Loan License for Drug Manufacturing in India: Procedure

Deepti Mudgal

Deepti Mudgal

Published on: Mar 31, 2026

Shatakshi Sharma

Updated on: Mar 31, 2026

★★★★★(2 Ratings)

629

Introduction

The loan license allows manufacturers who lack their own full-scale production facilities to utilise the infrastructure of another licensed manufacturer whilst maintaining accountability for their products’ quality and compliance. These licenses are needed to ensure that the manufacture, sale, distribution of sensitive products like Large Volume Parenterals (LVP), Sera and Vaccines, and Recombinant DNA (r-DNA) Derived Drugs adhere to the strict regulatory standards of safety and efficacy.

APPLICABLE PROVISIONS

Rule: 75A, 76A of Drug rules,1945

DOCUMENTS REQUIRED

Proof of firm constitution (Partnership deed, Memorandum of Association).
Site plan and key plan (blueprint) of the manufacturing premises.
Affidavits regarding non-conviction under the Act.
Details and qualifications of technical staff (pharmacists, experienced persons).

PROCESS FOR LICENSE

Manufacturer shall obtain a Loan License to manufacture for sale or distribution of drugs in Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs by making an application in Form 27DA 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.

PROCESS FOR RENEWAL

A license issued in Form 28DA shall continue to remain valid without a separate renewal application, provided the licensee deposits a license retention fee equivalent to the fee required for grant of the license (excluding inspection fees) at intervals of every five (5) years from the date of its issue, unless it is suspended or cancelled by the licensing authority.

Procedure for Loan Licenses to Manufacture for Sale of Drugs in Large Volume Parenteral, Sera and Vaccine and Recombinant DNA (r-DNA) Derived Drugs								
Introduction
The loan license allows manufacturers who lack their own full-scale production facilities to utilise the infrastructure of another licensed manufacturer whilst maintaining accountability for their products’ quality and compliance. These licenses are needed to ensure that the manufacture, sale, distribution of sensitive products like Large Volume Parenterals (LVP), Sera and Vaccines, and Recombinant DNA (r-DNA) Derived Drugs adhere to the strict regulatory standards of safety and efficacy.
APPLICABLE PROVISIONS
Rule: 75A, 76A of Drug rules,1945
DOCUMENTS REQUIRED

Proof of firm constitution (Partnership deed, Memorandum of Association).
    Site plan and key plan (blueprint) of the manufacturing premises.
    Affidavits regarding non-conviction under the Act.
    Details and qualifications of technical staff (pharmacists, experienced persons).

PROCESS FOR LICENSE 
Manufacturer shall obtain a Loan License to manufacture for sale or distribution of drugs in Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs by making an application in Form 27DA 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.
PROCESS FOR RENEWAL 
A license issued in Form 28DA shall continue to remain valid without a separate renewal application, provided the licensee deposits a license retention fee equivalent to the fee required for grant of the license (excluding inspection fees) at intervals of every five (5) years from the date of its issue, unless it is suspended or cancelled by the licensing authority.

Industry Specific

Procedure for Loan Licenses to Manufacture for Sale of Drugs in Large Volume Parenteral, Sera and Vaccine and Recombinant DNA (r-DNA) Derived Drugs