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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.

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