Ensuring everyone has equal and fair access to drugs and medicine is the primary concern of any government. But the right to manufacture and sell drugs and medicines has to be given cautiously. Hence the government has stringent rules for granting license for manufacturing and selling of drugs and medicine. The Act that governs the end to end process from manufacture to the sale of drugs in India is the Drugs and Cosmetics Act, 1940.
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. The definition was amended in 1964, to include Ayurvedic and Unani Drugs.
Looking at the definition of “drug”, the pharmaceutical business in India requires the following types of licenses:
The following are the steps to be taken for obtaining the drug license:
The documents essential for obtaining a sale license are:
|Sr. No||Form No||Purpose|
|1||Form 19||Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those specified in Schedule X.|
|2||Form 19A||Application for granting or renewing a restricted license to sell, stock, exhibit or offer for sale, or distribute drugs by retail via dealers who don’t engage the service of a qualified individual.|
|3||Form 19B||Application for license to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines.|
|4||Form 19C||Application for grant or renewal of a [license to sell, stock, exhibit or offer for sale, or distribute] drugs specified in Schedule X.|
|5||Form 24||Application for either the grant of a license or for the renewal of a license or to manufacture for sale or for distribution of drugs other than those which are specified in [Schedule C, C (1) and X].|
|6||Form 24A||Application for either the grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.|
|7||Form 24B||Application for grant or renewal of a licensee to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those specified in Schedule X.|
|8||Form 24C||Application for the grant or renewal of a license to manufacture for sale [or for distribution] of Homoeopathic medicines or a license to manufacture potentized preparations from back potencies by licensees holding a license in Form 20-C|
|9||Form 24F||Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C(1).|
|10||Form 27||Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X|
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