Scrutiny Alarm For Indian Pharma Companies

It is time for Indian pharma companies to brace for heightened scrutiny as the US drug regulator ups the ante on standards.  

- Kumar Sharma

November 15, 2015: Dr Reddy’s Laboratories, India’s only New York Stock Exchange-listed pharma company and among the top three players from India, receives a mail from the US Food and Drugs Administration (USFDA) about an inspection the latter carried out of three Dr Reddy’s manufacturing facilities in Andhra Pradesh and Telangana. “We identified significant deviations from current good manufacturing practice for the manufacture of active pharmaceutical ingredients,” it says. It then gets down to details, which include some rather surprising specifics like: “Because the conveyor belt was not operational (at one of the units), an operator manually intervened.....Each of these manual interventions risk compromising the sterility of the product.” And again: “During the inspection, the presence of an uncontrolled ‘custom QC laboratory’ was discovered by our inspection team. The existence of this laboratory was previously unknown to the FDA…”

December 17, 2015: India’s biggest pharma company, Sun Pharma, gets a mail from the USFDA pertaining to an inspection of one of its largest units in Halol, Gujarat, and one of the observations in the letter is: “The floors, walls and ceilings in your aseptic processing area were not maintained as smooth, hard surfaces that were easily cleaned. Our investigator documented the presence of leaks in the form of water stains and ceiling damage in the parenteral (injectables or infusions) manufacturing area personnel corridor. The FDA investigator observed buckets with water collected from ceiling leaks and other leaks in this manufacturing area…”