Drug & Cosmetics act 1948

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. Drug & Cosmetic Act 1940 Dr.Bankimchandra 2 nd PG Scholar

2. Contents History Amendments and Adaptations Definitions Recent Amendments In D & C Act Provisions relating to A yurvedic , Siddha and U nani drugs Conclusion.

3. HISTORY    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. LIST OF AMENDING ACTS AND ADAPTATION ORDERS 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. 5 chapters 38 sec. 2 schedules 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. OBJECTIVES  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. “the Board” 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. “Government Analyst” ( 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. “Inspector” in relation to Ayurvedic , Siddha or Unani drug, an Inspector appointed by the Central Government or a State Government under section 33G; and in relation to any other drug or cosmetic, an Inspector appointed by the Central Government or a State Government under section 21;]

10. “manufacture” 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 b ut 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. DEFINITIONS 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. DRUGS :- 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. COSMETICS :- 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. MISBRANDED DRUGS : I f 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 If it is not labelled in the prescribed manner.

15. ADULTERATED DRUG : ( 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. SPURIOUS DRUGS:- 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. PATENT OR PROPRIETARY MEDICINE : 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. MANUFACTURE 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. Penalty for manufacture, sale, etc., of Ayurveda, Siddha or Unani drug in contravention of this Chapter. — 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. Administration of the act and rules 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. Drugs Technical Advisory Board(DTAB) 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. The Board members :- ( 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. Ayurvedic,Siddha & Unani Drugs Technical Advisory Board 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 D rug 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. Drugs Consultative Committee(DCC) 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. The Ayurvedic , Siddha and Unani Drugs Consultative Committee 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. Recent Amendments In D & C Act With Reference To Ayurvedic Drug Industry 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.

28. [CHAPTER IVA] PROVISIONS RELATING TO AYURVEDIC,SIDDHA AND UNANI DRUGS 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

29. The list of books [The First Schedule of the Drugs & Cosmetics Act 1940]: 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.

30. Shelf life of ASU Drugs [Part XVII - Rule 161-B]: 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

31. Revised Gazette of April 1 2010 under 161-B

32. Poisonous Substances under ASU Systems of Medicine [Schedule-E(1)]: 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

33. 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   Other substances have been retained as such.

34. Permissible excipients for manufacturing of ASU formulations [RULE- 169]: 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.

35. Guidelines for evaluation of ASU Drugs & Other Traditional Medicines of India [RULE-170] The ASU and other traditional medicines have been categorized in to the following four categories: ASU Drugs. Patent or Proprietary ASU Drugs. Indian Ethno medicine based drugs not covered under I & II Medicines based on Extracts of Medicinal Plants of India.

36. Requirements and Guidelines for permission to manufacture of ASU Drugs for Sale or to undertake clinical trials [(Proposed) Schedule Z]: 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.

37. 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)

38. Conclusion 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

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