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Drug Manufacturing License
State/central licensing to manufacture pharmaceutical formulations.
What is Drug Manufacturing License?
A Drug Manufacturing Licence, issued under the Drugs and Cosmetics Act, authorises a facility to manufacture pharmaceutical formulations or bulk drugs, subject to Schedule M (GMP) compliance and inspection by the State Drug Controller.
Manufacturing licensing exists to ensure every batch of medicine produced in India is made under consistently controlled, hygienic, and quality-verified conditions โ Schedule M sets out the good manufacturing practice (GMP) standard the State Drug Controller inspects against before and after a licence is granted.
Two structures are common for companies without their own production facility: setting up owned manufacturing from the start, or operating as a loan licensee โ manufacturing under a licence held jointly with another licensed manufacturer whose facility is used, which lets a brand bring a formulation to market without the capital investment of building a plant first. Many companies start with a loan licence and transition to owned manufacturing as volumes grow.
Schedule M compliance isn't a one-time checkbox โ the State Drug Controller conducts renewal and, in many states, periodic surprise inspections to confirm the facility's actual practice still matches what was approved, covering everything from raw-material sourcing and in-process quality checks to staff hygiene protocols and batch documentation.
Who Needs It
Types & Categories
Owned Manufacturing Licence
Issued to a company manufacturing at its own licensed facility.
Loan Licence
Issued to a company manufacturing under licence at another licensed manufacturer's facility, without owning production infrastructure itself.
Key Benefits
Documents Required
- Site plan and Schedule M (GMP) compliance documentation
- List of manufacturing and testing equipment
- Qualified technical staff (pharmacist/competent person) details
- Formulation/product master file for each drug to be manufactured
- Loan licence agreement, where manufacturing is under a shared facility arrangement
Our Process
GMP Readiness Assessment
We evaluate your facility against Schedule M requirements ahead of filing.
Documentation Compilation
Site plan, equipment list, staff qualifications, and formulation files are compiled for the application.
Application & Inspection
The licence application is filed with the State Drug Controller, followed by a facility inspection.
Query Resolution
We respond to any inspection findings or documentation queries to keep the file moving toward grant.
Licence Grant
On satisfactory inspection, the manufacturing licence is granted for the applied formulations.
Validity & Renewal
Since a 2018 amendment to Rule 63 of the Drugs and Cosmetics Rules, 1945, drug manufacturing licences (Form 25 for non-biologicals, Form 28 for vaccines/sera/biologicals) are granted on a perpetual basis rather than the older five-year expiry-and-renewal cycle โ but 'perpetual' isn't unconditional: a licence retention fee is payable every 5 years to keep the licence in force, a late payment attracts a 2%-per-month surcharge for up to six months, and the licence remains valid only for as long as Schedule M/GMP conditions and other licence conditions continue to be met. We track your retention-fee window and flag any compliance risk that could put continued validity at stake.
Penalty for Non-Compliance
Manufacturing drugs without a valid licence under Section 18(c) is an offence under Section 27(b) of the Drugs and Cosmetics Act, 1940, punishable with imprisonment of not less than three years (extendable to five) and a fine of not less than โน1,00,000 or three times the value of the drugs seized, whichever is more โ rising to a minimum of seven years' imprisonment (extendable to life) and a fine of not less than โน3,00,000 where the drug is found spurious, and to a minimum of ten years (extendable to life) with a fine of not less than โน10,00,000 where a spurious or adulterated drug causes death or grievous harm โ alongside seizure of unlicensed stock and licence cancellation risk.
Frequently Asked Questions
What is a loan licence?
A loan licence lets a company manufacture drugs using another licensed manufacturer's facility, useful for brands without their own production unit.
Can a licence cover multiple formulations?
Yes, a single manufacturing licence can typically list multiple formulations, though each one needs to meet Schedule M and product-specific documentation requirements.
Are surprise inspections common?
Many states conduct periodic (sometimes unannounced) inspections after initial licence grant to confirm the facility continues to meet Schedule M standards.
Does adding a new formulation require a fresh licence?
Not always a fresh licence, but it typically requires an amendment/endorsement to the existing licence covering the new formulation.
Does the licence still need renewal now that it's perpetual?
Not a full renewal, but yes to ongoing action โ since a 2018 amendment, the licence itself doesn't expire on a fixed date, but a retention fee has to be paid every 5 years to keep it in force, and missing that window (plus a limited late-fee grace period) puts the licence at risk of lapsing.
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