Dilip Shah, Secretary General of IPA, told delegates at CPHI India last week “in the last eight months the quality of inspectors and of inspections both have significantly deteriorated, not only in India but also in the US.
“We have been working with the US FDA to get 19 inspector positions in India. We now have twelve, with seven more to come.”
Only two of these inspectors are based permanently in India, said Shah. “The rest of them come and they do not know Indian culture. They visit the facility and practically sheer psychosis is created by the way they conduct [inspections].
Shah said the FDA should take a less aggressive and more helpful attitude to teach manufacturers how to meet its standards.
“I told US FDA that your goal and our goal is common: providing safe effective and quality medicines to US citizens. How best can we do this? Can we work together?
“When a student in a classroom is lagging behind the onus is also on the teacher to help the student catch up with the rest of the class. This is the solution, not policing and filing 483s.”
FDA’s spokesman declined to respond directly when we asked about IPA’s complaints, but said the agency wants to make sure Indian facilities understand all the risks associated with manufacturing and stay compliant with safety requirements.
“The problems encountered by the FDA’s investigators in India are similar to those seen around the world in manufacturing. Common issues include inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing, and product contamination,” said the FDA’s Christopher Kelly.
“While some Indian companies meet US product quality standards, others do encounter problems and operational challenges. Staff from the FDA’s India office will work with these companies to identify the problems and will take the necessary steps to self-correct.”
The FDA’s presence in India “allows us to better collaborate with our Indian regulatory counterparts and enables us to leverage our combined resources, harmonise science-based standards and increase regulatory capacity,” added the spokesman.
IPA’s Secretary General also criticised what he called a lack of guidance for manufacturers on how to implement US laws.
In the UK, an Act of Parliament, law, and guidelines on how to interpret it “are all compiled together and available in one book.”
“The US FDA only have an Act, and guidances are issued from time to time but there is no compilation available of those guidances.
“So there is a need for US FDA to put its documents in order.”
In September the India Brand Equity Foundation accused American researchers of a “smear campaign” against Indian manufacturing after a paper claimed drug samples from Indian manufacturers were of unacceptable quality.