India wants to observe first-hand the processes undertaken by the US Food and Drug Administration (FDA) when the latter points out lapses in manufacturing processes of pharmaceutical companies operating in the country to rule out any attempts of a witch-hunt by the US regulator. The agreement of collaboration signed between the FDA and its Indian counterpart last week, however, doesn’t allow the Indian regulator to inform the company in advance of the FDA’s inspection plans. The surprise element of such inspections would be retained.
The FDA has, over the past year, hauled up leading India-based firms, including Ranbaxy, Wockhardt and Strides Arcolab, for failure to comply with its good manufacturing practices (GMPs). Lately, there have been accusations that some of the drug companies facing an import ban from the FDA were not granted adequate time to respond to the warning letters sent by the regulator before imposing the ban.
According to the statement of intent signed between Union health secretary Keshav Desiraju and FDA commissioner Margaret Hamburg on Monday, regulators need to inform “the respective regulatory authorities before undertaking inspections so that host-country inspectors may join inspections as observers”.
Industry sources said the move will allow Indian inspectors to make their own notes of any diversion on the part of the drug firm from domestic GMPs. It will also allow the drug manufacturer to seek counsel from the Drug Controller General of India when responding to US FDA warnings and rectifying the lapses.
While some segments of the industry contended that informing the Indian regulator about any upcoming inspections of domestic pharmaceutical facilities would be tantamount to notifying the drug maker, thereby removing the most important element of any inspection — surprise — the Indian drug controller’s office said that the agreement does not state anything about informing the drug company.
“The US FDA inspectors are extremely detailed and efficient in carrying out drug facility inspections. As part of the agreement, Indian inspectors would accompany them in the capacity of observers to learn the methods of inspection,” said Arun K Panda, joint secretary, health ministry.
He added that the timeline of informing the Indian regulator will be decided when the details of the agreement are thrashed out.
According to Hamburg, while the FDA would take appropriate action against any company that did not meet its requirements, the body was willing to work with the firms to help them address the issues they faced in