US FDA rap: Dr Reddy's eyes 3rd-party evaluation

Dr Reddy's Laboratories plans third-party verification of its manufacturing facilities. This comes in the aftermath of a warning letter issued last week by the US Food and Drug Administration (FDA) on three of its units. The units are all in Andhra, at Visakhapatnam, Srikakulam (both make active pharmaceutical ingredients) and Miryalguda (for oncology preparations).

G V Prasad, co-chairman and chief executive (CEO), said at an analysts’ call on Monday that they were in the process of determining whether or not to confine the third-party evaluation to the three facilities.

This is in addition to the corrective measures being initiated across its facilities, in the light of the FDA observations, he said. Dr Reddy's has to respond in 15 days (of getting the letter) to the FDA, on the plan for corrective steps.  The CEO said that the FDA had made inspections at other sites, too, after doing so for the three in question. Among these was a formulation facility at Bachupally in this city; “some small observations” had come out of these inspections, too.

"However, to the best of our knowledge they will not be included(in the warning letter)," he said.

Prasad said the observations in the warning letter fall in four broad categories — documentation practices and control, laboratory testing, adequacy of standard operating procedures and incident investigation practices.

While refusing to say when the US regulator was expected to come back with its assessment on the company's strategy and plan pertaining to the corrective measures, he, however, stated that it was going to take significant time and effort to implement the measures required. The company has to respond to the warning letter in 15 days time with a comprehensive plan and strategy on the corrective measures.

Responding to a question, Dr Reddy's chief operating officer(COO) Abhijit Mukherjee said though there was no significant impact arising from the inclusion of the Oncology unit, the company would use the mode of outsourcing, which was already in practice, to mitigate the impact going forward.