Regarding drugs and cosmetics

1. Compiled by : Harshita salhotra
Submitted to : DR Aman jot

2.  History
 Drugs and cosmetics act, 1940
 Objectives
 Administrator of the act and rules
 Provision of the act
 Amendments

3.  British misrule –providing poor healthcare system to India citizens
 Observations made by –Drugs enquiry committee, India medical association
 Reports in- India medical gazette during 1920-30
 1940- Drugs and cosmetics act
 1945-rules under the act

4.  Drugs and cosmetics act ,1940 is an act of the
parliament of the India which regulates the import,
manufacture and distribution of drugs in India .
 This act was passed in 10th April,1940.
 The primary objective of the act is to ensure that the
drugs and the cosmetics sold in India are safe effective
and confirm to state quality standards.
 The related drugs and cosmetics rule in 1945 contains
provision for classification of drugs under given
schedule and there are guidelines for the storage,
display and prescription of each schedule.
 It has 5 chapters and 38 sections.

5.  The original act was prepared in accordance to the recommendation
of the Chopra committee formed in 1930 .
 The term “drug” as define in the act includes variety of substance such
as, diagnostic and medical devices.
 And the act defines” cosmetic”as any product that is meant to be
applied to the human body for the purpose of beautifying or cleansing.
 In 1964 the act was amended which include Ayurveda and Unani
drugs.

6.  The section 16 of the act defines the standards of quality for drugs
 The section 17 defines “Misbranding”.
 Section 27 deals with fake and adulterated drugs .
 Section 22 define the power of the drug and inspectors.
 Section 23 define district procedures which should be followed by the inspector
during any raids.

7. MISBRANDED DRUGS ;
If its label or container accompaning the drug design which makes any false claim for
the drug is called misbranded drugs.
SPURIOUS DRUGS;
If it is imported under a name which belongs to another drug is called spurious drug.
ADULTRATED DRUGS;
Any poisonous substance that may render the contents injurious to health.

8.  The primary objective of the act is to ensure that the drugs and cosmetics sold in India are
safe and effective and confirm to prescribed quality standards.
 To prevent suspended in drugs for treatment and maintaining high standards of medical
care.
 Manufacture,distribution and sale of drugs and cosmetics by qualified person only.
 To regulate the import,manufacture ,distribution and sale of drugs and cosmetic through
licensing.
 To regulate the manufacture and sale of ayurvedic, Unani,siddha and homeopathic drugs.
 To establish drugs technical advisory board and drug consulative committee.

9. ADVISORY :
 Drug technical advisory board-DTAB
 Drug consulative Committee-D.C.C
ANALYTICAL :
 Central drug laboratory-CDL
 Drug control laboratory in states
 Government analyst
EXECUTIVES:
 Lisensing authorities
 Controlling authorities
 Drug inspector

10.  Central govt. appoints DTAB to advice the central and state govt. on technical matters
arising out of the administration of this act .
CONSTITUTION OF DTAB ;
EX OFFICIO MEMBERS
1 drug controller of india
2 president, pharmacy counsil of india
NOMINATED MEMBERS
1Two govt analyst

11.  The central govt. may constitute an advisory committee to be called ‘the drug
consulative committee’ to advice the central govt. the state govt. and the DTAB on any
matter tending to secure uniformly throughout india in the administration of this act .
CONSTITUTION OF DCC;
1 the drug consulative committee shall consist of ;
*two representatives of the central govt.
*one representatives of state govt.

12. *To analyze the sample of drugs or cosmetics send to it by;
1a custom collector or any authorized officer
2 by court
* To carry out such duties as may be assigned to it by central govt. with the permission
of central govt. after consultation with DTAB

13.  every state has a laboratory for the analysis and testing of the drugs and cosmetics
manufactured or sold in that particular area
 Samples send by drug industry are analyzed by such laboratories
 Also analyzed the drugs send by any person or purchaser

14.  Means ..
In relation to ayurvedic ,siddha or unani drugs a person appointed by central or state
govt. under section 33-F
In relation to any other drugs or cosmetics a person appointed by cental or state govt.
under section20
DUTIES OF GOVERNMENT ANALYST ;
* To cause testing of sample of drugs or cosmetics sent to him by drug inspectors and
furnish as per rules

15.  Means
In relation to a ayurvedic,siddha,unani drug,an inspector appointed by the central
government or a state government under section33G and
In relation to any other drug or cosmetics,an inspector appointed by the central govt. or a
state govt. under section 21
POWER OF DRUG INSPECTORS ;
1 Inspect
2 take samples of any drug or cosmetic
3enter and search
4 stop and search
5Give order in writing
6examine

16.  It means a license issued by the licensing authority to a applicant who does not have
its own arrangements for manufacture but who intends to avail himself of the
manufacturing facilities owned by another licensee

19.  Classes of drugs prohibited to imported :
1 misbranded drugs
2Adulterated drugs
3 Spurious drugs
 Import of drugs under Lisensing
A.(Specified in schedule C/C1)
1 License must have adequate facility of the storage
2 License must maintain the record of the sale
3 License must furnish the sample to the authority
B .(Specified in schedule –X)
1 License must have adequate storage facility

20. C.(Imported for test/analysis)
1 License is necessary under form-11
2 must keep the record with the name of the manufacturer and date of import
D.(Imported for personal use)
1 Drug must be bonafide personal use
 Offences and Penalties

22.  Prohibition of manufacture
1 Drug of not standard quality
2 Drug in schedule-j
3 Risky to human beings or animals
 Manufacture of Other than in Schedule-c/c1
1 Maintain reference samples for each batch
2 should provide samples to authority
 Manufacture of drugs in schedule c/c1
1 Tests for sterelity should be carried out
 Manufacture of schedule X-Drugs
1 preparations must be labelled with XRx

23.  Loan license
(Defination)
A applicant who does not have its own Factory For
manufacturer But,who wish to manufacturing Facility
owned By other license.such License are called loan
license.
Loan license are issued for :
1 Drugs other than specified in schedule C/c1
 Repacking License
(Defination)
Process of breaking up any drug from bulk Container into
small packages and labelling With a view To their sales and
distribution

24.  Penalties related to manufacture

25.  Manufacture of cosmetics:

28.  Sale of Drugs
1 classes of drugs prohibited to be sold
2 wholesale of biological (c/c1)
 Retail sale
For retail sale ,2 types of license are issued;
- General License
- Restricted License

34. The act has been amended server times .the following are a list of amending acts.
 The drugs (amendment) act,1960
 The drugs (Amendment) act,1962
 The drugs and cosmetics (Amendment) act,1964
 The drugs and cosmetics (Amendment) act,1972
 The drugs and cosmetic (Amendment) act, 1982
 The drugs and cosmetic (Amendment) act, 1986
 The drugs and cosmetic (Amendment) act, 1995
 The drugs and cosmetics (Amendment) act, 2008

35. Salient features of the act:
 The below provisions of license certificates of renewal have been omitted by
amendments rule
 The provisions of renewal have been incorporated in form 24C’HOMOEOPATHIC
MEDICINES’
 The insertion of rule 77 and rule 82 to add more clarification regarding ‘duration of
licenses’