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

Deepti Mudgal

Deepti Mudgal

Published on: Mar 30, 2026

Shatakshi Sharma

Updated on: Mar 30, 2026

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Introduction

A license is required to manufacture Ayurvedic, Siddha, Sowa-Rigpa and Unani Drugs as it provides essential consumer protection, ensures the safety, quality, and efficacy of these traditional medicines. This framework establishes that products are safe and efficient, as it standardizes the production processes and ingredients used in these systems of medicine.

APPLICABLE PROVISIONS

Rule 153, 156 of Drug Rules, 1945

WHO CAN APPLY?

1. Person having a degree in Ayurveda or Ayurvedic Pharmacy, Siddha or Unani system of medicine, as the case may be, conferred by a University, a State Government or Statutory Faculties, Councils and Boards of Indian Systems of Medicine recognised by the Central Government or a State Government for this purpose.
2. Person having diploma in Ayurveda, Siddha or Unani system of medicine granted by a State Government or an Institution recognised by the Central Government for this purpose.
3. A graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany or a University recognised by the Central Government with experience of at least two (2) years in the manufacture of drugs pertaining to the Ayurvedic or Siddha or Unani system of medicine.
4. A Vaid or Hakim registered in a State Register of Practitioners of indigenous system of medicines having experience of at least four years in the manufacture of Siddha or Unani drugs
5. Person having a qualification as Pharmacist in Ayurvedic (including Siddha) or Unani systems of medicine, possessing experience of not less than eight (8) years in the manufacture of Ayurvedic or Siddha or Unani drugs as may be recognised by the Central Government

MANDATORY DOCUMENTS

• Application in Form 24D
• Company registration certificate and identity/address proof of directors/partners
• Good Manufacturing Practices (GMP) certificate (as per Schedule T)
• Proof of premises (ownership documents or rent/lease agreement)
• Site plan and layout of the manufacturing unit
• Details of technical staff (qualifications, experience certificates, appointment letters)
• List of machinery and equipment’s
• Product formulations and a list of drugs to be manufactured
• Details of the quality control lab
• No Objection Certificate (NOC) from the Pollution Control Board, if applicable
• Proof of safety and effectiveness as per Rule 158B of the Drugs & Cosmetics Rules, 1945 (applicable mainly for patent/proprietary medicines)

PROCEDURE

Applicant shall apply for Licence to Manufacture Ayurvedic, Siddha, Sowa-Rigpa and Unani Drugs in Form 24D through the e-AUSHADHI portal or through the concerned State Licensing Authority portal, as applicable, along with the prescribed fee of three thousand rupees (Rs. 3,000) for the first ten products and after the said ten products, an additional fee of two thousand rupees (Rs. 2,000) per product (fees may vary as per state rules) and required documents and then upon satisfaction after inspection of the site is completed, the state licensing authority (SLA) will issue the license through Form 25D.

RENEWAL

Manufacturing licence for Ayurvedic, Siddha, Sowa-Rigpa and Unani Drugs shall remain valid perpetually, subject to payment of retention fee every five (5) years to the licensing authority. Failure to pay the retention fee within the prescribed period may result in cancellation of the licence.