The government exercises control over drugs from the raw material stage during manufacture, sale, distribution and till it is sold on to a patient or consumer by a pharmacist in a retail pharmacy, hospital or dispensary. The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, help the government regulate and monitor the quality of drugs sold in India. No enterprise or individual can operate a business dealing in drugs, medicines or cosmetics without obtaining a drug license in India. The purpose of the drug license is to grant permission to allow enterprises or individuals to engage in businesses related to drugs and cosmetics. Thus, all pharmacists, wholesalers, retailers, manufacturers, sellers, dealers and importers of drugs, cosmetics, ayurvedic, Siddha and Unani drugs have to mandatorily obtain drug license under the Drugs and Cosmetics Act, 1940. The access to medicines and drugs must be restricted and regulated to ensure that such goods are not abused or misused by individuals. The definition was amended in 1964, to include Ayurvedic and Unani Drugs.
Section 3(b) of the Drugs and Cosmetics Act,1940 defines “drug” to include all medicines and devices for the use of human beings or animals internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body for the purpose of repelling insects like mosquitoes it also includes all substances that can be used for the destruction of insects and all components of a drug – like empty gelatin capsules.
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