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Syllabus of Unit 2 :-
Drugs and Cosmetics Act, 1940 and its rules 1945- Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA)
- Sale of Drugs - Wholesale, Retail sale and Restricted license. Offences and penalties
- Labeling & Packing of drugs - General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties.
- 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
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
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).
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).
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