Manufacturing Drug License

Manufacturing Drug License
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In India, the manufacturing of drugs is regulated by the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare. If you intend to manufacture pharmaceutical drugs in India, you must obtain a manufacturing drug license from the appropriate authority. Here are the general steps involved in obtaining a manufacturing drug license:

1. Establish a Business Entity:
– Set up a legal entity for your pharmaceutical manufacturing business. This may involve registering a company or partnership.

2. Qualified Person for Manufacturing:
– Appoint a qualified person responsible for compliance with regulatory requirements. This person is often referred to as the “Technical Person” or “Competent Person.”

 3. Plant and Premises Requirements:
– Ensure that the manufacturing plant and premises meet the standards set by the CDSCO. This includes adherence to Good Manufacturing Practices (GMP).

 4. Technical Staff:
– Employ qualified technical staff, including pharmacists and other professionals required for the manufacturing process.

 5. Wholesale Drug License:
– Obtain a Wholesale Drug License from the State Drug Licensing Authority. This license is often a prerequisite for obtaining a manufacturing license.

6. Goods and Service Tax (GST) Registration
– Register your business for Goods and Service Tax (GST) as it is mandatory for all businesses engaged in the manufacture and distribution of goods.

7. Prepare Technical Documentation:
– Develop comprehensive technical documentation for the drugs you intend to manufacture. This should include information about the manufacturing process, quality control, safety, and efficacy.

8. Apply for Manufacturing License:
– Prepare and submit the application for a manufacturing drug license to the CDSCO. Include all required documents, such as the Wholesale Drug License, technical dossier, proof of premises, and details of the manufacturing process.

 9. Payment of Fees:
– Pay the applicable fees associated with the manufacturing license application.

 10. Site Inspection:
– The CDSCO may conduct an inspection of the manufacturing facility to ensure compliance with GMP and other regulatory standards.

 11. Review by CDSCO:
– The CDSCO will review the application, inspect the premises, and assess the compliance of the manufacturing process with regulatory requirements.

12. Issuance of Manufacturing License:
– If the CDSCO is satisfied with the application and inspection, they will issue the manufacturing drug license.

13. Post-License Compliance:
– Comply with any post-license requirements, including regular reporting, adherence to GMP, and updates on any changes in the manufacturing process.

It’s important to note that specific requirements and procedures may vary based on the type of drugs, their classification, and any updates to regulations. Always refer to the latest guidelines from the CDSCO for the most accurate and up-to-date information. Additionally, consulting with regulatory experts familiar with pharmaceutical manufacturing regulations in India is advisable to ensure compliance.

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