Procedure for Drug Licence to Manufacture for Sale or Distribution of Drugs Specified In Schedules C And C(1) And X

Deepti Mudgal

Deepti Mudgal

Published on: Feb 9, 2026

Akshit Rai

Updated on: Feb 9, 2026

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INTRODUCTION

The drug manufacturing license granted by the concerned authorities that allows individuals or companies to manufacture, process and distribute drug products. The access to medicines and drugs must be restricted and regulated to ensure that such goods are not abused or misused by individuals. That’s why all pharmacists, wholesalers, retailers, manufacturers, sellers, dealers, and importers of drugs, cosmetics, ayurvedic, Siddha and Unani drugs have to mandatorily obtain drug license under the Drugs and Cosmetics Act,1940.

APPLICABLE PROVISIONS

Rule 75, 76 of Drug Rules, 1945

DOCUMENTS REQUIRED

1. Application Form 27-B
2. License fees of Rs. 6000/- and Inspection fees of Rs. 1500/-
3. Declaration Form
4. Proof of Constitution of Firm in case of Partnership / Pvt. Ltd./ Ltd. /Trust.
5. Copy of Resolution passed by Board of Directors.
6. Key Plan and Site Plan in Blue Print / Ammonia Print.
7. Proof of Possession:
   • Rented: Rent Receipt & Rent Agreement. (Notary Attested)
   • Self-Occupied.
8. Proof of Ownership: Copy of Regd. GPA / Sale Deed / Property Tax Receipt
9. Affidavit of non-conviction as per format given in Guide Line Booklet.
10. List of Equipment and Machineries Provided for Manufacturing.
11. List of Equipment Provided for Testing.
12. List of Technical Staff for manufacturing along with their Self Certified photocopies w.r.t. Certificates of Education Qualification, Experience Certificate, Biodata on Proforma, Appointment Letter, three photographs.
13. List of Technical Staff for testing along with their Self Certified photocopies w.r.t. Certificates of Education Qualification, Experience Certificate, Biodata on proforma, Appointment Letter, three photographs.
14. Affidavit from employer and or Technical Staff for full time working with the firm as per format given in Guide Line Booklet.
15. List of Formulations to be permitted along with product information separately for each drug and affidavit about owner / user of the trade name applied for.
16. Consent of Approved Testing Laboratory for Sophisticated Testing.

PROCESS FOR LICENSE

1. Application submission: Applicant shall submit Form 27-B on their State’s Drug Control Organization (DCO) portal along with the prescribed fee and the required documents to obtain licence to manufacture for sale or distribution of drugs specified in Schedules C And C (1) And X;
2. Inspection & approval: Upon a satisfactory report by a drug inspector, the licensing authority will issue the licence to manufacture for sale or distribution of drugs specified in Schedules C And C (1) And X in Form 28.

PROCESS OF RENEWAL

Manufacturer shall submit Form 27-B to renew the licence to Manufacture for Sale or Distribution of Drugs Specified in Schedules C And C (1) And X.

VALIDITY OF LICENSE

The license to manufacture for sale or distribution of drugs specified in Schedules C And C (1) And X is valid for a period of 5 years.