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A Drug Loan License allows an applicant to manufacture drugs, formulations, or cosmetics without setting up their own manufacturing facility, by using the premises, machinery, and technical staff of another manufacturer who already holds a valid drug manufacturing license. This route is a preferred option for start-ups and brand owners who want to enter the pharmaceutical business without the heavy capital investment of building their own plant.
Under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, a loan license is granted in Form 25 (allopathic drugs) or Form 25-A (homoeopathic medicines), and requires the consent and No Objection of the manufacturer whose facility will be used. This makes it a collaborative license, held jointly on the basis of a documented arrangement between the loan licensee and the manufacturing unit.
Depending on the category of products you wish to manufacture, different types of loan license apply.
Issued for manufacturing allopathic drugs at a licensed manufacturer's premises.
Granted for manufacturing homoeopathic medicines on a loan basis at an existing facility.
Applicable to businesses looking to manufacture cosmetic products using another licensed manufacturer's facility.
Issued by the state licensing authority for manufacturing Ayurvedic, Siddha, or Unani formulations on loan basis.
A drug loan license is ideal for businesses that want to launch pharmaceutical or cosmetic products without investing in their own manufacturing infrastructure.
To be eligible for a drug loan license, the applicant must meet the following criteria:
The following documents are required for a drug loan license application:
The following is a concise description of the procedure for obtaining a drug loan license.
Get in touch with our experts to discuss your product line and identify a suitable manufacturing partner.
Execute a loan manufacturing agreement with the licensed manufacturer and obtain their No Objection Certificate.
Register on the drug licensing portal. After registration, login information is sent to the registered email address or mobile number.
Submit all requisite details, product information, and manufacturer documents. The application is filed along with required payments.
A drug inspector visits the manufacturing location to authenticate the arrangement and check the originality of documents. The inspection report is submitted to DLA.
Based on the inspection report, the final loan license is issued by the Drug Licensing Authority.
The drug loan license is valid indefinitely, subject to compliance with periodic inspections and continuation of the manufacturing arrangement. To maintain the license, businesses must:
We manage every step, document, and follow-up with the Drug Licensing Authority so you can focus on your pharmaceutical business.
We verify your eligibility and ensure all required documents are complete and valid.
Assistance in identifying a suitable licensed manufacturer and structuring the loan agreement.
Complete drug loan license application drafting and verification to ensure error-free submission.
Assistance in verifying pharmacist qualifications and registrations at the manufacturing unit.
Complete application filing through the drug licensing portal.
We respond to all queries from the Drug Licensing Authority on your behalf.
Regular follow-up with DLA to ensure timely processing of your application.
Assistance with post-license compliance, renewals, and regulatory updates.
Help with preparing and organizing all required documents for the application.
Talk to a First Auditor specialist today — get a clear fee quote and document checklist before you start.
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