India's pharmaceutical regulation crisis: An interview with Prashant Reddy

PRASHANT Reddy Thikkavarapu studied law at the National Law School of India University, Bangalore and Stanford Law School, California, as a J.N. Tata Scholar.After a stint in the litigation teams at two Delhi-based law firms specialising in intellectual property law, he worked in academia and think tanks in New Delhi, Hyderabad and Singapore.Over the last few years, he has been advising Ranbaxy Whistleblower Dinesh Thakur in his advocacy campaign for the reform of drug regulatory law in India. Prashant is the co-author of The Truth Pill: The Myth of Drug Regulation in India.He is also the co-author of Create, Copy, Disrupt: India’s Intellectual Property Dilemmas. In an exclusive interview with The Leaflet, Prashant discusses India's pharmaceutical regulation crisis, highlighting corruption, lack of transparency, and compromised public health. He advocates for reforms, increased transparency and accountability to ensure quality drugs and patient safety.Excerpts from the interview.Abhish K. Bose: Investigative journalist Catherine Eban's groundbreaking work has shed light on the alarming lapses in India's pharmaceutical industry, including contaminated chemotherapy drugs and compromised manufacturing practices. This raises critical concerns about patient safety, public health and the integrity of India's pharmaceutical sector.What comprehensive regulatory reforms and enforcement mechanisms can be implemented to ensure the Indian pharmaceutical industry produces foolproof drugs, adhering to global standards of quality, safety and efficacy?.Prashant Reddy: The Indian drug regulatory system needs a complete overhaul, as I have outlined in my book with Dinesh Thakur, titled The Truth Pill: The Myth of Drug Regulation.We need to consider centralising some aspects of drug regulation with a national regulator in order to ensure great uniformity with which the law is implemented across the country.The current model of each state being responsible for regulating drug manufacturing within its territory is one of the reasons that there is little consistency in drug quality across the country. Equally important is the fact that there is far greater transparency in the enforcement of the law against the pharmaceutical industry..Abhish K. Bose: The revelations of Ranbaxy's systematic manipulation of test results compromised the health and well-being of millions had shocked the world. It was a major case of egregious pharmaceutical malfeasance, which raised fundamental concerns about data integrity, regulatory oversight and patient safety.What critical lessons have been gleaned from the Ranbaxy scandal, and how can similar incidents be prevented in the future?.Prashant Reddy: The Ranbaxy scandal was uncovered by US drug inspectors and they followed up by trying to increase the frequency of their inspections of drug manufacturing plants exporting to the US.India’s own drug regulators have never taken any action against Ranbaxy because they barely ever look at underlying data that is submitted to the regulator as part of the regulatory process, which is often also key to determining whether a pharmaceutical manufacturer is following good manufacturing practices.The law needs to be revamped to make data fabrication a clear-cut offence and then Indian drug inspectors need to be rigorously trained to ensure that they can detect data fraud by the pharmaceutical industry..Abhish K. Bose: What are the implications of India’s compromised pharmaceutical regulation for the global South, given its role as the ‘pharmacy of the developing world,’ and how can international cooperation and standards be leveraged to improve India’s regulatory framework?.Prashant Reddy: The poor quality of drugs being manufactured in India will have serious implications for health outcomes in all developing countries importing a bulk of their drugs from India.Also read: XXWhile the US and Europeans have the resources to send drug inspectors to inspect the Indian manufacturers exporting to their countries, most of the developing countries in Asia and Africa buy their drugs from Indian manufacturers who are inspected only by Indian drug inspectors.There is no scope for international cooperation and standards to improve India’s drug regulatory framework since the World Health Organisation (WHO) has adopted a ‘hands-off’ approach to the issue of drug quality and the Indian government very aggressively protects the Indian pharmaceutical industry from any kind of external scrutiny. This is a problem that will have to be fixed internally..Abhish K. Bose: To what extent have economic interests and growth aspirations compromised India’s commitment to public health principles, and what policy interventions can strike a balance between pharmaceutical industry growth and patient safety?.Prashant Reddy: The Indian pharmaceutical industry is the only manufacturing success story in India. The government is aware of this fact and is deeply invested in promoting the growth of the industry without paying attention to the quality of drugs being manufactured and sold by the industry.While the mandate to grow the pharmaceutical industry lies with specific departments such as the department of pharmaceuticals or the ministry of commerce, which promotes exports, the ministry of health, which is responsible for ensuring quality, has lost sight of its objectives.For the most part, the ministry of health and the drug regulator which functions under its control are more interested in ensuring the growth of the drug industry than looking at quality.As long as the regulator looks at its job as facilitating the growth of the industry, they are bound to ignore quality concerns since improved regulation will come at a cost of the growth of the industry..Abhish K. Bose: Can India's Drugs and Cosmetics Act of 1940 be revised and strengthened to ensure rigorous clinical trials, effective inspection and enforcement, and prioritisation of therapeutic evidence, and what role should civil society, media and international organisations play in advocating for these reforms?.Prashant Reddy: I have written extensively about policy prescriptions to fix the system in my book with Dinesh Thakur. Transparency and rigorous science need to be at the core of any attempt to reform the system. The rest will follow..Abhish K. Bose: What role have corruption, the nexus between regulators and industry, and lack of transparency played in undermining India's pharmaceutical regulation?.Prashant Reddy: The 59th report of the Parliamentary Standing Committee on Health, tabled in the Parliament in 2012, has clearly alluded to corruption and collusion between the national drug regulator— the Central Drugs Standard Control Organisation— and the pharmaceutical industry.In response, the Drug Controller General of India setup an inquiry committee report and never made its report public. When we asked for a copy of the report under the Right to Information Act, 2005, we were told that the report had gone missing.They finally had to contact the officials who authored the report in order to source a copy and provide it to us and even that report only scratched the surface of the issue. Much of this corruption is facilitated by the opaque functioning of the drug regulator where even basic information is not made publicly available..Abhish K. Bose: How have India's pharmaceutical companies responded to quality concerns and regulatory actions, and what measures can ensure accountability?.Prashant Reddy: There is no way to answer this question because data is not publicly available..Abhish K. Bose: What international best practices can inform India's pharmaceutical regulation, and how can collaboration with global regulatory bodies enhance standards?.Prashant Reddy: There is no international treaty or agreement that sets standards or enforcement requirements for drugs beings traded across borders. The WHO has created some frameworks but even those depend on national drug regulation enforcing standards.At most, some countries may require Indian plants exporting to their territories to be inspected by their own inspectors but most developing countries lack the resources to conduct such inspections.There have been calls for India to join the International Council for Harmonisation (ICH), which works outside the purview of the WHO system and sets standards for drug quality but it depends on national authorities to enforce those standards. Given that India struggles to enforce existing meagre standards, we doubt that joining the ICH is going to help improve the situation..Abhish K. Bose: What are the human and economic costs of India’s pharmaceutical quality crisis, and how can these be quantified and addressed?.Prashant Reddy: The immediate consequence is that many patients will simply not recover because of poor-quality drugs. In some cases, the outcomes will be worse with patients losing their lives because of drug-induced treatment failure.There is no way to quantify these failures unless doctors are trained to spot treatment failures due to drug quality and report the same to a pharmacovigilance mechanism run by the government.The government claims that it has a pharmacovigilance system, administered by the Indian Pharmacopeia Commission but nobody really knows how efficient it is at its job.