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P.T. Jyothi Datta

New Delhi , Dec. 2

IN what is being termed as "radical" by the pharmaceutical industry, the final report of the Mashelkar Committee looking into the drug regulatory issues and spurious drugs has proposed the elevation of the Central Drugs Standard Control Organisation to the level of a Central Drug Administration (CDA).

The drug administration, a Central body reporting directly to the Health Ministry, would, among other things, have complete control over the licensing of manufacturing units in the country — a power that was earlier vested with the State drug departments. To be headed by the Drug Controller General of India, the administration is to be set up by December 2005, the report has proposed.

Dr R.A. Mashelkar, Director-General, Council of Scientific and Industrial Research (CSIR), told Business Line that the need for a truly global regulatory framework was important since the "whole world is watching India. The country should not look at providing drugs just for the Indian population, but for the world population too."

The expert committee under Dr Mashelkar, which was set up recognising the need to globally harmonise regulatory and scientific requirements, submitted its final report to the Health Ministry recently. The voluminous report comprises two parts, one dealing with the regulatory issues that monitor and guide the activities of healthcare providers, the Indian Systems of Medicine, food supplements, medical devices, diagnostics etc., while the second takes up the issue of spurious drugs.

The report has hinted that its recommendation on "centralising enforcement over drug manufacturing activities in the country" did not come without some heartburn. "Apprehensions have been expressed, among others, by the All India Drug Control Officers Confederation, the Gujarat State Food and Drug Control Administration Gazetted Officers Association and, to some extent, the Indian Drug Manufacturers Association," the report said.

"Majority of the State Drug Controllers are also not in favour of central licensing," the report added. The fee for the grant of licences, product permission and various certificates were the only source of revenue for State drug departments and the centralisation would cause loss of revenue to the States, they argued.

However, countering this argument, Ministry officials said, "About 75 per cent of drugs are manufactured in about seven States. Sometimes, companies seek out States with a weak regulatory framework to cut corners. A stringent framework is necessary to ensure the health of the people, which is more important than the revenue flowing to the States."

Allaying apprehensions that the drug administration would be Delhi-centric, the report said that the Central body would have its offices in most of the State capitals, where there is significant manufacturing activity. Further, the report has noted that the drug administration would be system-based. That is, for every activity, there would be a clear policy framework and supervision to ensure a uniform implementation. This would include timely and transparent disposal of licence applications, renewals, etc. The proposed roadmap for setting up the administration looks at three phases starting end-2005.

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