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Indian Pharma companies biggest violators of USFDA integrity norms

Indian Pharma companies biggest violators of USFDA integrity norms


Mumbai:Sixty percent  of reported data integrity violations in the records of US  regulator since 2011 are against drug manufacturing units in India. This is gradually turning a serious quality control issue.

The Nomura Research report reveals that 27 of the 45 warning letters issued by the Food and Drug Administration were issued to Indian plants owned both by Indian and foreign brands.

The names brought to book include Wockhardt, Sun Pharmaceutical, Dr Reddy’s Laboratories, Cadila Healthcare, Sandoz, IPCA Laboratories and Mylan Laboratories reports Business Standard.

Currently 15 plants have been issued import alerts against them; the step has been taken due to data integrity being a matter of concern with the US pharma regulator. It has also resulted in delayed product approvals.

Data integrity is of significance for US regulators for it is an indication to whether the processes have been well managed; and if the end product is safe and efficacious. Approval by the FDA is directly related to data provided by the company to the regulator. Any negligence in this area leads to stringent action against the company.

The increase of India made products to the US between 2009-14, from 18 to 33 percent is the primary reason, for scrutiny tightening on all fronts of drug manufacturing. A close scrutiny of the warning letters issued by the US regulator to the big India pharma units, by analysts Saion Mukherjee and Ayan Deb of Nomura Research over this five year span brought to light  that most pertained to data violations. The highest number of  warning letters issued to both nationally and internationally housed Indian pharma groups being 11 and 16 in 2015 and 2016,respectively.

2012 observed a quiet on the violation front, however, seven and nine quality control procedure violations were observed in 2014 and 2015.

Of the 27 warnings issued only one issued to Cadila Healthcare in 2011 was withdrawn. Approved in 2012 Cadilla’s Moraiya unit came under flak in 2015, once again. According to Nomura Report, 26 warning letters are still applicable, as they have not been closed.

Sun Pharma has maintained a quiet on the issue; while  E-mails sent to Dr Reddy’s and Wockhardt’s spokespersons have not got a response either.

“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.

“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.”

There are  other measures being taken up by companies 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 on the other hand is setting up an institution in Vadodara for staff quality management training.


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Geeta Sharma

Geeta Sharma

Studied at Carmel Convent School headed the sports wing of the school, was the General Secretary Miranda House Students/ Union,, Did journalism at Patriot and Eenadu/Newstime. worked as teacher warden in schools of Mussoorie/ Dehradun/ Noida

Source: Inputs from Business Standard
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