Drug & Cosmetic License (CDSCO)

How It Works

1. 1

   Regulatory scoping and license identification

   We identify the correct license forms and authorities based on your product category (allopathic drug, ASU drug, cosmetic, medical device), activity type (manufacture, wholesale, retail, import), and state of operation, and review your premises and qualified person arrangement against the applicable schedule requirements.

2. 2

   Premises and infrastructure readiness assessment

   We conduct a pre-inspection review of your manufacturing or storage premises against Schedule M (for drug manufacturers) or the Cosmetics Rules (for cosmetic manufacturers) and provide a gap analysis report with specific remediation actions before the official inspection.

3. 3

   Qualified person verification and documentation

   We verify that your proposed technical staff member meets the educational and experience criteria prescribed in Schedule M or the applicable rules for the specific drug category, and compile the supporting educational and experience documentation.

4. 4

   Application compilation and filing

   We prepare the prescribed application form (Form 24, 25, 28, 32, or equivalent), compile all supporting documents, arrange for payment of the prescribed license fee, and file the application with the State Drugs Controller or CDSCO as appropriate.

5. 5

   Inspection coordination and representation

   We coordinate the premises inspection by the Drug Inspector, accompany the inspection team, respond to any observations raised during the inspection, and submit the compliance report within the prescribed timeline.

6. 6

   License receipt, renewal planning, and ongoing compliance

   Upon grant of the license we collect the license certificate, brief your team on record-keeping requirements under the applicable schedules, set up a renewal calendar, and advise on post-licensing obligations including adverse drug reaction reporting and recall procedures.