Facing higher scrutiny, IPA plans monthly meetings with members on quality

Data suggests that Indian sites received fewer OAIs in the first six months of 2023

The Indian Pharmaceutical Alliance (IPA) is planning to hold monthly meetings to discuss quality issues and overcome inspection observations among its members and other pharmaceutical companies. Earlier, the frequency of meetings was not fixed and the alliance would meet when needed. This move comes amid heightened scrutiny from the United States Food and Drug Administration (US FDA).

IPA counts India’s top drug makers such as Cipla, Abbott, Sun Pharma, Torrent Pharmaceuticals, Zydus Lifesciences, and Dr Reddy’s Laboratories among its members. 

Shirish Belapure, senior technical advisor, IPA, said the alliance has regular meetings on the issue of quality with the members. “Exactly a month back, the IPA had a meeting on the (quality) issue, where a pharmaceutical company shared the actions they took and how they implemented it after observation,” he said. “We plan to have meetings on a monthly basis within our group and other companies to share their experience on how they overcame their observations,” Belapure added.

At a recent event, USFDA Country Director Sarah McMullen said that the USFDA encouraged knowledge sharing among industry players. “We encourage the industry to share and learn within the industry. The USFDA has constraints on what we can share about firms in relation to their corrective actions,” she said.

Meanwhile, data suggests that Indian sites received fewer official action indicated (OAIs) in the first six months of 2023.

The IPA’s data (representing 24 firms) suggests that the majority of inspections conducted this year resulted in positive outcomes, with VAI (voluntary action indicated) and NAI (no action indicated) status, indicating no major concerns.