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Pharma policy in limbo as ministries lock horns

May 01, 2008 01:29 IST

The group of ministers looking into the new pharma policy has failed to finalise its views as the health ministry has developed cold feet over several key proposals.

The health ministry feels the proposals related to quality control and supply of medicines should not be part of the policy.

While the chemicals ministry, which drafted the policy, is the administrative ministry for the pharma industry, quality regulation and marketing approvals come under the purview of the health ministry.

Agriculture Minister Sharad Pawar, who heads the GoM, asked health and chemicals secretaries to sort out the issues and get back to the GoM at the earliest.

"The health ministry has a different view on certain issues. They say some proposals in the draft policy have already been incorporated in a bill that is under consideration of the Rajya Sabha. So the health ministry feels there might be duplication and confusion. We want the secretaries of both the ministries to sit together, see if there is duplication, and then come to us." Pawar said.

Though Pawar refused to provide details, the bill he was referring to is the Drugs and Cosmetics Act (Amendment Bill), 1940, which calls for an autonomous drug regulatory body for pharmaceuticals.

The draft pharma policy had stressed the need to strengthen drug regulatory systems to make quality medicines available at affordable prices.

Health Minister Anbumani Ramadoss is part of the GoM, which was set up on January 11, 2007. However, this is the first time his ministry is seen as expressing strong reservations against the proposals in the draft policy.

Wednesday's GoM meeting was the fourth in the last 16 months.

According to sources, what irked the health ministry the most is the chemical ministry's move to carve out a separate department for pharmaceuticals.

While quality regulation and marketing approval of medicines is the responsibility of the health ministry, drug pricing regulation is carried out by the chemicals ministry.

A separate pharma department was mooted to take up the multiple regulatory and administrative functions related to medicines.

The draft pharma policy calls for increasing the span of price control on an additional 354 drugs.

The draft policy also talks about regulating trade margins of all medicines, public procurement of drugs, price negotiation for patented drugs and medical devices, and legislation of new law to compound drug-related offences.

Other members of the GoM are Chemicals Minister Ram Vilas Paswan, Commerce Minister Kamal Nath, Science and Technology Minister Kapil Sibal, and Montek Singh Ahluwalia, deputy chairman of the Planning Commission.

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