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Drug License

Government of India has restricted the use of Drugs and medicines and to manufacture, sell, or deal in drugs for medicines purpose, prior permission of Government of respective state is mandatory and Government department, after ensuring that the required conditions are adequately fulfilled, grant license to the applicant upon such terms and conditions and it deems fit.

Types of Drug License:

Manufacturing License:Manufacturing licenses are issued to the business which produces Drugs and Medicines.

Sale License:Sale licenses are issued to the business which deals in either wholesale or retail sale of drugs.

List of Documents required for Obtaining a Drug License

 MOA, AOA for a company, partnership deed in case of partnership and , LLP deed in case of LLP.

 ID proof of director/ partner/proprietor.

 Copy of ownership documents of property or rental agreement as the case may be.

 Site plan and key plan of the premises.

 Copy of Board resolution.

 Proof of availability of storage space as cold storage, refrigerator, etc.

 Affidavit regarding non-conviction of proprietor/partner/director and the firm.

 The affidavit from the registered pharmacist/competent person.

 Proof of Qualification.

Pre-requisites for Obtaining a Drug License

Pharmacist: The pharmacist must be qualified in the case of a retail business. In case of a wholesale business, the individual must be a graduate with 1-year experience or an undergraduate with 4 years of experience.

Space: The other requirement is space that the area of the pharmacy/unit for both wholesale and retail license is 15 sq m and in all other cases 10 sq m. The clear height of the sales premises shall be as per the guidelines laid down under the National Building Code of India, 2005.

Storage Facility: The other perquisite is storage facility as drugs are required to be stored in low temperatures, refrigerators and air conditioners are a must.

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