Procedure for Loan Licence to Manufacture Ayurvedic, Siddha, Sowa-Rigpa and Unani Drugs

Deepti Mudgal

Deepti Mudgal

Published on: Feb 20, 2026

Akshit Rai

Updated on: Feb 20, 2026

★★★★★(1 Rating)

21

INTRODUCTION

A loan license is required to manufacture Ayurvedic, Siddha, Sowa-Rigpa and Unani Drugs as it lets the businesses which do not have their own manufacturing facility and resources to legally produce their own products use the infrastructure and the expertise of an already licensed and a Good Manufacturing Practice (GMP) certified manufacturer. This safeguards all the traditional medicines stick to the strict safety, efficacy, and the quality standards which are mandated by the Drugs and Cosmetics Act, 1940 and Drug Rules, 1945.

APPLICABLE PROVISIONS

1. Section 3 of Drug and Cosmetic Act, 1940
2. Rule 153A,154A,156A,158A of Drug Rules, 1945

MANDATORY DOCUMENTS

1. Application in Form 24E
2. Company registration certificate and identity/address proof of directors/partners
3. Good Manufacturing Practices (GMP) certificate
4. Proof of premises (ownership documents or rent/lease agreement)
5. Adequate space (minimum 1200 sq. ft.), equipment, and testing facilities to handle the additional production volume.
6. List of machinery and equipment.
7. Product formulations and a list of drugs to be manufactured
8. Details of the quality control lab
9. No Objection Certificate (NOC) from the Pollution Control Board, if applicable
10. Proof of safety and effectiveness as per Rule 158A of the Drugs & Cosmetics Rules, 1945

PROCESS OF LICENSE

Applicant shall submit Form 24E to obtain licence to manufacture ayurvedic, siddha, sowa-rigpa and unani drugs in through the e-AUSHADHI portal, along with the prescribed fee of rupees three thousand (Rs.3000/-) for the first ten products and after those ten products, an additional fee of rupees two thousand (Rs.2000/-) per product with the required documents; Upon satisfactory inspection of the site is completed after that the state licensing authority (SLA) issues the license through Form 25E.

RENEWAL

Applicant shall submit Form 24E to renew the Licence to Manufacture Ayurvedic, Siddha, Sowa-Rigpa and Unani Drugs.