The Hindu Business Line : Health Ministry proposes independent drug regulator

THE Health Ministry is planning to set up an independent drug regulatory authority on the lines of the US Food and Drug Administration (FDA) and hopes that a structure will be in place in the next two years.

Speaking at the 36th Meeting of Drugs Consultative Committee, the Health Minister, Dr Anbumani Ramadoss, said, "In the first phase, we will try and replicate the mechanisms followed by the FDA while in the second stage we could look at tying up with the US drug regulatory authority." A system could be put in place whereby the regulatory clearances given by the Indian authority would be valid in the US as well.

The proposed regulatory authority could be called Central Drug Administration or National Drug Authority and would have ten different sub-committees to look into drugs, cosmetics, blood safety, medical devises, biological products, recombinant products and so on.

The step has been initiated on the recommendations of the Mashelkar Committee, which submitted a report on drug safety and spurious drugs. According to officials, the current system, which is guided by the Central Drugs Standard Control Organisation, is "old, fragmented and not independent".

Dr Ramadoss said that there is a need to make drug regulation more stringent to ensure that quality and standards are met. Pointing out that India has the fourth largest pharmaceutical industry in the world, he said, there was a need for regulation to keep pace with the growth in manufacturing. India is the biggest manufacturer of FDA-approved pharmaceutical products outside the US.

The new drug authority will also help curb the spurious drugs menace through extensive testing. At present, only 35,000 drug samples are being tested in various labs each year. The Government hopes to increase this figure to one lakh samples.

Referring to the recent controversy surrounding baby products, the Minister said that there is a need to enforce standards and ensure proper labelling.

"With newer inventions and newer diseases, there is a need to look at regulation for blood safety, stem cells banks, cosmetics and even medical devices," he added. The Ministry is also planning to bring medical devices under the purview of the Drugs Controller General of India.

The two-day meeting of the Drugs Consultative Committee, which is being attended by Drugs Controllers in the various States is likely to take a view on amendments to the labeling products under Rule 148 of the Drugs and Cosmetics Rules to ensure that all ingredients in a cosmetic product are mentioned on the labels in the descending order.

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page