 "'Peer pressure crucial to ensure quality in pharma'")
Indian Pharmaceutical Alliance (IPA) secretary general DG Shah on Monday said efforts at improving quality and compliance among the domestic pharma companies should also be encouraged through peer pressure.
“We want peer pressure also to grow because one incident (import alert from drug regulatory agencies) impacts the entire industry,” he said on the sidelines of a workshop being held here in association with the US Food and Drugs Administration (USFDA).
The workshop, attended by officials of various Indian companies involved in quality management, is a part of a series of similar events lined up in other cities including Ahmedabad and Chandigarh. While the initial round of workshops deal with the topic Effective Quality Systems, three more topics have been planned to be introduce in the latter rounds, he said.
Responding to a question on increased scrutiny of Indian pharma exports by the US FDA, he said the scrutiny was not directed against any one country in particular. “The US needs Indian pharma products as much as we want our exports to grow to that country. The US healthcare Bill has been kept within limits only because of the import of affordable medicines from India,” he said.
The US FDA warning letters, which largely concern manufacturing facility inspection, relating to APIs (active pharmaceutical ingredients) have decreased whereas those relating to formulations have increased in the last three-and-a-half years.
Across the world, the number of firms named through FDA drug recalls, withdrawals or safety alerts almost doubled from 19 in 2010 to 36 in 2012 and there had been 32 in just the first six months of 2013, he said.
“We want peer pressure also to grow because one incident (import alert from drug regulatory agencies) impacts the entire industry,” he said on the sidelines of a workshop being held here in association with the US Food and Drugs Administration (USFDA).
The workshop, attended by officials of various Indian companies involved in quality management, is a part of a series of similar events lined up in other cities including Ahmedabad and Chandigarh. While the initial round of workshops deal with the topic Effective Quality Systems, three more topics have been planned to be introduce in the latter rounds, he said.
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According to Shah, both big pharma and small companies still fail in terms of cGMP (current good manufacturing practices) compliance. “The number of drug recalls, market withdrawals and safety alerts reported over the last three years indicates that while many instances of noncompliance are inadvertent, some are deliberate,”he said in the Industry Expert Panel submissions.
Responding to a question on increased scrutiny of Indian pharma exports by the US FDA, he said the scrutiny was not directed against any one country in particular. “The US needs Indian pharma products as much as we want our exports to grow to that country. The US healthcare Bill has been kept within limits only because of the import of affordable medicines from India,” he said.
The US FDA warning letters, which largely concern manufacturing facility inspection, relating to APIs (active pharmaceutical ingredients) have decreased whereas those relating to formulations have increased in the last three-and-a-half years.
Across the world, the number of firms named through FDA drug recalls, withdrawals or safety alerts almost doubled from 19 in 2010 to 36 in 2012 and there had been 32 in just the first six months of 2013, he said.