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Syllabus of Unit 2 :-

Drugs and Cosmetics Act, 1940 and its rules 1945
  1. Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA)
  2. Sale of Drugs - Wholesale, Retail sale and Restricted license. Offences and penalties
  3. Labeling & Packing of drugs - General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties.
  4. Administration of the Act and Rules - Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing authorities, controlling authorities, Drugs Inspectors

Sale of Drugs

Drugs Enquiry Committee appointed by Government in 1931 under the chairmanship of Colonel R.N.Copra to have a control on the import, manufacture and sale of drugs. But it not have strict rule. thus Finally, to control the import, manufacture, distribution and sale of drugs and cosmetics, Drugs and Cosmetics Act was passed on10th April 1940 by the Indian Legislature.

Schedules to the Act - (List of drug and equipment)
Schedule A : It prescribes different forms required under Drugs and Cosmetic Act, for making the application to grant or issue of licenses, sending memorandum, etc.

Schedule B : It prescribes the fees to be charged for test or analysis of samples of drugs by Central Drugs Laboratory and Government Analyst.

Schedule C& C(i) : It prescribes the list of the biological and other special products.

Schedule E(i) : It prescribes list of Ayurvedic, Siddha and Unani poisonous substances.

Schedule F : It prescribes provisions applicable to the blood bank requirements and licensing to process the blood components.

Schedule G : It prescribes list of drugs which are required to be taken only under the supervision of a Registered Medical Practitioner. It is labelled with direction: ‘Schedule G Drug’
Caution “It is dangerous to take this preparation except under the supervision of Registered Medical Practitioner”.

Schedule H : It prescribes list of drugs which are to be sold by retail only on the prescription of Registered Medical Practitioner. Schedule H drugs are labelled with direction
Warning - “To be sold by retail only on the prescription of Registered Medical Practitioner.”

Schedule J : It prescribes the list of ailments or diseases for which drugs may not claim to prevent or cure.

Schedule L : It prescribes list of drugs to be sold on prescription only- omitted

Schedule M : It prescribes the good manufacturing practices (GMP) and the requirements of factory premises, plant, equipments, etc. for manufacture of drugs.

Schedule P : It prescribes life period of drugs

Schedule R : It prescribes the standards for condoms made of rubber latex intended for single use.

Schedule S : It prescribes standards for cosmetic

Schedule T : It prescribes the requirements of factory premises, plant, equipments and hygienic conditions for manufacture of Ayurvedic, Siddha, and Unani

Schedule X : It prescribes list of habit-forming Narcotic drugs and Psychotropic substances for the import, manufacture, distribution and sale of which requires a licence (NRx).