Drug manufacturing units in India accounted for 60 per cent of reported data integrity violations in the records of the US sector regulator from 2011 till date, highlighting serious quality control issues.

A report by Nomura Research reveals that 27 of the 45 Food and Drug Administration’s (FDA’s) warning letters in this regard were to plants in India, both domestic and foreign-owned. Those under the scanner included Wockhardt, Sun Pharmaceutical, Dr Reddy’s Laboratories, Cadila Healthcare, Sandoz, IPCA Laboratories and Mylan Laboratories.

Data integrity is an issue of serious concern for health regulators globally and violations have resulted in delayed product approvals and, in some cases, import alerts for pharma companies. Currently, 15 plants in India have import alerts against them.

Drug regulators accord high importance to data generated during research and manufacture, to establish whether processes are well managed and if the finished product is safe and of good quality. FDA’s decision to approve a drug depends upon data given to it. Any violation results in tough action.

The increase in regulatory scrutiny comes after the share of India-made products in the US market increased from 18 per cent to 33 per cent in the five years till 2014.

Nomura Research analysts Saion Mukherjee and Ayan Deb analysed about 200 warning letters issued by the FDA during the five-year period, of which 45 explicitly mention data reliability violations. The highest number of such violations were reported globally in 2014 and 2015, of 11 and 16, respectively.

While no plant in India was found violating data integrity by the FDA in 2012, as many as seven and nine in 2014 and 2015, respectively, a global high, were found slipping on quality control procedures. Of the 27 warning letters to Indian facilities, only one — issued to Cadila Healthcare in 2011 — has been withdrawn; the company’s Moraiya (in Mp) unit was approved by the US regulator in 2012. However, the company faced regulatory ire again and the Moraiya unit once more received a warning letter in December 2015. The Nomura report reveals that the other 26 warning letters have not been closed and are still in force.

Sun Pharma declined to comment on the issue. E-mails sent to Dr Reddy’s and Wockhardt’s spokespersons did not elicit a response.

“When an organisation receives data reliability observations, it does not necessarily indicate a manipulation. It could, however, indicate that controls and systems in the organisation need to be foolproof,” says Vikas Bhadoria, director, Mckinsey & Company.

Adding: “There have been instances when companies have received these observations as some of its older manufacturing units had standalone process equipment and were not linked to its integrated information technology system. Organisations need to invest in IT systems and automation, and raise awareness among its employees about data integrity. Data reliability is a crucial issue and cannot be ignored. Indian companies are already working on improving data reliability and have come out with their own draft guidelines. I believe that in the near future, the proportion of warning letters on data reliability to Indian plants will come down.”



Companies are taking other measures, too, to improve compliance. Zydus Cadila, Torrent and Cipla are focusing on automation in manufacturing, building a talent pool and setting up quality cells in factories. Sun Pharma is setting up an institute in Vadodara to train its staff on quality management.

UNDER THE SCANNER