Procedure for Licenses to Manufacture for Sale or Distribution of Drugs in Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (R-DNA) Derived Drugs

Deepti Mudgal

Deepti Mudgal

Published on: Mar 17, 2026

Shatakshi Sharma

Updated on: Mar 17, 2026

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INTRODUCTION

Obtaining licences is essential for the manufacture of Large Volume Parenterals (LVPs), sera, vaccines, and recombinant DNA (r-DNA) derived drugs, as these are complex and life-saving biological products that require strict regulatory oversight. The manufacturing process is regulated under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 to ensure safety, quality, and efficacy at every stage, from procurement of raw materials to the final distribution of the drugs.

Applicable Provisions

Rule 75(3),77 of Drugs and Cosmetics Rules, 1945.

WHO CAN APPLY?

Applicant shall appoint competent technical staff possessing the following qualifications and experience :

1. Pharmacy or Engineering graduate from a university recognised by the central government and must have eighteen (18) months of experience in the field the license applies after their graduation.
2. Science graduate from a university recognised by the central government and must have at least three (3) years of experience in the field the license applies after their graduation.
3. Diploma in Pharmacy or engineering from a board or institute recognised by the central/state government, and must have at least four (4) years of experience in the field the license applies after their Diploma.
4. Having a foreign qualification, and if it has the quality and content of training which are comparable with those mentioned above, and is competent enough to work as a technical staff.

DOCUMENTS REQUIRED

1. Proof of firm constitution (Partnership deed, Memorandum of Association).
2. Site plan and key plan (blueprint) of the manufacturing premises.
3. Affidavits regarding non-conviction under Drugs and Cosmetics Act, 1940.
4. Details and qualifications of technical staff (pharmacists, experienced persons).

PROCEDURE

Manufacturer intending to obtain a licence to manufacture Large Volume Parenterals, sera, vaccines, and recombinant DNA (r-DNA) derived drugs for sale or distribution shall make an application in Form 27D to the Licensing Authority 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.

After inspection of the manufacturing premises and verification of compliance with the applicable rules, if the Central Drugs Standard Control Organisation (CDSCO) and/or the State Licensing Authority is satisfied, the licence shall be granted in Form 28-D, authorising the manufacture of specified LVPs, sera, vaccines, and r-DNA derived drugs.

RENEWAL

Applicant shall submit Form 27D to renew the license along with the prescribed 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.

VALIDITY

The licences shall be valid for period of 5 years on and from the date on which it is granted or renewed.