Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this has been made in Drugs & Cosmetics Act, 1940 which is applicable to 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 license based on their business.
Eligibility of Drug License
- Minimum Area Requirement
- In case of wholesale outlet or Medical Shop : Minimum area of 10 sq. meter.
- In case wholesale+ Retail: Minimum area of 15 sq. meter
- Storage Facility
- Refrigerator and air-conditioner in the premises is must.
- Technical Staff
- In case of whole sale business, the sale of Drug shall be made before the registered pharmacist or any graduate having an experience of not less than 1 year in dealing in Drugs or any person who has passed the intermediate level of schooling and having the experience of at least 4 years in dealing in drugs.