The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
The US Food & Drug Administration (FDA) is conducting an unannounced inspection of Dr Reddy’s Laboratories’ unit at Visakhapatnam since Tuesday evening, it is learnt. It could go on till the end of the week.
The unit, meant for formulations, supplies to the European Union and US markets. Some discrepancies have been found at the unit, it is learnt, and the American drug regulator is expected to give some recommendations to the company.
Dr Reddy’s had, a day earlier, intervened in a lawsuit, inclining towards the FDA and against another domestic generic drug maker, Ranbaxy. The latter had sued the regulator for revoking the key exclusivity period of two of its major drugs in the US market, Nexium and Valcyte. Dr. Reddy’s was granted a nod to launch the Valcyte generic after the revocation order for Ranbaxy.
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes.
In September, it made an unannounced inspection at Sun Pharmaceutical Industries’ Halol unit. In May, another manufacturing unit of Sun Pharma, at Karkhadi, also in Gujarat, got a warning letter from the FDA after investigators identified violations of current good manufacturing practices and regulations for finished pharmaceuticals.
Of late, Indian drug makers have been facing stringent enforcements in the US, the world’s largest pharma market. Several manufacturing plants of leading domestic companies — including Ranbaxy, Sun Pharma, Wockhardt and Strides Arcolab — have come under the FDA’s scanner on compliance issues. The frequency of regulatory inspections has risen significantly in recent years.
