Separate regulator for AYUSH drugs soon

homeo medicinesCabinet likely to take up the issue in two weeks

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.

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. [Source]

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