Cipla feels FDA heat: nine ‘deviations’ found

After Ranbaxy Laboratories and Sun Pharma, it is now the turn of Cipla Ltd to feel the heat of the US Food and Drug Administration. The FDA found nine deviations in the drug maker's manufacturing process during a recent inspection of the company's Bangalore plant.

The company, however, has said that the deviations are ''routine and minor'', requiring adjustments to conform to the FDA's drug manufacturing quality standards. ''One of the nine deviations is related to incorrect data entry,'' a Cipla spokesman said.

He said the company has taken immediate steps to correct deficiencies, and will mail a formal response to FDA within the stipulated 30 days.

Nonetheless, Cipla shares took a beating on the Bombay Stock Exchange on Monday after the news was publicised.

In September last year, FDA had banned 30 Ranbaxy drugs, which are manufactured at two of its plants in India. A month later, the regulator issued a warning letter to Caraco Pharmaceutical, Sun Pharma's American subsidiary, and has also halted approval of new drug applications from its Detroit facility. In November, the agency found 15 manufacturing deficiencies at Lupin's plant in Madhya Pradesh.

While some say the FDA needs to take a strong line on manufacturing practices in view of the large number of cheap generic drugs being imported into the US – the bulk of them from Indian companies – others grumble that the US regulator is merely acting to protect the interests of pharmaceutical majors, whose profits have been hurt.