Drug License in India

To initiate a Drug or Cosmetic Business in India, a Drug License is mandatory, governed by the Drugs & Cosmetics Act, 1940, applicable throughout India. The Act consolidates laws related to drugs and cosmetics and established the Drugs Control Department. In 1964, amendments were made to include Ayurvedic & Unani drugs.

Documents Required for Drug License Registration:

1. Preliminary Documents: Memorandum of Association, Articles of Association, or any Bye-laws.
2. Identity proof of the head of the business.
3. Proof of Address: Property Receipt, Rental Agreement.
4. Site Plan of Business.
5. Affidavit regarding compliance with MPD 2021.
6. Proof of Qualification.
7. Registration from council.
8. Appointment letter and Bio-Data.

Conditions for Obtaining Drug License in India:

• Premises for Form 20 or Form 21 should be of an area not less than 10 square meters.
• Premises for Form 20-B or Form 21-B should be of an area not less than 15 square meters.
• Clear height of sales premises should comply with the National Building Code of India, 2005.

Types of Licenses:

1. Manufacturing License.
2. Sale License:
   • a. Wholesale License.
   • b. Retail License.
3. Loan License.

Registration Process for Drug License:

1. Obtain User ID and Password:
   • Submit a request letter with firm details to obtain user ID and password.
2. Document Scanning and Uploading:
   • Scan documents in 100 dpi, black and white, and upload using the provided ID and password.
3. Application Submission:
   • Fill precise information for the application and e-send it.
4. Follow-Up:
   • Follow up with the government department for updates.
5. Review and Approval:
   • The government department takes 45-60 working days to review and approve the application.

General FAQ – Drug Registration

If a person is having business in two different states, should he/she need to have single or multiple registration?
He/She has to obtain drug licence in every state in which business is being carried on. Drug licence is location specific.

Where a person can lodge a complaint regarding voilation?
Written complaint about doubtful quality of Drugs can be made to the Drugs Control Department, Govt. of N.C.T. of Delhi, at F-17, Karkardooma, Shahdara, Delhi-32 indicating name and address of the complainant,name and other particulars of the Drug under complaint and nature of complaint.