs 80 crore bet on Incred Finance. The investment is predominantly a primary round with only a minor secondary component where a few old investors exited.

In March 2017, the Rajasthan-

based eye care chain had hired investment bank Allegro Advisors for a fresh capital raise. Previously, ASG Eye Hospitals had received its first external funding of about $11 million in two tranches from Sequoia Capital India Advisors Pvt Ltd in 2012.

The hospital chain has 24 operating centres across nine Indian states, in addition to a centre in Kampala, Uganda. The chain is founded by Dr Singhvi and Dr Shashank Gang, who are alumni of the All India Institute of Medical Sciences, Delhi.

Medicover to acquire 22% stake in MaxCure

PE firm invests inASG Eye Hospitals

For more information, contact West today. www.westpharma.com

North America 1-800-345-9800 option 8 | South America +55 11 4055 6061 | Europe +49 (0) 2403-7960 | Asia Pacific +65 6862 3400

West and the diamond logo is a registered trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions. © 2017 West Pharmaceutical Services, Inc. #10313 0617

West offers: Extractables & Leachables Analysis

Packaging & Performance Testing

Particle Analysis

Container Closure Integrity

Industry Leading Expertise for the Drug Product Lifecycle Management Whether you’re seeking a recommendation for a packaging and delivery system for your drug product, or need help testing for extractables and leachables, West is here to support you.

Our Technical Customer Service Experts provide information and packaging recommendations, and can supply technical reports, quality assurance and regulatory assistance to assist in the use of West’s products.

12 START-UP NEWS l BioSpectrum | October 2017 | www.biospectrumindia.com

Karnataka Government has picked up 100 most innovative start-ups after following through a four-layered selection process. These startups will get a funding support of about Rs 35 crore from the government to pursue their tech-ideas and scale them up. During the final leg of selection process, 270

startups were vying for these top 100 slots. The contest saw the participation of more than 1700

startups from across Karnataka, but most of the nominations were from Bengaluru.

The startups are being selected under the government’s ELEVATE 100 programme. The initiative also attracted 350 women

entrepreneurs and 400 applicants from the rural areas.

The ELEVATE 100 roadshow has traversed the length and breadth of Karnataka in a rigorous

hunt to pick the 100 most innovative start-ups and help them turn their ideas into successful businesses. The short-listed startups will have access to the government’s start-up fund besides access to government VC funds, pilots, private VC funds, world class accelerators and mentors. Of the 100 startups finalised, 27 are from electronic semiconductor design, 19 from life sciences, 11 each from biotech, agri tech, four each from animation and gaming, and clean tech, and 26 from IT/ITES. There are also 19 startups founded by women entrepreneurs and 11 from rural areas.

Healthcare startup raises another round of fundingHealers at Home, an online marketplace for Home Healthcare & Wellness services, announced a successful second round of funding for an undisclosed amount. The round saw investment from Let’s Venture and Chandigarh Angels Network with some of the names including the likes of Dr Jay Patel (US-Based Doctor & Investor – Chandigarh Angels), Chand Das (Ex-CEO – ITC) and Pawan Kumar (Ex-President – IBM Global Services).

The funds raised by the startup will be used to build deeper technology, traction and penetrate further in the Delhi NCR region along with enhancing the quality across all its services.

Healers at Home is an online marketplace for Home Healthcare & Wellness services. The core team comprises of IIT- Kanpur graduates and healthcare professionals who have a diverse combined experience of over 35 years in the field of Healthcare, Marketing, Microfinance and Technology. They currently provide five services at home: Physiotherapy, Yoga, Nursing, Attendant Care and Mother & Child Care.

The learnings and team efforts have helped the startup grow 10X in terms of traction and revenue in the year 2016 and they have done more than 100,000 Home Visits in the last 1 year.

100 innovative startupsget government funding

MedGenome gets$30 M series C fundingBengaluru-based genomics research and diagnostics company MedGenome has secured $30 million in Series C financing led by Sequoia India and Sofina s.a. The round also saw participation from Zodius Capital, Kris Gopalakrishnan of Infosys, and Lakshmi Narayanan, former CEO of Cognizant. The health tech startup will use the proceeds to accelerate development of its affordable diagnostics tests.

MedGenome will also tackle market penetration by increasing customer awareness on the importance of genetic tests. Additionally, the funding will also be used to broaden biomarker discovery programmes.

The genomics-driven research and diagnostics company aims to improve global health by decoding the genetic information contained in an individual’s genome. Its access to genomics data with clinical and phenotypic data provides insights into complex diseases at the genetic and molecular level to facilitate research in personalised healthcare.

Its diagnostics tests include many firsts for genetic diagnostics in India, including first liquid biopsy OncoTrack for monitoring cancer treatment, a non-invasive prenatal screening test (NIPT) for pregnant women, and whole exome sequencing test for identifying mutations in rare diseases.

R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MH/MR/SOUTH-284/2014-16Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month. Total Pages:- 56

BioSpectrum | October 2017 | www.biospectrumindia.com14 WHO NEWS l

The government of the Democratic Republic of Congo has set aside a special team to address the current cholera outbreak in the country. More than 500 people have died so far in a cholera epidemic that is sweeping the Democratic Republic of Congo. The World Health Organization (WHO) has also joined hands to curb this waterborne disease. The WHO donated 400 billion dollars to the Congolese health ministry to address the outbreak. Several measures have already been taken that include awareness to the public and various ways to minimise the disease spreading to other regions. So far, health officials have recorded more than 24,000 suspected cases of the disease across the vast nation this year, averaging more than 1,500 new cases per week since the end of July.

World Health Organization (WHO) estimates that around $800 million is required to eliminate measles by 2020 from India and other countries of south and south east Asia. Measles is one of the major causes of death in children, MMR (measles, mumps and rubella) jabs are one of the major public health interventions aimed at eliminating childhood deaths. For unhampered progress against the viral disease, WHO states that a total of 400 million children in India, Bangladesh, Myanmar, Timor Leste and Indonesia must receive the Measles Rubella (MR) vaccine by 2018, while 140 million should be reached by the end of 2017. In 2015, the National Technical Advisory Group on Immunization in India recommended introduction of a combined measles-rubella vaccine, as a nation-wide campaign covering children in the age group of nine months to 15 years.

After the campaign, the MR vaccine will replace the current two doses of measles vaccine. The ongoing MR campaign in five states and union territories—Tamil Nadu, Karnataka, Goa, Puducherry and Lakshadweep—to vaccinate 34.8 million children, has till date, reached 11.6 million children.

Blood transfusions help save thousands of lives every year in Afghanistan. Given the intensifying conflict in many parts of the country, more people than ever rely on the availability of safe blood transfusion services. With the support of the EU's European Civil Protection and Humanitarian Aid Operations department (ECHO), the World Health Organization (WHO) supports Afghanistan’s blood banks to ensure safe and efficient services.

In the past year, thanks to funding from the European Civil Protection and Humanitarian Aid

Operations department (ECHO), WHO has equipped 10 provincial and regional hospitals with necessary supplies to strengthen blood transfusion services and to enable them to gather, test, store

and preserve blood safely and effectively. Plasma separation, which can be used to treat a range of diseases, had also not been available in Afghanistan before WHO and ECHO joined forces to strengthen the country’s blood banks. Now, a single unit of blood can be used to benefit several patients.

In addition to providing equipment and supplies to guarantee the effective and safe operation of blood banks, in the past year WHO has trained 31 blood bank staff from 19 provinces on plasma separation and safe blood transfusions.

Blood banks in Afghanistan gets support from WHO

WHO lends ahand to Congo for cholera outbreak

WHO estimatesfunds for eliminating measles in India

Announcing… Highly Characterized Hepatocytes

©2017 Lonza. All trademarks belong to Lonza or its affiliates. The information contained herein is believed to be correct. No warranty is made, either expressed or implied.

Hepatocytes_Ad 031717 - India

From the Trusted Primary Cells ExpertsCritical decisions are made from your drug discovery and development research. Our highly characterized primary hepatocytes come with a global team of experts, providing the support you need.

– PhD level support – High quality standards for lot-to-lot consistency – User-friendly protocols

Visit our website to learn more.

Bioscience Solutions

www.lonza.com/hepatocytes

Available Globally

BioSpectrum | October 2017 | www.biospectrumindia.com16 COMPANY NEWS l

Japanese drug maker Otsuka Pharmaceutical has granted US pharmaceutical firm Mylan’s subsidiary an exclusive license to supply to India and South Africa a drug to treat patients with pulmonary multi-drug resistant tuberculosis (MDR TB). The agreement is expected to speed up India’s access to the potentially life-saving drug, which had not been made available in the country despite Otsuka having received a patent for it back in 2011.

The Drug Controller General of India (DCGI), India’s apex drug regulator, has granted Mylan’s subsidiary approval for the drug, according to a release by the company. The drug, delamanid, was discovered and developed by Otsuka.

The Revised National Tuberculosis Control Programme (RNTCP) will now begin drafting the protocol to administer delamanid with other drugs to patients with MDR TB and identify sites where the drug will be rolled

out. Mylan will use clinical data from these sites to conduct a post marketing survey, after which DCGI may give them permission to introduce it in the private market.

The government intends to enter into discussions with Mylan to ensure that delamanid remains affordable to India. The only other drug available in India for patients with MDR TB, a growing issue in the country, is bedaquiline by Johnson & Johnson. This drug was introduced last year and is also supplied to a limited number of patients through the government's conditional access programme.

MDR TB drug byOtsuka reaches India

Suven Life Sciences has secured the process patents from Europe, Japan and New Zealand. The company has received patents for new chemical entities (NCEs) which are for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2034.

Suven Life Sciences is a biopharmaceutical company focused on discovering, developing and commercialising novel pharmaceutical products, which are best in class CNS therapies using GPCR targets.

These process patents are for company’s pipeline compounds which are in the class of selective 5HT6 compounds and are being developed as therapeutic agents and useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia.

The company is very pleased by the grant of these patents to Suven for the pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally.

Piramal Enterprises Ltd (PEL) is looking at growing organically in pharmaceutical segment to move up the value chain and expanding in services like antibody drug conjugates, injectables and drug discovery, according to its annual report.

In the last two years, the pharma segment deployed around half a billion dollar of capital for future growth through various organic as well as inorganic initiatives. PEL is now looking at investments for expansion of the manufacturing and service delivering capabilities in niche areas of ADC, injectables, inhalation anaesthesia and discovery services.

It also plans to launch first generic version of Desflurane, the latest generation inhalation anaesthesia product, in FY18. Last year, the company added two niche differentiated product portfolios in global pharma products business.

It has acquired a portfolio of five branded products in the injectable anaesthesia and pain management area from Janssen and a portfolio of intrathecal spasticity and two pain management products under development from Mallinckrodt LLC.

Piramal goes organic for pharma growth

Suven Life Sciences receives patents for new chemical entities

l COMPANY NEWS 17www.biospectrumindia.com | October 2017 | BioSpectrum

Siemens Healthineers has received CE-Mark for its ultra-high-field 7T magnetic resonance (MR) scanner Magnetom Terra, making it available for neurological and musculoskeletal clinical examinations in Europe. In addition to detailed insights of the musculoskeletal system, Magnetom Terra’s high spatial and spectral resolution enables imaging of metabolic processes in the brain, as well as visualisation of neurological diseases such as Alzheimer's,

epilepsy, and multiple sclerosis (MS). It is expected that the high-resolution of the scanner will provide clear pictures of brain lesions, including better white and gray matter differentiation in epilepsy and improved visibility in gray matter in multiple sclerosis. Use of the new MR scanner will enable anatomical imaging of small pathologies and sub-cortical brain activation, while it will also aid the assessment of anatomy, function and metabolism of body tissue.

Bio Agile Therapeutics Pvt. Ltd was honoured as the Emerging Clinical Research Organisation of the year 2017 hosted by “Times Television Network - Times Influence National Marketing Excellence Awards (For Excellence in Healthcare)”. Managing Director Divya Chandradhar received the award at a ceremony held in Mumbai recently. The award demonstrates company’s commitment and expertise in providing better clinical research services in India. Bio Agile Therapeutics caters research services to Pharmaceuticals, Nutraceuticals, Herbs, Cosmetics and Medical Devices industries. The company has been structured to provide quality services to its sponsors. Bio Agile Therapeutics provides end-to-end clinical trial support for Phase II-IV clinical trials. The company focuses on conducting successful clinical trials and development programs.

Bio Agile gets emerging CRO award

Aurobindo Pharma plans new growth strategiesAurobindo Pharma would broaden product portfolio in the US while entering new markets in Europe as part of its growth strategy over the next 3-4 years. In the US, it plans to broaden portfolio through accelerated growth in injectable, OTC and higher complexity products. On the other hand, in Europe, the company is planning to expand presence into new geographies such as Poland and Czech Republic besides enhancing its position in existing countries such as France, Germany, Netherlands, Spain and the UK. Aurobindo has been following a strategy of differentiated pipeline with new launches, including injectables, ophthalmics, speciality products and controlled substances in the US market. Moreover, it has also expanded presence in dietary supplement business through Natrol, which it had acquired in 2014. The company had posted consolidated net revenue from operations of Rs 3,678.7 crore for the first quarter ended June 30, 2017-18. Out of this the US formulation sales were at Rs 1,694.9 crore and Europe formulations sales were at Rs 917.6 crore.

Siemens receives CE mark for magnetic resonance scanner

BioSpectrum | October 2017 | www.biospectrumindia.com18 WORLD NEWS l

US Biotechnology company, Amgen and leading health organization, Humana have teamed up to identify opportunities to improve health outcomes and improve efficiency by unlocking new insights from the real world health care experiences of Humana's 13 million members.

In the collaboration agreement between Amgen and Humana, six projects are currently underway or planned, with more expected over the term of the agreement. Both organizations are committed to expanding the work into further therapeutic areas where the partnership can bring value to both Amgen and Humana. The goal is the same across all projects: deliver increased value to patients and the health care system by focusing on working to improve quality and outcomes in the context of total health care costs.

The collaboration will initially target multiple serious conditions, including cardiovascular disease, osteoporosis, neurologic disorders, inflammatory diseases and cancer. Researchers will combine available sources of real world evidence (RWE) with data from wearable technology, digital apps and Bluetooth-enabled drug delivery devices. Prospective observational studies are also planned.

US-based molecular diagnostics firm Myriad Genetics has introduced a new medical tool, riskScore, to support its myRisk test developed for hereditary cancer. riskScore is an algorithm designed to combine genetic markers with a patient’s family and clinical history to quantify the risk of breast cancer development. The tool will combine data from more than 80 genetic markers called single nucleotide polymorphisms (SNPs) throughout the genome with a family and personal history algorithm called Tyrer-Cuzick model. The Myriad myRisk Hereditary Cancer test is a 28-gene panel that can identify the risk of breast, ovarian, gastric, colorectal, pancreatic, melanoma, prostate and endometrial cancers. In addition to a risk assessment, the simple and easy-to-use test delivers specific medical management recommendations to patients who test either positive or negative according to the guidelines of select professional medical societies.

Private equity firm Calculus Capital, a leading EIS and VCT investor, has further expanded its life sciences portfolio, by investing £2.5 million in Cambridge-based Axol Bioscience (Axol), a provider of stem cells produced from reprogrammed human blood and tissue cells.

Axol supplies the world’s top pharma companies, biotech and research institutions with sustainable, physiologically relevant human derived cell culture models for pioneering research and drug discovery applications. By harnessing advances in stem cell biology, Axol is able to generate self-renewing cell-lines specific to any part of the human body from healthy and unhealthy tissue.

Importantly, Axol’s unique and innovative approach to this process ensures that each cell line is identical to its previous production batch, maintaining the high quality and the consistency required for the development of novel therapeutics.

Once a new cell line is developed from a healthy or unhealthy tissue source, it is added to Axol’s suite of ‘off the shelf’ products available via their website. The combination of these properties means that the reprogrammed stem cells developed by Axol are an essential research tool for the development of new treatments for serious illnesses and diseases, including Alzheimer’s and Huntington’s.

Myriad launches hereditary cancer detection tool

Calculus Capital enhances life sciences portfolio

Amgen collaborates with Humana to improve health outcomes

Praava Health inaugurated its first family health centre in Banani of Dhaka recently. A Microsoft Bangladesh Biz Spark partner, Praava is building a better patient experience enabled by technology. It is also reintroducing the concept of family medicine, particularly the family doctor, to Bangladesh.

The Banani Praava Family Health Centre is the first in a network of many facilities which will offer consultations with family doctors and a full range of diagnostic services including lab and imaging. The company is introducing Bangladesh’s first molecular cancer diagnostics (Polymerase Chain Reaction, or PCR) lab in breast, cervical, colorectal, and lung cancers, as well as the country’s first fully integrated

Hospital Information System (HIS), including Electronic Health Records (EHR) and featuring a patient portal available on the internet and as a phone app. The future of healthcare will leverage artificial intelligence, smart design, and biotechnology, and Praava is planning to use technology to enable a better patient experience and improve access and outcomes in Bangladesh.

MedHack is Sri Lanka’s first ever Hackathon for the health sector organized by Mobitel, the National Mobile Service Provider of Sri Lanka, in collaboration with the Ministry of Health, Nutrition and Indigenous Medicine and the ICT Agency of Sri Lanka.

MedHack aims to innovate solutions for the health sector and bring medical and health professionals together with tech experts and problem solvers to address the challenges faced by the Sri Lankan health sector.

This is yet another initiative spearheaded by Mobitel that focuses on the development of digital health sector along with the addition of a pioneer in digital health services and Sri Lanka’s largest doctor channeling network, eChanneling to its portfolio.

This initiative will nurture the Digital Services eco system of Mobitel and Sri Lanka as a whole. As a way forward, Mobitel together with the Ministry of Health, Nutrition and Indigenous Medicine and the ICT Agency of Sri Lanka will be supporting the selected teams in realizing their solutions and nurturing them to success.

Nepaladapts Smart’s ehealth systemSHINE OS+, an electronic medical record and referral system initiated by PLDT wireless unit Smart Communications Inc. (Smart), has been adapted in Nepal as a tool for disaster risk reduction. Shine OS+ Nepal was developed as a post-disaster surveillance system in 2015. Now called EpiNurse or Epidemiology + Nursing for Disaster Risk Reduction, the program will serve as a public health emergency reduction tool for the country. The program is seen as crucial in preventing disease outbreaks and consequently mitigating disaster risk. Last May, EpiNurse received the Risk Award at the 2017 Global Platform for Disaster Risk Reduction in Cancun, Mexico. The award, issued every two years by the Munich Re Foundation, the UN office for Disaster Risk Reduction (UNISDR) and the Global Risk Forum Davos, honors innovations aimed at disaster risk mitigation. EpiNurse provides a holistic approach by empowering nurses in Nepal not only in care management but also in surveillance reporting during the different phases of a disaster. EpiNurse will be powered by Shine OS+ in developing three applications that will allow EpiNurses to collect data at the school and community levels for preparedness, as well as surveillance data during and post-disaster. The system will be simple, straightforward and localized so that the language and the design suit the Nepal culture and community.

Praava builds first family health centre

Mobitel to launch medical hackathon in Sri Lanka

BioSpectrum | October 2017 | www.biospectrumindia.com20 WORLD NEWS l

21COVERStorywww.biospectrumindia.com | October 2017 | BioSpectrum

We have also re-constituted our central ethics committee on health research. It is chaired by Justice Madhava Menon. This committee will debate on all sorts of ethical issues such as uterus transplant or any experimental procedure suggested by the doctors on the patients.

Do you feel the clinical research space in India will get a boost with these measures?

Yes of course. Earlier we had a three tier committee for the reviewing and approval process. It used to include a subject expert, ethical committee and an apex committee. So this entire process used to take a lot of time. Based on this, we decided to cut down on the time by establishing one strong committee at the end. A lot of responsibility is now on the ethics committee. The apex committee now only takes care of appeals. So ICMR is working on the guidelines for the ethics committee. DCGI only works with the clinical trials but ICMR deals with all the clinical research that is taking place in the country. ICMR is also planning to develop a regulatory authority under the Department of Health Research in order to oversee all the non-clinical research. Also, the stem cell research guidelines have been revised with respect to the 2013 version that we had.

What kind of support the industry has been looking at from the government?

The industry itself has been very supportive in this whole thing. They are the ones who have identified all the barriers and challenges which led to new implementations now. We have now revised the ICMR ethical guidelines, which was last touched upon in 2006. So we have included a lot of new chapters in that, on public health research, use of gene therapy and so on. The draft guidelines will be officially released very soon. The industry will be of course benefited by them.

“We have streamlined the whole process of reviewing and approval”

«Dr Soumya SwaminathanDirector General, ICMR & Secretary, Department of Health Research (DHR)

Indian Council of Medical Research (ICMR) signed an agreement recently with other global agencies to develop and implement policies within the next

12 months that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available registry. ICMR as a signatory to the statement agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting. Most of these trials and their results will be accessible via WHO's International Clinical Trials Registry Platform which is a unique global database of clinical trials that compiles data from 17 registries around the world.

Dr Manbeena Chawla of BioSpectrum India spoke to Dr Soumya Swaminathan, Director General, ICMR & Secretary, Department of Health Research (DHR) about the measures taken by ICMR to improve the CROs space in the country.

Excerpts of the interview

What measures ICMR has taken up to boost the clinical trials space in the country?

We have been working with the Drug Controller General of India (DCGI) office for the last two years and looking at where the obstacles are, and trying to design the entire pathway of clinical development. This is because we had a number of different stakeholders telling us about the issues they were facing, not only from the commercial side but also from the academic and scientific side, and also the industry. So we have streamlined the whole process of reviewing and approval and for marketing authorization of the drugs.

We have also looked at the rules and regulations in other countries especially in the case of stem cell, dendritic cell based therapies where the same pathway of drug approval cannot be employed. So in such cases there can be conditional approvals granted.

We are also looking at training the ethics committee. For this, a series of online programmes would be conducted along with a few workshops with the help of Clinical Skills Development Service (CDSC).

We are also tying up with Department of Biotechnology for looking into human challenge models which have not been so far explored in India in case of diseases such as typhoid, cholera etc. This basically includes vaccinating a person and then giving him or her an oral challenge of the bacteria. This might be ethically challenging but it is a well-accepted model in many other countries.

India to bounce back as clinical

research hub

India was considered as an all-time favoured destination for clinical trials. Most of the outsourced studies are phase III studies where India has a diverse pool of patients. After 2010 there was major setback in the CRO industry in India. Drug Controller General of India (DCGI) approvals were delayed and multinational sponsors stepped back outsourcing studies to India. But slowly post 2016 DCGI has been generous enough in proving approvals and online application system has brought a lot of difference. Indian Clinical Trial market and clinical trial services is expected to grow significantly along with trends.

With 17% of the global population and 20% of the world’s disease burden, India faces a ‘triple burden’ caused

by communicable disease, non-communicable disease and socio-behavioral illness. The increasing disease burden is propelling the pharmaceutical and biotechnology industry to bring up new chemical entities into the market at a higher rate. Most companies are outsourcing the clinical trials of their newly developed drugs to various contract research organizations as this could save them the hassles of regulatory issues and patient recruitment burden from the research and development phase.

COVERStory22 BioSpectrum | October 2017 | www.biospectrumindia.com


Making his point on triple burden of diseases, Naz Haji, SVP & Managing Director, QuintilesIMS India said “We have diseases that are close to being eradicated in other regions like cholera and tuberculosis, and at the same time must contend with rising rates of diabetes, cardio-vascular and other lifestyle-related diseases. Despite this high burden of disease, according to www.clinicaltrials.gov, less than 1.4% of global clinical trials are carried out in India and we need to be doing more for our patients. Besides our large population of treatment-naïve patients, India also has excellent site infrastructure, skilled investigators and cost efficiencies.”

Market trends According to Boston Consulting Group, 48% ($30 billion) of all clinical research investment in 2017 will be spent on outsourced services. India is home to 16 per cent of the world’s population, 20 per cent of the global disease burden, yet it has less than 2 per cent of clinical trials registered worldwide.

On the current trends in CRO space, Divya Chandradhara, Director of Bio Agile Therapeutics said “Total number of registered studies worldwide is about 253,462 (as on September 1, 2017) as per clinicaltrails.gov. 5673 trails have been registered on Clinical Trials Registry- India (CTRI) till date. In 2010 when India

was in peak of the getting major MNC studies there was almost 500 trials registered in CTRI, in 2013 it was only 107 studies, in 2014 we have 133 trials registered, in 2015 its about 121 studies, in 2016, 84 studies, in 2017 about 45 studies till date and its slowly picking.”

The percentage of clinical trials registered in diabetes, CAD, asthma, COPD, epilepsy, schizophrenia, malaria, and tuberculosis are more in India compared to other nations. Still India is lagging far behind the western

countries as well as other Asian countries like China and Japan in the total number of trials registered.

There are about 400 + companies (multinational and local) in India which have been offering clinical research services. About the number of employees Divya Chandradhara observed that major CROs

include more than 20,000 employees worldwide, but many CROs are small, with fewer than 50 employees. Staff includes entry-level Co-ordinators, Associates, Project managers, Medical writers, Data managers, Statisticians.

Though there was a slight slowdown during last five years, the clinical trials industry in India is seeing an upward trend. Sharing her thoughts Dr Chaitra Harsha, Managing Director, Vipragen Biosciences said “There are several reasons behind the positive growth in clinical phase I and phase II trials in India, the least being the proactive approach and business-friendly ‘Make in India’ initiative of the Indian government.”

Needs attention The recent amendments in the regulatory framework have significantly streamlined the clinical trial review process. Central Drugs Standard Control Organization

“India presents one of the most promising trials arenas available today. Currently, India represents 17% (1/6th) of the world’s population, with genetically diverse patient base in various disease areas (1/5th or 20% of the global disease burden) and only 1-2 % of all global clinical trials. High prevalence of both the developing and developed world provides access to a variety of diseases including access to a large pool of ethnically diverse and often treatment-naïve patients. With a high standard of medical care available via expert clinicians (including those returning western-trained physicians), access to technology and competitive operational costs, India offers an attractive option, for those wanting quality data collected from an internationally harmonized environment.”- Dr Aparna Parikh, Executive Director – Scientific Affairs, Pediatrics & Infectious Diseases, PRA Health Sciences

“We have been working with the DCGI office for the last two years and looking at where the obstacles are, and trying to design the entire pathway of clinical

development. This is because we had a number of different

stakeholders telling us about the issues they were facing, not only from the

commercial side but also from the academic and scientific side, and also the industry. We have now revised the ICMR ethical guidelines, which was last touched upon in 2006. So we have included a lot of new chapters in that, on public health research, use of gene therapy and so on. The draft guidelines will be officially released very soon. The industry will be of course benefited by them. ”- Dr Soumya Swaminathan, Director General, ICMR


(CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, and serves, has initiated online submission of applications and monitoring of clinical trials in the country in order to improve transparency, accountability and efficiency in processing of trials. The application and review process needs to be made simpler with fewer administrative hurdles and less uncertainties associated with the approval timelines. Faster approval timelines would make it conducive for more clinical studies to be conducted in India.

Though DCGI has made the application process simpler compared to previous and reduced the timeline for getting approval the number of studies conducted is still not significant. There are many other issues that need immediate attention of the regulatory agencies.

Referring to the issues Dr Chaitra Harsha said “There is a lack of awareness among the researchers regarding the registration of clinical trials in clinical trial registries. Another reason could be the availability of a limited number of recognized courses for training physicians and other healthcare professionals involved in the conductance of clinical trials, resulting in shortage of trained manpower.”

Hence to meet the growing demands of clinical research and to increase the number of registered trials in the country, she suggested that India needs to train more qualified, ethical clinical investigators, skilled nurses and biostatisticians to suit the clinical trial appraisal. With experienced clinical researchers and technological developments, India is sure to contribute as a major clinical trial destination for the global clinical research in the near future.

On challenges before the CROs, Dr Aparna Parikh, Executive Director – Scientific Affairs, Pediatrics & Infectious Diseases, PRA Health Sciences said “Ethics Committees (ECs) have been empowered to regulate clinical research at each individual study site and are

responsible for safeguarding the rights and safety of research participants. It is therefore important to ensure that these ECs have trained manpower, adequate standard operating procedures, sufficient administrative support and compliance with Schedule Y requirements. Also, the high recruitment in India can challenge both the sites and the study monitors as struggle to keep up. Hence the need to select sites with trained investigators, site staff and accredited ethics committees. As clinicians and sites in the major metros get busier with more and more clinical trials, it is important to develop newer sites by educating and training investigators, clinical research professionals and ethics committee members.”

Outcomes of global inspections in recent past (data integrity and GCP violations), lack of conducive regulatory framework, knee-jerk implementation of regulations, delays in clinical trial permissions, cross-participation risk (BA/BE studies), need of streamlining clinical research processes and close collaboration of all stakeholders in the ecosystem are the other issues that need serious attention said Dr Shrinivas Savale, Pharmaceutical and Biopharmaceutical Consultant, Ahmedabad.

“I think the biggest challenge we have in India is the need to restore confidence and trust amongst

“Though India makes up 16% of the world's population and 20% of the world's disease burden, less than 1.4% of global clinical trials are carried out in the country. Of 236,329

ongoing global clinical studies, only 3,016 studies are being done

in India, placing it way behind the USA, Europe, Japan, China, Malaysia and

Taiwan. The low number ranks India in the fifth position in Asia.”- Dr Chaitra Harsha, Managing Director, Vipragen Biosciences

“Previously due to regulatory approval delays some sponsor companies were diverting to conduct their trials in countries like China, Taiwan and Malaysia going by their

expertise and speedy clearances. One exciting development is that

approvals for clinical trials are now taking about six to seven months, which is

the global standard. It used to be 15 months in India a couple of years back.”- Divya Chandradhara, Director, Bio Agile Therapeutics

NO OF CLINICAL TRIALS IN INDIA

Sour

ce :

CDSC

O

Year No of clinical trials approved 2013 1072014 1162015 1212016 842017* 52*as on September 15, 2017


done in India. It is unfortunate that the one or two instances of transgression that we read about in the media seem to drive the narrative around clinical research in our country. There is so much of high quality clinical research being done in India and we must ensure the world knows about it,” Naz Haji of QuintilesIMS India added.

Dr Aparna Parikh further observed that media can play a major role to support clinical research in India by educating the public on research and development and disseminating accurate information about clinical trials. Both media and patient support groups can help promote public awareness and engagement to increase the trust, support, participation in clinical research and thus patients gain access to safe and effective new treatments for unmet medical needs. Adverse media reports, long, uncertain regulatory approval timelines will only delay introduction of new and relevant therapies, worsening the problem of drug lag in our country.

Global companies lack trust in Indian CRO’s due to data quality issues created by few CRO’s. Ethics committee approval for studies is one of the challenge. Divya Chandradhara, said that maintenance of high quality data, improvements in infrastructure, accommodative regulatory environment, will play major role in improving the Indian market size in clinical research.

There is definitely a need to safeguard the interests of research participants. Dr Shrinivas Savale observed that the sector being highly regulated strict compliance to the good clinical practice (GCP), good laboratory practice (GLP) and other good practices need to be monitored and verified by qualified people/regulatory inspectors. Media also needs to be sensitive to this industry emphasizing on the larger benefits of clinical research. Most importantly all the contributing players for core and supporting roles need to commit for maintaining the high standards of conduct clinical research, with

MEASURES TAKEN BY DCGI

Earlier requirement of Audio-Visual (AV) recording of Informed Consent Process (ICP) of all subjects in all clinical trials have been revised and the Audio-Visual (AV) recording of ICP has been made mandatory only in case of vulnerable subjects in clinical trials of New Chemical Entity (NCE)/New Molecular Entity (NME) and in case of clinical trial of anti-HIV and anti-Leprosy drugs, only audio recording of the ICP is required.

The Drugs and Cosmetics Rules have been amended on March 16, 2016 providing that no permission is required from DCG (I) for conduct of clinical trial of approved drug formulation for new indication, route of administration etc. for Academic / Research purposes subject to conditions that the trial has been approved by the Ethics Committee and the data generated will not be submitted to the regulatory Authority for new drug approval purpose and certain other conditions.

Earlier restriction that number of clinical trials an Investigator can undertake should be not be more than three has been removed providing that the number of clinical trials should be decide by the respective Ethics Committee.

Earlier requirement of at least 50 bedded hospitals for conduct of clinical trial have been revised providing that centres irrespective of number of beds, could be allowed to conduct clinical trials after the Ethics Committee approval.

For addition of new clinical trial site or investigator in clinical trial, no NOC from DCG (I), in the normal course, would be necessary. The respective Ethics Committee after due diligence can approve such proposals for addition of site(s) and investigator(s). However the applicant would inform the DCG (I) about any such addition/deletion and if, no objection was received from DCG (I), it would be deemed to have concurrence of CDSCO.

global stakeholders in doing research in India. We have come out of a very challenging regulatory environment and now have regulation that is scientific, balanced and patient-centric. Our regulators are committed to bringing trials back to India and it is a responsibility that all stakeholders have to play a role in so that our patients have access to the best and newest treatment and therapies. It is also important that we create more awareness about the high quality of clinical research

“Indian companies need to focus on quality. Greater emphasis and consistent outlook on all aspects of quality is essential to gain recognition in the global platform. From the regulatory perspective, even though much has been done in the last couple of years there is space to improve on the level of clarity that is needed on certain issues and also on the trained manpower needed to implement the plans.”- Dr Saral Thangam, CEO & Managing Director, Norwich Clinical Services


ethics and quality at its centre, year-on-year. In spite of the many challenges, opportunities and

strengths India has, will help it to bounce back from a troubled period that the industry has experienced in 2013-14 for conducting clinical trials. Dr Saral Thangam, CEO & Managing Director, Norwich Clinical Services said “There have been considerable improvements from the perspective of timelines, and predictability of outcomes for clinical trial applications. There are multiple positive initiatives by the government bodies to engage the stakeholders. Several of the rules that were impeding trial conduct in India have been repealed or modified to allow a reasonable clinical trial framework to emerge.”

India to bounce back With recent setbacks in the international regulatory scrutiny has cost dearly to the sponsors globally and

PHARMA SHOULD ENCOURAGE THE INTEREST OFPHYSICIANS TO PARTICIPATE IN CLINICAL TRIALS

India is globally recognized as an attractive destination for conducting clinical trials owing to its huge patient pool, a technically competent workforce and significant cost savings. However, it accounts for less than 1.4% of global clinical trials at present. While the government is already working on the regulatory environment to increase these numbers, it will be equally important to encourage higher participation from the medical community.

Physician-researchers play a huge role in improving the quality of both services and research studies. In India, the linguistic barrier is a major problem for recruiting patients and giving them proper instructions and knowledge about trials. Hence, it is of utmost importance for physicians from all across the country to take part in clinical trials. Since a majority of trials are industry-sponsored, it is crucial for pharma to examine and eliminate factors that hold physicians back from being actively involved in regulatory studies.

Docplexus, a largest and fastest growing online community for doctors of India, conducted a survey on 1105 doctors specializing in Pharmacology/Clinical Pharmacology, General Medicine, Cardiology, Orthopedics, Neurology and Urology to understand their inclinations and concerns regarding clinical trials in India. It revealed following key insights: Doctors are interested in clinical trials data Doctors want to be updated on clinical practices Several barriers restrict physicians’ participation in clinical trials Poor access to latest practices is creating misconceptions

It is evident that physicians acknowledge the huge role played by clinical trials in improving healthcare outcomes. Their participation will only increase as they get adequate financial assistance, protected time for research, help with data management and regular updates on regulations and practices.

KEY TAKEAWAYS FOR PHARMA Doctors track clinical trials data to gauge the prevalence of disease, stay updated on new molecules, and

understand the role of ethnicity in patient’s responsiveness to treatment. Pharma should encourage the interest of physicians to participate in clinical trials by giving them

adequate financial assistance. There should be a system or information portal in place to educate and train the doctors about regulations

and trials methodology in clinical trials.

Source: www.docplexus.in

“Given the supportive regulatory environment we now have in India and the commitment from regulators to encouraging more clinical research in the country, the outlook for clinical

research is positive. We are likely to also see a lot more local

innovation and R&D for illnesses prevalent in our country which bodes well

for our patients. We are also likely to see, as in the rest of the world, greater adoption and integration of technology and data and analytics in the conduct of clinical research.”- Naz Haji, SVP & Managing Director, QuintilesIMS India


faster trial approvals will help us to achieve the goal.” “It must be recognised that all stake holders have a

role to play in this. Indian pharma companies, CROs, Ethics committees, regulators, the public and the media have to act in a responsible and sustainable manner to support clinical research in India. The announcement of ICMR regarding the sharing of data is definitely a

“Recent actions from regulatory authorities – automation/online submission of applications, smoothening the process of import/export of biological samples, registration of ethics committees, scientific approach to granting the permission for first-in-man studies on case-by-case basis, improved regulatory vigilance of regulatory agency and recruitment of competent regulatory staff/training of the staff to update the skills and understanding in the clinical research – indications of improving the clinical research ecosystem and boosting the sector.”- Dr Shrinivas Savale, Pharmaceutical and Biopharmaceutical Consultant, Ahmedabad

the ‘noncompliant and integrity lapses’ have created a huge negativity about Indian clinical research sector. “There is a need for concentrated efforts from all the stakeholders, especially CROs who have been performing the world-class research for last couple of decades and regulatory agency ensuring transparent and robust system as well as conducive regulatory atmosphere safeguarding interests of all contributors, to improve the image of Indian Clinical Research industry. These efforts have started reflecting with positive outcomes of regulatory inspections at the CROs and sites as well as changes in the regulatory systems. Definitely the industry will bounce back in next 5-7 years,” Dr Shrinivas Savale said.

The industry players are optimistic about the growth of the industry in the coming years. Given the mere population of the country and the disease burden, India qualifies to be major clinical research hub in the years to come. The other major reasons for the same are simplification of regulatory procedures; latest proactive steps taken by the government; encouragement to local stakeholders in clinical research and global incentives to grow, sums up Dr Chaitra Harsha.

Making her point Divya Chandradhara said “India has the potential to establish itself as a hub for global clinical trials. Emerging technologies, quality output and


of the industry won’t reflect the decline in clinical trial activity. Indeed, Novotech’s Indian workforce has increased by around six-fold since 2012. While setting up any business in Asia has it’s complexities with a range of regulations, and bureaucratic institutions needing to be navigated, we have found India to be a relatively business-friendly environment,, with notable improvements over the last three years.

We remain very optimistic about the future of clinical trials in India, and the key macro factors that will influence the market are: i) huge treatment naïve population, with India expected to surpass China as the most populous county in the world in coming decades ii) highly educated technical staff iii) A well-established pharmaceutical manufacturing sector ensuring sponsors continue to invest in infrastructure and talent iv) An attractive cost base.

We are currently starting a couple of clinical trials in India for smaller biopharma clients and we are very excited by the progress. Regulatory timelines have been faster than expected, and everyone is very engaged including sites,

investigators, ethics committees, and Subject Expert Committees. Novotech is investing additional resources in overseeing our Indian clinical trials

because we are very keen to anticipate and minimise any issues, so that we can promote India as the clinical trial

destination it deserves to be.- Dr John Moller

CEO, Novotech, a Sydney-based full-service contract research

organisation (CRO), having operations in India, with a

focus on clinical monitoring

The Indian CRO market has undoubtedly contracted over the last few years following the effective shutdown of clinical trial

activity after the 2012 Supreme Court petition by the NGO Swasthya Adhikar Manch.

Since then the Indian government has worked hard to restructure clinical trial oversight and governance, and as we know there were some challenges implementing a number of the new rules. Notable examples were issues around video consenting and patient compensation.

Many of these challenges have now been resolved, but the reality is that sponsors have been much slower to re-enter the Indian market than expected.

If we look at data from clinicaltrials.gov, there were 101 “Industry Funded” trials started in 2012, but only 27 recorded in 2016. Novotech’s key customer group is small to midsized biopharmaceutical companies, and they have fallen from 44% of trial activity in 2012 to 15% in 2016. This shift is understandable as the larger pharmaceutical companies often have experience in India and established JV relationships, while smaller biopharmaceutical companies, with a smaller portfolio of compounds will be more risk averse until they are very certain that the environment has improved.

As clinical trial activity, has declined, many CROs have redeployed their very talented staff into areas such global or regional project management, biometrics, pharmacovigilance, risk-based monitoring and administrative support, and so the contraction

“We remain very optimistic aboutthe future of clinical trials in India”

positive step forward,” Dr Saral Thangam added. With regulatory reforms in place, India is certainly

once again on an upward cycle as its appeal to both international and local sponsor companies recognize the advantages and opportunities available. The understanding of trials continues to grow in this relatively young trial arena providing strong data quality to match its recruitment abilities.

“India will continue to increase in appeal as it increases its culture of quality alongside its protection

of patient safety maturity in the trials arena. Improved regulations, training and education of research professionals, increased base of qualified and trained investigators and supporting staff, high quality data will once again make India an attractive destination for global clinical trials,” concludes Dr Aparna Parikh, of PRA Health Sciences.

Narayan Kulkarni (With inputs from Aishwarya Venkatesh

and Dr Manbeena Chawla)


Due to the regulatory challenges of 2013, many investigators have stopped conducting clinical trials. Hence, there is some amount of work that needs to be done for the Physician community and Ethics Committees so that we can have a good number of them conducting quality clinical trials in future given the fact that the regulations have become more balanced and predictable and at the same time, are protective of the rights, safety and wellbeing of trial participants. Regulators too can play a significant role in building confidence amongst various stakeholders.

Finally we need to raise more awareness about the high quality of clinical research that is being done in India and the good that it has done for our Indian patients. In the larger context of India’s unique healthcare

requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, we need clinical research to develop new and effective medicines and vaccines to tackle our mammoth disease burden and unmet medical needs. India has 17 per cent of the world’s population and 20 perc ent of the global disease burden and yet, less than 1.4 per cent of global trials take place in India.

What needs to be done to overcome these issues?

I do believe that more awareness around the regulatory changes, the high quality of clinical research being done in India, our growing burden of disease and patient population and reiteration by the regulators to creating a more conducive clinical research environment will go a long way in encouraging more clinical research in India.

Can India bounce back as clinical research hub in the coming years?

I think the word ‘hub’ is a misnomer. India was never a hub for clinical research and it really does not matter whether it is or not. What matters is that the quantum of clinical research being done in our country should be proportionate to our disease burden. Clearly it is not at the moment and the ones most impacted by this are patients. We have a huge task on hand of fighting the unmet medical needs of Indian patients.

“Creating a more conducive environment will go a long way in encouraging more clinical research”

«Dr Chirag TrivediPresident, Indian Society for Clinical Research (ISCR)

What are major issues before the industry? The last few years have been a transformative one

for clinical research in India. Important regulatory changes have led to a more supportive environment for conducting research. The number of global clinical trials is slowly picking up and it will take a year or two before we see a significant increase. Overall, there has been a positive shift in people's attitudes and perceptions about clinical trials but, given the huge disease burden India carries, a lot remains to be done.

Part of this is because there is a still lack of awareness globally about all the regulatory changes that have taken place in the last few years and part of it is because sponsors are waiting for the environment to settle down further.There are still a few areas that need to be addressed: There is a need for better clarity on the accreditation

process of Ethics Committees that is intended to take effect from January 1, 2018.

While the approval process was streamlined further recently, approval timelines are still around five months and we need them to come down further.

Indian Society for Clinical Research (ISCR), an association of clinical research professionals, aims to build awareness of clinical research as a specialty in India and to facilitate its growth while helping to evolve the highest standards of quality and ethics. In an interaction with Aishwarya Venkatesh of BioSpectrum, Dr Chirag Trivedi, President, ISCR shared his thoughts about the issues before the industry and means of overcoming these challenges.


opportunity in contributing data for oncology trials. To support this, oncologists are increasingly using genomic testing to generate quality genomics data and identify patients based on their genomic profiles.,India has the highest number of FDA-approved manufacturing plants outside the US. With increasing focus on constraining healthcare costs in the US, India’s low-cost manufacturing capabilities combined with high quality standards are advantageous.India also has proven capabilities in mmedical skills, IT capacity, and a large pool of scientific manpower with 200 years of shared legacy with the US in medical education and medical practice.

And can India bounce back as clinical research hub in the coming years?

In recent years, there was a decline in the number of clinical trials, which was associated with an increase in reported clinical research mishaps, negative media coverage, activist protests, stagnation of the regulatory process and departure of sponsors and collaborators. In 2014, CDSCO has taken cognizance of patient safety and reimbursement in case of mishaps and made fresh guidelines and protocols for patient consent, issued a directive that clinical trials could only be carried out at accredited centers with stringent quality checks by ethics committees, and limiting the number of concurrent trials by a Principal Investigator. In 2016, CDSCO has also issued GCP inspection checklist to help sponsors and sites. In a way, CDSCO has taken initiative to ensure better quality trials and cleaner data ensuring patient safety. The evolving process positively supports clinical research in India. With 12-13% year-on-year growth, the Indian pharma industry is rapidly achieving a distinctive position in the global pharma space with CROs and clinical trials.

What are you suggestions to improve the situations of the clinical research space in the country?

CROs need to be faster, smarter and more responsive to accommodate the needs, combination regimens, delivery system and companion diagnostics. Apart from managing complexity, they should utilize creative study design tool such as adaptive design, which means the ability to gather and visualize data faster which is essential to make smarter decision. They should focus on cost containment and shortening development timelines without compromising quality data generation, while guidelines on subject protection, documentation and audit practices need to be strictly enforced.

“CROs need to be faster, smarter and more responsive to accommodate”

«Dr Sujay SinghCEO, IMGENEXIndia Pvt Ltd.

IMGENEX India Pvt. Ltd., a Bhubaneswar based biotechnology company has received several grants from Department of Biotechnology to develop drugs for osteoporosis using nanotechnology based drug delivery. Its biosimilar trastuzumab will be ready for pre-clinical study at the end of 2017. Other biosimilars in the pipeline includes humira, avastin, embrel and stellara. In an interaction with BioSpectrum India Dr Sujay Singh, CEO, IMGENEX India Pvt Ltd. shared his views about the issues before the CROs and how to improve situations.


What are the major issues before the industry?

The FDA stated that clinical studies conducted in association with a drug or medical device must follow Good Clinical Practice (GCP) guidelines and is reviewed by an independent ethical committee (IEC) to reduce the unethical practice and poor quality. India’s clinical trial industry faced serious legal challenges and disruption of all clinical trial activities due to 2011 litigation challenging the regulatory framework and patient safety guidelines. The result was the implementation of restrictive three-tier clinical trial application process, which considerably delayed approval timelines and India became less competitive in comparison to other emerging markets for conducting clinical trials.

Do you feel the clinical research space in India will get boost?

Considering the advantages of a large and diverse genetic pool of a treatment-naive population combined with cost savings and increasing difficulty in sourcing patients for clinical trials in developed countries, India stands aside as a prime choice for clinical trials. Apart from that with highest disease burden (cancer incidence of one million patients and a prevalent population of 2.5 million), India specifically offers a tremendous

BIOPolicy 32 BioSpectrum | October 2017 | www.biospectrumindia.com

United States’ Food and Drug Administration (USFDA), recently has increased the fee for processing Abbreviated New Drug Application

(ANDA) by over $ 1 lakh to $ 1.71 lakh for the fiscal year 2018. This move is considered as a major setback for the Indian drug makers which accounts for major chunk generic medicines sold in that country. The hike was made under Generic Drug User Fee Amendments of 2017 (GDUFA II). The fee in FY17 was $ 70,480.

According to a notification on USFDA's website, fee for Drug Master File was reduced to $ 47,829 for 2017-18 from $ 51,140 in the last fiscal. These fees are effective on October 1, 2017, and will remain in effect through September 30, 2018.

The move will hurt the Indian pharma industry which is heavily dependent on the US market for exports, said a top official of Pharmaceuticals Export Promotion Council of India (Pharmexcil), a body under the Ministry of Commerce and Industry.

According to the Pharmexcil, this step will certainly going to put immense pressure on the Indian pharma industry and hence, resulting eviction of many small players from this pharma export business. However, the FDA has reduced the inspection fee for overseas Finished Dosage Firms to $ 2,26,087 from previous $2,72,646. Similarly, the inspection fee for overseas API (Active Pharma Ingredient) plant was fixed at $ 60,367 from previous $ 59,234.

The Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of five per cent between the same periods. The market is expected to grow to $ 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size, as stated by Arun Singh, Indian Ambassador to the US. Branded generics dominate the pharmaceuticals market, constituting nearly 80 per cent of the market share (in terms of revenues). The sector is expected to generate 58,000 additional job

opportunities by the year 2025. India’s pharmaceutical exports stood at $ 16.4

billion in 2016-17 and are expected to grow by 30 per cent over the next three years to reach $ 20 billion by 2020, according to the Pharmaceuticals Export Promotion Council of India.

“According to Pharmaceuticals Export Promotion Council of India, Indian companies received 55 Abbreviated New Drug Application (ANDA) approvals and 16 tentative approvals from the US Food and Drug Administration (USFDA) in Q1 of 2017. The USFDA approvals are expected to cross 700 ANDA in 2017. The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ 70-80 billion US generics market. This hike will definitely going to curb

Hike in ANDA processing fees

Recent USFDA hike of fee for processing ANDA will certainly going to put immense pressure on the Indian pharma industry, resulting eviction of many small players from this pharma export business.

“Indian companies received 55 Abbreviated New Drug Application (ANDA) approvals and 16 tentative approvals from the US Food and Drug Administration (USFDA) in Q1 of 2017. The USFDA approvals are expected to cross 700 ANDA in 2017. The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the $ 70-80 billion US generics market. This hike will definitely going to curb the growth of this sector.”- Asoke Talukder, Cofounder & Chief Scientific Officer, InterpretOmics, Bangalore

Pharma exportersto US under pressure

33BIOPolicy www.biospectrumindia.com | October 2017 | BioSpectrum

the growth of this sector and many players will have to leave this business,” said Asoke Talukder, Co-founder & Chief Scientific Officer, InterpretOmics, Bengaluru.

Pushpa Vijayaraghavan, Director, Sathguru Management Consultants, said that the three most significant changes in the Generic Drug User Fee Act (GDUFA Act) are – substantial increase in ANDA filing fees, introduction of size based annual program fees and significantly lower annual facility fees for contract manufacturing units. The $100k increase in ANDA filing fee (from about $70k in 2017 to $170k in 2018) will act as a strong deterrent for late entrants or marginal players in the US market.

This implies substantially higher financial risk per asset and will also result in more judicious portfolio decisions and capital allocation decisions. To justify higher fee levels, companies will choose more opportune pipeline assets and will only selectively focus on already genericized assets in leaner competition products. In fact, this is reflective of the current trend in larger Indian pharma companies that have already started focusing on more complex products. I also foresee a trend of small to mid-sized companies being financially constrained to file ANDAs on their own and more active pursuing partnerships for US market

access, added Vijayaraghavan. The revenue base for GDUFA II is $ 493.6 million versus $ 323 million in the final year of GDUFA I - ANDAs are the primary workload driver of the program. GDUFA I was built on the assumption that FDA would receive 750 ANDAs per year.

Indian companies received 55 Abbreviated New Drug Application (ANDA) approvals and 16 tentative approvals from the US Food and Drug Administration (USFDA) in Q1 of 2017. The USFDA approvals are expected to cross 700 ANDA in 2017, thereby recording a year-on-year growth of 17 per cent.

For 2018, the Trump administration has budgeted over $2 billion in fees to be collected by the U.S. Food and Drug Administration from industry, twice as much as in 2017, according to budget documents.

“Though there are different categories of fee structures, definitely the hike is going to be a burden for Indian Pharma companies. However, given the potential, this would not deter us from filing ANDAs for the US market,” Uday Bhaskar, Director General, Pharmexcil. Bhaskar further explained that the US drug regulator cleared 598 ANDAs in 2016, out of which 201 were from Indian companies. During the first quarter of the current calendar year, the FDA Okayed 171 generic drug and 55 of them were filed by Indian companies.

“Over the past decade, India has evolved into a key supplier of generic drugs to the US. It is estimated that 35 per cent of the Abbreviated New Drug Applications (ANDAs) approved in the US every year come from Indian companies. Consequently, the regulatory compliance expected of Indian manufacturers is of the highest order. In addition to good manufacturing practice issues, FDA has also been raising concerns on systems and data integrity. We believe such increased levels of regulatory scrutiny are here to stay, and companies need to factor in the costs of operating at higher compliance levels into their business plans," said Krishnakumar V, Partner, E&Y India.

Contradicting all the other odds, Ajay Piramal, Chairman, Piramal Group, “I do not think the USFDA has been unnecessarily harsh on Indian plants. I think they do this across the board. If you see, some of the observations they make for some of the FDA stoppages that they have done, these are all public. So, there is nothing. Some of them are really strong reasons why they have done it.”

USFDA’s move to hike fee for processing ANDA is certainly not welcomed by the Indian pharma players. This will not only going to increase the financial burden on them but it will also knock off many small fishes from the pool. This step will torpedo the country’s market which accounts to supply huge chunk of generic medicines to the US market. However, how adversely this move is going to affect the Indian pharma sector that can be analysed in the coming months. But this stride will certainly going to pull the growth rate of the Indian pharmaceutical industry.

Nitin Konde [email protected]

With the aim to boost domestic manufacturing of drugs, levy cap on trade margins, crackdown on unfair marketing practices and limit 'loan

licensing' by pharma companies, the Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, government of India has come up with a 18 page Draft Pharmaceutical Policy, 2017 on August 17.

The new Draft Pharmaceutical Policy, 2017 addresses a range of issues including indigenous production of active pharmaceutical ingredient (API), quality control and regulatory approval, manufacturing arrangements, foreign direct investment, innovation and R&D and intellectual property. A major portion of the draft is devoted to pricing and makes various recommendations for the re-structuring of the National Pharmaceuticals Pricing Authority (NPPA) and changes to the Drug Price Control Orders (DPCO) says All India Drug Action Network (AIDAN), an independent network of several non-government organizations working to increase access and improve the rational use of essential medicines.

Welcoming the efforts of Department of Pharmaceuticals, Indian Pharmaceutical Alliance (IPA) compliments secretary, DoP for initiating work

on a comprehensive Pharmaceutical Policy. Reacting to the draft policy DG Shah, Secretary General, IPA said “We welcome the efforts of DoP to incorporate in one document various elements from the 1978 Policy as modified in 1986 and 1994 and focus on some new issues.”

Commenting on the draft policy related to manufacturing and quality, IPA noted that the draft makes several observations about the current state of quality and the Good Manufacturing Practices (GMP). These observations need to be moderated as, if read out of context, they could damage the national industry's reputation in the world as provider of quality medicines at affordable prices. These observations can also compromise the country's aspirations to be recognized as Stringent Regulatory Authority (SRA) by the World Health Organisation (WHO). These observations also cast a shadow on some excellent work done in a short time by the drug regulatory authority and the health ministry to strengthen the regulatory function and its working.

IPA pointed that the draft reiterates some proposals from the old documents. Many of them have not been implemented for more than two decades. It would

BIOPolicy34 BioSpectrum | October 2017 | www.biospectrumindia.com

Aims at providing a longer term stable policy environmentTo overcome the challenges like Declining CAGR; Non-adherence to quality standards and norms; Growing competition from other countries; Dependence on imports for the key starting materials as also of the APIs; Lack of R&D and discovery of new molecules, and to improve the situation of the pharma industry, India has come up with draft pharma policy 2017.

DRAFT PHARMACEUTICAL POLICY – 2017

be useful to examine and evaluate their utility and relevance to the outcomes. The draft also proposes some new initiatives. It is pertinent to have a narrative on the objectives of these new initiatives. They need to be examined with appropriate data to assess their impact on the outcomes. In the current context of improving industry's competitiveness and creating employment, it is all the more critical that these initiatives are also evaluated for their impact on these two parameters.

The draft recommends certain actions aimed at improving the quality and the GMP. These include mandatory bioavailability (BA) and bio-equivalence (BE) studies by all manufacturers and suggest self-certification as solution for large number of products currently marketed without BA/BE studies. It also recommends annual inspection of manufacturing facilities with option for self-certification. These solutions grossly undermine the importance of the quality.

Ensuring “world class quality of drugs” require more quality parameters than mere bio equivalence with the innovator product. The world class quality also needs the stability data, in-vitro dissolution, impurity profile and GMP compliance. These being technical matters, they are best left to the drug regulatory authority and the appropriate technical committees and bodies.

Making point on price and availability of the drugs, IPA noted that the draft makes suggestions that alters the basic tenets and the structure of the National Pharmaceutical Pricing Policy (NPPP), 2012 and modifies the Drugs (Prices Control) Order (DPCO), 2013. It would be essential that the draft provides the rationale and objective of these changes. The changes

include: conferring absolute powers to the Department of Pharmaceuticals for vetting National List of Essential Medicines (NLEM) and deciding the drugs that should be excluded from price control; bringing all strengths and dosages of specified drugs under price control; doing away with the "Retail Price" and having only the "Ceiling Price" for non-scheduled products, thereby expanding the span of control; considering manufacturers' one-time bonus and promotional offers to trade in price fixation; fixing margin for the wholesalers; etc.

The draft also proposes to strengthen the NPPA by induction of representatives of civil society, doctors, pharmacists, industry and the government in the advisory board. In addition, it seeks to convert the NPPA into a multi-member body, which has to work by consensus. IPA apprehends that both these measures will lead to further delays and complicate the functioning of the NPPA, instead of simplifying its working.

The IPA recognizes the need to make medicines affordable and supports this initiative. However, the industry alone cannot take this burden. The over emphasis on affordability is a matter of concern as it could disturb the delicate balance between the price and availability. Also, several measures proposed in the draft to improve quality and GMP will have major impact on the cost of production. The pressures to reduce the prices and improve the quality at the same time will only squeeze the manufacturers' margin, impacting the availability of medicines.

Talking about the innovation and indigenization, DG Shah pointed out that the draft displays inadequate appreciation of the industry's efforts towards innovation and complete ignorance of the drug discovery process. The industry's spend on research and development has increased by more than 150% in the ten-year period from Rs 1,441 crore in 2004 to Rs 3,632 crore in 2014, according to Capitaline. A few major companies spend about 8% to 12% of their revenues in research, which is comparable to the global generic players, in spite of operating in a hostile pricing environment. The notion


Unless all concerned are convinced of its long term benefit to the consumer and are agreeable to patients paying more today

for better tomorrow, this could remain just a thought. It also

observed that the outcomes of these policy initiatives will be neither in the interest of the patients nor in the

interest of the industry as the industry has been facing many other challenges.

- DG Shah, Secretary General, Indian

Pharmaceutical Alliance (IPA)

KEY OBJECTIVES OF THE DRAFT PHARMACEUTICAL POLICY, 2017

a. Making essential drugs accessible at affordable prices to the common masses;

b. Providing a longer term stable policy environment for the pharmaceutical sector;

c. Making India sufficiently self-reliant in end to end indigenous drug manufacturing;

d. Ensuring world class quality of drugs for domestic consumption & exports;

e. Creating an environment for R&D to produce innovator drugs

37BIOPolicywww.biospectrumindia.com | October 2017 | BioSpectrum

that "giving brand names to generic drugs hampers real innovation" is without any basis. On the contrary, learning to build brands is a first step in the process of innovation.

Innovation needs a supporting policy environment, including protecting trademarks and promoting brands, whereas the earlier policies and the current draft suggest abolishing brands. Even in the absence of such a policy environment, the national industry has not lost sight of putting India on the global map of innovative countries. It should therefore be recognized for its efforts and risk taking.

The draft needs to recognize that research and development require lot more than mere concessional rate of customs duty. It is a high risk investment and needs returns commensurate with the risks.

The IPA compliments secretary-Department of Pharmaceutical for the very thought of creating demand for indigenously produced APIs to reduce

CHALLENGES BEFORE THE PHARMACEUTICAL INDUSTRY

a. Defiance of Government Orders by the Pricing Regulator (NPPA) – Creating unstable environment for the industry;

b. Sudden and major changes in the drug regulatory regime – Some for ease of doing business whereas some others requiring companies to unwarranted and costly litigations;

c. Disruption in business from demonetization and introduction of the GST regime;

d. Price Erosion in the US Market, impacting overall profitability; and

e. Growing Global Competition, impacting exports.

POTENTIAL OUTCOMES OFTHE DRAFT POLICY

a. Emphasis on improving Quality and GMP will increase cost of production.

b. The phasing out of loan licensing and contract manufacturing will make installed capacities redundant and create unemployment.

c. The investment for creating new capacities for in-house production will further increase product cost.

d. Over emphasis on affordability will put pressure on pricing.

e. Thus, policy prescription would lead to higher production costs and lower prices.

f. This may impact competitiveness of the industry and in turn affect its export led growth.

g. Certain observations in the Policy about the quality of medicines, GMP compliance, the inadequate oversight of the drug regulatory authorities, etc. may put off the regulators, doctors and patients from using medicines made in India and provide a field day to competitors to hut India’s exports. This would further slowdown exports.

h. The benefit of scale, currently enjoyed by the Indian patients, from huge export volumes may slowly disappear and push up the costs and prices of medicines.

i. The latest data of domestic sales and exports speak for themselves.

Source: Indian Pharmaceutical Alliance (IPA)

dependence on imports. However, its implementation is a challenge. Unless all concerned are convinced of its long term benefit to the consumer and are agreeable to patients paying more today for better tomorrow, this could remain just a thought. It also observed that the outcomes of these policy initiatives will be neither in the interest of the patients nor in the interest of the industry as the industry has been facing many other challenges.

Because of the many challenges, the industry’s growth has slowed down. The domestic market has declined to mid-single digit rate and the exports have reported absolute decline. DG Shah suggested that the draft should be viewed against this background. Its disruptive proposals could further hurt the sentiments and destabilize the industry. The timing of these disruptive changes is not opportune. The IPA therefore requests that the draft policy be held in abeyance until such time as some stability is restored and the industry is ready to handle new disruptions.

Narayan Kulkarni [email protected]

The generics business is facing challenges both in the domestic as well as the international market; on exports, Indian pharmaceutical

companies are facing a sharp decline in returns as a result of increasing product price erosion, largely due to the consolidation of distribution channels and increase in competition in the U.S. This, coupled with reduced value of product patent expirations over the next five years, implies lower growth potential for the pharmaceutical sector.

On the domestic front, the environment for pharmaceutical companies remains challenging with more products coming under price control, increase in scrutiny by global regulators, high active pharmaceutical ingredient (API) import dependency and complex process for approval of new products.

In the midst of these growing concerns, the Department of Pharmaceuticals (DoP) introduced an action plan to strengthen the Indian pharmaceutical industry and has released the ‘Draft Pharmaceutical Policy – 2017’ to make essential drugs accessible at affordable prices, provide a stable policy environment, achieve self-sufficiency in drug manufacturing, ensure quality drugs and create a favourable environment for R&D. The top five highlights of the proposed policy are as follows:

Encourage domestic API manufacturingIt has been proposed that formulations prepared using indigenously produced API and its intermediates will be given preference in government procurement. Such formulations will be taken out of price control for five years with prices linked to the indigenous content of these formulations. The APIs which can be indigenously manufactured will be imported at peak customs duty.

The policy also supports setting up of mega bulk drug parks having common facilities.

The policy encourages indigenous production of APIs and Key Starting Materials (KSMs) in several ways. However, a more thorough approach is required to once again enable the domestic API industry to become competitive. The Indian government needs to focus on developing the local chemical industry by providing a favourable manufacturing ecosystem, which can then in turn support API manufacturing the way it has happened in China. This could be an important step towards self-sufficiency in APIs and can go a long way in providing affordable drugs to the domestic as well as the international market.

Pricing - National Pharmaceutical Pricing Authority (NPPA) restructuringThe National List of Essential Medicines (NLEM) will remain the basis for medicines brought under price regulation. The government in consultation with the Department of Pharmaceuticals will prepare the list of medicines for price regulation and transmit them to the NPPA for fixing price ceilings; the NPPA will be assisted by an advisory body for pricing, nominated by the government in the NPPA. All strengths and dosage forms of a chemical entity under NLEM will be under price control; the NLEM list will be amended through an addition and deletion list; ceiling prices will be linked to WPI; DPCO will include only off-patent drugs. Patented drugs will not be subject to price controls, but would be regulated through the CL (compulsory pricing) mechanism of the patent act or by use of emergency powers under paragraph 19 of DPCO-2013. The draft policy proposes some fundamental changes in controlling prices for generic drugs with modifications in the Drugs (Prices Control) Order. It further states

The generic drug push needs further clarity

«Utkarsh Palnitkar *Partner and Head, Infrastructure, Government and Healthcare, Life Sciences, KPMG in India

The policy encourages indigenous production of APIs and Key Starting Materials (KSMs) in several ways. However, a more thorough approach is required to once again enable the domestic API industry to become competitive. The Indian government needs to focus on developing the local chemical industry which can then in turn support API manufacturing.


that the DoP will play a more active role in pricing related matters by taking charge of the list of medicines for price regulation and transmitting it to NPPA for fixing the price ceilings. These measures go beyond the remit of the DoP and would necessitate legislative changes.

Further, the draft policy mentions that patented drugs will not be subject to price control and their prices will be regulated through compulsory licensing; this, along with the fact that the draft policy is also looking to phase out loan licensing has created a level of uncertainty among MNC pharmaceutical companies. For example, if a multinational holds a patent for a certain drug and does not manufacture that product in India, the company will not be able to manufacture the same through loan licensing any more. In such a scenario, Indian pharmaceutical companies can file for compulsory licensing for such products. The move is likely to deter pharmaceutical multinationals to launch patented products in the Indian market.

Loan licensing curbThird-party manufacturing or loan licensing will be discontinued, except for biopharmaceutical manufacturing as it raises many quality maintenance and assurance issues. The provision to discontinue loan licensing could directly impact contract manufacturing and the MSME sectors in India, which have developed generic manufacturing capabilities over the last few decades; this provision can however make these installed capacities redundant. Further, biopharmaceutical manufacturing is very difficult and the country has limited capability and capacity in this area; that the policy allows loan licensing in this area is therefore confusing.

Trade margin capThe level of trade margins will be prescribed to create a level playing field for the industry and to bring down prices. Even institutions receiving supplies directly from manufacturers/distributors or retailers will be covered under trade margin reforms. The provision to cap trade margins is expected to impact the pharmaceutical industry directly, covering almost 95 per cent of the; however implementation may prove to be an onerous task for the government.

Generic drug push – ‘one company – one drug – one brand name – one price’Public procurement and dispensing of drugs will be of generic drugs in their salt names; to facilitate this, the government will pursue the policy of sale of single ingredient drugs by their pharmacopeial name/salt name. For patented drugs and Fixed Dose Combination (FDCs) drugs the brand names may be used. The generic drug push through ‘one company – one drug – one brand name – one price’ needs further clarity as many Indian pharmaceutical companies manufacture drugs for their subsidiary companies and whether the underline subsidiary company comes under the definition of ‘one company’, is currently not clear.

(*The views and opinions expressed herein are those of the author and do not necessarily represent the views and

opinions of KPMG in India.)

39BIOPolicywww.biospectrumindia.com | October 2017 | BioSpectrum

The draft policy proposes some fundamental changes in controlling prices for generic drugs with modifications in the Drugs (Prices Control) Order. It further states that the DoP will play a more active role in pricing related matters by taking charge of the list of medicines for price regulation and transmitting it to NPPA for fixing the price ceilings. These measures go beyond the remit of the DoP and would necessitate legislative changes.

BIOTalk40 BioSpectrum | October 2017 | www.biospectrumindia.com

“India accounts for 60% ofvaccine supplies made to UNICEF”

«Dr K Anand KumarManaging Director Indian Immunologicals Ltd

What according to you are upcoming trends in India’s vaccine market?

The Indian vaccine market can be broadly be classified as the Domestic Trade Market (DTM) and Government Business (GB) including UIP supplies. There is also an Export Market that the Indian manufacturers tap into supplying to UNICEF/GAVI by way of WHO PQ. The total market size for vaccines would be about a billion USD. Value wise the Export Market would be 50%, the trade market would be around 30% and the GB would be around 20%. There is growing awareness on preventive measures to fight against diseases in India. While Indian pharma industry is growing at 10% over the past year, the vaccine industry is growing at 25% between 2011- 2015.

The upcoming trends in the market space include the following:1. Increased uptake of new generation vaccines such as

Pneumococcal conjugate vaccine, Varicella vaccine, Rotavirus vaccine, HPV, typhoid conjugate vaccine in the trade segment.

2. Increased uptake of multivalent vaccines such as the Hexavalent vaccine.

3. Large scale introduction of vaccines such as Pentavalent vaccine, inactivated polio vaccine, MR vaccine by the Government Business.

4. Ready to use presentation such as Prefilled syringes.5. Needle free delivery.6. Independent clinics for vaccination purposes only.7. More and more focus on vaccines for Zoonotic

diseases.8. More and more recombinant vaccines will be seen in

the animal vaccine segment.

Please elaborate on some on the key drivers of India’s vaccine businesses?

There is more awareness now about the ability of vaccines to prevent disease than ever before. The Swach Bharat Mission also has helped bring in sense of good hygiene and cleanliness. It is inevitable that the government in the coming years will spend significant amount on Healthcare. Similarly the per capita government spend on routine immunization is also going to increase with the addition of vaccines such as Pneumococcal conjugate vaccine, inactivated polio vaccine etc. Several programmes including the India New born Action Plan launched in 2014 will increase the uptake of vaccines to prevent death below the age of 5. This will drive more volume.

The educated and growing middle class segment is

Undoubtedly, India is the epicentre for vaccine manufacturing in the world. With many top vaccine giants supplying basic and advanced vaccines to nearly 150 countries, India, over the years, has emerged as the global vaccines hub. Indian vaccine industry with many state-of-the-art manufacturing facilities has earned India the recognition of having the largest global capacity for WHO prequalified vaccine manufacturing. Along with other factors, increased public awareness about vaccination and public immunization programs, coupled with government support to develop new vaccine act as key factors driving India’s vaccine industry. Speaking to Aishwarya Venkatesh of BioSpectrum Asia Magazine, Dr K Anand Kumar, Managing Director Indian Immunologicals Ltd & Director Pristine Biologicals (NZ) Ltd, shared his views on challenges and upcoming trends in Indian vaccine market.


41BIOTalkwww.biospectrumindia.com | October 2017 | BioSpectrum

Indian manufacturers have the technical expertise to produce several vaccines at an affordable price. Having tasted success, several companies have expanded facilities to cater to the global markets to get a better price.

vary of the benefits of vaccination and will ensure their children will get vaccinated to as many preventable diseases as possible.

The trade market is currently dominated by multinational companies (GSK, Pfizer, MSD) as many of the Indian manufacturers have only conventional vaccines in their product basket at the present moment. Indian manufacturers have several products in their R&D pipeline and as they roll out, the dominance of the multinational companies will subside in the coming years. With the introduction of vaccines by the Indian manufacturers, the market now will have a choice and pricing pressures will make it more affordable than what is being sold currently.

Indian manufacturers have the technical expertise to produce several vaccines at an affordable price. Indian manufacturers accounted for 60% of supplies made to UNICEF. Having tasted success several companies have expanded facilities to cater to the global markets to get a better price.

Where do you see the vaccine industry heading; five years from now?

The existing vaccine manufacturers will consolidate their position and with new product introductions will continue to dominate the domestic and UNICEF/GAVI markets. The current market of USD 1 billion could easily double to USD 2 billion in less than 5 years.

Several factors at the present moment may see new entrants in the form of big pharma houses enter into the vaccine business. Factors include a higher CAGR of the vaccine business than the pharma business, constant USFDA woes, NPPA and eroding margins, attractiveness of few players in the vaccine business etc. Given the huge capital costs and long lead times, this business is not for small time players and entrepreneurs.

Partnerships with vaccine companies abroad to access the Indian market will become common. In order to shorten regulatory time lines, companies may explore the possibility of importing the bulk of an approved product for fill/finish in India. Similarly Indian companies will also look at exporting bulk vaccines for fill finish in other markets.

Several new vaccines would be introduced by domestic players for several diseases such as Pneumonia, Varicella, Hepatitis A, IPV, Chikungunya etc.

In your opinion what are the most difficult challenges in vaccine business in India?

The challenges are: Vaccine manufacturing involves huge capital

investment upfront and subsequently the regulatory approval process for licensure i.e from conducting Pre Clinical Toxicology (PCT) studies to obtaining Marketing Authorization may take 5 years. Added to

that if supplies are to be made to the government, some states require 3 year market standing. Based on the above cash flows will happen several years after investment is made.

Vaccine manufacturing is a complex process that involves several upstream and down stream processing steps. Throughout manufacturing several in process control tests are employed. The final vaccine testing in some cases may take upto 3 months. All vaccines sold must be cleared by the Central; Testing Lab in Kasauli and this further adds to the timeline. All this can add to inventory build up.

Getting Industry ready candidates from educational institutions is a challenge. Most candidates have limited practical knowledge and the company has top spend almost a year in training them.

Majority of the vaccines are for government sale and is procured based on tenders. If one fails to win a bid, the facilities and people will remain idle till the next tender.

The nature of some disease such as Swine fever, Flu are unpredictable. Anticipating demand at times would lead to excess inventory which may remain unconsumed.

Getting quality epidemiological and surveillance data is also a challenge. Accurate incidence reporting and burden of disease estimates are all in infancy.

Many deadly diseases like Zika still do not have an approved vaccine. In your opinion what could be the reasons?

There are millions of microorganisms that exist in nature. Based on environmental conditions and genetic changes some of these organisms may exert higher levels of virulence at some period of time. It is economically unviable to develop vaccines in anticipation when the disease manifests at a low level and only in certain regions. I do not see any technical challenge in developing a vaccine for Zika, it’s just that like any other vaccine candidate it has to go through a long journey to establish safety and efficacy credentials as a part of licensure.

BIOCareers 42 BioSpectrum | October 2017 | www.biospectrumindia.com

offer jobs to young and promising life sciences interns who come to us from both international universities as well as premier Indian academic institutes such as NIPER and IIT. We had started Biocon Academy in 2013 as part of our CSR initiative to offer advanced courses that address the need of the biopharma industry and enable global competitiveness of the sector. In the last few years, we have successfully recruited from the Academy as well.

What criteria do you look for while selecting the candidates?

Biocon seeks candidates who have a sound theoretical knowledge of scientific principles and the ability to connect those to the applications in the industry. In addition to application knowhow, they should have process knowhow and regulatory knowhow. As far as soft skills are concerned, candidates should have good communication skills and the ability to work in teams. Ideally, they should be industry-ready so that they can start contributing to the company from Day 1.

What kind of packages a fresher can expect?

Freshers can expect salary packages starting from Rs 2.5 lakh per annum.

What kind of opportunities/ openings, students with biotechnology/pharmaceutical can expect in biotechnology, pharma industry?

The Biotechnology sector in India, which is witnessing a Compounded Annual Growth Rate (CAGR) of about 20%, holds immense potential for future growth. Today, biosciences students have excellent career opportunities in traditional segments like Healthcare, as well as, emerging ones like Bio-Agriculture, Bio-informatics etc. There is also increasing demand for talented, trained manpower in fields such as Bio-statistics, Clinical Trials, Research & Development, Animal Husbandry, Cropping Systems and Crop Management, Cell Biology, Food Manufacturing, Genetics, Biochemistry, Microbiology, Immunology, Virology, Chemistry and Engineering etc. Biotech startups, which are coming up with innovative technology-based products and services, are also adding to the job prospects in the Indian biotech sector.

“Biosciences studentshave excellent opportunitiesin traditional segments”

Biocon Ltd., Asia's premier biopharmaceutical company, is committed to ensure a global right to healthcare by addressing the worldwide need for safe, effective and affordable biotherapeutics. Biocon has been creating long-term value for its shareholders with the market capitalisation of the company having multiplied almost four times since its debut on the bourses in 2004. Biocon was only the second Indian company to cross the $ 1 billion market capitalisation milestone on the first day of listing. In 2015, the successful IPO of Biocon's research services subsidiary Syngene unlocked immense value for shareholders. Syngene's market capitalization crossed the $ 1 billion mark within a week of listing.

Biocon has built an employee-friendly environment for its gender-diverse workforce that is comparable to the best in the world. This has been validated by its position among the Top 20 Best Employers in the Biotech Industry as ranked by the prestigious Science magazine. In an interaction with Narayan Kulkarni of BioSpectrum India, Amitava Saha, Sr. Vice President & Head, Human Resources, Biocon Limited, who has over 17 years of work experience with companies like Firstsource Solutions, Mashreq Bank, Accenture and Infosys shared his views about campus placements and opportunities/ openings for students with biotechnology/ pharmaceutical.


What criteria do you have while identifying the campus placements for hiring?

Biocon’s positioning as a ‘world- class employer brand’ enables us to recruit top talent from some of the country’s premier institutes. For campus recruitment, we look at institutes that have a good track record of producing industry-ready, high-end talent. We also

«Amitava SahaSr. Vice President& Head,Human Resources,Biocon Limited

43BIOCareers www.biospectrumindia.com | October 2017 | BioSpectrum

BIOTECHNOLOGY

Since the inception of biotechnology courses in the late 90s, the situation is still the same stating that the number of job openings and pay packages are

both very low when compared with IT and other fields.There are a number of colleges and universities

across India that offer Biotechnology courses either in the form of undergraduate courses such as B.Sc., B.Tech, or post graduate courses such as M.Sc., M.Tech, MBA.

B.Tech degree in Biotechnology covers subjects such as Microbiology, Molecular Biology, Genetics, Cell Biology and engineering subjects like Bioprocess Engineering, Biochemical Engineering, Thermodynamics, Mass Transfer etc. On the other hand, a B.Sc degree focuses on subjects like Biochemistry, Plant and Animal Biotechnology, Microbiology, Molecular Biology and Microbial Genetics etc.

But the students are struggling to get a decent job in hand. A biotech graduate finds it very hard to get a job in QC (quality control) or R & D because most companies have small teams and there isn't much job hopping. What's more, pharmacy graduates are preferred because they can do formulation as well as QC.

A quick look at various job sites would indicate that openings for fresh Biotech graduates are few and far between. An exception to all the above would be the handful who complete a B.Tech from IIT or M.Sc. from IISc. The alternate option after graduation is to do a PhD, either in India or abroad. However, even after a PhD, prospects in India remain limited.

“At Amity, we understand this concern very well. We feel that it is necessary to see how the different players such as the industries, university, society and government concerned with biotechnology can act in unison and in a mutually beneficial way. An integrated approach to the field of biotechnology combining different subject areas is necessary and the courses and approach should reflect this”, shares Dr Surendra Khatodia, Assistant Professor, Amity Institute of Biotechnology, Haryana.

University Business School (UBS), Panjab University, had recently decided to discontinue Master of Business Administration (MBA) in the biotechnology course offered by institute, stating that it was unviable. The course, which started with an intake of 14 students, failed to evolve into what UBS envisioned. While it was initiated with the hope that it would develop into a mainstream field in the country, it found very few takers in companies.

Sharing her experience Piu Banerjee, a biotechnology student from Shiv Nadar University, said, “The laboratories are well equipped and the curriculum is very flexible and student friendly. As far as the future aspect of biotech is concerned, there is minimal scope in India since India lacks research infrastructure. One can opt for academia or sales and marketing as a career option after completing a masters in biotechnology. For pursuing a PhD, going abroad is the best option”.

Career counselors and those engaged in educational guidance are flooded with inquiries about biotechnology courses and their scope. It is observed, on the one hand, that the biotechnology field is starved of talent and, on the other hand, that there are several universities and colleges, producing large numbers of unemployable graduates. Some serious thinking needs to be done urgently to overcome this problem.

Dr Manbeena [email protected]

On one hand, the biotechnology industry is starved of skilled talent pool. On the other hand, there are several universities and colleges, producing number of unemployable graduates. While some of them are struggling due to lack of

students. So serious thinking needs to be done urgently to overcome this problem.

Where is it heading?

Keck Graduate Institute (KGI), a leader in applied life sciences and pharmacy education, has added Biocon Chairperson and Managing Director Kiran Mazumdar-Shaw to its Board of Trustees. KGI's Board of Trustees consists of 26 leaders in the industries of biosciences, healthcare, and education. Mazumdar-Shaw is a pioneer of the biotechnology industry in India, and through a growing partnership with KGI, she established Biocon Academy, a Center of Excellence for Advanced Learning in Biosciences, in 2014. The program develops high-quality biotech talent that addresses the needs of the biotechnology sector in India.

In collaboration with KGI, Biocon Academy's flagship certificate programme in biosciences is an 18-week

programme that includes classroom sessions in the areas of drug development, research and development, and quality and regulatory affairs. All sessions are delivered by renowned faculty from KGI, along

with experiential learning sessions at Biocon through subject matter experts. Mazumdar-Shaw's commitment to affordable healthcare extends beyond business. Her philanthropic initiatives are directed at making a difference to the lives of marginalized communities. She is making an enduring impact on society through Biocon Foundation's initiatives in the area of primary healthcare, education,

and community development.

Novartis Chief Executive Joseph Jimenez will retire in 2018, with chief drug developer Vasant Narasimhan taking over as CEO starting in February. Jimenez, 58, is stepping down following a decade at Novartis after having successfully secured U S approval for a new gene therapy for leukemia but before Novartis returned to sales growth, which the company has forecast will resume in 2018.

A Novartis employee since 2005, Narasimhan has increased his public presence at Novartis since becoming global head of drug development and chief medical officer in 2016. Just 41, he is among a new generation of youthful leaders at Novartis that include head researcher Jay Bradner at the Novartis Institutes For Biomedical Research who have sought to improve the process in which drugs move from research to actually becoming a commercial product.

Jimenez arrived in 2007 to lead Novartis's consumer health division and rose to CEO in 2010 under former Chairman Daniel Vasella, who left in 2013. Jimenez is handing over the reins at a crucial juncture, with the drugmaker yet to make a decision on the future of its ailing Alcon eye-care business or its stake in crosstown rival Roche Holding AG.

Rao Inderjit Singh took over as the Minister of State for Chemicals and Fertilizers in New Delhi on September 5. Speaking on the occasion, he said that he will strive forward to implement the dream of the Prime Minister. Rao Inderjit Singh was born on 11 Feb 1950. He now represents Gurgaon (Haryana) Parliamentary constituency in Lok Sabha. He is also the Minister of State (Independent Charge), Ministry of Planning. He was a Member, Haryana Vidhan Sabha, Minister of State (Independent Charge), Food and Civil Supplies, Govt. of Haryana, Cabinet Minister, Environment & Forests and Medical & Technical Education, Government of Haryana, Member, Standing Committee on Science and Technology; Environment and Forests. He was also elected to 12th, 14th, 15th & 16th Lok Sabha. He was also Union Minister of State, External Affairs, Defence Production. He was also Chairman, Standing Committee on Information Technology. He was Union Minister of State (Independent Charge) Planning; Statistics and Programme Implementation; and Union Minister of State, Ministry of Defence.

Rao Inderjit Singh steps into Chemicals & Fertilizers Ministry

KGI brings Kiran Mazumdar- Shaw on board

Vasant Narasimhan to succeed Jimenez at Novartis

44 PEOPLE NEWS l BioSpectrum | October 2017 | www.biospectrumindia.com

IIT- Kharagpur to start genomics laboratory facilityIndian Institutes of Technology (IIT) Kharagpur is going start a genomics laboratory facility for students from all the branches of engineering. The primary objective of this laboratory will be to teach all the students at the second year the basic techniques of life sciences that will include microscopy-based observation, molecular biology, protein structure and function and lastly, bioinformatics.

The third year onwards, they will be allowed to plan and execute experiments by their own under the mentorship of faculties from Biotechnology, Bioscience, Chemistry, Medical Science and Technology and Computer Science and Engineering. The lab will be running 24x7 and be equipped with all the essential equipments needed for cell and molecular biology, biochemistry, sequencing facility, microscopy facility, etc.

Though there are few laboratories of similar nature abroad, this will the first of its kind in India. The lab will be headed by Prof Sudip K. Ghosh of the Biotechnology Department at the institute. In addition to the genomics laboratory, IIT Kharagpur also plans to collaborate with Tata Medical Centre in education, research and outreach programmes in the field of interdisciplinary medical research.

New centre of excellence opensat IISER-PunePerkinElmer, an American multinational company focused on human and environmental health, has opened a new Centre of Excellence at the Indian Institute of Science Education and Research (IISER) in Pune with an aim to assist the region’s current and future scientists on high-throughput analyses in life sciences. The initiative undertaken jointly by PerkinElmer India in collaboration with IISER-Pune, is part of the Skill India campaign. The centre will house instruments such as high content analysis and automated liquid handling workstations, plate readers, and instruments used for multispectral imaging and DNA/RNA analysis. The advanced bio-analytical set up by PerkinElmer will not only hone the analytical skills of undergraduate students but also elevate their understanding of interdisciplinary science, and will nurture the institute mandate of integrating teaching with state-of the-art research.

Andhra Pradesh MedTech Zone (AMTZ) has signed a Memorandum of Understanding (MoU) with Indian Institute of Technology-Bombay (IIT-B) to accelerate medical device innovation and commercialisation within the country.

This partnership will contribute positively towards the development of the overall medical technology ecosystem in the country. New product development, research, government policy promotion will also receive a boost with this partnership between industry and academia.

As part of the MoU, IIT-Bombay would provide AMTZ with access to laboratories, training programmes and talent. Startups in the field of medical technology which are part of the IIT- Bombay incubator programme will also benefit from the large integrated ecosystem being provided by AMTZ. The MoU has been signed by Jitendar Sharma, CEO, AMTZ and Petety V Balaji, Dean-R&D, IIT-Bombay.

AMTZ signs MoU with IIT-Bombay

45 l ACADEMIC NEWSwww.biospectrumindia.com | October 2017 | BioSpectrum

Researchers at the Indian Institute of Science (IISc) Bengaluru have developed a water-filter membrane with copper ions to make drinking water safe. The team of researchers made the commonly used polyvinylidene fluoride (PVDF) water-filter membrane to prevent biofouling and kill bacteria. To do this they first made the inert PVDF membrane functional by blending it with a polymer (styrene maleic anhydride or SMA).

The SMA polymer coated on the membrane, which gets partially hydrolysed when in contact with water, interacts with the outer membrane of the bacteria to produce disc shaped structures. It solubilises the membrane protein but does not kill bacteria. But the interaction with the bacterial cell membrane leads to release of a particular enzyme (phosphatase and/or phospholipase).

This enzyme released from the bacteria cleaves the polymer coating found on copper oxide resulting in controlled release of copper ions from the membrane into water. These membranes with controlled release of copper ion may turn out to be a potential candidate for water purification applications with enhanced antibacterial and antifouling performances.

46 SCIENCE NEWS l BioSpectrum | October 2017 | www.biospectrumindia.com

Indian scientists have developed a nature-inspired biomaterial with enhanced blood clotting efficiency to treat injuries. The new material has been developed by scientists at Indian Institute of Science Education and Research, Kolkata (IISER-K) and Saha Institute of Nuclear Physics, Kolkata. Researchers have modified natural biomaterials, peptides, to develop sealants with improved strength, stability and clotting properties.

Computer based analyses was employed, using various approaches, to generate sealant structures with desired properties. These structures were then synthesized and evaluated under laboratory conditions.

These tests revealed that the engineered sealant was able to self-assemble, much like human body’s natural clotting mechanism, to form an interwoven structure resembling a clot but in nearly half the time. This enhanced clotting rate can play an

extremely crucial role in treating injuries sustained during accidents or military combat. The natural material of the engineered sealant will ensure that it is tolerated by the body with minimal inflammatory response. It is also bio-degradable, similar to the natural clotting factor.

IIT- Guwahati researchers make implantable pancreasResearchers at the Indian Institute of Technology (IIT) Guwahati have successfully created an implantable bioartificial pancreas model grown within a 3D silk scaffold. The “pancreas”, which encapsulates insulin-producing cells, is capable of naturally producing insulin in a sustained manner. The silk scaffold was found to be biocompatible (not toxic to living tissue) as it did not trigger any immune reaction or cause any adverse reaction when implanted. Since type 1 diabetes patients do not have insulin-producing beta cells, the researchers have turned to stem cells to produce beta cells. The team coated the scaffold containing beta cells with a semi-permeable membrane barrier. The membrane allows insulin produced to be released into the blood stream but does not allow the immune cells to cross the membrane and kill the islet cells. To ensure that the implant is not rejected by the body’s immune system, drugs that suppress the immune system were embedded in the scaffold. The researchers are planning to carry out trials in animals. If successful in animal and human trials, it can be used for treating people with type 1 diabetes.

Scientists develop biomaterial for faster blood clotting

Researchers at IISc develop membranes for safe drinking water

48 SUPPLIER NEWS l BioSpectrum | October 2017 | www.biospectrumindia.com

Agilent Technologies Inc. has announced that it has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the GenetiSure Dx Postnatal Assay: its first comparative genomic hybridization (CGH) assay for diagnostic use. This assay enables clinical geneticists to detect genetic aberrations associated with developmental delay, intellectual disabilities, congenital irregularities, and unexplained dysmorphic features, earlier and more accurately than traditional methods.

The GenetiSure Dx Postnatal Assay is the result of an extensive clinical validation utilizing 900 samples from multiple partner laboratories and brings CGH technology into diagnostics. Based on Agilent's proprietary array for comparative genomic hybridization, this assay provides data on copy number variations and absence of heterozygosity in genomic DNA obtained from peripheral whole blood in patients who have been referred for chromosomal testing based on clinical presentation. The ability to detect both types of aberrations using a single assay provides greater diagnostic yield and faster time-to-results.

Previously available only in Europe, US clinical genetic scientists can now use this assay to help identify a definitive genetic diagnosis, and rapidly change the focus of a medical investigation from finding the cause to administering appropriate medical care and family support.

Agilent obtains approval for GenetiSure Dx Postnasal Assay

Five years ago, for the first time in the country, to train young scientists and researchers on flow cytometry, BD Life Sciences -Biosciences and Jamia Hamdard University started BD-JH FACS Academy at Jamia Hamdard in New Delhi, India. BD-JH FACS Academy is an Industry-Academia collaboration that aims at offering basic and advanced training courses, workshops and seminars in flow cytometry.

Having a deep expertise in bioscience and genomics, BD Biosciences has taken up a leadership role in evolving Flow Cytometry, one of the most advanced techniques in Biomedical Sciences, in the country. With programmes like FACS eLEARN, BD Biosciences not only managed to bring industry and academia on one platform to develop capacity in Flow Cytometry but with the digital format, also

is enabling professionals from across the country to have an easy access to advanced technologies.

In the year 2012, BD and Jamia Hamdard established a flow cytometry training and education facility named BD-JH FACS Academy. In last five years, it has trained 750 users across the country and overseas. Encouraged by the overwhelming response, BD Biosciences designed the web based training program - FACS eLEARN, for professionals who are already in a job or a regular academic program and may not be available for regular contact time with the faculty. The web module and e-mail support program will be followed by a hands-on experience on Flow Cytometry instruments and applications at the Academy. The programme will start from October 3, 2017 and is open for the registration.

Sartorius Stedim Biotech (SSB) announced an agreement with Nova Biomedical to integrate their BioProfile FLEX2 into the ambr multi-parallel bioreactor systems for automated, at-line cell culture analytics. Both the BioProfile FLEX2 analyzer and the parallel bioprocessing functionality of the ambr create a unique tool able to simultaneously run, sample and analyze a massive number of cell culture conditions during high-throughput cell line, media and process development by Design of Experiments (DoE). This will allow biopharmaceutical companies to develop well-characterized cell culture processes in less time while preventing the process development bottleneck being shifted to the analytical laboratory. The partnership will deliver full integrated analytics for the ambr 15 cell culture system in Q3 2017 and later in 2017 for the ambr 250 high throughput. The ambr platform mimics the characteristics of classical bioreactors at the microscale by allowing automated parallel processing of single-use bioreactors.

Sartorius entersinto partnershipwith Nova Biomedical

BD Biosciences commences FACS e-learning programme

49 l SUPPLIER NEWSwww.biospectrumindia.com | October 2017 | BioSpectrum

Energy-based medical devices company, Lumenis Ltd. is planning to launch PiQo4 – the dual nano + Pico technology laser, equipped with four different wavelengths and largest spot size in the market ideal for multicolor tattoo removal and skin pigmentation treatment.

The PiQo4 brings unique technology with combination of unsurpassed advantages. Its four different wavelengths (1064nm, 532nm, 585nm and 650nm) enable effective shattering of nine of the most popular ink colors ranging from light orange to dark blue on wide range of skin types. The PiQo4’s versatile energy matrix allows tattoo removal with 40 per cent less treatments compared to other technologies. PiQo4 offers up to 15mm spot size ranging from 2 – 15mm that allows deep reach into dermis and better disperse the embedded ink particles significantly decreasing chances of blisters, discoloration and scarring.

Jenway, a leading UK manufacturer of analytical laboratory instruments, has launched the new Genova Bio Life Science Spectrophotometer. The Genova Bio, a UV/visible spectrophotometer, has been designed for fast and easy use in life sciences applications, whilst having a low-price point. It is ideal for molecular biology laboratories, biotechnology, biochemistry and cell biology applications. The Genova Bio adds to Jenway’s comprehensive range of spectrophotometers. The instrument is compatible with a wide range of small volume cuvettes, making it an excellent tool for measuring the purity and concentration of DNA, RNA and other biological samples. To optimise sample preparation, the Genova Bio is pre-programmed with methods for the quantification of nucleic acids and proteins. The instrument also has a pre-programmed method for measuring optical density of bacterial cell cultures such as E. coli and yeast cells, enabling scientists to measure cell growth before cell harvesting.

Thermo Fisher joins hands with IPHThermo Fisher Scientific has signed an agreement with the Institute of Pathology Heidelberg (IPH) to establish its Center of Molecular Pathology at Heidelberg University Hospital as the newest member of the Next Generation Sequencing Companion Dx Center of Excellence Program (COEP). The initiative focuses on forging strategic collaborations with leading, European-based organizations that can lead studies using Thermo Fisher’s Oncomine portfolio of research panels destined for development as companion diagnostics to help drive precision oncology in the region. Working in collaboration with pharmaceutical partners and Thermo Fisher, the IPH Center of Molecular Pathology, headed by Dr Albrecht Stenzinger, will conduct studies and clinical trials under the leadership of Prof Peter Schirmacher, director of the Institute of Pathology of Heidelberg University Hospital. Leaders in their field, Dr Stenzinger and his team have in-depth expertise with Thermo Fisher’s next-generation sequencing (NGS) platforms and various gene panels, which they use to profile in clinical trials across several cancer types and more than 3,500 samples in clinical diagnostics annually.

The Institute is also the site of Germany’s largest tissue biobank, featuring a sophisticated laboratory information management system that has incorporated Thermo Fisher’s Ion Torrent bioinformatics software. Coupled with its biomarker development and translational diagnostics program, the IPH is uniquely positioned as an ideal Thermo Fisher partner to develop NGS-based diagnostics.

Lumenis to introduce new laser technology in India

Jenway launches new spectrophotometer

BIOEvent50 BioSpectrum | October 2017 | www.biospectrumindia.com

“Data Sharing and Post study access to trial medication for study subjects are the two emerging frontiers in clinical research space,” said Dr Saral Thangam, CEO & Managing Director, Norwich Clinical Services.

Speaking at a conference on “CLINICA: Recent trends and approaches in Clinical research, Clinical trial and Medical writing” organised by ABC Biologics in Bangalore on September 1, she said “Data sharing, whether elective or required, creates an obligation for the original investigators who obtain funding, design studies, collect and analyze data, and publish results to make their curated data and associated”.

She further noted that data from well-designed and well-executed research not only are useful for the original purpose and secondary analyses by the original researcher but also can be repurposed for a variety of applications, including independent replication, avoidance of duplicative studies, generation or testing of new hypotheses, and the general advancement of clinical and biologic understanding.

Talking about Post Trial responsibilities: continued access to trial medication she observed that informed consent for continued access to medication must be obtained. “The regulations that bind this complex topic is still under evolution,” she concluded.

Speaking on “Evolving global regulatory expectations on data integrity”, Dr Shrinivas Savale, Pharmaceutical and Biopharmaceutical Consultant, Ahmedabad said “With the regulatory inspections world over identifying several incidences of critical/major gaps in the compliance to various GxP requirements, a lot of emphasis has been given on data integrity, and thus, reliability of the data supporting any regulatory approvals.”

During his presentation he thrown some light on the need/approaches for ensuring data integrity through good process controls (QMS with data governance), data sharing/transparency as well as global initiatives in the era of ‘big data’ and technological advancements in clinical research in coming years.

Talking on “Ethics Committees - recent developments & Challenges in Scientific and Ethical Review” Nagendrappa. M. H, Chief Executive Officer, Clinotek India - Center for Advanced Clinical Research Studies, Bangalore said that for all practical reasons, it is impossible for regulatory authorities to be present at all clinical trial sites to ensure safety for the

“Data sharing, post study access totrial medication are emerging frontiers”

Delegates posing with speakers of CLINICA -2017

participants. They rely on Ethics Committees (ECS) to ensure protection of trial subjects.

He also pointed out the gross negligence happening in the stage of informed consent process which is one of the most important, but unfortunately the most ignored in India. As a result of the above and not limited to, there were over 2000 cases of serious adverse events (SAEs) leading to death were reported since 2009. In very few cases, the compensation was paid to the victim's family. To prevent scientific misconduct and better handle the identification and reporting of SAEs, it was inevitable for Central Drugs Standard Control Organization (CDSCO) to implement strict measures in place to ensure the protection of rights, safety and wellbeing of trial participants

Besides, Dr Sam T Mathew, Head-Clinical e-Submission and Technical Compliance Delivery, Scientific and Medical writing, GlaxoSmithKline, Bangalore spoke on “Authorship in Clinical Publictions: Is there a way to Quantify the Contributions?”, Dr Anand Eswaraiah, Head Biometrics, Medical and Regulatory Affairs, Syngene International, Bangalore on “Innovation and Future Clinical Trials”, Ranjith P.U, Senior Associate Manager (QC), Eli Lilly services India on “Medical writing deliverables-Different Attributes of Quality” and Dr Shabana Khan, Senior Manager PK/PD, Navitas Lifesciences, Bangalore on “Stem Cells in Clinical Trials” at the one day conference.

Representatives from MSN Pharma, Bioclinica, D2L Clinical Solutions, Norwich Clinical Services, Panexcell Clinical Lab, Clinotek, Sapthagiri Clintrac, Alchemy Clinical Research Services, Biointegrity, and Institute of Clinical Research India (ICRI) were present during this conference. The conference concluded with adoption of a resolution in which its participants set forth their recommendations to future of clinical trials.

CLINICA -2017

RNI No. DELENG/2004/13061 Published on 28th of previous month PCW/193/2017-2019 Posting Date: 30th of every month Posted at Ex Servicemen Colony PO, Pune-38

deliversvipragen.com.bh-in-14.webhostbox.net/wp2/wp-content/[email protected] mumbai...

Documents