Book Review: How rotten is drug regulation in India?

Over the past decade, India’s drug exports have doubled to over $24 billion per year.

While its long-established and rapidly growing generics industry has earned the country the accolade of ‘pharmacy of the world’, Indian companies are now also running clinical trials and developing new innovative products, including one of the world’s first nasal Covid vaccines. In other words, India has become firmly established as a global player in medicines.

However, India’s rise as a global hub of pharmaceutical production and innovation has not been without hiccups, to put it mildly.

Concerns about vaccines and generics

Last year started off with the company behind India’s flagship home-made Covid vaccine Covaxin, Bharat Biotech, going through the courts to force an investigative outlet to take down 14 stories critical of the vaccine’s development and approval process. Eventually, additional reporting confirmed that India’s drug regulator had approved the vaccine based on a rushed clinical trials programme that did not meet established national standards.

In the meantime, the World Health Organisation suspended the procurement of Covaxin by UN agencies due to concerns about subpar manufacturing practices.

Also in 2022, the European Medicines Agency suspended the marketing authorisations of dozens of generic medicines due to “irregularities” in bioequivalence studies conducted by an Indian contract research organisation, Indian generics manufacturers came under fire for apparently concealing clinical trial results, and dozens of children in Gambia and Uzbekistan were reported to have died after taking contaminated cough syrup made in India.

Update to original blog:

Substandard generic versions of a paediatric cancer drug have reportedly also been exported from India, harming children worldwide.

Rotten apples or a rotten system?

Pharma critics often jump on isolated instances of corporate malfeasance or regulatory failure to argue that the entire system is rotten.

In their new book, “The Truth Pill: The Myth of Drug Regulation in India”, veteran industry critics Dinesh S. Thakur and Prashant Reddy T. argue that in the case of India, this charge is fully justified.

Drawing on in-depth legal and regulatory analyses, numerous case studies and responses to hundreds of Freedom of Information requests, they exhaustively document glaring gaps in India’s legal framework and severe shortcomings in regulatory oversight and enforcement. For example, the monitoring of drug quality is the responsibility of the 28 individual states within India, some of which have devoted woefully insufficient resources to the task and show little appetite for prosecuting offenders.

This allows manufacturers to take advantage of lax local oversight of production facilities while retaining access to India’s huge domestic market, and the ability to export generics to low-income foreign countries that do not systematically control the quality of imported drugs.

Dodgy drugs and broken rules

The authors cite multiple studies that have found major discrepancies between drug content stated on packaging, and actual content contained within pills, including for antibiotics.

Regarding newly developed drugs, on paper India has adopted evidence standards that broadly mirror those in the United States. However, in practice these standards were not consistently upheld during the pandemic. India’s drug regulator approved Covid drugs and vaccines based on an accelerated ‘pathway’ that removed the requirement for presenting data from phase III clinical trials – but that ‘pathway’ had no basis in national law.

Overall, the book fully achieves its objective of demonstrating that there are severe structural flaws in Indian drug regulation that go beyond the malfeasance of individual companies, bureaucrats or judges.

The authors’ obsessive attention to detail, backed up by copious referencing, has produced a comprehensive overview on what is amiss with drug regulation in India. Sadly, the sheer wealth of detail means that the resulting tome is unlikely to attract a broad audience.

Opportunities for reform?

Where do we go from here? Refreshingly, the final chapter offers policy recommendations that appear to be politically feasible and grounded in realism.

One angle that remains unexplored is the wisdom of Indian policy makers’ apparent belief that lax regulation confers competitive advantages on domestic drug companies. A few more headlines about dead children could quickly turn the ‘Made in India’ label into a toxic brand with consumers overseas, especially if Indian stakeholders’ response is to smear whistle-blowers as unpatriotic rather than to take corrective action.

Update to original blog:

The Indian government recently announced that it will invest $80 million into strengthening its drug regulatory system.

Similarly, the WHO’s continuing suspension of Covaxin illustrates that lax domestic oversight can be a two-edged sword. If foreign regulators come to view all Indian data and products as inherently untrustworthy, Indian companies may find themselves blocked from moving up the global value chain from generics manufacturing into developing highly profitable new medicines. Regulatory scientists must now take Dinesh S. Thakur and Prashant Reddy T.’s excellent work further by placing it into an international context.

We need a truly global regulatory science

Substandard medicines and vaccines are now a major global health problem that directly affects patients around the world and fuels antimicrobial resistance.

Today, what happens in India (or China, or America) no longer stays in India (or China, or America). Also, just as India does not have a monopoly on regulatory problems – see the Implant Files scandal – Europe and America do not have a monopoly on regulatory solutions.

We urgently need a truly global regulatory science that moves beyond Western navel-gazing and systematically compares and evaluates regulatory approaches across all major jurisdictions.

Hopefully, such comparisons will not only dwell on failures, but will also identify successful innovations in India, China, Japan, and elsewhere that regulators everywhere can learn from.

This blog by TranspariMED founder Till Bruckner was originally published under the title "Book review: How rotten is drug regulation in India?" on the BMJ Global Health blog. Reproduced with permission by BMJ under a CC-BY license. Two updates added.