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					DRUGS AND COSMETICS ACT 1940

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HISTORICAL PERSPECTIVE
 In the beginning of the current century Drug

Industry was practically non-existent in India and pharmaceuticals were being imported from abroad  The first world war changed the situation and not only were finished and cheap drugs imported in increasing volume, the demand for indigenous products also was voiced from all sides.

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HISTORICAL PERSPECTIVE (Cont.)
 Indian and Foreign sprang up to produce

pharmaceuticals at cheaper rates to compete with imported products Naturally some of these were of inferior quality and harmful for public health  The Government was, therefore, called upon to take notice of the situation and consider the matter of introducing legislation to control the manufacture, distribution and sale of drugs and medicines.

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 Safety of a new molecule is a pre-requisite for obtaining

a marketing approval  Clinical research is currently in the news for its immense business potential in India  “Safety” consideration must take precedence over the “Efficacy” consideration of NCE  The only aim of these directives is to safeguard the rights and wellbeing of the trial subjects.

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ACTS
 Two of the laws  The Poisons Act -1919  The Dangerous Drugs Act 1930

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.
   

PRESENT ACTS AND RULES

The Drugs and Cosmetics Act, 1940 The Pharmacy Act, 1948 The Drugs and Magic Remedies Act, 1954 The Narcotic Drugs and Psychotropic Substances Act, 1985  The Medicinal and Toilet Preparations Act, 1956  The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act)

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PHARMACY ACT
The Pharmacy Act was passed in 1948 and was amended in 1959, 1976 and 1984. The aim of this law is to regulate the profession of Pharmacy in India.

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SOME OTHER LAWS
 There are some other laws which have a bearing    

on pharmaceutical manufacture, distribution and sale in India. The important ones being: The Industries (Development and Regulation) Act, 1951 The Trade and Merchandise Marks Act, 1958 The Indian Patent and Design Act, 1970 Factories Act

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Act 1954

 This Act is meant to control the Advertisements

regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities and to provide for matters connected therewith.

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The Narcotic Drugs and Psychotropic Substances Act, 1985

 This is an Act to consolidate and amend the law

relating to Narcotic Drugs, to make stringent provisions for the control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances and for matters connected therewith.

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DRUG ENQUIRY COMMITEE
 The Indian Government appointed, in 1931, a Drugs

Enquiry Committee under the Chairmanship Lt. Col. R. N. Chopra which was asked to make enquiries into the whole matter of drug production, distribution and sale by inviting opinions and meeting concerned people.

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DRUGS ENQUIRY COMMITEE
 As per recommendations of the Chopra Committee,

the govt. of India passed the Drugs and Cosmetics act 1940.  In 1945 the rules were framed to give effect to the provisions of the Act.  Both the Act and the Rules came into force from April 1947.

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COSMETICS ACT, 1940
 An Act to regulate import, manufacture, distribution

& sale of drugs and cosmetics
 Passed by the Indian Parliament  It extends to the whole of India

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DRUG
 “Drug” includes all medicines intended for

internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of medicine.

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TERMINOLOGY
 Act: A law or formal decision made by a

Parliament or other group of elected lawmakers.  Rule: an accepted principle or instruction that states the way things are or should be done, and tells you what you are allowed or are not allowed to do.

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MAIN FEATURES OF DRUG CONTROL
 Control on import  Licensing and inspections (import and

manufacture)  Rules for labeling, packaging, and storage  Penal provisions of act and rules ( prosecutions, confiscations, suspension and cancellation)

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CONTROL ORGANISATIONS
 Central Drug Standard Control Organization

(CDSCO)  State Drug Control Organizations (SDCO).

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CONTROL ORGANISATION (CDSCO)
 Headed by DCGI.
 Assisted by deputy Drug Controller.  Assistant Drug Controller.  Technical Officers.  Assistant secretary for revision of Pharmacopoeia.

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RESPONSIBILITIES OF CDSCO
   

1. Maintain Quality of Drugs. CDL Kolkata tests antibiotics, vitamins etc CRI Kasauli tests sera, vaccines, toxoids,. IVRI Izzatnagar tests veterinary biological products. Central Drug testing Labs

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RESPONSIBILITIES OF CDSCO
2. Approval of new drugs. 3. Arranging meetings.( DTAB and DCC ) 4. Approval for License for manufacture of blood and blood products.

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STATE DRUG CONTROL ORGANISATION
 Controls manufacture , sale and distribution of drugs

in its territory.  Headed by State Drug Controller.  Deputy Drug Controller.  Drug Inspectors.

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STATUTORY BODIES
1.Drug Technical Advisory Board  Comprises 18 members  Advice Central and State govt. about technical matters arising out of Drug Control

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STATUTORY BODIES ( Cont.)
2.Drug Consultative Committee
 Comprises 2 representatives of Central Government

and one from each state.  Enforces Drug Control measures in States.  Mainly concerned with framing of rules for all India implementation.

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SCHEDULES TO THE ACT
 Schedule A: Applications and Licenses.  Schedule B: Fees paid to the central Drug Labs  Schedule C: Biological , immunological,

ophthalmic, Antibiotics, Parenterals.  S- CI: Drugs for oral use  S – D: Exemptions granted to drugs.

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SCHEDULES TO THE ACT
 S- DI: Information submitted by

manufacturer abroad for import of drugs to india.  S– DII: Information submitted by manufacturer for bulk drugs.  S- EI : Poisonous substances under Unani,Ayurvedic and Siddha system.

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SCHEDULES TO THE ACT
 S- F: Requirements for running blood    

banks. S- FI: Manufacture Labeling and testing of Veterinary products. S- FII: Standards for surgical dressings. S- FIII: Standards for umbilical tapes. S- FF: Additional standards for ophthalmic products.

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SCHEDULES TO THE ACT
 S- G: Drugs used under medical

supervision and labeled with “CAUTION”.  S- H: Drugs to be sold under prescription of Medical Practitioner.  S- J: Name of the diseases/ailments which a drug may not purport to prevent or cure by means of claims made on the label of the container.

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SCHEDULES TO THE ACT
 S- K: Name of drugs exempted from    

certain provisions. S- M: GMP. S- MI: Factory premises for Homeopathic drugs. S- MII: Factory premises for manufacture of cosmetics. S- MIII: Factory premises for manufacture of medical devices drugs.

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SCHEDULES TO THE ACT
 S- N: requirements for running Pharmacy  S- O: Standards for disinfectant fluids  S- P: Life period, storage conditions.  S- Q: coal tar colors used in drugs.  S- R: Standards for mechanical

contraceptives.  S- RI: standards for medical devices.

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SCHEDULES TO THE ACT
 S- S: standards for cosmetics.  S- T: Factory premises and hygiene conditions for

Ayurvedi, unani and Siddha drugs.  S- U : Particulars to be shown in the manufacture records, raw material records and analytical records.

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SCHEDULES TO THE ACT
 S- V: Standards for patent and proprietary drugs.  S- X: Name of psychotropic drugs for which

special control measures have to be taken.  S- Y: Requirements and guidelines on clinical trials for import and manufacture of drugs.

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APPLICATIONS AND LICENSES
1.   

FOR IMPORT Form 8:Application made to the DCGI for import of drugs other than Schedule-X. Form 8A: Application made to the DCGI for import of drugs in Schedule-X Form 9:Undertaking signed by the manufacturer abroad.

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APPLICATIONS AND LICENSES
 Form 10:Import license granted by DCGI for

import of drugs other than S-X.  Form 10 A:10:Import license granted by DCGI for import of drugs in S-X.  Form 40:Application made to DCGI for the issue of registration certificate

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APPLICATIONS AND LICENSES
 Form 44:application made to DCGI for import

and manufacture of new drug or to undertake trial.  Form 45:Approval to import finished formula of the drug.  Form 45A:Approval to manufacture raw material.  Form 46:Approval to manufacture new drug formulation.

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IMPORT OF DRUGS
 Drugs of standard quality are imported.  License for import of drugs (finished or bulk).

 Importer applies to DCGI.
 Manufacturers undertaking attached in form 9.  License for drugs of examination in form 11..

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NEW DRUGS
 Whose medicinal properties have been recently

discovered.  Control on new drugs to ensure innovator makes no false claims, and permit use of drugs whose safety and efficacy is well documented.  Drug is considered new up to four years from its approval.

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NEW DRUGS
 a)

b)

Under section 122A:Application for the permission for import of new drugs. No new drug shall be imported except under and in accordance with the permission granted by the licensing authority. An application for grant of permission is done through form 44.

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NEW DRUGS
 Section 122B. Application for approval to

manufacture new drug other than the drug classifiable under S- C and S- CI. a) No new drug shall be manufactured for sale unless it is approved by the licensing authority.

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NEW DRUGS
b) Application for grant of license is made in form 44. c) Permission issued in form 46 and 46A.

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NEW DRUGS
 Section 122D. Permission to import or

manufacture fixed dose combination inform 44 with fee of 50 k.  The licensing authority after being satisfied issues permission in form 45 or form46

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NEW DRUGS


a)
b)

Section 122DA. Application for permission to conduct clinical trials for new drug. No clinical trial to be conducted without the permission of licensing authority. Applications for grant of permission to conduct i) Human clinical trials (Phase I) in form44

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NEW DRUGS
ii) Exploratory clinical Trials ( Phase II) on a new drug shall be made on the basis of data emerging from Phase I trials. iii) Confirmatory Clinical Trials ( Phase III) made on the basis of data of Phase II.  Licensing authority after satisfied grants permission in form 45 0r 46.

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EXPORT
 Comply with the specifications of law of that

country.  Particulars on the label: i) Name of the Drug ii) Name & address of the Manufacturer iii) Batch No. iv) Exp. date

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EXPORT( cont)
v) Code ( Provision introduced in 1988, except for S- X, sera, vaccines, vet. Products and blood products)
 Certification of products to be exported done by State

and Central drug inspectors.

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EXEMPTIONS FROM DRUG AND COSMETICS ACT
Import  Drugs not for medical use  Articles of food/ drugs Manufacture  Drugs not sold for medical use  Quinine selling  RMP selling drugs to patients  Hospital and dispensaries need no sale license  Insecticides

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THE DRUGS AND COSMETICS ACT, 1940(AMMENDMENTS)
 The Drugs (Amendment) Act, 1955,
 The Drugs (Amendment) Act, 1960,  The Drugs (Amendment) Act, 1962,  Drugs and Cosmetics (Amendments)

Act, 1964,  The Drugs and Cosmetics (Amendments) Act, 1972,

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AMMENDMENTS
 The Drugs and Cosmetics (Amendments) Act,

1982,  The Drugs and Cosmetics (Amendments) Act, 1986 and  The Drugs and Cosmetics (Amendments) Act, 1995.

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 With the latest amendment (dated 20th Jan 2005) to the

Schedule Y of Drugs and Cosmetic Act 1945, the reporting of adverse events from clinical trials has become clearer and unambiguous

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 Old Schedule Y : “Any unusual, unexpected or serious

adverse reaction to be communicated promptly to the local regulatory authority”  New Schedule Y : All „unexpected SAEs‟ within 14 calendar days would be communicated to the local regulatory authority & other participating investigators”.

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THANK YOU

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