Indian Pharma Companies To Face Strict U.S. Drug Approval Norms

By siliconindia   |   Monday, 29 July 2013, 10:55 Hrs
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Bangalore: In a major crackdown on illegal sale of India-originating drugs labelled as 'natural' cure for diabetes, the U.S. health regulator FDA had initiated action against 15 companies, including a Gujarat-based drugmaker, for supply of such products.

Following the action the U.S. pharmaceutical companies may tighten the drug approval norms. The FDA (Food & Drug Administration) has also made it mandatory for the companies to give data which comprises safety, efficacy and stability, reports Business Standard.

“The U.S. FDA has mandated data will have to be filed for three batches from January 2014,” said an industry representative, involved in development of generics at a domestic Pharma company.

It is said that the move will be affecting the cost and increase it up to three times in cases where ingredients used were expensive.

It is estimated that the total cost of generic drug development is estimated at around $3 million per product. “The major cost increase will come due to active ingredients. The more the number of batches, the more will be the ingredients required. Besides, we will also have to do studies for a longer period,” the official said.

The domestic drug manufacturing conglomerates like Sun Pharma, Lupin, Dr Reddy’s, Cadila Health and Ranbaxy each year file around 15-20 generic drug applications, seeking approval from the U.S. drug regulator.

India is the second largest drug exporter to the U.S. and Indian drug makers have a significant presence there. Those having faced FDA action in recent times include Wockhardt, Fresenius Kabi, Ranbaxy, Sun Pharma, Cadilla, Aurobindo Pharma, RPG Life Science, Dabur and Glenmark.

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