Indian drug firms okay with US law on enhanced inspection

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The Indian generic drug industry is generally receptive to the proposed US law on medicine even though it seeks to enhance US-FDA inspection of the manufacturing facilities globally for a fee.

Industry players and analysts feel that while the level of inspection by the US Food and Drug Administration will increase, the clearances will be faster to enable expeditious exports of the generics to the world's biggest and most lucrative market.

The 'FDA user fee reauthorisation bill', which has been cleared by US House of Representatives, now goes to the Senate, which is expected to vote on it this week.

"In the long term, this is a clear positive for the generic sector, including Indian pharma companies," according to a Sun Pharma spokesperson.

By taking a fee for new drug filings and for foreign inspections, the US-FDA will build resources it needs to complete inspections fast, the spokesperson added.

India is one of the prominent generic medicine producing countries in the world. The industry size is estimated to be USD 20 billion, of which about USD 10 billlion worth of drugs are shipped to the export markets.

The US accounts for more than half of these exports, according to industry estimates.

Ranbaxy, Sun Pharma, Lupin, Cipla, Dr Reddy's and Aurobindo Pharma are the major exporters to the US market.

"Long-term players committed to quality should welcome rather than fret over this proposed legislation as it would ensure that best-in-class compliance with regulatory policy and procedures becomes completely embedded in their DNA," KPMG executive director Hitesh Gajaria said.

According to estimates, the FDA could collect around USD 6.4 billion in fees from companies all over the world over the next five years. According to industry estimates, the FDA currently has a backlog of roughly 2,700 generic drugs awaiting review.