Even as the move to set up a Central Drug Authority (CDA) by the Health Ministry with a view to centralising the operations of the pharmaceutical sector is stuck for three years now, the Department of Pharmaceuticals (DoP) is now mooting a proposal to set up the National Authority for Drugs and Therapeutics (NADT).

The Department is learnt to have made a draft proposal in this regard, though it is yet to make the proposal public or consult the stakeholders on the formation of the new authority. Sources said, the proposal was still in the draft stage and details would be disclosed for consideration and comments by all concerned after finalisation.

The basic idea behind creating NADT is to bring the Central Drugs Standard Control Organisation including Drugs Control General of India (DCGI) which is now under the Health Ministry and the National Pharmaceutical Pricing Authority (NPPA) which is already under the DoP under one roof for better coordination, it is learnt. When the DoP was created a few years back, one of the plans was to bring the CDSCO also under its ambit in due course of time. The new move is aimed at fulfilling this plan, sources indicated.

The proposal is likely to be discussed soon at a meeting of the sub-committee on regulatory affairs involving representatives of industry associations, departments like Health, Health Research, Biotechnology, Science and Technology, and Planning Commission, apart from the DoP, sources said.

A few years back, a Task Force under the chairmanship of Dr. Pronab Sen, then Principal Advisor, Planning Commission had recommended to establish the NADT as a long term objective. This was aimed at integrating the offices of the DCGI, CDSCO and NPPA along with all its powers and functions.  The Government then said it was holding consultations with various stake-holders to examine the recommendations of the Task Force.

It is not yet known how this would exist along with the proposed CDA which being pushed by the Health Ministry. The Drugs & Cosmetics (Amendment) Bill 2007 to amend the Drugs & Cosmetics Act, 1940 and to set up the CDA was introduced in the ‘Rajya Sabha’ on August 21, 2007 and was thereafter referred to the Parliamentary Standing Committee of Health and Family Welfare for review. The Committee also had submitted its recommendations to the Government since quite some time. But no further step was yet taken in this regard.