Lupin
By Ekta Batra and Abhishek Jha
Indian pharmaceutical companies are hiring former US Food and Drug Administration (USFDA) officers to tide over compliance issues. Lupin has hired one such officer, Diana Amador-Toro, as senior vice-president, the company informed shareholders in an exchange notification.
Toro who will be based in New Jersey and has nearly four decades of experience with the USFDA and will be responsible for leading Lupin’s global compliance functions including training, internal audits and investigations.
This is not the first time that an Indian company has hired a former drug regulator.
Another example is Massoud Motamed, a former USFDA investigator who was a director and looked after auditing and compliance at Cipla from 2017 to 2020. Similarly, Pratik Upadhyay joined Glenmark’s compliance operations after five years with the US drug regulator.
For Lupin, hiring Toro as their compliance head is viewed as a positive due to her extensive experience. Besides spending 38 years in the US office of regulatory affairs, she has held two leadership positions and has been recognised with the USFDA’s highest award, the Award of Merit.
Why these hires
Experts believe that these hires are already aware of issues being faced by Indian companies in getting clearances. For example, Toro is the same compliance officer who signed off on the warning letter issued to Lupin’s Somerset facility in June 2021. Similarly, Upadhyay had inspected Glenmark’s Pithampur plant amongst other plants in the country.
Motamed who carried a reputation of a tough officer was the one to sign off on many tough FDA 483s ( a notice sent by the FDA to highlight any potential regulatory violations) such as erstwhile Claris and now Baxter’s injectable plant in Ahmedabad which turned to a warning letter pointing out shredding off documents in hetero’s Telangana plant in December 2016.
Toro’s experience is expected to help Lupin turn around its patchy compliance record, say experts. Whilst the company managed to clear its Goa plant in December 2021 which was in trouble since 2017, it has multiple other plants under the scanner. including Pithampur Unit 2 and Mandideep.
Credibiiliity and utility
Heads of companies, on condition of anonymity, have told CNBC-TV18, that ex-USFDA hires add a layer of credibility to the company’s compliance but the final clearance is dependent on a lot of other factors as per the complaint raised. For example, both Massoud and Upadhyay failed to prevent or solve issues at Cipla’s Goa facility, which was issued a warning letter in 2020, and Glenmark’s Baddi facility, which was issued a warning letter in 2019.
Global practice
A move to the private pharma sector from the US drug office is quite a common practice, especially globally. For example, 9 out of 10 of the former USFDA commissioners have gone on to join private pharma
