Procedure for Loan License for Sale or Distribution of Drugs Specified in ​Schedules C And C (1) (Excluding Those Specified in Part Xb and Schedule X)

Deepti Mudgal

Deepti Mudgal

Published on: Feb 20, 2026

Akshit Rai

Updated on: Feb 20, 2026

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INTRODUCTION

A drug loan license for sale or distribution of drugs specified in schedules C And C(1) (excluding those specified in part Xb and schedule X) allows a company to produce medicines using another firm’s already licensed manufacturing facilities, ideal for the businesses which don’t have their own plant but they do hold the product’s brand/specification, this is overseen by India’s Drugs & Cosmetics Act,1940 and Drug Rules, 1945.

APPLICABLE PROVISIONS

Rule 75A (1), 75A (3), 76A, 83(1), 83(2) of Drug Rules, 1945

DOCUMENTS REQUIRED

1. Attested copies of partnership deed/Memorandum of Articles, plus an affidavit for the person in charge.
2. Proof of Premises (Rent Agreement, Electricity Bill, Site Plan etc.)
3. Consent Letter from the parent company (Means that you use another company’s manufacturing facility; this parent company must provide a consent letter detailing their own valid license.)
4. Details of Technical Staff (Production & Analysis).
5. KYC documents (Proprietor/Partners/Directors).

PROCESS FOR LICENSE

Manufacturer shall submit Form 27-A to obtain a loan licenses for the manufacture for sale or for distribution of drugs specified in Schedules Cand C(l) (excluding those specified in Part XB and Schedule X) , along with an undertaking to the effect that there is no existence of the proposed brand name or trade name under Form 51 and such application shall be accompanied by a license fee of rupees six thousand (Rs. 6000) and an inspection fee of rupees one thousand and five hundred (Rs. 1500) for every inspection to the licensing authority; Upon satisfactory inspection, the Licensing Authority will issue the license under Form 28-A.

PROCESS OF RENEWAL

Applicant shall fill the Form 27-A along with the prescribed license and inspection fees, for renewal of the Loan License for Sale or Distribution of Drugs Specified in Schedules C And C(1) (Excluding Those Specified In Part Xb And Schedule X)

VALIDITY OF LICENSE

The license is valid for 5 years from the date of its issue, though duration can still vary slightly based on state guidelines and license type.