Cabinet to take up proposal for national drug authority

New Delhi: In order to regulate the drug industry better, the Health Ministry has moved a Cabinet note on a proposal for setting up of a National Drug Authority (NDA).

Along the lines of the US Food and Drug Administration (FDA), the proposed authority will have 10 basic divisions looking into various issues related to drug safety, licensing, medical devises and equipment, Indian System of Medicine and so on. The present Drug Controller General of India (DCGI) will be subsumed into the new authority.

Speaking to newspersons on the sidelines of the Social Editors' Conference, the Union Health Minister, Dr Anbumani Ramadoss, said, 'Once the Cabinet clears the proposal, an enabling legislation would be tabled in Parliament at the earliest. We hope that the authority will be in place within one-and-a-half years of enacting the legislation.'

He said that the authority would be independent and will have representatives from the Government, industry and legal.

On the inclusion of regulation of food safety, the Minister said that while the Integrated Food Bill has already been tabled in Parliament, the implementation Ministry has not yet been finalised. 'The Prime Minister has set up a committee to take a decision on this. If the Health Ministry is designated as the implementation Ministry, the scope of the NDA would be expanded,' he added.

However, the National Pharmaceutical Pricing Authority (NPPA) that monitors pricing of pharma products is expected to remain a separate entity.

On stem cell research, the Minister said that the regulations would be notified shortly. He further added that the Indian Council of Medical Research (ICMR) has initiated an enquiry into the claims made by a Delhi-based stem cell research outfit.

The Health Ministry has also initiated discussions with the Finance Ministry of unused funds. According to the norms, Ministries are expected to utilise their funds by the end of the financial year and will not be allowed to carry the balance forward to the next year. 'We are in talks with the Finance Ministry. Some States have not submitted their financial statements,' he added.