The set of rules came into existence to regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing. In 1964The drugs belonging to the systems of Ayurveda, Siddha and Unani (ASU) Systems were brought within the purview of the D & C Act Categorisation of Ayurvedic products under three categories viz. 1.Ayurvedic supplements, 2.Ayurvedic cosmetics and 3. Ayurvedic extracts under Rule 158-B’

1. Dr.Bankimchandra
2nd PG Scholar

2.  History
 Amendments and Adaptations
 Definitions
 Recent Amendments In D & C Act
 Provisions relating to Ayurvedic, Siddha and Unani drugs
 Conclusion.

3.  British misrule-Providing poor healthcare system to Indian
citizens
 Observations made by-Drugs Enquiry Committee, Indian
Medical Association
 Reports in- Indian Medical Gazette during 1920-30
 1940 – Drugs and Cosmetics Act
 1945 – Rules under the Act
 1962 - The scope of the Drugs Act was extended to cosmetics
1962 and the title of the act was changed to ‘Drugs & Cosmetics Act’
 1964-The drugs belonging to the systems of Ayurveda, Siddha and
Unani (ASU) Systems were brought within the purview of the D & C
Act

4. 1.The Drugs (Amendment) Act, 1955
2. The Drugs (Amendment) Act, 1960
3. The Drugs (Amendment) Act, 1962
4. The Drugs and Cosmetics (Amendment) Act, 1964
5. The Drugs and Cosmetics (Amendment) Act, 1972
6. The Drugs and Cosmetics (Amendment) Act, 1982
7. The Drugs and Cosmetics (Amendment) Act, 1995
8. The Drugs and cosmetics (Amendment) Act, 2008

5. Chapter I (Section 1-4) –INTRODUCTORY
Chapter II (Section 5-7) –THE DRUG ADVISORY BOARD ,THE
CENTRAL DRUGS LAB. AND DRUG CONSULTATIVE
COMMITTEE
Chapter III (Section 16-33) –MANUFACTURE ,SALE AND
DISTUBUTION OF DRUGS AND COSMETICS
Chapter IV A-(Section 33B-33O) PROVISION RELATING TO
AYURVEDIC SIDDHA AND UNANI DRUGS
Chapter V –(Section -33P-38)
MISCELLLANEOUS
THE FIRST SCHEDULE
THE SECOND SCHEDULE

6.  To regulate the import, manufacture, distribution and sale of
drugs & cosmetics through licensing.
 Manufacture, distribution and sale of drugs and cosmetics by
qualified persons only.
 To prevent substandard in drugs.
 To regulate the manufacture and sale of Ayurvedic, Siddha and
Unani drugs.
 To establish Drugs Technical Advisory Board(DTAB) and Drugs
Consultative Committees(DCC) for Allopathic and all system of
medicine.

7. means—
(i) in relation to Ayurvedic, Siddha2 or Unani drug, the
Ayurvedic, Siddha or Unani Drugs Technical Advisory
Board constituted under section 33C; and
(ii) in relation to any other drug or cosmetic, the Drugs
Technical Advisory Board constituted under section 5;

8. (i) in relation to Ayurvedic, Siddha or Unani drug, a
Government Analyst appointed by Central Government or a
State Government under section 33F; and
(ii) in relation to any other drug or cosmetic , a
Government Analyst appointed by the Central Government
or a State Government under section 20;]

9. (i) in relation to Ayurvedic, Siddha or Unani drug, an
Inspector appointed by the Central Government or a
State Government under section 33G; and
(ii) in relation to any other drug or cosmetic, an Inspector
appointed by the Central Government or a State
Government under section 21;]

10. in relation to any drug [or cosmetic] includes any process
or part of a process for making, altering, ornamenting,
finishing, packing, labelling, breaking up or otherwise
treating or adopting any drug [or cosmetic] with a view to
its sale or distribution but does not include the
compounding or dispensing of any drug, or the packing of
any drug or cosmetic, in the ordinary course of retail
business; and “to manufacture” shall be construed
accordingly;

11. In this Act, unless there is anything repugnant in the
subject or context,-- “Ayurvedic, Siddha or Unani 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
Ayurvedic, Siddha6 and Unani (Tibb) systems of medicine,
specified in the First Schedule.

12. All medicines for internal or external use of human beings
or animals and all substances intended to be used for or in
the diagnosis, treatment, mitigation or prevention of any
disease or disorder in human beings or animals, including
preparations applied on human body for the purpose of
repelling insects like mosquitoes.

13. Any article intended to be rubbed, poured, sprinkled or
sprayed on, or introduced into, or otherwise applied to, the
human body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance, and
includes any article intended for use as a component of
cosmetic.

14. (a) If it is so coloured, coated, powdered or polished that
damage is concealed or if it is made to appear of better or
greater therapeutic value than it really is; or
(b) If it is not labelled in the prescribed manner.

15. (a) if it consists, in whole or in part, of any filthy, putrid or
decomposed substance; or
(b) if it has been prepared, packed or stored under insanitary
conditions whereby it may have been contaminated with filth or
whereby it may have been rendered injurious to health; or
(c) if its container is composed in whole or in part, of any poisonous
or deleterious substance which may render the contents injurious
to health.

16. if it is imported under a name which belongs to another
drug; or (b) if it is an imitation of, or a substitute for, another
drug or resembles another drug in a manner likely to deceive
or bears upon it or upon its label or container the name of
another drug

17.  In relation to Ayurvedic,Siddha or Unani Tibb systems of medicine all
formulations containing only such ingredients mentioned in the formulae
described in the authoritative books of Ayurveda, Siddha or Unani Tibb
systems of medicine specified in the First Schedule, but does not include a
medicine which is administered by parenteral route and also a formulation
included in the authoritative books as specified in clause.
 In relation to other system ,A drug which is a remedy or prescription
presented in a form ready for internal or external administration of human
beings or animals and which is not included in the edition of the Indian
Pharmacopoeia for the time being or any other Pharmacopoeia authorized
in this behalf by the Central Government.

18. In relation to any drug or cosmetic, it includes any
process or part of a process for making, altering,
ornamenting, finishing, packing, labelling, breaking up or
otherwise treating or adopting any drug or cosmetic with a
view to its sale or distribution but does not include the
compounding or dispensing of any drug, or the packing of
any drug or cosmetic, in the ordinary course of retail
business.

19.  —Whoever himself or by any other person on his behalf manufactures for sale or for
distribution any
 (a) Ayurvedic, Siddha or Unani drugs-
(i) deemed to be adulterated under section 33EE, or
(ii) without a valid licence as required under clause (c) of section
33EEC,
shall be punishable with imprisonment for a term which may extend to one year
and with fine which shall not be less than two thousand rupees;
 (b) Any Ayurvedic, Siddha or Unani drug deemed to be spurious under section 33EEA,
shall be punishable with imprisonment for a term which shall not be less than one
year but which may extend to three years and with fine which shall not be less than
five thousand rupees:
Provided that the Court may, for any adequate and special reasons to be mentioned in
the judgment, impose a sentence of imprisonment for a term of less than one year and
of fine of less than five thousand rupees; or

20. A) Advisory :
1)Drugs Technical Advisory Board-DTAB
2)Drugs Consultative Committee-D.C.C.
B) Analytical :
1)Central Drugs Laboratory - CDL
2)Drug Control Laboratory in states
3)Government Analysts
C) Executives :
1)Licensing authorities
2)Controlling authorities
3)Drug Inspectors

21. Functions:
To advise the Central Government and the State
Governments on technical matters to carry out the other
functions assigned to it by this Act.

22.  (i) theDirectorGeneral of Health Services ,exofficio;
(ii) the Drugs Controller, India ex officio;
(iii)the principal officer dealing with Indian systems of medicine in the Ministry of Health, ex-officio;]
(iv) the Director of the Central Drugs Laboratory, Calcutta, ex officio;
(v) Government Analyst under section 3F,to be nominated by the Central Government.
(vi) one Pharmacognocist to be nominated by the Central Government;
(vii) one Phyto-chemist to be nominated by the Central Government;
(viii) four persons to be nominated by the Central Government, two from amongst the members of the Ayurvedic
Pharmacopoeia Committee, one from amongst the members of the Unani Pharmacopoeia Committee and one from
amongst the members of the Siddha Pharmacopoeia Committee;]
 (ix)one teacher in Dravyaguna and Bhaishajya Kalpana, to be nominated by the Central Government;
 (x)one teacher in Ilm-Ul-Advia and Taklis-Wa-Dawa-sazi,to be nominated by the Central Government;
 1[(xi) one teacher in Gunapadam to be nominated by the Central Government;
 (xii) three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the
Central Government;
 (xiii) three persons, one each from among the practitioners of Ayurvedic, Siddha and Unani Tibb system of medicine
to be nominated by the Central Government.]
 (3) The central Govern

23. Director General of Health Services
Drugs Controller, India ex officio
Principal officer dealing with Indian systems
of medicine in the Ministry of Health, ex-
officio
Director of the Central Drugs Laboratory, Calcutta, ex officio
Government Analyst under section 3F
Pharmacognocist
Phyto-chemist
Pharmacopoeia Committee of. Ayurveda(2) Unani(1) Siddha(1)
Ilm-Ul-Advia and Taklis-Wa-Dawa-sazi Teacher
Gunapadam Teacher
Teachers in Dravyaguna& Bhaishajya
Kalpana
Drug industrials of Ayurveda, Siddha, Unani
Practitioners of Ayurveda, Siddha, unani

24.  The central Government shall appoint a member of the Board as its Chairman.
 The nominated members of the Board shall hold office for three years but shall be
eligible for re nomination.
 The Board may, subject to the previous approval of the Central Government, make
bye- laws fixing a quorum and regulating its own procedure and conduct of all
business to be transacted by it.
 The functions of the Board may be exercised notwithstanding any vacancy
therein.
 The Central Government shall appoint a person to be Secretary of the Board and
shall provide the Board with clerical and other staff

25. It is also an advisory body constituted by central government.
 Constitution:
Two representatives of central Government.
One representative of the of each State Government.
Functions:
 To advise the Central Government, the State Governments and the
Drugs Technical Advisory Board on any other matter tending to
secure uniformity throughout India in the administration of this Act.
The Drugs Consultative Committee shall meet when required
 Has power to regulate its own procedure.

26.  Central Government may constitute an Advisory Committee to be called the
Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise the
Central Government, the State Governments and the Ayurvedic, Siddha and
Unani Drugs Technical Advisory Board on any matter for the purpose of securing
uniformity throughout India in the administration of this Act in so far as it relates
to Ayurvedic, Siddha or Unani drugs.
The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of
two persons to be nominated by the Central Government as representatives of that
Government

27. Introduction
 If one goes through the history of drug legislations of various countries, it can be
learnt that, the legislations were enacted essentially to stop distribution
deteriorated or adulterated drugs in to the market.
 The oldest drug legislation is ‘Drug Legislation of the United States of America’,
which was approved during 1848. Followed by approval of food and drug laws (in
1906) under Federal Food and Drug Act (FDA), recognition of National Formulary
(NF) and the United States Pharmacopoeia (USP) as the official standards for
drugs has taken place.
 Many amendments were made in FDA and in 1963 the first GMPs were
published. The drugs further being manufactured were required to meet the
standards set out therein. Most of the drug legislations of different countries
followed this approach.
Indian Scenario
 Quality, safety and efficacy of drugs has always been a matter of concern for public
even in India.
Dr Galib Ruknuddin, Assistant Professor,
Dept. of Rasa Shastra & Bhaishajya Kalpana, Institute for
Post Graduate Teaching & Research in Ayurveda, Gujarat
Ayurved University, Jamnagar, Gujarat, India.

29. Ayurvedic,Siddha and Unani Drugs Technical Advisory Board
 Function -to advise the Central Government and the State Governments on
technical matters arising out of this Chapter and to carry out the other functions
assigned to it by this Chapter

30. This schedule holds a list of 98 books of different systems of medicines as
mentioned here: Ayurveda -54
Unani. -30
Siddha. -14
The list of scheduled books under Ayurvedic system of medicine holds 54
books. In addition to this, 54-A, B & C have also been added in
consecutive amendments, which includes Ayurvedic Formulary of India
(AFI), Ayurveda Sara Sangraha and Ayurvedic Pharmacopoeia of India
(API) respectively.
All successive volumes / parts being published under AFI and API will
become a part of Schedule - I automatically. This amendment is even
applicable to other systems of medicines (Siddha and Unani) too.

31. Shelf life is the length of time that a substance can be
considered as suitable for sale or consumption.
Information pertaining to shelf life of different
formulations does exist in classics of Ayurveda, which is
scattered. This information has been gathered and explained
under the umbrella of “Saviryata Avadhi” by Acharya
Sharangadhara (I-1/51-3) for the first time. According to him;
the shelf life of different dosage forms is described

33.  Few substances being used in the preparation of formulations under ASU systems
have been identified as poisonous and been categorized under Schedule E (1). An
amendment in this regard has been released during August 2010 making certain
changes in the list.
The numbers of substances under individual groups are as under.
Category 1970 2010
Herbal 15 13
Animal 01 01
Mineral 09 07
Total 25 21

35. Omission: The seeds of two herbal sources (Ahiphena and Bhanga)
have not been considered as poisonous.
 One herbal source i.e. Snuhi has been omitted from the list.
Two minerals i.e. Sindura and Girisindura have been omitted from
the list.
 Other Amendments:
 Only the seeds of Gunja and Jayapala have been considered as
poisonous.
 Vatsanabha and Shringivisha both have been grouped under
one.
  The chemical composition of Haratala and Manahshila has
been specified clearly.
 The botanical identity of Parasika Yavani has been changed from
Hyoscyamus inibar Linn to Hyoscyamus niger Linn

36. Permissible excipients for manufacturing of ASU
formulations [RULE- 169]: A Gazette has been notified
during July 2001 permitting preservatives, excipients etc.
for Patent and Proprietary ASU Formulations.
Additionally, it has been mentioned that, no patent or
proprietary ASU formulation should contain preservatives,
excipients, coloring and flavoring agents other than the
specified ones in the Gazette.

38. The ASU and other traditional medicines have
been categorized in to the following four
categories:
1. ASU Drugs.
2. Patent or Proprietary ASU Drugs.
3. Indian Ethno medicine based drugs not covered
under I & II
4. Medicines based on Extracts of Medicinal
Plants of India.

39. Good Clinical Practice (GCP)
It is a set of guidelines which
encompasses the design, conduct, termination,
audit, analysis, reporting and documentation
of the studies involving human subjects.

40.  In addition to this, the Gazette also holds information on the required
data to be submitted while conducting clinical trials with ASU
Medicines. The below data needs to be provided:
1. Introduction
2. Information on the formulation
3. Experimental Pharmacology (if required) 
4. Safety Data
5.Investigator Brochure
6. Protocol
7. Case Report Form
8.Patient Information Sheet
9.Informed Consent Form (in English & Local Language)

41. In 1964The drugs belonging to the systems of Ayurveda, Siddha and Unani (ASU)
Systems were brought within the purview of the D & C Act
Categorization of Ayurvedic products under three categories viz. 1.Ayurvedic
supplements, 2.Ayurvedic cosmetics and3. Ayurvedic extracts under Rule 158-B’ etc.
For the administration of the act and rules govt. designed 1.Advisory board
2.Analytical Board 3. Executive board.
Recent Amendments In D & C Act With Reference To Ayurvedic Drug Industry
includes
The list of books. ,Shelf life of ASU Drugs
Poisonous Substances under ASU Systems of Medicine
Permissible excipients for manufacturing of ASU formulations
Guidelines for evaluation of ASU Drugs & Other Traditional Medicines of India
Requirements and Guidelines for permission to manufacture of ASU Drugs for Sale
or to undertake clinical trials