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USFDA warning on Indian drugs

27 February 2017 | News | By BioSpectrum Bureau

USFDA warning on Indian drugs

The US Food and Drug Administration (FDA) wants Indian drug manufacturers to get their act together, citing instances of sale of drugs which lack the stated content and complaints of medicines not delivering desired results.

Between 2011 and 2016, as many as 27 drug manufacturing plants in India got FDA warning letters for data integrity violations. And 15 of these had import alerts issued against them, according to a Nomura Research report. None of the alerts has been withdrawn, resulting in delayed product approvals or restrictions in export to the world's largest pharmaceutical market.

Matthew Thomas, director, FDA's Indian office said, "I had the opportunity to test some of the products with a rapid test tool. I got a blister pack of paracetamol and the test showed there was no drug in it."

He also said, "I Occasionally got samples from the US embassy's health unit in Delhi and the complaints are usually about the medicines not giving the desired results. I do not think any one of us wants to take such drugs which lack efficacy."

"Further tests would be required in laboratories to ascertain whether these drugs are non-standard. What we are telling Indian companies is that they need to take the onus of developing quality products, and investigate and follow up on complaints", he added

 

According to Pankaj Patel, chairperson, Cadila Halthcare, "Companies here do not have a different standard of quality for medicines sold in India and those exported to the US. As a company, we follow a global standard but in order to have it uniformly implemented across the entire industry, Indian regulators will have to adopt it."

Commenting on the same, D.G. Shah, IPA general secretary said, "FDA's observation was an illustration to explain the issue of investigation of complaints, and that it was by no means a reflection of the state of Indian pharma."

Nilesh Gupta, managing director, Lupin added, "There will be quality problems but how you deal with these is a more important issue. We have a global pharmacovigilance cell in Lupin and we investigate all the complaints we receive."

Umang Vohra, Cipla's global chief executive said, "We have created teams at the plant level to identify root causes of problems and find solutions at their level."

 

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