Separate regulator for AYUSH drugs soon

Cabinet likely to take up the issue in two weeks

Companies like Himalaya, Dabur, Baidyanath and Charak might have to be more watchful now. The reason: The government plans to set up a separate regulator for alternative medicine streams like Ayurveda, Siddha, Homeopathy and Unani.

The health ministry has floated a Cabinet note to create Central Drug Controller for AYUSH (Ayurveda, Unani, Siddha and Homeopathic) stream of medicines.

The proposal was expected to be taken up by the Union Cabinet in two weeks, a senior official in the know told Business Standard.

"It will be an overarching body looking specifically into AYUSH products and standards. Initially, we are looking at creating 13 positions within the authority to frame standards and guidelines and monitor quality of AYUSH products sold in the country," said the official.

According to the official, the proposed regulatory authority would be equivalent to the Drugs Controller General of India (DCGI), which currently looks at all medicines sold in the country. However, like in the case of pharmaceuticals or allopathic products, licensing and approval of AYUSH products will continue to be under the purview of state drug regulatory authorities, which coordinate and follow standards set by the central authority.

Currently, all medicines, including AYUSH products, come under DCGI's purview and follow the guidelines primarily framed keeping in view allopathic drugs.

"There is a need to frame separate standards and guidelines for AYUSH products, which are very different from the allopathic ones. Also, it is important that officials looking at these products are trained specifically in these streams and have knowledge about these," said the official quoted above.

Also, DCGI is short-staffed to handle allopathic drugs, which are high in circulation.

A separate regulator to deal with issues related to AYUSH has become necessary in the light of the government's major plans to push development of alternative medicine streams.

The Department of AYUSH, under the health ministry, also recently invited consultants and market research agencies to conduct two separate studies to assess the demand and supply situation, production scales, business models, mapping of supply chain, etc, for these products. The studies will be conducted to estimate not only for the domestic market but foreign as well.

According to officials, the government is keen to promote alternative medicine streams, mainly Ayurveda, which has picked up rapidly in the past few years. In fact, the Bharatiya Janata Party's election manifesto also emphasised and promised to promote the Ayurvedic drug industry.

However, the AYUSH industry still remains largely unorganised, with only a handful of big players selling branded products and doing business in international markets.

It is difficult to quantify the market for traditional Indian medicine systems, as many practitioners formulate and dispense their own recipes. Even so, annual turnover of products manufactured by large firms alone is estimated at $300 million a year. According to government estimates, there are about 700,000 registered AYUSH doctors across the country.

However, in the absence of proper standards, guidelines and regulatory mechanism, the industry has failed to gain credibility and make a mark in global markets, even as other nations like China have excelled.