India to have US FDA-like drug regulator

The government has decided to revamp the drug regulatory structure in the country and set up an independent authority on the lines of US Food and Drug Administration for quality control of drugs.

Once the regulatory body was put in place, the government would approach the American FDA for an agreement on mutual approval of clinical trials and drugs, Union Health Minister Anbumani Ramdoss announced at the 36th meeting of the Drugs Consultative Committee in Delhi on Thursday.

"The independent drug regulatory authority would be set up in two years. All the strong points of FDA would be replicated in the new structure," he said.

The minister had visited the United States recently and the Drug Controller General of India was to leave for the country soon in this connection.

The proposed structure, which will be called Central Drug Administration or National Drug Authority, would have ten different sub-authorities to deal with areas like cosmetics, blood safety, medical equipment, biological products, recombinant products, etc, the minister said.

The step was being initiated on the recommendations of the Mashelkar Committee, which went into the issue of drug safety and spurious drugs.