No clinical trial to get ayurvedic drug licence

New Delhi: In a major move aimed at giving a push to the manufacturing of Ayurvedic drugs in the country, the government has decided to do away with the clinical trial norm for issuing a licence to ayurvedic drug formulations.

According to a circular issued by the Ayush Ministry, the licence for Ayurvedic, Unani and Siddha medicines would now be issued on the basis of logic, published subject material and experience of experimental study and the availability of evidence on the basis of available texts. The circular in this regard has been issued to all the state drug regulators for its compliance.

According to a senior government official, the Ayush Ministry has issued the circular after it came to the notice of the Ministry that licensing authorities have started interpreting Rule 158-B of Drug and Cosmetics Rules, 1945 as per their own convenience.

The drug licensing agencies have started asking for clinical trial reports to issue a license to Ayurvedic, Unani, etc drugs resulting into an unnecessary delay in obtaining or renewing the license of Ayush drugs, the official said.

The circular has made it very clear that there is no mention of a clinical trial in the Drug and Cosmetics Rules, 1945 for the issuance of a license to ayurvedic and other traditional medicines.

The circular also states that there is no provision to authorise, nominate or notify any institution for the pilot study of Ayush drugs in the Drug and Cosmetics Rules. All the drug regulators have also been directed to decide on the application of licences for ayurvedic drugs within three months.

Notably, the Ayush drugs/therapies are mostly used to treat lifestyle based diseases such as diabetic, hypertension, blood pressure, digestive problems, etc. Some of the Ayurvedic formulations which have been proving a boon for patients suffering from such disease include BGR-34 for diabetic patients, NeeriKFT for treating kidney ailments, Lukoskin for leucoderma, Triphala for digestive problems, etc.

The market for Ayurvedic medicines is of 16,000 crore, which is expected to grow up to Rs 52,000 crore by 2022.

However, the experts have raised their eyebrows over the decision by saying that it would damage the reliability of alternative medicine as several drugs of poor quality would come into the market.