Procedure for Drug Licence to Manufacture 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 9, 2026

Akshit Rai

Updated on: Feb 9, 2026

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INTRODUCTION

A drug license is required to manufacture, sell or distribution of drugs specified in Schedule C and C1(excluding those specified in Part XB and Schedule X) because these substances, which primarily consist of biological products like vaccines, sera and certain potent antibiotics, and they pose specific health risks that make it necessary to have a strict regulatory control to ensure their safety and quality.

APPLICABLE PROVISION

Rule 75 of the Drug Rules, 1945

DOCUMENTS REQUIRED

1. Duly filled Form 27
2. Ownership or rental agreement for the premises
3. Manufacturing and testing equipment list
4. Details and certificates of technical staff
5. Product-wise formulation and manufacturing processes
6. Stability data, method of analysis, and specifications
7. Environmental clearance or pollution No Objection Certificate (NOC) (if applicable)
8. Goods Manufacturing Practices (GMP) compliance declaration and Site Master File (SMF)
9. Quality Assurance protocols and batch manufacturing records templates

PROCESS FOR LICENSE

Applicant shall submit Form 27 on their SDSCO/CDSCO portal, along with the prescribed fees i.e. License fee of rupees six thousand (Rs.6000/-) and Inspection fee of rupees one thousand five hundred (Rs.1500/-) (per inspection) and the required documents to obtain licence to manufacture for sale or distribution of drugs specified in Schedules C And C(1) (excluding those specified in Part XB and Schedule X) , and then the licensing authority will issue the license through Form 28.

VALIDITY OF LICENSE

The license to manufacture for sale or distribution of drugs specified in Schedules C And C (1) (excluding those specified in Part XB and Schedule X) is valid for 5 years from the grant/renewal date.

PROCESS OF RENEWAL

Applicant shall submit Form 27 with the prescribed fee within 6 months before expiry to obtain licence to manufacture for sale or distribution of drugs specified in Schedules C And C (1) (excluding those specified in Part XB and Schedule X).