Union government is getting ready with the draft of an exclusive bill with regulatory provisions for the Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs. The Ayush industry associations provided their comments on the same, following a communiqué from the Department of Ayush to forward their suggestions on the Bill before November 27, 2013. Now having received the associations' views, the government is ready to finalise the legislation.

A dedicated bill was demanded by the industry because of lack of comprehension from the regulatory authority on the Ayush drugs as it came under the Drugs & Cosmetics (D&C) Act. Therefore industry associations were insisting for a separate legislation.

A Standing Committee was formed to put forth the need for a dedicated Bill for Ayush sector. The proposal was sent to Union government and referred to the Ministry of Finance which did not allocate a separate budget for the same. The finance officials were not convinced on the need for an exclusive legislation as that would mean separate funding which the government did not want to incur during the current phase of economic slowdown, Dr DBA Narayana, chairman, Herbal Products Committee, Indian Pharmacopoeia Commission, told Pharmabiz.

Now, with the pending Drugs & Cosmetics (Amendment) Bill, to centralize the licensing process with the setting up of the central drug authority (CDA)  which is placed before the Parliament for approval, the Ayush industry and its panel of experts feel that the efforts to consider the ASU&H Bill could be in the back burner.

With the rising demand for Ayush drugs driven by the awareness on holistic health practices, a dedicated ASU&H Bill will give a fillip to the sector. There is need to separate the two streams of medicines: allopathy and Ayush in terms of regulatory provisions which requires dedicated experts to comprehend the contents, noted Dr Narayana.

Now the Union government is contemplating to introduce a bill in the Parliament for the control and regulation of ASU&H drugs. It is making a big mistake by permitting the inclusion of giving the marketing authorization to phytopharmaceuticals as a 'drug' in the Drugs & Cosmetics Rules. These are drugs produced mostly using medicinal plants, said JSD Pani, president, Karnataka Indian Medicine Manufacturers Association (KIMMA).

“Lot of research is taking place on these medicinal plants and its extracts. The manufacture of such drugs is also widespread now. However, directly and indirectly all these drugs are technically termed as phytopharmaceuticals. Hence KIMMA is of the opinion that it is only more appropriate to include  ‘phytopharmaceuticals under the proposed ASU&H Drugs and Cosmetics Act Act instead of bringing amendment to the present D&C Act, pointed out Pani.