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P.T. Jyothi Datta

NEW DELHI, April 28

THE Government is said to be revisiting a plan to set up a National Drug Authority (NDA), an autonomous regulatory authority, on the lines of the Telecom Regulatory Authority of India (TRAI) or the Insurance Regulatory and Development Authority (IRDA). The issue is slated to be deliberated at a meeting scheduled for this week.

The ball was set rolling when the previous Union Health Minister, Mr Shatrughan Sinha, instituted a committee under the chairmanship of Dr R.A. Mashelkar, Director-General, Council for Scientific and Industrial Research (CSIR), to look into the issue of spurious drugs.

"The committee had its first meeting and since its terms and reference were too broad-based, it was decided to further set-up two sub-committees — one to look at the spurious drugs issue and the other to revisit a proposal made by the Mashelkar Committee on pharmaceutical research and development, to look at the regulatory framework," senior pharma industry officials told Business Line.

Further, they pointed out that the need for a central authority was felt necessary, as the pharmaceutical industry had too many bosses, figuratively speaking.

"The Drug Controller General of India (DCGI), the present regulatory authority, is under the Health Ministry; the National Pharmaceutical Pricing Authority (NPPA) — the body that monitors drug pricing — is under the Chemicals and Fertiliser Ministry and the Research & Development Fund comes under the Ministry of Science and Technology. Deliberations are at a nascent stage and how the sub-committee expects to circumvent issues of jurisdiction of the different ministries is something that would unfold subsequently," they observed.

"The proposed NDA would be a central regulatory authority, autonomous in its operations. Given the precedents set by TRAI and IRDA, the NDA would be modelled on them. The role defined for the NDA would be related to the licensing of drugs, monitoring and pricing," the official said. Dr Mashelkar was not available for comment as he was out of the Capital.

Meanwhile, pharma-industry watchers pointed out that it was not the first time that the need to have a central regulatory authority was being deliberated by the respective ministries.

"It has come up twice in the past — when the Hathi Committee first recommended it and later during the Drug Policy of 1986, but both times there was no follow up action. In 1999, the Mashelkar Committee brought up the issue again." The meeting this week could determine the direction the issue is expected to take, or whether the proposal would be put to sleep, yet again.

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