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SECRETARIAL AUDIT

OF PHARMACEUTICAL COMPANIES

April 27, 2015

SECRETARIAL AUDIT OF –

Pharmaceutical CompaniesRelevant Terms/Concepts

1. Generic Vs Original Research – Companies Total Pharma Medical Expenses – US$ 1 Trillion

Generic Contribute about 27% of the total

Generic is growing @ 10-12% per annum

2. Indian Pharma Sector is generic Ranbaxy’s Synriam is so far the only Innovator product from India

3. Active Pharmaceutical Ingredients (APIs) Bulk Drugs

4. Formulation/Dosage Forms – Products (Tablets, Capsules, injectibles etc)

5. Loan Licensing – Use of manufacturing facility of another licensee

6. Prescription Drugs – Schedule H

7. OTC products (Over the Counter products)- exempted from Schedule H

8. Therapeutical segments Chronic Vs Acute

10. PharmacovigilancePatient Safety – Adverse Drug Reaction (ADR) – Side effects

11. Drug Master File (DMF) – API Products – Filed with Drug Authorities for approval

12. Dossier – Formulation, Manufacturing process BE Studies

13. Food Vs Drug

14. NLEM – National List of Essential Medicines


Pharmaceutical Companies

Regulatory Authorities

1. Drug Controller General of India (DCGI)

2. National Pharmaceutical Pricing Authority (NPPA)

3. Medical Council of India (MCI)

4. US Food & Drugs Authority (US FDA)

5. European Medical Agency (EMA)

6. South Africa – Medicines Control Council (MCC)

7. Australia – Therapeutic Goods Administration (TGA)

8. Canada – Health Ministry


Pharmaceutical CompaniesStatues/Regulations/Rules

The Drugs & Cosmetics Act, 1940 Regulates the import, manufacture, distribution and sale of

drugs in India. Applies to Ayurvedic, Siddha, Unani and

Homeopathic Medicines.

The Drugs & Cosmetics Rules, 1945 Rules prescribed under the Drugs & Cosmetics Act.

Drugs (Price Control) Order 2013 Enforced by National Pharmaceutical Pricing Authority

(NPPA), Government of India. View the list of drugs under

price control to ensure abundant availability of essential and

life saving drugs at reasonable price.

Food Safety and Standards Act, 2006 The Food Safety and Standards Authority of India has been

established under this Act for laying down science based

standards for articles of food and regulating manufacturing,

processing, distribution, sale and import of food so as to

ensure safe and wholesome food for human consumption.

The Legal Metrology Act, 2009 Weights and measures which are standard and duly verified

The Trade Marks Act, 1999 & Rules

made thereunder

It provides registration and better protection of Trade Marks

for goods and services and for the prevention of use of

fraudulent marks.


Pharmaceutical Companies

Statues/Regulations/Rules

The Drugs and Magic Remedies

(Objectionable) Advertisement

Act, 1954

It provides to control the advertisement regarding drugs. It

prohibits the advertising of remedies alleged to possess

magic qualities

Bio-Medical Waste (Management

and Handling) Rules, 1998

These rules apply to all persons who generate, collect,

receive, store, transport, treat, dispose or handle bio

medical waste in any form.

The Patents Act, 1970 It provides exclusive rights for a limited period of time in

exchange for detailed public disclosure of an invention.

Pollution Control Act & Rules To protect the outdoor environment against pollution and

to reduce existing pollution, to reduce the quantity of

waste and to promote better waste management.

The Narcotic Drugs and

Psychotropic Substances Act

1985

This act is concerned with control and regulation of

operations relating to Narcotic Drugs and Psychotropic

Substances.


Pharmaceutical CompaniesProcess1. Processes and Compliance System

Understand the System

Evaluate internal compliance mechanism

Discuss with the Management

2. Notices/Show Cause Notice received from the Authorities Review all the Notices received

Replies by the Company

Disclosure by the Company – as required under Listing Agreement etc

Evaluate and discuss with the Management – impact, consequences – penalties

Remedial Measures taken by the Company

3. Litigation Status

Disclosure

Contingent Liability

4. Check List of compliances Legislations Licenses – Renewal

Approvals

Statutory Records

Filing of Returns


Pharmaceutical CompaniesImportant Statutory Compliances under Drug Laws1. Drugs & Cosmetics Act – Licensing & maintenance of records

Validity of License

Manufacturing License separate for each location - 5 years

Wholesale, distribution, retail sale license - 5 years

Loan License - to use manufacturing facility o f - 5 years

another licensee

Renewal of License - Within a period of six months of expiryof license once applied continue toremain valid

Manufacturing Records - Batch Manufacturing - To be maintained for each batch of

Records, Development (R&D) Records production as prescribed under

Schedule U – to be maintained for a

period of 5 years

Control Sample for each batch of drug - To be taken for each batch of

manufactured production and to be kept for a period

of three months beyond the expiry date

Inspection Book - To be maintained for recording by the Inspectors

2. Returns to filed under Food & Drug Laws No Return under Allopathic drug,

For Ayurvedic Medicines – Annual record for the API used

Quarterly return of the of the sale of Narcotic substances ( under NDPS Act)

Food Laws- Annual Turnover of the products manufactured


Pharmaceutical CompaniesImportant Statutory Compliances

3. DPCO, 2013, Form to be filed with NPPA Form I – Price approval for new products.

Form II - Return of the price increase taken on Scheduled Formulations basis the wholesale price index of previous year.

Form III – Quarterly productions/sales of scheduled formulations

Form IV –Discontinuation of scheduled formulations

Form V – Price list of all the scheduled and non scheduled formulations- consolidated list of filed annually and quarterly list of the products for which prices have been revised in the said quarter.

4. Legal Metrology Act

Every importer, manufacturer or packer of packaged commodities will require registration under Rule 27 of the LM (Packaged Commodities) Rules, 2011. The registration may be made with the Director of Legal Metrology of the GOI (in case of Union Territories)or the Controller of Legal Metrology (in cases of States)where the importing or packing is made.

For import of any Weight or Measure, Registration with the Director of Legal Metrology, GOI, is required as per Rule 15 of the Legal Metrology (General) Rules, 2011

8

BACK-UP

DPCO - 2013

All strengths and dosages specified in the NLEM 2011 will be under price control;

Ceiling Prices (CP) will be fixed on the basis of market-based data (MBD);

Formula for computing CP is simple average price of all having Market Share of 1%

or more;

Manufacturers will be free to fix any price for their products equal to or below CP;

Automatic annual price adjustment (up or down) linked to WPI for NLEM products;

CP will be revised every five-year or as and when the NLEM is updated/revised;

However, if there is a significant change in the market structure of a product, the

government will revise the CP even earlier; CP will also apply to imported drugs

under the NLEM;

Annual price increase of up to 10% for Non-NLEM products;

Prices of DPCO 1995 products not in NLEM 2011 would be frozen for one year and

thereafter will be allowed increase of up to 10% per annum;

Original research products having product/process patent and New Drug Delivery

System (NDDS) products exempted from price control for 5 years;

Any new combination of NLEM+NLEM or NLEM +Non-NLEM will require price

approval by NPPA;

Any addition to NLEM 2011 by ministry of health will come under price control;

DPCO - 2013

The department of pharmaceuticals will monitor production and availability of NLEM

products;

Price Control will be for Formulations only and not on the Bulk Drugs;

“New drug" means a formulation launched by existing manufacturer or importer of an

NLEM drug with dosage and strength as specified in NLEM, BY combining the NLEM

drug with another NLEM drug or non NLEM drug or by changing the strength and or

dosage form of the same NLEM drug. Price approval for New Drug will be required if

launched post DPCO 2013;

Ceiling Price notified up to 31-May-2012 of those Products currently covered under

DPCO 1995 and NLEM will continue up to 30-May-2013 and thereafter price to be

revised as per Annual WPI (Wholesale Price Index) of previous Calendar year. From

01-April-2014, Ceiling Price will have to be followed as per DPCO 2013;

Ceiling Price notified after 31-May-2012 of those Products currently covered under

DPCO 1995 and NLEM will continue for 1 year. After 1 year price to be revised as per

Annual WPI (Wholesale Price Index) as per previous Calendar year. From 1st April of

subsequent year Ceiling Price will have to be followed as per DPCO 2013;

Ceiling Price notified up to 31-May-2012 of those Products currently covered under

DPCO 1995 only and not under NLEM will continue up to 30-May-2013 and thereafter

price can be revised as any other Non Scheduled Formulations as per DPCO 2013.

DPCO - 2013

Ceiling Price notified after 31-May-2012 of those Products currently covered under

DPCO 1995 only and not under NLEM will continue for 1 year. After 1 year price can

be revised as any other Non Scheduled Formulations as per DPCO 2013;

The methodology of fixing a ceiling price of NLEM medicines, by adopting the Simple

Average Price of all the brands having market share (on the basis of Moving Annual

Turnover) more than and equal to 1% of the total market turnover of that medicine,

will be as per the given formula i.e. (Sum of prices of all the brands of the medicine

having market share more than and equal to 1% of the total market turnover of that

medicine)/(Total number of manufacturers producing such brands of the medicine);

All the existing manufactures selling scheduled formulations at a price higher than the

ceiling price (plus local taxes as applicable) so fixed and notified by the Government,

shall revise the prices of all such formulations downward not exceeding the ceiling

price (plus local taxes as applicable) within a period of forty-five days of the date of

such notification;

All the existing manufactures selling scheduled formulations at a price lower than the

ceiling price (plus local taxes as applicable) so fixed and notified by the Government

shall maintain their existing maximum retail price;

The basis for this readily monitorable market data would be the data available with

the company – IMS Health (IMS). Wherever required this data would be checked by

appropriate survey/ evaluation by the National Pharmaceutical Pricing Authority

(NPPA);

DPCO - 2013

The market based data, for fixing the ceiling price of scheduled formulations for the

first time after the notification of this order, shall be the data of May, 2012;

The Government may in the due course of time come out with other appropriate

mechanism of collecting or obtaining the market based data related to drugs and the

decision of Government with respect to collection or obtaining of data shall be final;

The market based data for fixing the retail price of new drugs available in the market,

shall be the data available for the month ending immediately before six months of

receipt of application for fixing the price of the new drug;

The market based data for fixing the ceiling price of a scheduled formulation due to a

revision in the first schedule shall be the data available for the month ending

immediately before six month of notification of revision in the first schedule;

As the IMS data gives price figures for stockiest level prices hence in order to arrive

at ceiling Price (which will be the maximum retail price), the IMS price will be further

increased by 16% as margin to the retailer so as to arrive at a reasonable ceiling

price chargeable from the consumers;

For drugs not in the IMS data, NPPA would collect data by commissioning the same.

For the medicines where there is no reduction of price due to absence of competition,

the overall percentage reduction in the price of same molecule with other dosage and

strength will be applied; otherwise the overall percentage reduction in the price of

medicines in the same therapeutic category will be applied.

DPCO - 2013

Any manufacturer of scheduled formulation, intending to discontinue any scheduled

formulation from the market shall issue a public notice and also intimate the

Government at least six month prior to the intended date of discontinuation and the

Government may, in public interest, direct the manufacturer of the scheduled

formulation to continue with required level of production or import for a period not

exceeding one year, from the intended date of such discontinuation within a period of

sixty days of receipt of such intimation.

Drugs and Cosmetics, 1940

(Sales & Import)

Provision Section/

Rule

Name of

Register/ Form

Time Limit

The Company is required to, obtain an import licence for

which an application to the Licensing Authority is to be

made with fee, for the import of following drugs:

(a) drugs specified in Schedule X

(b) drugs excluding those specified in Schedule X

Rule 24, 23 Form 8 A

Form 8

Before Import

The Company in case where it manufactures shall give

undertaking that the applicant is its agent for import of

Drugs into India where it is so required and also that the

conditions imposed on a licence are complied with

Rule 24 Form 9 With the

application for

obtaining

Licence

The Company shall not import:

- any drug which is not of a standard quality

-any misbranded drug

-any adulterated or spurious drug

-any drug for which licence is required except under & in

accordance with licence.

-any patent or proprietary medicine without prescribed

display on the label or container -[the true formula or list

of active ingredients contained in it & quantities thereof]

-any drug which by means of any statement, design or

device purports to cure any prescribed disease or ailment

-any drug the import of which is prohibited by the Rules.

Section 10(a-3)

& (f)

Standard as per second

schedule

All time


(Sales & Import)

Provision Section/

Rule

Name of

Register/ Form

Time Limit

The Company shall not import any biological or other

special product specified in Schedule C or C(1) after the

date shown on the label, wrapper or container of the

drug, as the date up to which the drug may be expected

to retain a potency not less than , or not to acquire a

toxicity greater than, that required or, as the case may

be, permitted by prescribed test.

Rule 30 - All Time

The Company shall not import any drug the manufacture,

sale or distribution of which is prohibited in the country of

origin shall except for the purpose of examination, test or

analysis.

Rule 30B - All Time

The Company shall not import any drug unless it is

packed and labeled in conformity with the rules in Part IX

and X and with the standards laid down in Part XII.

Provided in case of drugs for veterinary use, the

Company is to ensure that the packing and labeling

should conform to the Rules in Part IX and X and

Schedule F (1)

Rule 32 - All time

Small quantities of drugs the import of which is prohibited

under Sec 10 as above may be imported for the purpose

of examination, test or analysis by obtaining licence.

Rule 33 Form 12 As & when


(Sales & Import)

Provision Section/

Rule

Name of

Register/ Form

Time Limit

The Company holding licence to import may import

patent or proprietary medicine in bulk containers after

obtaining permission in writing from the Licensing

Authority.

Rule 37 - Atleast three

months prior to

date of Import

The company is required to ensure that All consignments

of imported drugs to be accompanied by an Invoice/

statement stating name & address of the manufacturer &

the names & quantities of the drugs.

Rule 38 - All Time

If Company imports drugs for the import of which a

licence is not required it shall give a signed declaration to

the Customs Collector stating that the drugs comply with

the provisions of Chapter III of the Drugs and Cosmetics

Act and Rules.

Rule 39 - As & when

The Company shall not import drugs in India except

through the places provided for in the rules.Rule 43A Form 12 All Time


(Sales & Import)

Provision Section/

Rule

Name of

Register/ Form

Time Limit

Sale of Drugs

The Company in order to sell, stock, exhibit, or offer for

sale or distribute drugs is required to obtain grant/

renewal of licence for which application is to be made:

(a) For drugs other than those specified in Schedule X;

(b) For drugs specified in schedule X

Rule 59(2)

Form 19/Form 19A as

the case may be

Form 19C

Before it sells,

stock, exhibits

or offers for sale

or distributes

The Company is to obtain grant/renewal of licence for

manufacture for sale or for distribution of drugs other

than those specified in Schedules C & C (1) from the

Licensing Authority and application shall be made up to

ten items for each category of drugs categorized in

Schedule M/MIII as the case may be with fee:

a. in case of repacking of drugs excluding those specified

in Schedule X for sale or distribution

b. in the case of manufacture of drugs included in

Schedule X

c. in any other case

Rule 69

Form 24B

Form 24F

From 24

Before

manufacturing

for sale or

distribution


(Sales & Import)

Provision Section/

Rule

Name of

Register/ Form

Time Limit

Sale of Drugs


manufacture for sale or for distribution of drugs specified

in Schedules C & C (1) [excluding those specified in Part

XB and Schedule X for which an application shall be

made to the Licensing authority up to ten items for each

category of drugs categorized in Schedule M and

Schedule M III as the case may be with fee.

Rule 75(1) Form 27 Before

manufacturing

for sale or

distribution


manufacture for sale or for distribution of drugs specified

in Schedules C, C(1) and X for which an application shall

be made to the Licensing authority up to ten items for

each category of drugs categorized in Schedule M and

Schedule M III as the case may be with fee.

Rule 75(2) Form 27B Before

manufacturing

for sale or

distribution

The Company is to obtain grant/renewal of licence to

manufacture for sale or for distribution of drugs in ‘Large

volume Parenterals’ and ‘Sera Vaccines’ for which an

application shall be to the Licensing Authority up to ten

items for each category of drugs categorized in Schedule

M with fee.

Rule 75(3) Form 27D Before

manufacturing

for sale or

distribution


(Sales & Import)Provision Section/

Rule

Name of

Register/ Form

Time Limit

The Company is to obtain grant/renewal of loan licences

to manufacture for sale or for distribution of drugs other

than those specified in Schedule C, C(1) and X for which

application shall be to the Licensing Authority up to ten

items for each category of drugs categorized in Schedule

M and M III With fee.

Rule 69A Form 24A In case of loan

licence before

manufacturng

for sale or

distribution

The Company is to obtain grant/renewal of loan licences

to manufacture for sale or for distribution of drugs

specified in Schedule C, C(1) [excluding those specified

in Part X B and Schedule X] for which application shall be

to the Licensing Authority up to ten items for each

category of drugs categorized in Schedule M and M III

With fee.

Rule 75A Form 27A In case of loan

licence before

manufacturng

for sale or

distribution

The Company shall ensure while applying for a licence to

manufacture patent or proprietary medicines furnishing to

the Licensing Authority evidence and data justifying that

the patent or proprietary medicines: i. Contain the

constituent ingredients in therapeutic/ prophylactic

quantities as determined in relation to the claims/

conditions for use or claimed to be useful; ii. Are safe for

use in the context of vehicles, excipients, additives, and

pharmaceutical aids used in the formulations for

administration and use are recommended; iii. are stable

under the conditions of storage recommended; and

iv. Contain such ingredients and in such quantities for

which there is a therapeutic justification.

Rule 76A


(Sales & Import)Provision Section/

Rule

Name of

Register/ Form

Time Limit

Not to manufacture for sale or for distribution or sell, or

stock or exhibit or offer for sale or distribute

-any drug which is not of a standard quality or is

misbranded, adulterated or spurious,

-any drug which by means of any statement, design, or

device accompanying it or purports or claims to

prevent, cure or mitigate any prescribed disease or

ailment.

-any drug in contravention of the Act/rules

-manufacture for sale or for distribution or sell or stock or

exhibit or offer for sale or distribute any drug except in

accordance with the licence obtained.

Section 18 Standard as per second

Schedule

-

The Licencee company shall keep and maintain

prescribed records, registers and other documents and

shall furnish the same when required.

Section 18-B - -

The above provisions shall not apply to the manufacture

of any drug in small quantity for the purpose of

examination, test or analysis if the conditions specified in

Part VIII of the Rules are fulfilled.

Rule 86 - -

The Company is required to file separate application for

obtaining a separate licence for drugs sold or stocked for

sale at more than one place.

Rule 62 - -

The Company shall not manufacture for sale cyclamates

and preparations containing cyclamates.Rule 84B

Drugs and Magic Remedies

(Objectionable Advertisements)

Act, 1954Provision Section/

Rule

Time Limit

Whether there is compliance of the provisions of the Act, requiring the company

not to participate in the publication of any advertisement of certain drugs which

suggest the use of the drug for the purposes of following nature:

(a) of the procurement miscarriage or prevention of conception in women or,

(b) maintenance or improvement of the capacity of human beings for sexual

pleasure or,

(c) the correction of menstrual disorder in women or,

(d) the diagnosis, cure, mitigation, treatment or prevention of any disease,

disorder or condition specified in the Schedule or,

(e) any other disease, disorder or condition which is provided for in the Rules.

Section 3 (a) (b)

(c), (d) and (e)

All Time

Whether there is compliance of the provisions of the Act, requiring the Company

not to take part in the publication of any advertisement relating to a drug if the

advertisement contains any matter which has the following implications relating

to the drug:

(a) directly or indirectly giving false impression regarding its true character or,

(b) making false claim for the drug; or

(c) false or misleading in any material particular

Section 4(a), (b)

and (c)

All time

Whether there is compliance in the provisions of the Act, requiring no person carrying

on or purporting to carry on the profession of administering magic remedies is taking

part in the publication of any advertisement referring to any magic remedy which

directly or indirectly claims to be efficacious for any purpose specified in Sec. 3 above?

Section 5 -

Whether there is compliance in the provisions of the Act, requiring no person to

import into and export from India, any documents containing any

advertisements of the nature referred to in Sec 3, or Sec. 4, or Sec. 5?

Section 6 -



Provision Section/

Rule

Time Limit

Whether or not the occupier/operator of an institution generating, collecting,

receiving, storing, transporting, treating, disposing and/or handling bio-medical

waste in any other manner is making an application to the prescribed authority

(State Pollution Control Board) for grant of authorization ?

Rule 7(a) At the earliest

Whether the application in Form 1 for grant of authorization is being

accompanied by a fee as may be prescribed by the government of the State of

Union Territory?

Rule 7 (c) -

Whether an annual report to the prescribed authority has been submitted, which

shall include information about the categories and quantities of bio-medical

wastes handled during the preceeding year?

Rule 9 Submission of

Annual Report on

January 30

Whether records have been mainatined relating to the generation, collection

,reception, storage , transportation, treatment disposal and/ or any form of

handling of bio-medical wastes have been complied with?

Rule 10 All Time

Whether reporting of any accident occurring at any institution or facility or any

other site where bio-medical waste is handled or during transportation of such

waste is made to the prescribed authority?

Rule 11 All Time

Whether a requisite bio-medical waste treatment facilities like icenerator,

autoclave, microwave system for the treatment of waste has been set up ?

Rule 4 (b) All Time

Whether Bio-medical waste has not been mixed with other wastes? Rule 5(a) All Time



Provision Section/

Rule

Time Limit

Whether Bio-medical wastes has been segregated into containers/bags at the

point of generation prior to storage, transportation, treatment and disposal?

The Lable shall be non-washable and prominently visible (Schedule III)

Rule 5(b) All Time

Whether a container being transported from the premises where bio medical

waste is generated to a waste treatment facility outside the premises is carrying

the "Label for Transport of Bio-medical Waste Containers/Bags" as per

Schedule IV?

Rule 5(c) All Time

Whether untreated bio-medical waste is being transported only in such vehicles

as may be authorized for the purpose by the competent authority as specified

by the government?

Rule 5(d)

All Time

Whether no untreated bio-medical waste is being kept/stored beyond a period of

48 hours?

Provided that if for any reason it becomes necessary to store the waste beyond

such period, the authorized person must take permission of the prescribed

authority and take measures to ensure that the waste does not adversely affect

human health and the environment.

Rule 5(e) All Time

Whether bio-medical waste is being treated and disposed of in accordance with

Schedule I and in compliance with the sandards prescribed in Schedule V ?

Link to Schedule I - http://dpcc.delhigovt.nic.in/bmwsch1.htm

Link to Schedule V - http://dpcc.delhigovt.nic.in/bmwsch5.htm

Rule 4(a) All Time

http://dpcc.delhigovt.nic.in/bmwsch5.htm

Legal Metrology Act, 2009

Relevant

Section/Rules

Periodicity Compliance Activity Consequences of

Non-Compliance

Section 8(3) Ongoing No weight, measure or numeral, other

than the standard weight, measure or

numeral, shall be used as a standard

weight, measure or numeral.

Section 25- Fine which may

extend to Rs. 25,000/- and for

second and subsequent

offence with an imprisonment

for a term which may extend

to 6 months or with fine or

with both.

Section 8(4) Ongoing No weight or measure, shall be

manufactured or imported unless it

conforms to the standards of weight or

measure specified under Section 8.

Section 27- Penalty for

manufacture or sale: Fine

which may extend to Rs.

25,000/- and for second and

subsequent offence with an

imprisonment for a term

which may extend to 3 years

or with fine or with both.

Section 39- Penalty for

import: Fine which may

extend to Rs. 50,000/- and for

the second and subsequent

offence, with an imprisonment

for a term which may extend

to 1 year and also which fine.

Legal Metrology Act, 2009Relevant

Section/

Rules

Periodi

city

Compliance Activity Consequences of Non-

Compliance

Section 8(3) Ongoing No weight, measure or numeral, other than

the standard weight, measure or numeral,

shall be used as a standard weight, measure

or numeral.

Section 25- Fine which may extend to

Rs. 25,000/- and for second and

subsequent offence with an

imprisonment for a term which may

extend to 6 months or with fine or with

both.

Section 10 Ongoing Any transaction, dealing or contract in respect

of any goods, class of goods or undertakings


Rs. 10,000/- and for the second or

subsequent offence, with imprisonment

for a term which may extend to 1 year,

or with fine, or with

both.

Section 11 Ongoing No person shall, in relation to any goods,

things or service except in case of exports:

(a) quote, or make announcement of, whether

by word of mouth or otherwise, any price or

charge, or b)issue or exhibit any price list,

invoice, cash memo or other document, or

(c)prepare or publish any advertisement,

poster or other document, or

(d)indicate the net quantity of a pre-packaged

commodity, or (e)express in relation to any

transaction or protection, any quantity





or with fine, or with both.


Section/

Rules

Periodi

city


Compliance

Section 17 Ongoing Every manufacturer, repairer or dealer of

weight or measure shall maintain such

records and registers as may be prescribed.

The records and registers shall be produced

at the time of inspection to the authorised

person.

Section 31- Penalty for non-

production of documents: Fine which

may extend to Rs. 5,000/- and for the

second or subsequent offence, with


extend to 1 year and also with

fine.

Section 18 Ongoing No person shall manufacture, pack, sell,

import, distribute, deliver, offer, expose or

possess for sale any pre-packaged commodity

unless such package is in such standard

quantities or number and bears thereon such

declarations and particulars in such manner as

may be prescribed. Any advertisements

mentioning the retail sale price of a pre-

packaged commodity shall contain a

declaration as to the net quantity or number of

the commodity contained in the package in

such form and manner as may be prescribed.

Section 36- Declaration on the

packages not in conformity with the Act:

Fine which may extend to Rs. 25,000/-,

for the second offence, with fine which


subsequent offence, with a fine which

shall not be less than Rs. 50,000/- but

which may extend to Rs. 1,00,000/-or

with imprisonment for a term which may

extend to 1 year or with both.

Error in Net quantity: Fine which shall

not be less than Rs. 10,000/- but which


second and subsequent offence, with a

fine which may extend to Rs. 1,00,000/-

or with imprisonment for a term which

may extend to 1 year or with both


Section/

Rules

Periodi

city


Compliance

Section 19 Ongoing No person shall import any weight or

measure unless he is registered with the

Director in such manner and on payment of

such fees, as may be prescribed.

Section 38-Fine which may extend to



for a term which may extend to 6

months, or with fine, or with both.

Section 20 Ongoing No weight or measure, whether singly or as a

part or component of any machine shall be

imported unless it conforms to the standards of

weight or measure.

Section 39-Fine, which may extend to



for a term which may extend to 1 year

and also with fine.

Section 23 Ongoing Every person is required to hold a licence

issued by the Controller to manufacture, repair

or sell, or offer, expose or possess for repair or

sale, any weight or measure.

Section 45- Penalty for manufacture:

Fine which may extend to Rs. 20,000/-

and for second and subsequent offence,

with imprisonment for a term which may

extend to 1 year, or with fine, orwithboth.


Rs.5,000/- and for second and

subsequent offence, with an


extend to 1 year, or with fine, orwithboth.


Section/

Rules

Periodi

city


Compliance

Section 47- Tampering with License:

Fine which may extend to Rs. 20,000/-

and for second and subsequent

offence, with an imprisonment for a

term which may extend to 1 year, or

with both.

Section 30 Ongoing Not to sell any article or thing by weight,

measure or number, delivers or cause to be

delivered to the purchaser any quantity or

number of that article or thing less than the

quantity or number contracted for or paid for; or

not to render any service by weight, measure

or number, render that service less than the

service contracted for or paid for; or not to buy

any article or thing by weight, measure or

number, fraudulently receives, or cause to be

received any quantity or number of that article

or thing in excess of the quantity or number

contracted for or paid for; or not to obtain any

service by weight, measure or number, obtain

that service in excess of the service contracted

for or paid for.


Rs. 10,000/- and for second and



or with fine, or with both.

SECRETARIAL AUDIT OF PHARMACEUTICAL COMPANIES

THANK YOU

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