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Vol:5 Issue: 17 January 1-15 2009 Price Rs 20/-

UNETHICAL MEDICAL EXPERIMENTS IN INDIA‘Medical experiments are being conducted on society’s most vulnerable, says Indian doctor Amar Jesani in Wemos’ new internet fi lm on clinical drug trials in developing countries. The fi lm can be viewed at the Wemos channel on You Tube. Amar Jesani is a medical doctor from Mumbai with expertise in ethics and human rights. ‘They are doing it because it is cheap to do it’, he says when asked why pharmaceutical companies are increasingly shifting their clinical drug trials to developing countries. ‘We fi nd that a cost reduction of almost 50 to 75 percent can be carried out if they do it in developing countries. Another reason is that India is a very big country. So pharmaceutical companies are able to fi nd enough patients for their trials.’

Desperate people‘They are very desperate’, Jesani says about the people participating in clinical trials in India. ‘They have either terminal diseases or they have no way of getting good health care in India. So the most vulnerable people of society are being used for the trials. That bothers me the most.’

UnethicalWhen asked what clinical trials on people in developing countries have to do with European citizens, Jesani answers: ‘If trials are done in an unethical manner, in violation of human rights, Europeans would be guilty of making use of such drugs. So it’s very important for Europe and all the developed countries to ensure that during the trial, no human rights violation has taken place.’

AvailableDr Jesani and Wemos are working together to address the issue of unethical drug testing in developing countries. Wemos wants to secure stricter ethical checks by the European regula-tory bodies charged with the approval of new medicines and their admission to the European market. Dr Jesani is fi ghting for three things: ˜The fi rst thing is that clinical trials in develop-ing countries should be relevant to their needs. The second is that in the course of trials, no human rights violation should take place. And the third is that if the trial is successful, the drug which is developed should be available to developing countries at an affordable price.’View the fi lm at http://www.youtube.com/wemosnl

Joint Statement From ACC, ADA And AHA

Some people with diabetes may require less stringent glycemic control than previously recommended, but most should stick with the target goal of less than 7 percent long advised for reducing the risk of diabetes-related complications, according to a position statement issued jointly today by the American College of Cardiology, American Diabetes Association and American Heart Association and published online in the journals of each organization, the Journal of the American College of Cardiology, Diabetes Care and Circulation: Journal of the American Heart Association.

The national health associations conducted a careful re-examination of glycemic control guidelines in light of three recent clinical trials in people with longstanding type 2 diabetes and high cardiovascular risk that suggested no signifi cant benefi t and/or risks related to intensive glycemic control and heart disease prevention. One trial -- the ACCORD study -- was halted early because of an increased death rate in the intensive control group, while two others, the ADVANCE and VADT studies, found no apparent increase in deaths, but no signifi cant cardiovascular benefi t. Previous observational studies had found an association between higher levels of A1C (a measure of blood glucose level over the prior 2-3 months) and cardiovascular events. Long-term follow-up of the DCCT and UKPDS cohorts found cardiovascular benefi t for people with type 1 and type 2 diabetes who underwent intensive glycemic control soon after the diagnosis of diabetes.

“Given the confusion created by these confl icting results, we thought it imperative to review our recommendations for all people with diabetes,” said Dr. Jay Skyler, who headed the writing group. “What we conclude is that for most people with diabetes, there’s no need to change treatment goals in light of

these fi ndings and many reasons to continue to strive for good glycemic control. But for some people with type 2 diabetes, depending upon their history and current medical condition, it may be wise to make adjustments.” The recommendations are consistent with prior suggestions that glycemic goals should be individualized depending on the medical history of the patient.

Maintaining A1C levels at or below 7 percent should remain the goal for most people with diabetes, because numerous studies provide evidence that achieving this goal substantially reduces the risk of microvascular complications, such as eye, kidney and nerve disease. The long-term follow-up of the DCCT and UKPDS participants, as well as subgroup analyses from the three recent studies, also suggest a cardiovascular benefi t for people without known cardiovascular disease and who have had diabetes for a relatively short period of time.

“The lack of signifi cant reduction in CVD events with intensive glycemic control should not lead clinicians to abandon the general target of A1C levels of less than 7 percent, and thereby discount the benefi t of good control on what are serious and debilitating microvascular complications,” the joint statement concluded.

However, for those who have a “history of severe hypoglycemia, limited life expectancy, advanced micro vascular or macro vascular complications, extensive co morbid conditions, and those with longstanding diabetes in whom the general goal is diffi cult to attain despite diabetes self-management education, appropriate glucose monitoring, and effective doses of multiple glucose lowering agents including insulin,” less stringent A1C goals should be considered, according to the statement. Specifi c goals for people with these conditions should be determined by an individual’s health care team.

PhaRMeD Trade News January,1-15, 2009 Page 2

ESOPHAGEAL CANCER

According to the American Cancer Society (ACS),

more than 16,000 new esophageal cancer cases are

diagnosed each year in the U.S. Unfortunately the

survival rate in these cases is only 10 percent. This

alarming statistic is due largely to the fact that

by the time the majority of cases are diagnosed,

the cancerous tumors have grown to the point of

inoperability. Raising patient awareness about

potential conditions that, if left untreated, could

progress into esophageal cancer, will encourage

patients to seek the appropriate care through their

physician.

Many people are aware that tobacco use increases

the risk of developing esophageal cancer; however,

there are several other common contributing risk

factors including:

◆ Excessive alcohol consumption;

◆ Obesity;

◆ Lye ingestion; and,

◆ Gastroesophageal refl ux disease

(GERD), also known as acid refl ux or

heartburn.

If GERD becomes a chronic condition, it can

develop into Barrett’s esophagus, a precursor to

esophageal cancer. Barrett’s esophagus is a condition

in which the color and composition of the cells

lining the lower esophagus change due to repeated

exposure to stomach acid. Only a small percentage

of people with GERD develop Barrett’s esophagus,

but once it is diagnosed, patients should be sure to

meet with their physician regularly as they are at a

greater risk of developing esophageal cancer.

Symptoms of advanced GERD or the presence of

Barrett’s esophagus include:

◆ Frequent heartburn. A burning-type pain

in the lower part of the mid-chest, behind

the breast bone, and in the mid-abdomen.

◆ Diffi culty swallowing. Often, a narrowing

of the esophagus (esophageal stricture)

leads to trouble swallowing or dysphagia.

◆ Bleeding. A person may vomit red blood

or blood that looks like coffee grounds, or

your stools may be black, tarry or bloody.

◆ Weight loss and loss of appetite.

According to the ACS, prevention of Barrett’s

esophagus can begin with controlling

GERD by making some simple lifestyle

changes, such as:

◆ Losing weight. Obesity increases

abdominal pressure, which can then push

stomach contents up into the esophagus;

◆ Eating a diet full of fruits and vegetables,

eating smaller and more frequent meals

and not eating two to three hours prior to

bedtime;

◆ Smoking cessation, as nicotine relaxes

the esophageal sphincter and smoking

also stimulates the production of stomach

acid;

✍Discontinuing the consumption of alcohol. People with severe GERD and Barrett’s

esophagus often require aggressive treatment and prevention methods including medications, other nonsurgical medical procedures such as endoscopic therapies, or even laparoscopic and open surgeries. Often times, swallowing diffi culty (known as dysphagia) and other symptoms can be treated if identifi ed early.

Nighttime Breathing ProblemsSnoring and daytime sleepiness are not associ-

ated with allergic rhinitis, but are associated with obstructed nasal passages, regardless of an individ-ual’s allergic status, according to an article released on December 15, 2008 in Archives of Otolaryngol-ogy--Head & Neck Surgery, one of the JAMA/Ar-

chives journals.

PhaRMeD Trade News January,1-15, 2009 Page 3

PhaRMeD Trade News January,1-15, 2009 Page 4

One persistent symptom of allergic rhinitis, a

runny nose due to allergies, is nasal obstruction.

The authors point out that the resulting obstructed

breathing can cause complications. “People with

nasal obstruction often experience other symp-

toms, including headache, thirst, lack of concentra-

tion, daytime cognitive defi cits, daytime sleepiness

and disturbed sleep, which impair their daily and

social activities,” they write. “There has been grow-

ing awareness that the morbidity [illness] of aller-

gic rhinitis in the general population is increasing

and is leading to a decline in school and work per-

formance, resulting not only in a medical economic

loss but also in a large social economic loss.”

In order to explore the relationship between

nasal obstruction, snoring, and excessive daytime

sleepiness with the presence or absence of allergies,

Nobuaki Hiraki, M.D., and colleagues at the Uni-

versity of Occupational and Environmental Health,

Kitakyushu, Japan, analyzed a survey distributed

to 1,878 workers, 78% (1,459) of whom responded

with suffi cient information to perform the analy-

sis.

The participants were, based on their responses,

classifi ed into one of the following groups of par-

ticipants: allergies and nasal obstruction, nasal

obstruction but no allergies, allergies but no na-

sal obstruction, and neither ailment. The odds of

snoring and daytime sleepiness were greater in the

nasal obstruction groups, regardless of allergy sta-

tus, while no signifi cant differences were found in

these symptoms for the allergies only and control

groups.

The authors infer that nasal obstruction is more di-

rectly related to the problem: “The present results

strongly suggest that nasal obstruction causes sleep-

disordered breathing and, thus, daytime sleepiness

in individuals without allergic rhinitis as well as in

those with allergic rhinitis,” they write. This is pos-

tulated to occur by several different means, such as

pressure abnormalities causing parts of the throat

to collapse, a shift from nasal to mouth breathing,

or changes in the neurological signals sent from the

respiratory system to the brain.

The authors conclude that pursuing rhinologic

treatment is a worthy investment. “We speculate

that, although nasal obstruction itself is not a life-

threatening condition, prompt and appropriate

rhinologic treatment would improve sleep quality

and, thus, daily and social activities in patients with

sinonasal diseases,” they write. “This remains to be

further investigated in future studies.”

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PhaRMeD Trade News January,1-15, 2009 Page 5

PRE-ECLAMPSIA RISK INCREASEDRepeated miscarriages and hormone treatment

for infertility give an increased risk of pre-eclampsia among pregnant women. This comes from a new study from the Norwegian Institute of Public Health. More than 20 000 fi rst-time mothers from the Norwegian Mother and Child Cohort Study (MoBa) were included in the study.

Normal risk First-time mothers who had not miscarried or

had problems getting pregnant had a 5.2 % risk of pre-eclampsia.

Risk after miscarriage Women who had three or more miscarriages had

a 50 % increased risk of pre-eclampsia compared with women who had not miscarried.

Women who had one or two miscarriages are not thought to be at higher risk.

Among women who had both miscarriages and treatment for infertility, the risk for pre-eclampsia was 13 %.

RISK AFTER INFERTILITY TREATMENT

The study also shows that women who had infertility treatment had a 25 % higher risk of pre-eclampsia.

Women who became pregnant after hormone treatment to stimulate ovulation had a doubled risk of pre-eclampsia compared to women without treatment.

Assisted conception treatment was not linked to an increased risk, even though hormone stimulation is part of the procedure.

Different causes of infertility (polycystic ovary syndrome, blocked Fallopian tubes etc.) can probably explain the difference in risk for pre-eclampsia. It is likely that factors in mothers that cause infertility may also give an increased risk of pre-eclampsia.

It is less likely that the treatment itself explains the increased risk, even if this cannot be excluded.

The study has been recently published in the British Journal of Obstetrics and Gynecology, BJOG.

PhaRMeD Trade News January,1-15, 2009 Page 6

HUMOR CLINICFour Proud DadsFour friends, who hadn’t seen each other in 30 years, reunited at a party. After several drinks, one of the men had to use the rest room. Those who remained talked about their kids.

The fi rst guy said, “My son is my pride and joy. He started working at a successful company at the bottom of the barrel. He studied Economics and Business Administration and soon began to climb the corporate ladder and now he’s the president of the company. He became so rich that he gave his best friend a top of the line Mercedes for his birthday. “The second guy said, “Darn, that’s terrifi c! My son is also my pride and joy. He started working for a big airline, and then went to fl ight school to become a pilot. Eventually he became a partner in the company, where he owns the majority of its assets. He’s so rich that he gave his best friend a brand new jet for his birthday.”

The third man said: “Well, that’s terrifi c! My son studied in the best universities and became an engineer. Then he started his own construction company and is now a multimillionaire. He also

gave away something very nice and expensive to his best friend for his birthday: A 30,000 square foot mansion.”

The three friends congratulated each other just as the fourth returned from the restroom and asked: “What are all the congratulations for?”

One of the three said: “We were talking about the pride we feel for the successes of our sons.... What about your son?”

The fourth man replied: “My son is gay and makes a living dancing as a stripper at a nightclub.”

The three friends said: “What a shame...what a disappointment.”

The fourth man replied: “No, I’m not ashamed. He’s my son and I love him. And he hasn’t done too bad either. His birthday was two weeks ago, and he received a beautiful 30,000 square foot mansion, a brand new jet and a top of the line Mercedes from his 3 boyfriends”

from -RA HOSPITAL &RESERACH CENTRE, MAIN ROAD , RANCHI

PhaRMeD Trade News January,1-15, 2009 Page 7

PhaRMeD Trade News January,1-15, 2009 Page 8

ARTESMININArtemisinin, the drug used as monotherapy to treat multi-drug resistant strains of falciparum malaria, will no longer be in the Indian market after some time as a decision to discontinue its use has already been taken.

The 39th Drugs Consultative Committee (DCC), which held in New Delhi on December 10, unani-mously decided to phase out the Oral Single Drug Formulations (OSDF) of artemisinin and its deriva-tives from the Indian market.

The DCC has set up a sub-committee to lay down the norms by which this class of anti-malarial drugs known as artemisinin-based combination therapies (ACTs) should be weeded out from the market.

The Drug Controllers meeting also set a time limit of six months for the sub-committee to submit its report.

ACTs were in the market as they had been approved by various international health organizations such as the WHO and the United Nations Children’s Fund (UNICEF) as the fi rst-line treatment for ma-laria in Africa.

The threat of lawsuits have become a doctor’s biggest nightmare. The commonest reason for these are:1. Poor doctor-patient communication; and 2. Failure of the doctor to update himself with the latest medical knowledge.

Now, for less than Rs 30 per day, you can protect yourself by subscribing to the world’s largest online medical library, at www.mdconsult.com ! You can try out a risk-free 30 day demo– free of charge ! MDConsult allows you to remain up-to-date by providing online instant access to the FULL-TEXT of over 40 respected medical books and 50 prestigious medical journals which are constantly updated. This means you will never need to buy another medical book in your life !

MD Consult provides convenience and peace of mind – at your desktop - for only Rs 9995 per year. Remember, this is a tax- deductible expense ! You could also request a pharmaceutical company through their medical representative to gift you a free membership. Many companies have done this for their key doctors as goodwill gesture !

To subscribe, please send a DD for Rs 9995 only, payable to Health Education Library for People.

HELP - Health Education Library for PeopleExcelsior Business Center, National Insurance Building,

Ground Floor, Near Excelsior Cinema, 206, Dr.D.N Road, Mumbai 400 001 Tel. No.: 65952393/ 65952394/22061101

helplib@vsnl.com www.healthlibrary.com

CONFORMITYByazid. The Moslem saint. Would sometimes deliberately act against the outward forms and rituals of Islam. It once happened that, on his way back from Mecca. He stopped at the Iranian town of Rey. The towns folk, who revered him. Rush to welcome him and created a great stir in the town.Bayazid. Who was quite tired of this adulation, waited till he reached the market place. There he bought a loaf of bread and began to munch it in full view of his followers. It was a day of fasting in the month of Ramzan. But Bayazid knew that his journey justifi ed the breaking of the law. Not so his followers. They were so shocked at his behavior that they promptly left him and went back to their homes. Bayazid impishly remarked to a disciple, “Did you see how, the moment I did something contrary to their expectations, their veneration vanished?”Levels of LearningL1. A. We are stuck with the rules.B. We venerate a person as long as heConforms to our expectations.C. We place more importance on rules thanon wisdom.L2. A. Share a similar experience of yours.B. Share your response to the above incident.C. Share a similar experience of someone known to you.L3. A. Why do I fail to understand what is behind the rule?B. What is the nature of ‘conformity’?C. Why do I turn my back when someone acts contrary to the rules I believe in?

PhaRMeD Trade News January,1-15, 2009 Page 9

THE HIFA2015 GOAL: By 2015, every person worldwide will have access to an informed healthcare provider.

Join HIFA2015: Send your name, organization

and brief description of interests to HIFA2015-admin@dgroups.orgHIFA2015 email group website:

www.dgroups.org/groups/hifa2015Further info on

HIFA2015: www.hifa2015.org

FDA-Antiepileptic MedicationsThe U.S. Food and Drug Administration

announced it will require the manufacturers of antiepileptic drugs to add to these products’ prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications. “Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “ Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

NEW ANTIBIOTICSwissmedic, the Swiss agency for therapeutic

products, has approved ZEVTERA™ (ceftobiprole medocaril) for the treatment of complicated skin and soft tissue infections, including diabetic foot infections which have not spread to the bone.

Ceftobiprole is licensed from and co-developed with Basilea Pharmaceutica Ltd. Janssen-Cilag will market ceftobiprole in Switzerland under the trade name ZEVTERA™. Swiss based Basilea Pharmaceutica Ltd will co-promote the drug in key European markets and North America.

Ceftobiprole is the fi rst, broad-spectrum, anti-MRSA cephalosporin antibiotic with activity against a range of diffi cult-to-treat Gram-positive and Gram-negative hospital and community-acquired pathogens including methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa1. In clinical trials, ceftobiprole has demonstrated high cure rates in patients with complicated skin infections, including those caused by the potentially deadly MRSA.

The use of ceftobiprole in adults for the treatment of complicated soft tissue infections, including diabetic foot infections which have not spread to the bone, is under regulatory review in United States, Australia and in the European Union among other countries. In Canada, ceftobiprole was launched in August 2008 under the trade name ZEFTERA.

PhaRMeD Trade News January,1-15, 2009 Page 10

SPURIOUS DRUGSThe central government has appointed an

expert committee to look into the issues of spu-rious drugs, medical devices and the plight of diagnostic centers in the country and to suggest ways and means to tackle these issues which have attracted fl ak from different quarters. Dr PN Tandon, emeritus professor at All India In-stitute of Medical Sciences (AIIMS), New Delhi, is the chairman of the nine-member commit-tee.

The committee, appointed by the Principal Scientifi c Advisor to the government of India, has been given nine months time to submit a de-tailed report on these burning issues. The com-mittee will broadly look into these issues and will prepare detailed legislative and adminis-trative guidelines for these segments which are in real mess in the country.

ICMR Director General Dr VK Katoch, DCGI Dr Surinder Singh, well known oncology sur-geon at Gangaram Hospital Dr Indraneel Mit-tra, famous paediatric surgeon at Teerathram Shah Hospital Dr Sudhir Krishna, chief scien-tifi c offi cer at Bilcare, Pune, Dr Praful Naik and MIMS editor Dr CM Gulhati are some of the members of the committee. Neeraj Sinha is the member secretary of the committee.

The constitution of an expert committee of this calibre is signifi cant as it shows that the government is under immense pressure from different world bodies to address these health issues. There were reports appearing in the world media that point at India as a major source of spurious drugs in the world. The committee will study and analyse scientifi c and technical measures which are adopted in US and other advanced countries to tackle the menace of spurious drugs.

The committee has also been asked to broad-ly look into the mess prevailing in the medical devices market in the country and to suggest ways to regulate this segment.

RIMONABANTDrug Controller General of India (DCGI) Dr

Surinder Singh had recently cancelled the licenses of 17 companies to manufacture rimonabant after the Europe’s drug regulator European Medicines Agency (EMEA) suspended the manufacture of this drug in UK and the European Union coun-tries on reports that the slimmming drug caused serious psychiatric side effects including suicidal tendencies.

Rimonabant was in the news for some time due to its severe side effects like depression and other psychiatric disorders. Last year, the UK’s premier medical journal, The Lancet, had reported that four slimming drugs sold in the market put pa-tients at risk of severe psychiatric side effects. But, the drug was not launched in US as it did not get the US FDA approval.

Rimonabant was launched by Sanofi Aventis in June 2006 in the European Union (EU) under the brand name Accomplia. Apart from 18 countries in the EU, Sanofi Aventis was selling the drug in 14 countries including some in Latin America. In India, the copycat versions of the drug are manufactured by Torrent Pharmaceuticals in the name of Remos-lim, Zydus Cadila under the brand name of Slimona and Sun Pharmaceuticals under the brand names of Riocity and Riobec.

GLENMARKThe Glenmark Pharmaceuticals Ltd was recog-

nised as ‘best pharma company in the world - SME’ at the SCRIP Awards 2008 in London, hosted by the UK broadcaster Peter Sissons on December 10. The awardees are recognised by SCRIP magazine.

In a press release issued by SCRIP, states Glen-mark crowned a busy year by winning the SCRIP Awards for best company in an emerging market and pharma company of the year for small and medium-sized enterprises. In judging, Dr Richard Barker said that the Indian fi rm scored well on al-most all dimensions, showing dramatic growth in its generics business plus a promising early stage pipeline in some high potential areas for branded medicines.

PhaRMeD Trade News January,1-15, 2009 Page 11

Shri. S.W. Deshpande, Former Joint Commissioner, FDA- Maharashtra State and the Director General of All India Drugs Control Offi cers ̓Confederation has been elected as the President of the Indian Pharmaceutical Congress Association by the council of IPCA in its meeting held at Delhi on 11/12/2008. Shri. S.W. Deshpande is graduate in

Pharmacy and Law. He retired from FDA after 33 years of outstanding service and his contribution and excellence in the pharmaceutical fi eld and regulatory fi eld is refl ected in his record and reputation in the pharmaceutical fi eld. His excellence and contribution has been recognized by various professional organizations by way of awards.

“Life Time Achievement Award” from All India Drugs Control Offi cers ̓Confederation presented at 58th IPC, Mumbai.

“K.C. Chaterjee Memorial Award, 2005” from Indian Pharmacy Graduates ̓ Association, during 57th IPC, Hyderabad.

“Pharma Excellence Award 2005” from Central India Pharmacy Promotion and Research Association

“Life Time Achievement Award” from Retail Druggists and Chemists Association, Mumbai.

Shri. Deshpande has played a very vital role in formation of the All India Drugs Control Offi cers ̓Confederation and has served AIDCOC as the founder Secretary General from 1995 to 2004 and as the President from 2004 to 2006. At present, he is the Director General,

AIDCOC. He has represented AIDCOC on the council of Indian Pharmaceutical Congress Association from 1998 to 2007.

Shri. Deshpande is considered as an authority on drug legislations and three books on drug legislations namely a booklet “Case Law on Drugs and Cosmetics Act, 1940”, “A Commentary on Drugs and Cosmetics Act, 1940” and “Commentary on Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954” authored by him are widely referred by the pharmacy professionals. He has also contributed in drafting the elaborate amendment proposal to the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 as a member of sub-committee constituted by the Government of India.

After Mumbai Terrorist attacaks India Govt should do

A. Conduct surgical strikes on terrorist training camps.

B. Should wage war and re-occupy POK

C. Beef up internal security

D. All the above

SMS TO : 919849551183

PhaRMeD Trade News January,1-15, 2009 Page 12

RNI NO : APBIL 2004/12036 POSTAL LIC NO : HSE-806/2009-11