The US drug regulator is likely to increase unannounced inspections of Indian sites, said Dr Robert Califf, the head of the US Food and Drug Administration (FDA). He added that the regulator will conduct a mix of both announced and unannounced inspections.
Experts, however, point out that the USFDA faces issues such as advanced intimations and a lack of independent translators during inspections. For instance, with announced inspections companies get an advance time of 9 to 12 weeks that allows them to prepare, which might prevent inspectors from getting a clear view of the plant in its steady state.
Unannounced inspections will help tackle the issue of lead times, say experts. The FDA chief said the rationale behind unannounced inspections is to develop a system where there are no surprises.
The idea behind increased inspection, as per the USFDA chief, isn’t to punish but to strengthen the system. He cited an example of an Indian company during his visit saying the USFDA can come anytime they want. The idea is that it shouldn’t matter when the FDA visits a company site if they are always adhering to good practices.
India is home to over 500 USFDA compliant plants, the largest number outside of the US. While companies continue to face issues in manufacturing and clinical studies, we have improved on some critical parameters such as data integrity.
On the issue of data falsification, the USFDA chief said companies have come up to standard. Besides, issues emerging from the top-down culture have also seen an improvement. Citing another example he said that during his trip to mark the 15th year of the FDA operations in the country, he met a number of employees who completed their PhDs and were paid by the company.
Lastly, while they are focusing on strengthening compliance, the FDA chief points out that the relationship with India is long-standing and stronger than ever. Both economies are powerful with strengths that match and India will continue to be a critical part of the supply chain for the US. CNBCTV18