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ResearchGate, , See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/264942241, Recent Amendments In D &C Act With Reference To Ayurvedic Drug Industry, , Article - March 2012, , CITATIONS READS, 0 16,583, 1 author:, , #8 Galib Ruknuddin, All india Institute of Ayurveda, New Delhi, 223 PUBLICATIONS 952 CITATIONS, , SEE PROFILE, , Some of the authors of this publication are also working on these related projects:, , Project, Pharmaceutical standardization of Ashtangavaleha prepared by two methods and their comparative clinical efficacy on Tamaka Shwasa (Bronchial asthma) View project, , Project Acomparative study of Shirishavaleha prepared by water and Kanji as liquid media and its effect on Tamaka Shwasa (Bronchial Asthma) View project, , All content following this page was uploaded by Galib Ruknuddin on 22 August 2014., , The user has requested enhancement of the downloaded file., , Scanned with CamScanner

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Recent Amendments In D & C Act With Reference To Ayurvedic Drug Industry, , I i I I, , 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., , 7 OK OK OK OK, , Intr ion, , 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 nari, , Quality, safety and efficacy of drugs has always been a matter of concern for, public even in India. During first quarter of 1900s, an agitation towards, substandard medicines was raised by the medical professionals of those days, who, brought the issue to the notice of ‘Council of States’ in 1927. Consecutive to this, the, Government appointed a ‘Drug Enquiry Committee’ under the Chairmanship of Lt., Col. RN Chopra in 1930, which recommended the formation of a ‘Central Legislation’, for setting up of suitable standards. Based on these recommendations, Government, has introduced ‘Import of Drugs Bill’ in Legislative Assembly in August 1937. This, bill was presented in Legislative Assembly on 15 March 1940. This was later, discussed and passed on 5 April 1940. Further, the same was discussed in the, Council of States and ultimately passed on 10‘ April 1940 under the name of ‘Drugs, Act’. This legislation gave powers to the Government to make rules to regulate, import, manufacture, sale and distribution of drugs in the country. Consecutive to, this, rules were framed during 1945. Later, the scope of the Drugs Act was extended, to cosmetics in 1962 and the title of the act was changed to ‘Drugs & Cosmetics Act’., The drugs belonging to the systems of Ayurveda, Siddha and Unani (ASU) Systems, were brought within the purview of the D & C Actin 1964., , In current scenario, the following Acts and Rules are regulating the, manufacture, export and clinical research of Drugs & Cosmetics in India., , [email protected] / 09428671275 Page 1 of 10, , Scanned with CamScanner

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Drugs and Cosmetics Act, 1940, , Drugs and Cosmetics Rules, 1945, , Pharmacy Act, 1948, , Drugs and Magic Remedies Act, 1954, , Medicinal and Toilet Preparations Act, 1955, , Narcotic Drugs and Psychotropic Substances Act, 1985, , By By Be Me KS, , In addition to these; there are some other laws, which have a bearing on, manufacture, distribution and sale of Drugs & Cosmetics in India. The important, ones are:, , Factories Act, 1948, , Industries Act, 1951, , Trade and Merchandise Marks Act, 1958, Indian Patents and Design Act, 1970, , a, & %, , RELEVANT PARTS OF D & C ACT & RULES RELATED TO AYURVEDA, , The below is a brief on the important parts of Drugs & Cosmetics Acts & Rules with, special reference to Ayurveda., , , , , , , , , , , , Part of Act / Rule Chapter / Part Nature of Activity, Drugs & Cosmetics Act Chapter IV-A Provides provisions related to, 1940 (section 33-B to 33-N) | Ayurveda, Siddha and Unani Drugs, The First Schedule List of scheduled books, Drugs & Cosmetics Act Standards to be complied with by, , imported drugs and by drugs, , , , , , , , , , , , , , , , 1940 - Schedules The Second Schedule wanna tsdbanoll for Gale Stedtod an, Exhibited for Sale or Distributed, Part XVI Manufacture for sale of Ayurvedic, (Rule 151-160) (including Siddha) or Unani Drugs, Part XVI-A Approval of institutions for carrying, , out tests on ASU Drugs and Raw, , (Rule 160 A - 160 J) material used in their manufacture, , , , , , , , , , , , , , , , , , ; Part XVII Labeling, Packing and Limit of, DENES ie aE (Rule 161) Alcohol in ASU Drugs, Part XVII Shelf life or date of expiry for ASU, (Rule 161-B) Medicines, Part XVIII Government analysts and Inspectors, (Rule 162-167) for ASU Drugs, ee Standards of ASU Drugs, Different types of forms, particularly, Drugs & Cosmetics Rules Schedule A 24D, 24E, 25D, 25E, 26D, 26E, 26E-1,, 1945 - Schedules 47,48, 49, , , , , , , , , , Schedule B-1 Fees for the test or analysis by, , , , [email protected] / 09428671275 Page 2 of 10, , Scanned with CamScanner

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12, , , , i, , , , 14, , , , 15, , , , , , 16, , , , Pharmacopoeial Laboratory, , Indian Medicine or the Govt. Analyst, , for, , , , List of poisonous substances u, , aeeale B+ ASU Systems of Medicine, , nder, , , , Standards for Opthalmic, , Schedule FF ;, Preparations, , , , Schedule T ASU Medicines, , Good Manufacturing Practices for, , , , Schedule Y permission to import and /, , Requirements and Guidelines for, , manufacture of New drugs for sale, or to undertake clinical trials, , or, , , , permission to manufacture of, Drugs for sale or to underta, clinical trials, , (Proposed) Schedule Z, , , , , , Requirements and Guidelines for, , ASU, ke, , , , , , 1. 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 below:, , , , , , , , , , System of Medicine | Number of Books, 1 Ayurveda 54, 2 Siddha 30, 3 Unani 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 - |, automatically. This amendment is even applicable to other systems of medicines, (Siddha and Unani) too., , . 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 as under:, , , , , , , , , , , , , , Shelf life Dosage Forms, 1 2 Months Churna, 2 Raw Material, 3 aeanigeths Gutika, Avaleha, , , , , , , , , , [email protected] / 09428671275 Page 3 of 10, , Scanned with CamScanner