Drugs and Cosmetics Act and Rules-rachana and sheetal madam

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Drugs and Cosmetics Act and Rules:



Purpose of this act-To regulate manufacture,sale and import of drugs and cosmetics. It regulates manufacture and sale of drugs by licensing authority such that they are manufactured, distributed and sold by qualified person. Accordingly Schedules E,I and L have been deleted , schedule G and H have been revised , and new Schedule X has been added. 28/11/2015 2 OBJECTIVES


Two categories of schedule drugs are :– Schedule C and C1 Drugs; and Drugs other than those specified in Schedule C and C1,subcategories of drugs:- A. Drugs specified in Schedule C,C1 and X ; B. Drugs other than those specified in Schedule C,C1 and X ; C. Drugs specified in Schedule C and C1 excluding those specified in Schedule X. D. Drugs specified in Schedule X 28/11/2015 3 Continue…….


Schedule M (GMP) and Y were introduced in 1988. DNC Act extends to whole of India. This Act came in 1940 and rule in 1945. This act is concerned with qualities and standards of drugs manufactured in this country and controls manufacture, sale and distribution of drugs. Main objective of this act-To prevent substandards in drugs,presumably for maintaining high standards in medical treatment. 28/11/2015 4 Continue…….


Provisions of this act are in addition to and not in derogation of Dangerous Drugs Act 1930 (now Narcotic and Psychotropic Substance Act) and other laws for time being in force. Schedule act:- 1 st Schedule –Book names under Ayurvedic,Siddha and Unani Systems. 2 nd Schedule – Compilation of standards by importing drugs to be manufactured for sale,sold,stocked and exhibited for distribution and sale. 28/11/2015 5 Continue…….

Appendices of Second Schedule of the Act:

1 st appendix- Submission of data with application for new drug marketing permission. 2 nd appendix- Clinical trial report submission format. 3 rd appendix- Requirement of animal toxicity for clinical trial and marketing new drug. 4 th appendix- Long term toxicity studies for number of animals. 5 th appendix- Participation of patient consent form in phase 1 clinical trial. 28/11/2015 6 Appendices of Second Schedule of the Act

Schedules of the Rules:

1. Schedule A – Application for issue and renewal of license for sending memoranda. 2. Schedule B – Fee rate for test and analysis by Central Drug Laboratory/Government Analyst. 3. Schedule C – Biological and special products for import ,sale and manufacture by special provisions. Schedule C1 – Other special products for import ,sale and manufacture by special provision. 4. Schedule D – List of drugs exempted from provisions of import of drug. 28/11/2015 7 Schedules of the Rules

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5.Schedule E1 – List of poisonous drugs under ayurvedic (siddha) and unani system of medicine. 6. Schedule F – F1 - Part 1-Production provisions for bacterial and viral vaccines. Part 2-Production provisions for sera from living animals Part 3-Production provisions for manufacture and standardization of diagnostic agents (bacterial origin). F2-Surgical dressing standards F3- Sterlized umblical tapes standards FF-Opthalmic preparation standards 28/11/2015 8

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7.Schedule G –Substances required to be used under medical supervision accordingly. 8.Schedule H – List of prescription drugs. 9.Schedule J – Drugs for purpose of curing , preventing and treating any disease or ailments 10.Schedule K – Exemption of drugs from provisions related to manufacture of drugs. 11.Schedule M – Goods Manufacturing Practices (GMP) requirements of factory premises, plants and equipments. Schedule M1- factory premises for manufacturing of Homeopathic medicines. Schedule M2- factory premises for manufacturing of Cosmetics. Schedule M3- factory premises for manufacturing of Medical Devices. 28/11/2015 1 9

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12.Schedule N – Minimum equipment list for efficient running in pharmacy. 13.Schedule O – Disinfectant standards. 14.Schedule P – Drugs life period. Schedule P1 – Drugs pack sizes. 15.Schedule Q – Part 1 – Colours , dyes and pigments for cosmetics and soaps Part 2 – Colours permitted in soaps. 16.Schedule R – Condoms for single use and medical contraceptive . Schedule R1 - Medical device standards 28/11/2015 10

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17.Schedule S – Cosmetics standards 18.Schedule T – Factory premises and hygienic conditions for ayurvedic/siddha and unani drugs. 19.Schedule U – Analytical records of drugs. Schedule U1- Analytical records of cosmetics. 20.Schedule V – Patent and proprietary medicine standards. 21.Schedule W – Drug list marketed only under generic names. 22. Schedule X – Drugs list for manufacture ,import and sale ,labelled and packaged under special provisions. 23.Schedule Y – Clinical trial guidelines requirement for import and manufacture of new drugs. 28/11/2015 11


28/11/2015 1 12 THANK YOU

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