The document discusses key provisions of the Drugs and Cosmetics Act related to Ayurvedic, Siddha, and Unani (ASU) drugs in India. It outlines (1) how ASU drugs were included under the Act in 1964 with the insertion of Chapter IVA, (2) the roles of bodies established under the Act such as the ASU Drugs Technical Advisory Board and Drugs Consultative Committees, and (3) definitions and penalties related to misbranded, adulterated, and spurious ASU drugs. The schedules list authoritative books and standards for ASU drugs covered under the Act.

1. HAKIM MOHD AKHTAR ALI
( M D I L M U L S A I D L A )
A S S I S TA N T P R O F E S S O R
D E PA RT M E N T O F I L M U L S A I D L A
ZH U N A N I M E D I C A L C O L L E G E & H O S P I TA L ,
S I WA N
Drug & Cosmetic Act in
respect to Unani Medicine

2. OBJECTIVES
To regulate the import, manufacture, distribution and sale of
drugs and cosmetics through licensing.
Manufacture, distribution and sale of drugs and cosmetics by qualified
persons only.
To control the manufacture, import and sale of ASU drugs.
To establish Drugs TechnicalAdvisory Board(DTAB) and
Drugs Consultative Committees(DCC).
To secure the maintenance of uniformity in standard of ASU
drugs

3. Introduction
 During 1920-1930 there were number of reports of
harmful substitutes and adulterants being marketed in
place of genuine drugs and toxic effects of such drugs
were published in Indian press from time to time.
 In the absence of effective Acts and Rules related to
drugs and pharmaceuticals in the country, there was a
rat race for manufacturing of sub-standard, spurious and
adulterated formulations.

4. Cont……
 On 11th August, 1930, Drugs Enquiry Committee
(D.E.C.) was constituted under the Chairmanship of Col.
R. N. Chopra.
 The Committee submitted its report in 1931. Finally, in
1940 The Drugs Bill was introduced in the Parliament,
based on the recommendation of D.E.C and after in-depth
deliberations.

5. Cont……
 The Drugs Act, 1940 was enacted which was latter
amended to the Drugs and Cosmetics Act, 1940.
 The Rules were framed under this Act in 1945.
 Drugs and Cosmetics Act, 1940 is extended to whole of
India.

6. Content

7. Chapter I
is an Introductory chapter, contains mainly
definitions of
Drug,
Cosmetics,
ASU drugs,
Inspector,
Manufacturer etc.

8. Chapter II
 is about
Drugs Technical Advisory Board,
Central Drugs Laboratory and
Drugs Consultative Committee.

9. Chapter III, IV & V
 Chapter III contains 13 sections which deal with the
import of drugs and cosmetics.
 Chapter IV contains provisions relating to
manufacture, sale and distribution of drugs and
cosmetics.
 Chapter V is miscellaneous.

10. Chapter IV (A)
 Ayurvedic and Unani Drugs were included under the
purview of Drugs and Cosmetics Act by an amendment
in year 1964.
 Among the five chapters, the provisions relating to
Ayurvedic, Siddha and Unani Drugs are mentioned in
chapter IV (A).

11. Cont...
In 1964, the act was amended to include ASU
drugs
ASU Medicines covered under the Act by
inserting Chapter IVA.
Came into force : 1stFebruary 1983.
GMP enforced : 7thMarch 2003.

12. Drugs & cosmetics
Act
Chapter 1
Chapter
IVA
Rul
e
Part XVI
(151-160)
Part XVIA
(160A-
160J)
Part VII
(161-
161B)
Part VIII
(162-167)
Part IX
(168-
169)

13. CHAPTER 1 (SECTION-3)
 Definitions-
(a) Drugs:
 Ayurvedic, Siddha or Unani Drugs” 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, manufacture] exclusively in
accordance with the formulae prescribed in the authoritative
books of [ASU systems of medicine, specified in the First
Schedule].
(aa)“the Board” means:
 In relation to ASU drug, the [ASU Drugs TechnicalAdvisory
Board] constituted under section 33C.

14. Cont…..
 (aaa)Cosmetics:
 Any article intended to be rubbed , poured , sprinkled or sprayed on, or
introduced into, or applicated to the human body or any part there of
for cleaning, beautifying, promoting attractiveness, or altering the
appearance.
 (c) Government Analyst means:
 In relation to ASU drug, a Government Analyst appointed bythe
Central Government or a State Government under section 33-F.
 (e) Inspector means:
In relation to ASU drug, an Inspector appointed by theCentral
Government or a State Government under section 33-G.

15. CHAPTER IVA (PROVISION RELATED TOASU DRUGS)
• Section33(B) Application of chapter IVA
• Section33(C) ASU drugs technical advisory board
• Section33(D)ASU drugs consultative committee
• Section33(E)Misbranded drugs
• Section33(EE) Adulterated drugs
• Section33(EEA) Spurious drugs
• Section33(EEB)Regulations of manufacture for sale of
ASU drugs

16. Drugs Technical advisory Board-DTAB
 Director General of health
 Drug Controller, India
 Principle officer of ISM
 Director of the Central drugs Laboratory
 GovernmentAnalyst
 Pharmacognocist
 Phyto-chemist
 4 person from ASU pharmacopeiacommittee
 1 teacher in Dravaguna
 1 teacher in Ilmul-advia
 1 teacher in Gunapadam
 3 person from ASU drugs industry
 3 practitioner of ASUmedicine

17. Drugs Consultative committee-DCC
It is also an Advisory Body consist of two representativecentral
 government to be nominated by Government .
One representative of each state Government to be nominated by
the State Government.
 Function
DCC to advise the Central Government, the State Governments
and the ASU-DTAB on any matter for the purpose of securing
uniformity throughout India in the administration of this Act in
so far as it relates to ASU drugs.
It shall meet when required.
It has power to regulate its own procedure

18. Cont…..
• Misbranded Drugs(33E)
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
valve.
If it is not labelled in the prescribed manner.
If its label or container or anything accompanying the drug bears
any statement, design or device which makes any false claim for
the drug or which is false or misleading in any particular

19. Adulterated Drugs (33EE)
 If it consists, in whole or in part, of any filthy, putrid or decomposed
substance.
 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
 If its container is composed, in whole or in part, of any poisonous
or deleterious substance which may render the contents injurious
to health
 If it bears or contains, for purposes of coloring only, a colour other
than one which is prescribed
 If it contains any harmful or toxic substance which may render it
injurious to health
 If any substance has been mixed therewith so as to reduce its
quality or strength.

20. Penalty of misbranded, adulterated & without a
valid licence
Imprisonment for a term which may extend to one year and
with fine which shall not be less than twenty thousand
rupees or three times the value of the drugs confiscated

21. Spurious Drugs (33EEA)
If it is sold, or offered or exhibited for sale, under a name which
belongs to another drug.
If it is an imitation of, or is an 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, unless it is plainly and
conspicuously marked so as to reveal its true character and its lack of
identity with such other drug.
If the label or container bears the name of an individual or company
purporting to be the manufacturer of the drug, which individual or
company is fictitious or does not exist.
If it has been substituted wholly or in part by any other drug or
substance
If it purports to be the product of a manufacturer of whom it is not
truly a product

22. Penalty of Spurious Drugs (33EEA)
 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 fifty thousand rupees or
three times the value of the drugs confiscated

23. Cont…..
• Section33(EEC) Prohibition of manufacture and sale
of certain ASU drugs
• Section33(EED) Power of central government to prohibit
manufacture, etc., of ASU drugs in public interest.
• Section33(F) Government analysts
• Section33(G) Inspectors
• Section33(H) Application of provision of section
22,23,24,25.
• Section33(I) Penalty for manufacture, sale, et,. Of ASU
drugs in contravention of this chapter.

24. Cont……
• Section33(J) Penalties for subsequent offences
• Section33(K) Confiscation
• Section33(I) Application of provisions to government
departments
• Section33(M) Cognizance of offences
• Section33(N)Power of central government to make rules
• Section33(O) Power to amend first schedule

25. Schedule
 In First Schedule the authoritative books of Ayurveda,
Siddha and Unani system of Medicine are mentioned.
Name of Books Name of Books
1- Qarabadin Qadri 8-Kitab-ul-Taklis
2-Qarabadin Kabir 9-Sanat-ul-Taklis
3- Qarabadin Azam 10-Mifta-ul-Khazain
4-Ilaj-ul-Amraz 11-Madan-ul-Aksir
5-Al Qarabadin 12-Makhzan-ul-Mufradat
6-Bayaz Kabir Vol. II 13-NFUM
7-Qarabadin Jadid 14-UPI

26. Second Schedule
 The Second Schedule deals with the standards to be
complied with by imported drugs and by drugs
manufactured for sale, stocked or exhibited for sale or
distributed.

27. GOVERNMENTANALYST
These officers are appointed by the Central or State
Government and perform the duties.
Persons having Qualification for appointments as
government as governmental analysis for drugs;
Must have a degree in Medicine/Ayurveda/Sidha/Unani
system and not less than 3 year post graduate
experience in the analysis of drug.

28. Cont……
 Duties of GovernmentAnalyst
Analyzed or tested such sample or drugs and
cosmetics may be sent to him by Inspectors.
Timely forward reports to the Government giving the
results of analytics work.

29. LICENSINGAUTHORITY
 Qualification:
 All member should be Graduate in Pharmacy on Pharmaceutical Chemistry or
in Medicine with Specialization in Clinical pharmacology or microbiology.
 5 year Experience in manufacture or testing of a drugs.
 Duties:
 To inspect all establishments licensed for the sale of drugs within the
area assigned to him.
 To send for test or analysis.
 To investigate any complaint.
 To maintain a record of all inspections made by him.
 To maintain a record of action taking by him in the performance of his duties.

30. Drug Inspector
 Qualification
 Has degree in Ayurvedic or Siddha or Unani system or a degree in
Ayurveda Pharmacy, as the case may be, conferred by a University or a
State Government or a Statutory Faculty, Council or Board of Indian
Systems of Medicine recognized by the Central Government or the
State Government.
 Has a diploma in Ayurveda, Siddha or Unani System, as the case
may be, granted by a State Government or an Institution recognized
by the Central Government or a State Government for this purpose).
 Who have not less than 18 months’ experience in testing of at least
one of the substances in Schedule C in a laboratory approved for
this purpose by the licensing authority.
 Who have gained experience of not less than three years in the
inspection of firm manufacturing any of the substances specified in
Schedule C

31. Function of Drug Inspector
 Inspection of all area where the drug and cosmetics
are being manufactured/sold/stocked.
 Take sample of any drug and cosmetic are being
manufactured/sold/stocked

32. PART XVI
 Manufacture for Sale of Ayurvedic (Including Siddha) or
Unani Drugs
 151. Manufacture on more than one set of premises
 152. Licensing Authorities
 153. Application for licence to manufacture Ayurvedic
(including Siddha) or Unani drugs

33. Cont…..
 153A. Loan Licence
 154. Form of license to manufacture Ayurvedic (including
Siddha) or Unani drugs
 154A. Form of loan license to manufacture for sale of
Ayurvedic (including Siddha) or Unani drugs
 155. Certificate of renewal
 155A. Certificate of renewal of a loan license
 155B. Certificate of award of G.M.P. of Ayurveda, Siddha and
Unani Drugs
 156. Duration of licence
 156A. Duration of loan license

34. Cont…..
 157. Conditions for the grant or renewal of a license in
Form 25-D
 157A. Maintaining of records of raw material used by
licensed manufacturing unit of Ayurveda, Siddha and
Unani drugs in the preceding financial year
 158. Conditions of licence
 158(B) Guidelines for issue of license with respect to
Ayurveda, Siddha or Unani drugs
 159. Cancellation and suspension of licenses
 160. Identification of raw materials

35. PART XVII
 Labelling, Packing And Limit of Alcohol in] Ayurvedic
(Including Siddha) or Unani Drugs
 161. Labelling, packing and limit of alcohol
 161A. Exemption in labeling and packing, provisions for
export of Ayurvedic (including Siddha) and Unani drugs
 161B. The date of expiry of Ayurveda, Siddha and Unani
medicines
 169. Permitted Excipients

36. Shelf life or date of expiry for USM
Sl. No. Name of the Group of Medicine
Shelf life and date of expiry with
effect from the date of manufacture
1. Habb (Pills) 3 years
2. Qurs (Tablets) 3 years
3. Majoon/Dawa 3 years
4. Khamira 3 years
5. Itrifal 3 years
6. Tiryaq 3 years
7. Laooq 2 years
8. Laboob 2 years
9. Halwa 2 years
10. Mufarreh/Yaqooti 2 years
11. Burood/Surma/Kohal 3 years
12. Kushta 5 years
13. Raughaniyat 3 years
14. Marham/Zimad/Qairooti 3 years
15. Ayarij/Sufoof 2 years
16. Safoof (Namak wala/containing salt) 1 year
17. Sharbat/Sikanjabeen 3 years
18. Jawarish 3 years
19. Capsule 3 years
20. Arq 1 year
21 Qutoor 1 year
22. Nabeez 5 years
23. Murabba 1 year
24. Tila 2 years]

37. SCHEDULE A
 Forms
 FORM 1(rule 4)-Memorandum to the Central Drugs Laboratory
 FORM 2(See rule 6)-Certificate of test or analysis by the Central Drugs
Laboratory
 FORM 2A(See rule 163E)-Certificate of test or analysis from the
Pharmacopoeial Laboratory for Indian Medicine or Governmen Analyst
 FORM 8(See rule 24)-Application for licence to import drugs (excluding those
specified in Schedule X) to the Drugs and Cosmetics Rules, 1945
 FORM 9(See rule 24)-Form of undertaking to accompany an application for
an import licence
 Etc……

38. SCHEDULE B
 Fees for test or analysis by the Central Drugs Laboratories
or State Drugs Laboratories
 Fees for test and assay of Drugs requiring use of animals
 Microbiological tests and assays
 Identification tests
 Physical tests etc…..
 SCHEDULE B(1)(See rules 163F)- fees for the test or
analysis by the pharmacopoeial laboratory for Indian
medicine (plim) or the government analyst

39. Cont….
 SCHEDULE C(See rules 23, 61 and 76 and Part X)-
Biological and Special Products
 SCHEDULE C (1)(See Rule 23, 61 and 76)-Other
Special Products --Fish Liver Oil, Vitamins, Hormones
etc.

40. SCHEDULE E(1)[See rule 161 (2)]
 List of poisonous substances under the Ayurvedic (including
Siddha) and Unani Systems of Medicine
Drugs of vegetable origin
S. No Name Botanical Name
1 Afiyun (except seed) Papaver somniferum Linn.
2 Bazrul-banj Hyoscyamus niger Linn.
3 Bish Aconitum chasmanthum Strapfex Holmes.
4 Bhang Cannabis sativa Linn.
5 Charas Canabis sativa Linn.
6 Dhatura seeds Datura metal Linn (seeds).
7 Kuchla Strychnos nuxvomica Linn.
8 Shokran Conium maculatum Linn.

41. Cont….
Drugs of Animal origin
S.
No
Name Scientific Name
9 Sanp (head) Snake (head).
10 Telni makkhi Mylabris cichori Linn.
Mylabaris pustulata
Thund. Mylabris
macilenta .

42. Cont…..
Drugs of Mineral origin
S. No Name Scientific Name
1 Darchikna Hydrargryi perchloridum.
2 Hira Diamond.
3 Ras Kapoor Hydrargryi Subchloridum
(calomel).
4 Shingruf Hydrargryi bisulphuratum.
5 Zangar Cupri subacetas.
6 Sammul-Far (Abyaz, Asfar, Aswad and Ahmar)
(white, yellow, black and red,
Arsenic).
7 Tootiya Copper Sulphate
8
Para
Hydrargyrum.
9 Hartal Arsenic trisulphide (yellow).]

43. Cont…..
 SCHEDULE F(I)–vaccines-provisions applicable to the production
of vaccines
 SCHEDULE F (II)(See Rule 124-C)-standards for surgical
dressings
 SCHEDULE FF( See rule 126-A)-Standards for ophthalmic
preparations
 SCHEDULE- H(See Rules 65 and 97)-prescription drugs
 SCHEDULE L-I(see rules 74, 78 and 150E)-good laboratory
practices and requirements of premises and equipments

44. Cont…..
 SCHEDULE M(See Rules 71, 74, 76 and 78)-good
manufacturing practices and requirements of premises, plant and
equipment for pharmaceutical products
 SCHEDULE N[See Rule 64(1)]-list of minimum equipment for
the efficient running of a pharmacy
 SCHEDULE O[See Rule 126]-standard for disinfectant fluids
 SCHEDULE Q(See rules 134 and 144)-list of dyes, colours and
pigments permitted to be used in cosmetics and soaps as given
and list of colours permitted to be used in soaps

45. Cont….
 SCHEDULE T(See rule 157)-good manufacturing
practices for ayurvedic, siddha and unani medicines
(GMP)
 SCHEDULE Y (See rules 122A, 122B, 122D, 122DA,
122DAA and 122E)-requirements and guidelines for
permission to import and / or manufacture of new drugs
for sale or to undertake clinical trials