Drug License

Drug License is required to store the scheduled drugs; in fact it is required for effecting a whole sale drug business or retail drug business.

Drug Licenses required for Manufactures and Distributors (Wholesale / Retail) in all over India or within a specific states or inter-states. Under the current Indian legal and regulatory regime, the manufacturing, sale, import, exports and clinical research of drugs and cosmetics is governed by the following laws:

The Drugs and Cosmetics Act, 1940	The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954
The Drugs (Prices Control) Order 1995 (Essential Commodities Act.)	The Pharmacy Act, 1948
The Narcotic Drugs and Psychotropic Substances Act, 1985	The Medicinal and Toilet Preparations (Excise Duties) Act, 1956

Documents required for grant of Licenses for sale of drugs –

1. Application forms in the prescribed format and prescribed form number. 
2. Challan of fee deposited.
3. Declaration form.
4. Blue print of key plan
5. Blue print of site plan
6. Basis of possession of the premises. For retail cum wholesale license, the premises should be 15 sqmtrs or more.
7. Proof of ownership of the premises, if rented.
8. Proof of constitution of the firm (Certified copy)
9. Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940.
10. Certified copy of Regn. Certificate of Delhi Pharmacy Council/Experience Certificate of the Registered Pharmacist/Competent person and qualification certificates.
11. Bio-data form.
12. Affidavit of Registered Pharmacist/Competent person regarding fulltime working with the firm duly attested by Notary.
13. Appointment letter of Registered Pharmacist/Competent person in charge, if employed person.

The counsels of Vashista & Associates with their expert knowledge and detailed understanding assist their clients in applying and getting the drug sales and manufacturing license.