Image from here
Although this blog concentrates mainly on IP issues, we occasionally do cover drug regulatory issues. The state of drug regulation in India, as most of you will know, is quite alarming. Plant after plant is being banned by foreign regulators, while CRO outfits like the GVK Bio stand accused of serious fraud. Clearly, the present Drug Controller General of India (DCGI) G. N. Singh is presiding over a system which is failing at every level. He admitted as much when he famously remarked that if he were to apply American safety standards in India, he would have to shut down almost all drug facilities in India.
Yet, in a month or so, his office is expected to release the results of an allegedly extensive survey of the quality of drugs in India which will declare that only a negligible percentage of drugs in the Indian markets are sub-standard. In fact, even before the survey was launched, G.N. Singh valiantly announced that the purpose of the survey was to prove that Indian drugs were safe – if the results were pre-determined, why even conduct the survey?
However, if the DCGI’s office is good at one thing, it is the art of giving a PR spin to all of its activities. Take this report in the ET, which first reported the expected results of the survey based on anonymous sources within the government. The report quotes anonymous sources from within the DCGI to claim that the survey will show that only 3.5% of all drugs surveyed were sub-standard – apparently the lowest in several decade. I have little faith in these survey figures because if you look at CAG reports auditing the Armed Forces Medical Services Depot (AFMSD), the Indian Railways hospitals or the Central Government Health Scheme (CGHS) they present a very different picture on the rate of substandard drugs in the market. Most importantly, however this methodology of judging the quality of drugs based on the end product misses the woods for the trees. Rather than a survey of the end product, the focus should be on auditing various aspects of the regulatory system, including the manner in which samples are drawn by drug inspectors, the manner in which cases are prosecuted, inspection of facilities, the rate of licence suspension and the rate of convictions.
Over the course of a year, ending a few months ago, I had the opportunity to act as a lawyer for Ranbaxy whistleblower Dinesh Thakur on the state of drug regulation in India. Dinesh was the man behind the prosecution of Ranbaxy behind the USFDA – Ranbaxy ultimately pled guilty and coughed out $500 million dollars in fines and penalties to the US Government. While Dinesh’s efforts changed the way the USFDA regulated Indian exporters he was concerned that the Indian government was doing nothing to change the manner in which the Indian market was being regulated. He therefore commissioned me to investigate and report the state of drug regulation in India. The results of that study were used to file two PILs (accessible here) before the Supreme Court which unfortunately declined to hear them because the Chief Justice of India T. S. Thakur was of the opinion that the PILs were raising academic issues. This is notwithstanding the fact the CJI has admitted a PIL to ban sardar jokes and another one to have the UK return the Kohinoor diamond. If those issues qualify as public interest, I’m not sure why drug regulation doesn’t qualify as public interest. In any case, Dinesh and I compiled the results of our year-long study into a comprehensive report which was submitted to the Ministry of Health. The report which is based on an extensive RTI campaign and research effort catalogues the various failings of the Indian drug regulatory system. The report can be accessed here. Several issues outlined in our report can be easily remedied through greater transparency and better co-ordination. Unfortunately, neither the DCGI nor the Health Minister have shown any inclination to make any changes. The least we can do as citizens is to begin an honest conversation on the true state of affairs rather than console ourselves with pointless surveys.