“I see quality compliance as a learning curve, while one should bear in mind that regulatory standards are also constantly evolving.”

Binish Chudgar, Intas

“In India, pharmaceutical companies have had mixed success in upgrading their quality systems, and the number of warning letters from the US FDA to Indian manufacturing sites has increased in the last five years. While the proportion of official action indicated (OAI) and voluntary action indicated (VAI) decisions in US FDA inspections has remained the same (around 65 percent), the number of inspections increased by 30 percent in 2015. That same year, when some of our members received warning letters from the US FDA, it came as quite a surprise,” relates Dilip G Shah of the IPA, before adding: “we did not, however, take the view that India and Indian companies were being targeted as we had a fairly positive relationship with the US FDA.”

“Our risk-based site selection model focuses on drug manufacturing establishments, rather than countries,” highlights Dr. Letitia Robinson, director of the US FDA India Office, while stressing that the problems encountered by the FDA’s investigators in India are similar to those seen around the world in manufacturing: “common issues include inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing, and product contamination,” she adds.

“The level of regulatory scrutiny that a pharmaceutical company has to cope with often depends on the significance of its market share in the relevant country – especially when it comes to the US FDA. In this regard, it truly makes a difference whether a company holds only a handful of products or ships 50+ INNs from a given plant; when holding a small market share, regulators would typically not go into full details, but compliance inspections suddenly reveal themselves extremely stringent and in depth once a company has a substantial position,” considers Binish Chudgar, vice-chairman and managing director of Intas, the largest privately-owned Indian pharmaceutical company with sales of over USD 1.7 billion during the last financial year. In the meantime, recent inspections seem to indicate that stringent regulatory scrutiny has been broadened to encompass API manufacturing plants, in addition to the formulation plants primarily targeted in the first place.


“I see quality compliance as a learning curve, while one should bear in mind that regulatory standards are also constantly evolving. Across our multiple manufacturing plants, Intas has successfully passed 50+ US FDA inspections over the past two decades, and the US FDA inspects one of our plants every six months on average,” he adds. As part of the findings of IPA’s Quality Forum – set up in 2015 with the vision of helping the Indian pharma industry achieve excellence in quality – progress has evidently already been made over the past three years: while Indian manufacturers accounted for 50 percent of all warning letters issued by the US FDA to non US-sites in 2015 – Chinese sites making up only 13 percent of the total – this number decreased to 29 percent in 2017 for India-based sites and grew to 35 percent for China-based sites.

In the meantime, regulatory and compliance issues do not seem to have utterly cooled down the eagerness of leading international companies to acquire India-based manufacturers and/or service providers, especially in very sophisticated product areas. For example, Swedish CDMO Recipharm completed the acquisition of India-based CDMO Kemwell in 2016 and acquired a majority stake in Nitin Lifesciences, an Indian sterile injectables CMO. In the same year Baxter agreed​ to purchase India-based Claris Injectables (including its three Ahmedabad-based manufacturing plants) for USD 625 million.

Writer: Laurent Pichotzki-Libano