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Manufacturing Drug License

Manufacturing Drug License

As per Drugs and Cosmetics Act, 1940 for manufacturing of Ayurvedic, Allopathic and Cosmetics drugs/ license like Drugs Sales License, Drugs Manufacturing License for Ayurvedic, Allopathic and Cosmetics etc. This license is usually issued to large industries for manufacture of drugs. In this form of license manufacturing of any form of drugs can occur. Products a manufacturing Licence is required. The State licensing authority is liable to issue and monitor the various.

The Advantages of Obtaining the Manufacturing Drug License are the following:

Legality A person must file a Manufacturing drug license application as it provides legality to the business. It is also illegal to engage in the Manufacturing or sale of drugs in India without obtaining a proper license.

Proper Monitoring and Regulation by The Authority Manufacturing drug license helps the authority to monitor and regulate the sale of medicines in India, which ultimately enhances business.

Proof Of Authenticity A Manufacturing Drug license plays a vital role, as it works as a proof of authenticity and builds an image of the company.

Confidence In the Consumers A drug license certificate proves to the consumers that the manufacturer is following strict quality measures while manufacturing drugs. Also, a valid license proves to the consumers that the drugs are safe and constitute no health hazards.

Documents to be uploaded along with the application form: (Aadhar card number with valid mobile number is mandatory)

  1. Application Form.
  2. Receipt of fees challan, if not paid through online portal
  3. Affidavit/ Declaration of Proprietor/ Partners/ Director(s)/ Managing Director
  4. List of all the Partners/ Directors with age & complete postal & residential address.
  5. Specific Power of attorney in favour of Authorised Signatory for submitting Application on behalf of the Company on Rs 10/- Non-judicial Stamp paper duly attested by Notary Public
  6. Affidavit / Declaration of Manufacturing Chemist.
  7. Affidavit / Declaration of Analytical Chemist.
  8. Documents of educational qualification, experience, and approval certificates of proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters; Id Proof; Registration certificate issued by Pharmacy Council (if applicable).
  9. Site Master File duly signed.
  10. Product sheets in specified proforma for approval of products.
  11. Section wise list of Plant and machineries, analytical instruments, apparatus for physico chemical, microbiological, biological testing along with attested photocopies of their purchase invoices. List of safety equipments.
  12. Details of AHUs (Air Handling Units) including Qualification details and Schematic Diagram. Details of Water System including Qualification details and Schematic diagram; Water testing reports.
  13. Medical examination Certificate of technical staff & employees includes absence of contagious disease.
  14. Registration from District Industries Center
  15. Consent to establish & consent to operate from Rajasthan State Pollution Control Board.
  16. List of Reference books and literature provided.
  17. Document pertaining to ownership for the proposed site of the unit & documents in its support. 18. Partnership deed / Memorandum & Article of Association.
  18. Specific resolution for commencing Drugs Manufacturing activities (if not already included in Memorandum of Association)
  19. Section wise lay-out /blueprint of location of plant and machineries (dimensions in metric system), & site plan.
  20. NOC from Fire Safety Office, and/ or NOC from Controller of Explosives (as applicable) if dealing with explosive / inflammable material.
  21. List of Products along with their manufacturing process, analysis procedure, stability data and standard operating procedures.
  22. Consent letter from government approved laboratory for sophisticated tests. (If applicable).

The procedure to follow while applying for the Manufacturing Drug License is mentioned below:

  • Preparation Of Documents The very initial step is preparing the requisite documents. The applicant must obtain all the necessary documents and get them attested by the authorities.
  • Filing The Application, the applicant has to fill online application form by visiting the official website of their respective state licensing authority. After filing the form and uploading all the required documents, the applicant will have to pay the required government fee for the same. However, in certain states, applicants will have to take a print of the application submitted online along with the documents and send it to the District Licensing Office.
  • Verification By the Authority A drug inspector will visit the premises to verify the submitted documents and to ensure that the premises are suitable for manufacturing drugs. After verification, the Drug inspector might call the applicant for an interview.
  • Issue Of Drug License Once verification is complete, and the authority is satisfied, the Controller of Drugs will issue a manufacturing drug license for the manufacturer. Once a registration is done successfully, the applicant will receive a unique Registration Number which they can use for further processing and reference.
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