Procedure for License to manufacture drugs included in Schedule X other than Specified in Schedules C And C(I)

Deepti Mudgal

Deepti Mudgal

Published on: Dec 12, 2025

Shreya Jain

Updated on: Dec 12, 2025

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Introduction

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. Thus, 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.

Who can apply?

Manufacturers of drugs included in Schedule X other than Specified in Schedules C And C(I)

Applicability Provisions

Section 18(c) of Drugs and Cosmetic Act, 1940, Rule 69 of Drugs Rules 1945

Documents to be submitted

For the sake of authenticity and to ensure confirmation of having submitted the same, all the documents are required to be self-attested by the applicant/authorized person:

1. Application Form
2. Online payment: Fees of Lic. Rs. 6000/- + Inspection Fees 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 alongwith 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.
17. Kindly refer “Drugs and Cosmetics Act, 1940 and Rules made there under” for more information.
18. At present, as per department policy “Licences are being granted in Industrial Area only”.

Process for License

Manufacturer shall apply for license to manufacture for sale or for distribution of drugs included in Schedule X other than those specified in Schedules C and C(l) in Form 24F along with license fee of rupees six thousand (Rs. 6000) and an inspection fee of rupees one thousand and five hundred (Rs. 1500) for every subsequent inspection which shall remain valid if the retention fee is deposited before the expiry of a period of every succeeding five (05) years from the date of its issue.

Process of Renewal

Manufacturer shall apply for licence to manufacture for sale or for distribution of drugs included in Schedule X other than those specified in Schedules C and C(l) in Form 24F for renewal.

Validity

License to manufacture for sale or for distribution of drugs included in Schedule X other than those specified in Schedules C and C(l) shall remain valid for a period of 5 years.