Rise in USFDA inspections marred image of Indian pharma industry: EY

G Naga Sridhar Hyderabad | Updated on January 24, 2018

The increase in foreign regulatory inspections has marred the image of the Indian pharmaceutical industry, according to a survey of Ernst & Young (EY).

Out of 19 US Food and Drug Administration's (USFDA) warning letters issued in 2014, eight were issued to Indian companies, EY said in its latest survey on analysing the state of data integrity compliance in Indian pharmaceutical industry.

India has the second largest number of manufacturing facilities outside the US (523 as on March 2014) registered with the USFDA.

There has also been a steady rise in drug exports to the US from India. They had gone up from $1.25 billion in FY’10 to $3.45 billion in FY14.

``With the growing importance of the Indian pharmaceutical industry in the global market, the number of foreign regulatory inspections has also increased considerably,’’ the survey said.

Referring to the data integrity issues in the industry, EY said shortage of staff and excessive work pressure can lead to inaccurate and incomplete documentation.

``Even companies with a good track record with regulators and regardless of the existing or anticipated Good Manufacturing Practices (GMP) compliance should initiate periodical and proactive data integrity assessment to assess their state of quality compliance,’’ it said.

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Published on June 04, 2015
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