The Singapore arbitration court ruling against the Singh brothers in the Ranbaxy-Daiichi case brings to the fore again the issue of drug quality and its control in India. A Nomura Research analysis cited by Business Standard found that 27 of the 45 drug manufacturing units that received warning letters between 2011 and May 2016 from the American drugs regulator, FDA, over poor data integrity were India-based plants belonging to, among others, Wockhardt, Sun Pharmaceutical, Dr Reddy’s Laboratories and Mylan Laboratories. Data integrity violations are a serious concern given they are seen as evidence of poorly managed production processes and, ultimately, of poor drug quality and safety. These violations thus often lead to delayed clearances and imposition of import alerts against suspect drugs/manufacturers. As of April 29, 42 Indian plants had standing FDA import alerts against them. The EU had banned 700 generic drugs tested by Hyderabad-based GVK Biosciences in August 2015, citing poor credibility of data from clinical trials conducted by it.
Quality control issues are far more endemic in domestic drug market, as Ranbaxy whistleblower Dinesh Thakur points out with his painstaking research on the quality check ecosystem in the country. Though Thakur’s petition to the Supreme Court to order the creation of a framework for recall of sub-standard drugs and examination of faulty approvals was rejected, the poor state of quality regulation in the country is stark from his research, which also includes information revealed through over-100 RTI applications, some of which are carefully curated in his blog-posts. While there is no system for a nationwide recall of a substandard drug—by the time a drug is tested for quality and found to be substandard, it would have already been sold to thousands—there is also a regulatory gap in the fact that states alone can revoke or suspend production licences of manufacturers in their jurisdiction. Thus, a Karnataka can only request a Himachal Pradesh to take action against the errant producer—as per Thakur’s analysis of data from RTI replies, most of the drugs found to be substandard by Karnataka’s drug regulator in FY12 and FY13 were manufactured in Himachal Pradesh. The problem is compounded with almost no uniformity between states on the duration for which a licence is suspended—Himachal Pradesh does it for anywhere between 15 days to 3 months while Gujarat does it for just a day. It is not that the Union government and various state governments have not acted against substandard drugs at all—as far as procurement for government hospitals and dispensaries is concerned, the Union government has blacklisted certain drugs from 8 firms including Alkem for a period of three years, and certain drugs from 9 firms including Abott and state-run Hindustan Antibiotics permanently. But the lack of cohesive quality control ecosystem could be a poison pill for the pharma sector’s exports and health of the masses in India.