Drug License

Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this have been made in the Drugs & Cosmetics Act, 1940 which applies to the whole of India. It is an Act to consolidate all the laws relating to drugs & cosmetics, which established the Drugs Control Department. In 1964, the Act was amended to include Ayurvedic & Unani drugs. However a particular business entity may require different types of drug licenses based on their business,

In case a business is operating in more than two states, it has to obtain a drug licence in every state in which business is being carried on. Drug licence is location-specific. If drugs are sold or stocked for sale at more than one place, an application shall be made, and a license shall be issued, in respect of each such place except migrant vendors.

Once the licence is granted to the business, all such License must ensure that all the condition in the drug licence complied at all the time during the business. All the records /registers /Forms must be maintained in the manner specified by the licensing authorities and authorities shall be kept informed of all the changes or modifications in the business activities.