Manufacturing allopathic drugs requires a licence from the State Licensing Authority, jointly inspected with CDSCO for certain categories, under the Drugs and Cosmetics Rules, 1945. Applicants need a facility compliant with revised Schedule M GMP, qualified technical staff for manufacturing and testing, and product permissions, with new drugs needing CDSCO approval.
Requirements
- GMP-compliant facility
- Quality control laboratory
- Qualified technical staff
- Product-specific permissions
Process
- Plan and build facility.
- Apply for licence with product list.
- Joint inspection.
- Licence grant.
Loan licence
Brand owners can manufacture at another licensed unit under a loan licence.
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Get expert help →Compliance
Batch records, stability studies, pharmacovigilance and recalls.
Frequently asked questions
Is WHO-GMP required?
Not for licensing, but often needed for exports.
Can I manufacture a new drug?
Only after CDSCO approval.
What is revised Schedule M?
Updated GMP requirements aligned with global standards.
How long does licensing take?
Several months including facility readiness.
Let Leegal handle your Manufacturing Drug License
Documentation, filing and follow-up by a dedicated expert, so you can focus on running your business.
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