India aims at U.S. FDA standards on drugs with name change afoot

Print 13 July 2015
EJ Lane / FeircePharmaAsia

Indian policymakers say one way to break the cycle of repeated manufacturing violations that freeze drugmakers out of the U.S. market is to adopt U.S. FDA rules wholesale domestically--and that may happen soon.

To that end, the Hindustan Times reports, the Health Ministry and Central Drug Standards Control Organisation (CDSCO), jointly plan to study the guidelines of global health regulators, but the U.S. model will likely dominate.

Last month, the CDSCO told staff to forget holidays and weekends as it undertakes a massive drug inspection exercise it intends to complete by the end of the year.

Drug Controller General of India G.N. Singh

The unprecedented plans in India to test at least 42,000 domestic drugs to prove their quality was put forth by G.N. Singh, Drugs Controller General of India (DCGI), in May. He said the inspections would "tell the world that our drugs are of quality."

Of concern however is the fact that India needn't get so far ahead of less developed countries that it gets priced out of a razor-thin business in generics. But at the same time, the country needs to stay on the right side of the top market in the United States, the newspaper said.

"Government is worried over the promises made to the U.S. Food and Drug Administration of late," a senior bureaucrat from India's Ministry of Health and Family Welfare told the Hindustan Times. "However, due to the certain quality lapses by Indian drug makers, U.S. FDA still continues to take harsh action against India drug-production plants."

One step would be a name change, with the CDSCO becoming the Central Drug Administration, an official told the newspaper.

"The cabinet may take up the proposal in this month."

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