Post on 31-May-2020
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
SECRETARIAL AUDIT OF –
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
SECRETARIAL AUDIT OF –
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.
SECRETARIAL AUDIT OF –
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.
SECRETARIAL AUDIT OF –
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
SECRETARIAL AUDIT OF –
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
SECRETARIAL AUDIT OF –
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
Drugs and Cosmetics, 1940
(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
Drugs and Cosmetics, 1940
(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
Drugs and Cosmetics, 1940
(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
Drugs and Cosmetics, 1940
(Sales & Import)
Provision Section/
Rule
Name of
Register/ Form
Time Limit
Sale of Drugs
The Company is to obtain grant/renewal of licence for
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
The Company is to obtain grant/renewal of licence for
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
Drugs and Cosmetics, 1940
(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
Drugs and Cosmetics, 1940
(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 -
Bio-Medical Waste (Management
and Handling) Rules, 1998
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
Bio-Medical Waste (Management
and Handling) Rules, 1998
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
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
Section 28- Fine which may extend to
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
Section 29- Fine which may extend to
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.
Legal Metrology Act, 2009Relevant
Section/
Rules
Periodi
city
Compliance Activity Consequences of Non-
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
imprisonment for a term which may
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
may extend to Rs. 50,000/- and for the
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
may extend to Rs. 50,000/- and for the
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
Legal Metrology Act, 2009Relevant
Section/
Rules
Periodi
city
Compliance Activity Consequences of Non-
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
Rs. 25,000/- and for the second or
subsequent offence, with imprisonment
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
Rs. 50,000/- and for the second or
subsequent offence, with imprisonment
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.
Section 46- Fine which may extend to
Rs.5,000/- and for second and
subsequent offence, with an
imprisonment for a term which may
extend to 1 year, or with fine, orwithboth.
Legal Metrology Act, 2009Relevant
Section/
Rules
Periodi
city
Compliance Activity Consequences of Non-
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.
Section 30- Fine which may extend to
Rs. 10,000/- and for second and
subsequent offence, with imprisonment
for a term which may extend to 1 year,
or with fine, or with both.
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