Central body to check quality of new ayurvedic drugs likely


NEW DELHI: The government is preparing to set up a central body to check the quality of new ayurvedic products before they are launched in the market, even as industry majors such as Dabur, Baidyanath and Baba Ramdev’s Patanjali expand their offerings to meet rising demand.

The ministry of ayurveda, yoga and naturopathy, unani, siddha and homoeopathy (AYUSH) has sought the opinion of the law ministry on setting up a Central Technical Authority whose approval will be necessary before any state government can permit manufacture and sale of a new ayurvedic drug, government sources said.

The move comes at a time when a number of ayurvedic drug samples have failed quality tests, many brands face charges of exaggerated and misleading advertisements, and some states are accused of doling out drug licences indiscriminately.

As of now, a state government’s relevant department has the sole prerogative to grant license to any ayurvedic pharmacy to manufacture and sell a new ayurvedic drug.

Bringing in the central government’s direct oversight will necessitate amendment to Section 158(B) of Drugs and Cosmetic Rules, and AYUSH ministry has proposed the same to make way for the Central Technical Authority.

Basic minimal testing of any new ayurvedic drug on a small sample size of patients will also be brought in to ensure some kind of efficacy proof – an element largely missing at present, sources said.
The ministry has also proposed amendments to the rules to bring in greater transparency and quality control into a sector that has largely resisted regulation of any kind.

The alarm bells began ringing last year when more than 600 ayurveda pharmacies were closed down after they were found to be violating the stipulated ‘good manufacturing policies (GMP).

AYUSH department also pointed out disparities and anomalies in states granting permission to ayurvedic products. While one state doled out over 2,000 licences for new ayurvedic drugs last year, another state hadn’t permitted a single licence.

Also, hundreds of drug samples have failed tests in recent years: 251 samples of 4,107 in 2015-16, 198 of 3,478 samples in 2014-15, and 317 of 4,349 samples in 2013-14. This was seen undesirable at a time when ayurvedic drugs are becoming popular across the globe.

That apart, ayurvedic drugs are now being heavily advertised, and central authorities have received over 600 complaints of exaggerated claims and misleading advertisements of ayurvedic drugs since 2015.

AYUSH ministry now intends to define a new drug clearly, enumerating specific licensing terms, sources said. As per the proposal, all ayurvedic pharmacies will be required to periodically submit data on raw material consumption for formulating ayurvedic drugs. And a digital database of manufacturers, medicines being produced, and raw material being consumed, will be brought in to streamline the system, sources said.

AYUSH also proposes to significantly augment the regulatory structure across states in view of increasing density of ayurvedic pharmacies.