After the government failed to include the traditional stream of medicines in the Drugs and Cosmetics (amendment) Bill, 2013, it is now mulling a separate legislation to regulate systems such as ayurveda and homeopathy.
According to official sources, the department of AYUSH, which administers development of ayurveda, yoga & naturopathy, unani, siddha and homoeopathy, has been asked to formulate the first draft of the Bill. The idea is to monitor manufacturing and sale of such medicines in the country, while also promoting them in global markets.
"This is a separate stream of medicines and is increasingly becoming popular not just in India but across the globe. It is, therefore, essential to govern the industry involved in promoting these systems," an official said.
Initially, the regulations were to be part of the Drugs and Cosmetics (amendment) Bill, 2013, which was introduced in the Rajya Sabha recently. However, though the Bill contains a separate chapter for regulatory provisions for medical devices and for regulating clinical trials and export of drugs and cosmetics, it excluded all provisions with regard to ayush medicines.
"Considering the significance and growth of the Ayush sector, we have decided that it needs a separate legislation. It is not right to monitor them with the same set of rules as for chemical-based products. The mechanism is different for the ayush system of medicines and therefore, the regulatory framework should also be framed accordingly," the official said.
The Bill might also create a separate regulator for ayush medicines. Currently, all medicines in the country are regulated by the Drugs Controller General of India, which is a Central authority.
A separate legislation would mean stringent check for all ayush medicines sold in the country. In the absence of a proper legislation, currently these streams are not regulated and all kind of products are freely available in the country. The Central regulator also does not have the wherewithal and resources to monitor ayush medicines.
According to industry estimates, the market for ayush is pegged at over Rs 9,000 crore including drugs, over-the-counter and wellness products, treatment and herbal extracts and it has been growing at 20 per cent year-on-year. Ayurveda alone accounts for Rs 5,000 crore of annual sales. Export of these products jumped from Rs 617.87 crore in 2005-06 to Rs 1,335.01 crore in 2009-10 and is expected to reach Rs 16,250 crore in 2014. Major export markets for ayush include Europe, the US, Japan and Southeast Asia.
