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Indian drug manufacturer Sun Pharma under scrutiny by USFDA

US Food and Drug Administration issues warning to Indian pharmaceutical giant Sun Pharma for data integrity issues. 

MUMBAI: Indian drug manufacturers continue to receive warnings and import bans by the US Food and Drug Administration (FDA) for violating drug manufacturing regulations.

The latest to face the heat is Sun Pharma.

Just two months after the US drug regulator imposed an import ban at one its plants, the FDA has now issued a warning letter pointing out data integrity issues… similar to those that plagued Ranbaxy Laboratories.

Analysts say if companies do not comply with US manufacturing standards, it could harm India's image of being the largest drugs exporter.

India is the biggest supplier of medicines to the US, and pharmaceutical exports from India to the US rose nearly 32 per cent last year to $4.23 billion.

But with the increase in exports, has come heightened scrutiny by the FDA over quality and manufacturing compliance.

"The reason it (FDA) is sensitive is because India is a really big portion of the US market," said Sujay Shetty, Director, Leader - Pharmaceuticals & Life Sciences, PwC India. "We have something like close to 200 plants in India that export to the US; so it's a very big supply to the US market.

"Approximately 10 per cent of the US finished dosage forms originate from India. It is 30 or 40 per cent of the US market and India's exports are significant from our side."

The FDA became more stringent after India's leading drug manufacturer Ranbaxy was found violating drug safety norms last year and was penalised half a billion dollars for the violations.

Since then, several drug manufacturers in India, including Wockhardt and now Sun Pharma, have faced similar charges.

The worry is that Indian companies are compromising on drug safety standards, but industry leaders insist these are exceptional cases.

"It's common sense… when 40 percent of my turnover comes from the US, I would do nothing which can actually jeopardise my chances in that particular market," said Ramesh Swaminathan, President - Finance & Planning, Lupin Limited.

"But again common sense is not necessarily common; there have been instances where people have taken shortcuts and paid a very heavy price for it.

"And there have been cases where perhaps they paid too heavy a price because they indulged in what is now generally acknowledged as fraud."
 

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