A strong dose

A fascinating and authoritative book on the opaque structure of India’s drug regulations.

Truth, they say, is a bitter pill to swallow. The Truth Pill by Dinesh S. Thakur and Prashant Reddy is replete with bitter truths about India’s drug regulatory architecture, which calls for some soul-searching by policymakers.

The Truth Pill: The Myth of Drug Regulation in India

Dinesh S. Thakur and Prashant Reddy T.

Simon and Schuster

Pages: 500

Price: Rs.899

One of the most fascinating and authoritative books on the structure of India’s drug regulation to be written in recent times, The Truth Pill is a revelation. The authors, one a chemical engineer and the other a legal expert, give an evolutionary and eclectic overview of the history of drug regulation in India before detailing the processes that resulted in a not-so-transparent system of accountability. The timing of the book itself could not have been more fortuitous, given the recent controversies over cough syrup exports by Indian manufacturers to countries like the Gambia and Uzbekistan.

Spread over 11 chapters, the book provides an insight into subjects that are little known and areas that have mostly stayed in the realm of opaque governance. The authors argue that the manufacturing and the quality of life-saving drugs and medicines are an issue of public health and that the pharmaceutical industry’s role is not just to pivot India as “the pharmacy of the world”, a moniker that has stuck because of its emergence as the largest producer of generic drugs.

The book is critical of government policies that have encouraged manufacturing through incentives but have been reluctant to rein in manufacturers on grounds of quality. It questions the laxity of inspections, and the overlap of Central and State inspection and quality certification agencies. It argues for better coordination between them in the interests of public health.

The authors argue that regulatory failures affect not only Indian citizens but trading partners as well. The Indian government, they say, “is more interested in propping up the pharmaceutical industry—the only manufacturing success story for India to showcase on the global stage—and towards this end it will always resist tightening the regulatory screws”.

Given a long rope

It would be unfair to label the entire generic pharmaceutical sector as dubious, but it is a fact that successive governments have given the industry a long rope and allowed it to function in an opaque manner. It is difficult to forget how the government’s premier medical research body declared, barely a few months after the COVID-19 pandemic broke out, that a vaccine would be ready by August 15, 2020. When experts questioned the scientific basis for such an announcement, the government floundered. The vaccines were eventually produced but not in the tight time frame declared earlier.

In fact, there is no statutory code to regulate unethical marketing practices by pharmaceutical companies. They are often given tax exemptions in industrial areas. While there is nothing wrong in incentivising, it should not be at the cost of quality assurances or fair labour practices.

Any government that is genuinely concerned about public health and the lives of the majority would alter the industry’s regulatory mechanism. It not only lacks transparency, say Thakur and Reddy, but its complex distribution across 38 authorities spread across States and Union Territories, including the Central Drugs Standard Control Organisation (CDSCO), is also part of the problem. Each State and Union Territory has its own drug controller that issues licences to manufacturers. There is little or no coordination between the States and the Centre.

The authors cite the example of a particular pharmaceutical firm with a manufacturing base in Himachal Pradesh that was responsible for the deaths of 11 children in Jammu in 2019 who consumed a drug that contained diethylene glycol (DEG). DEG is the same chemical that the Gambian and Uzbek authorities have recently said was found in the cough syrup imported from India. It is an industrial solvent used in the manufacture of anti-freeze and brake fluids, and can cause renal failure and even death. The Chandigarh-based Regional Testing Laboratory found traces of the chemical in the Jammu samples of cough syrup.

DEG poisoning

The book begins with the DEG poisoning cases to illustrate the worst possible consequences of what they describe as the lackadaisical, if not negligent, approach of the Health Ministry, the CDSCO, and the Himachal Pradesh Drug Controller Authority (HPDCA). The authors argue that regulatory lethargy may not always result in deaths but will always have an adverse impact on public health.

Samples of cough syrup collected in Banjul in the Gambia. In October 2022, the WHO issued an alert to Maiden Pharmaceuticals in India, warning that the cough syrup it manufacutured could be linked to the deaths of 66 children in the Gambia. | Photo Credit: MILAN BERCKMANS/AFP

The cause-effect connection between the chemical and the deaths is yet to be established. Yet, any pharmaceutical or medical intervention must necessarily aim to put public health and human lives, not the profits of pharmaceutical companies, at the centre of health policies. This understanding can only come and be enforced from the top.

A regulatory mechanism can be said to be effective only if there is robust testing of every drug to verify its safety and efficacy, as well as the ingredients it claims to have before it hits the market. The book enumerates the issues that contribute to poor outcomes in public health—such as the approval of dubious new drugs with little or no evidence of their therapeutic claims; the refusal to upgrade regulations for generic drugs to guarantee therapeutic equivalence with the innovator drug; and the manner in which drug inspectors move around the law to avoid the prosecution of pharmaceutical companies. Many of these regulatory issues lie at the intersection of regulatory science and public law, neither of which are popular with politicians or appear in the public eye.

The Jammu deaths were not the first case of DEG poisoning. In 1937, 105 people, including 34 children, died in the US after consuming cough syrup containing DEG manufactured by a Bristol company. The Federal Food, Drug and Cosmetics Act was overhauled, and the events of 1937 were not repeated. Yet, such incidents continue to occur with impunity in India and other developing countries such as South Africa, Nigeria, Bangladesh, Argentina, Haiti, Panama, and, more recently, the Gambia and Uzbekistan.

The authors say that India holds the record for DEG poisoning cases. They list five instances: the first in 1972 in Madras, killing 15 children, followed by the deaths of 14 patients in Mumbai in 1986, 11 in Bihar in 1988, 33 in Gurgaon in 1998, and 12 in Jammu in 2019.

Indian pharmaceutical companies often fail to test either the raw materials or the final formulation before shipping it to the market, despite the law prescribing such testing in the Good Manufacturing Practices for pharmaceutical products. Such testing also ensures that the company has received the correct solvent from the suppliers. In many of these disasters, the authors guess that the traders either mislabelled propylene glycol or adulterated it to reduce costs.

More importantly, the book speaks about the inability of inspection committees to get to the bottom of the matter and recommend measures for prosecution. In the Jammu poisoning case, the HPDCA stated before a court that the culpable company did not have an appropriate facility to test the finished formulation for DEG contamination and the analysis report from its quality control department was “misleading”.

The HPDCA, the authors say, should have conducted inspections as it had received complaints from drug controllers of at least three States. They cite an instance in 2013 in which drug regulators from Tamil Nadu visited the manufacturing premises of a company to check regulatory compliance after a diabetic medicine was substituted with another with a similar sounding name. It was a case of wrong labelling.

The Tamil Nadu Medical Services Corporation had procured this medicine in bulk to distribute in government hospitals. The regulator filed a criminal complaint. The company was prosecuted under the Drugs and Cosmetics Act of 1940 under a section that provided for life imprisonment and a fine of up to three times the value of the consignment seized. The case was filed in December 2014, but as of March 2022 the trial had not even started.

The book raises two questions: first, the need for centralisation if the States and the Centre keep passing the buck. Second, who will regulate the regulator? Regulation is meaningless if done with the objective of facilitating industry while compromising safety and quality.

Scientists at work in a laboratory of the research and development centre of Natco Pharma Limited, in Hyderabad in March 2012. India is the largest producer of generic drugs, giving it the moniker “the pharmacy of the world”.  | Photo Credit: A. MAHESH KUMAR/AP

In Chapter 11, titled “The Politics and Levers of Reforming India’s Drug Regulatory Framework”, the authors try to offer alternatives for a viable and credible regulatory framework. The first challenge, they say, is to recognise that the industry has a problem of quality. Part of the challenge is to dispel the notion that everything is a “conspiracy” by foreign regulators acting on behalf of MNC pharmaceutical companies.

Once India accepts this, it must choose to protect the health of its people over growth, employment, and export dollars. Then it has to resolve the “intense politics” between the Union and State governments as well as inter-ministerial politics that is opposed to the idea of an independent regulator.

It is a fact that India’s generic industry poses a challenge to the pharmaceutical industry in many advanced capitalist countries. The easiest way to put a clamp on the export of generic drugs is to impose non-tariff barriers on grounds of faulty manufacturing practices. But quality and growth do not have to be in conflict with one another. Countries like Cuba have demonstrated growth, quality, and internationalism despite being restricted by sanctions for over six decades.

Lack of clarity

A major drawback in the regulatory design, as the authors argue, is the lack of clarity in matters of accountability. The national regulator holds the State drug regulator responsible, as in the case of the Jammu deaths. Under drug regulatory law, the Centre is responsible for imports and approving new drugs on the basis of safety and efficacy data, but the licensing of manufacturing units and their prosecution falls under the purview of State governments. But, as the authors argue, changes at the policy level can only be done at the national level.

In September 2022, a Parliamentary Standing Committee pulled up the CDSCO for defaulting on ensuring drug quality. Earlier, in 2017, a draft pharmaceutical policy admitted that there were not enough accredited testing laboratories and that many manufacturing units were non-compliant with the WHO’s Good Manufacturing Practices. These are all legitimate issues for the pharmaceutical industry.

The authors caution that since 2014, matters have become worse because of the “new government’s obsession with improving ease of doing business in India”.

While some of their criticisms against public health activists may appear misdirected, The Truth Pill is mostly an honest treatise.