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Why India needs a national law to recall drugs

In the book ‘The Truth Pill’, the authors say the safety of medicines made in India is a critical public health issue to which no one is paying attention

India needs better regulation for drug manufacturing
India needs better regulation for drug manufacturing (HT_PRINT)

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In 2004, India’s largest pharmaceutical company, Ranbaxy, was accused of largescale fabrication of drug test reports and sale of poor quality medicines in markets with weaker regulatory systems. Behind the years-long investigation was whistleblower Dinesh S. Thakur, who has now written a book, along with lawyer Prashant Reddy T. In The Truth Pill: The Myth of Drug Regulation in India, they explore the many issues still plaguing India’s pharmaceutical industry and the drug regulatory mechanism. The question of how safe and effective medicines manufactured in India are should be a critical public health issue, yet neither health activists nor the government seem to be paying attention to it, they write. The book highlights crucial questions while also suggesting the way forward for reforms for better regulation. In an interview, Thakur and Reddy discuss the need for a comprehensive and clear public health policy that prioritises public health over profit. Edited excerpts.

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Why have successive governments failed to improve drug regulation despite major poisoning events in India because—as you explain in your book—pharmaceutical companies often fail to test either the raw material or the final formulation before shipping it to the market?

Dinesh Thakur (DT): There has rarely been a sustained demand for reforming drug regulation. At most there has been a demand to reform some issues like regulation of clinical trials or regulation of Fixed Dose Combinations (FDCs). What we need, however, is a complete systemic overhaul. After the scandal at Ranbaxy, I thought there would be more of a focus on reforming drug regulation in India but to my surprise the Government of India and several public health activists viewed the scandal through the lens of a conspiracy theory wherein the Americans were so terrified of competition from India that they were seeking to curb Indian exports through regulatory measures. There was no attempt to engage with facts.

You write that the problem of the Indian drug regulatory framework is not limited to corruption but there is also the question of poor regulatory design. How have these regulatory failures and shortcomings at the central and state government level exacerbated the situation?

Prashant Reddy (PR): To begin with, this system of requiring every state/UT as well as the Centre to have its own drug regulator has led to an unwieldy system of India having 38 drug regulators. This has led to inconsistent enforcement of the law and jurisdictional issues because drugs from one state can be sold in another but drug inspectors from one state cannot inspect manufacturing facilities in other states. Second, the Indian system is still oriented towards end products (medicines sold in the market) rather than processes. Third, the system is exceptionally opaque—there are no transparency requirements or mandatory disclosures requirements in the law.

The Truth Pill by Dinesh S. Thakur and Prashant Reddy T., Simon & Schuster, 512 pages, Rs.899
The Truth Pill by Dinesh S. Thakur and Prashant Reddy T., Simon & Schuster, 512 pages, Rs.899

India calls itself as the “developing world's pharmacy”, but why hasn’t India’s regulatory infrastructure evolved at pace when it comes to regulating the manufacture and sale of medicinal drugs?

DT: There appears to be no interest within the government and no sustained demand from civil society for reform. The government is more invested in the growth of the pharmaceutical industry rather than public health. There is possibly a perception that tighter regulation could slow the growth of the pharmaceutical industry.

Do we have a good system to recall medication that is deemed substandard or not fit for us to consume?

DT: It is crucial for India to have a national drug recall law to guarantee that once a drug is known to be Not of Standard Quality (NSQ), the entire batch is withdrawn from the market. As of today, no such mechanism exists. At most state drug regulators can order a withdrawal of a particular batch from their state but given that India is a common market, it is possible that the same batch is disbursed across multiple states. In such a case, there needs to be a central drug regulator who can execute and coordinate national recall. Despite flagging this as a major issue in 1976, India still lacks a national law on recalling drugs. As a result, even after government analysts declare drugs to be NSQ, there is no system to actually withdraw batches of drugs from across India.

You also write about several other problems—unhygienic conditions, impure water, open drains—in pharmaceutical manufacturing units across the country. Why have these basic issues remained unaddressed all these years?

PR: The people with the responsibility to enforce the law are simply not doing so. Drug inspectors are required to carry out inspections of manufacturing facilities on an annual basis to ensure compliance with the Good Manufacturing Practices (GMP) code. It is possible that in many states, there is a lack of capacity and training to do so. But the larger problem, we suspect, is a reluctance to actually enforce the GMP standards because it would put several SME pharma companies out of business.

Why does the Indian pharmaceutical industry tend to apply less rigorous standards to drugs exported to poorly regulated markets in other countries in Africa, for example?

DT: For the same reason that drug quality in government hospitals and pharmacies is much worse than drug quality in the private markets in India. The pharma industry knows that they will not face any consequences for their failures in these markets. Hence the incentive to sell poorer quality drugs in these markets. On the other hand, there is the US which will punish Indian companies for failing to meet quality standards and hence we see companies catering to the American market making bigger investments in their plants.

How can health activism help improve drug regulation in the country?

PR: As with any other aspect of Indian society, activism can help move the needle on any policy issues. If health activists accept there is a problem with drug regulation and ask for systemic reform, they will add to the medley of voices asking for reform. Right now, there appears to be a reluctance to even accept there is a problem with drug quality in India.

Do you think centralization of various aspects of drug regulation is the way forward?

PR: Yes, we strongly recommend the centralisation of at least the licensing aspect of drug regulation. All manufacturing facilities should be licensed by a national regulator. Regarding enforcement, we think there is room for having a federated structure wherein both states and the union can test products and prosecute pharmaceutical companies for violations of quality norms.

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