This site is intended for Healthcare professionals only.
×

No clinical trials need for Ayurveda, Unani, Siddha Medicines: Government of India


No clinical trials need for Ayurveda, Unani, Siddha Medicines: Government of India

New Delhi: Through a recent notification, the Government of India has clarified that no clinical trials are required for issuing licenses patented or proprietary Ayurvedic, Siddha and Unani (ASU) products

In a letter to All-State Licensing Authorities and Drug Controllers for ASU Drugs, Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), Under-Secretary, Ministry of AYUSH issued new directives to to issue licences for patented or proprietary Ayurvedic, Siddha and Unani (ASU) products without insisting on clinical trial or safety study reports.

The step was taken after it has come to the notice of Central Government that the provisions of Rule 158-B of the Drugs & Cosmetics Rules, 1945 pertaining to the requirements for issue of manufacturing license for Ayurvedic, Siddha or Unani drugs are being interpreted differently and clinical trial reports are reported to be sought from the manufacturers particularly for Patent or Proprietary category of such medicines, resulting in inordinate delay in granting license or renewal of license.

Providing clarification on the requirement of pilot study/clinical trial for the license of Ayurvedic, Siddha or Unani drugs under the provisions of Rule 158B of the Drugs and Cosmetics Rules, 1945 the ministry has issued a new directive and has advised all the State Licensing Authorities and Drug Controllers for ASU Drugs to comply that:

  1. The term ‘clinical trial’ as such is not mentioned in the context of ASU drugs-related provisions of Drugs & Cosmetics Rules, 1945. However, experience or evidence of effectiveness of the ASU drug based on textual rationale, published literature and pilot study is required in support of the claim of indication or use for issue of license in accordance with the provisions of Rule 158(b). Proof of effectiveness in the form of Pilot Study may be required for intended ASU drug, if the textual rationale, published literature and textual (authoritative book-based) indications are not furnished to support the claim of use or indication;
  2. there is no provision to designate, authorize or notify any particular institution or center for conducting such pilot studies on ASU drugs; and
  3. license applications for ASU drugs may accordingly be disposed of in a time bound manner within a period of three months provided under Rule 154 (i) of the Drugs & Cosmetics Rules, 1945.

Below is the attachment of the same

The following two tabs change content below.
Ruby Khatun

Ruby Khatun

Ruby Khatun joined Medical Dialogue as Reporter in 2016. She covers all the business news in different categories. She also covers all the updates in Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a post graduate from Jamia Hamdard. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751


Source: with inputs
2 comment(s) on No clinical trials need for Ayurveda, Unani, Siddha Medicines: Government of India

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted
  1. No comment for News but for your high tech mind… You guys fight for right to information and freedom of press etc etc… and on other hand you disbaled copy option so no one could copy your precious information like you have taken patent for this…

    I did Cntl+P then save the page as pdf and then copy info what i need….

    grow up … ye sab faltu ke kaam rahne do…
    Freedom of information agar tum log hi nhi doge to kon dega….

  2. Haa, its a joke what is happening in India .God save india