Warning letters to Indian pharma companies from US FDA declining: Study

Investment in automation, staff training and collaboration with regulators has resulted in Indian pharmaceutical plants receiving less than a third of US Food and Drug Administration warning letters in 2017. In 2015 the share of Indian sites receiving warning letters was 50%.

India supplies nearly a third of all medicines to the US but slippages in manufacturing processes and quality defects resulted in warning letters and import alerts on several plants in India. Three years ago the Indian Pharmaceutical Alliance (IPA) which represents top twenty drug makers began an initiative to improve quality standards and the efforts seem to be paying off.

According to a study by IPA and consultancy firm McKinsey released on Wednesday,  number of FDA inspections in India declined from 272 to 192 from 2017 to 2015 but the share of plants receiving a clearance without adverse observations increased from 32% to 51%.

While there is an increase in absolute number of warning letters issued to Indian plants, the proportion of such letters issued to plants in the country declined from 50% to 29% in the same period, according to the study. In 2015, 16 warning letters were issued to plants outside the US,  while in 2017 the number increased to 49.

“Pharmaceutical companies are faring better on quality compared to 2015,” said IPA secretary general D G Shah on Wednesday. 

The number of cases of data integrity violations too is showing a decline and the study shows that only 20% of warning letters in 2015 resulted from data integrity issues compared to 41% in 2015. 20% of such letters are now being issued for failures in investigations of product deviations compared to 18% two years ago. The nature of observations resulting in warning letters now is similar to those being witnessed in the US.

Companies have taken a lot of effort to build awareness and capabilities and now steps are being taken to improve investigation. Another focus area in 2018 is increasing the size and base of quality talent in the country,” said Vikas Bhadoria, director, McKinsey.