In 2002, the US Food and Drug Administration (FDA) did not conduct any bioavailability (BA) or bioequivalence (BE) study inspections in India for generic drug applications. A little more than a decade later, and nearly half of all FDA's BA/BE study inspections are conducted on the subcontinent.
That dramatic rise has resulted in a major uptick in significant data quality issues, which was the focus of an educational session at the DIA annual conference in Chicago on.
The session brought together three FDA officials to discuss unintentional and intentional study data manipulation, as well as FDA's increasing collaborations with India's government and drug regulators.
Arindam Dasgupta, a deputy director within FDA's Office of Study Integrity and Surveillance (OSIS), made clear: "If you are a CRO [contract research organization] or a sponsor and see intentional data breaches, they have to be taken seriously … FDA can do some inspections, but sponsors and CROs have to step up."
He noted that common breaches in data integrity can result from negligence or accidents, but also from deliberate misconduct as companies often try to save a failing study or satisfy a sponsor to attract future work. Dasgupta explained that the deficiencies found in India are not unique to the country but that because the volume of studies has grown by so much, the problems are more prominent there.
FDA's outgoing country director in India, Matthew Thomas, who has worked closely with India's Central Drugs Standards Control Organization (CDSCO) and the Drug Controller General of India over the past two and a half years, also told attendees of the progress made in improving interactions with the Indian government.
"The government is a lot more responsive and serious about strengthening its regulatory systems," Thomas said, noting the confidence level in interactions between FDA and the Indian government have improved dramatically, and although FDA conducts unannounced for-cause inspections in India, FDA's New Dehli-based operation also informs the government when certain inspections will take place.
He also explained that part of the reason that the number of BA/BE studies have grown in India is that since 2013, India's government relaxed some of its more stringent regulatory requirements. For instance, the government previously required companies to videotape the signing of informed consent forms but then "figured out that wasn't useful and said it's only necessary for certain vulnerable subjects."
India's government has also adopted a new quality checklist that did not exist before, in addition to a new handbook for companies to better figure out the application process and how it should work.
Sean Kassim, director of FDA's OSIS, further explained how the agency's risk-based inspection system is based on the time since the last inspection, the outcome of past inspections, corrective actions seen and the number of pending applications, among other criteria.
Leslie Ball of FDA's Office of International Programs added that Capt. Latisha Robinson will take over as head of FDA's India operations in the coming weeks and that business will go on as usual between now and when she gets started.
(Courtesy: http://raps.org/Regulatory-Focus/News/2017/06/19/27937/US-FDA-Sees-Major-Spike-in-BA-and-BE-Studies-in-India/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails&sthash.ZaLJ7Zk5.dQfu9k1h.mjjo&lipi=urn%3Ali%3Apage%3Ad_flagship3_feed%3B9TNNs1R5T%2BGZxsqLJShzLg%3D%3D)