Over the last year, India has witnessed many astonishing approvals granted by its drug regulator CDSCO. Most of these approvals have been wrapped in mysterious legal lingo like ‘restricted emergency use’ and ‘clinical trial mode’ despite Indian law never using such terms. The most astonishing of these approvals is the one granted to Bharat Biotech’s Covaxxin despite the company’s admission that efficacy data from the ongoing clinical trial will not be available until March 2021.

The only discernible reason it appears for this unholy rush in defiance of good science or medical ethics is the government’s obsession with its ‘Atmanirbhar’ agenda which is a version of economic nationalism that has many takers in the country.  

Of course, any criticism of the drug regulator’s whimsical ‘decision making’ process by doctors, scientists and journalists has been met by the establishment’s acolytes, with accusations of ‘vested interests’ and dollops of ‘anti-national’ rhetoric. The Atmanirbhar agenda apparently triumphs public health. None of this surprises me.

Many years ago, when I blew the whistle on Ranbaxy’s fraudulent practices which led to the company’s prosecution by the US government and its eventual guilty plea before American courts, I waited with bated breath to see whether and how the Indian government would prosecute Ranbaxy. After all, much of the fabrication and fudging of drug safety data, that the company pled guilty to took place on Indian soil and people of India were amongst the consumers of Ranbaxy’s adulterated drugs. Imagine my surprise when the then UPA government put out an official press release blaming “vested interests” who were apparently out to destroy the reputation of the Indian pharmaceutical industry. This after the company’s pled guilty to seven counts of criminal felony and paid up $500 million in penalties! A few years later when I filed a petition before the Supreme Court asking for reform of India’s drug regulatory framework, the then Drug Controller General of India is on the record questioning my ‘nationalism’. What does nationalism have to do with a company fabricating quality & safety data for drugs that is selling in India and abroad? Framing the issue of ‘drug regulation’ in the language of nationalism is a dangerously cynical ploy. Drug regulation is about science, medical ethics & patient safety.

The science of how drugs and vaccines work on the human body does not change across borders. After all science is the universal pursuit of truth. History has shown us how new drugs, even vaccines can be dangerous if not tested properly. The thalidomide tragedy of the sixties led to the birth of thousands of deformed babies and deaths of many more. Merck’s blockbuster drug Vioxx was withdrawn after it became clear that the drug increased the risk of heart-attacks and strokes. Rotravirus vaccines, including ones developed in India, have run into trouble because of their alleged association with an increased risk of intussusception in babies. It would be a mistake to presume the safety or efficacy of vaccines without large scale clinical trials. Even with the COVID vaccines, it should be remembered that apart from the Pfizer, Moderna and Astra-Zeneca/Oxford vaccine candidates, most of the other vaccine development efforts in the Western world have run into rough weather and are several months away from approval.           

As for medical ethics, these are principles that have evolved in the light of horrifying tragedies, many of which were due to the evil of men and some due to the inherent risks of experimental science. These include medical experimentation on Jewish women by Nazi scientists like Eduard Wirths, the Chief Physician at the Auschwitz concentration camp during World War II and the Tuskegee syphilis experimentation on African Americans in the United States. Closer to home, we have seen significant violations of ethics during clinical trials for HPV vaccines carried out on tribal girls in Chhattisgarh. In each of the above cases, it was vulnerable communities – Jews, women, tribals, children, African Americans – who have been exploited by not just pharmaceutical companies but also “well meaning” scientists and doctors. Medical ethics exist in the law to protect the rights of these marginalized communities in a deeply unequal world. To ignore medical ethics is to ignore the rule of law.  

India has never had a viable anti-vaccine sentiment unlike countries like the US. The success of national vaccination programs which are largely responsible for eradication of diseases like Polio from the country are a testament to this. Sadly, the preliminary data from the Covid-19 vaccination program is not encouraging. On the first day of the vaccination campaign, Delhi recorded an achievement of 3369 people who got their shots compared to their daily target of 8139. It appears one of collateral damages of this adventurism in the approval process is increasing vaccine hesitancy that we are seeing today; something the country can ill-afford during these trying times.

Inoculating people with vaccine candidates not tested exhaustively for safety and efficacy is a recipe for a disaster. Not only will it adversely affect public health but it will also seriously impact the long-term confidence that the world reposes in Indian science. If anything, it hurts the government’s ‘Atmanirbhar’ mission. Trust in science and experimental medicine is built by regulators following sound science and the rule of law. Nationalism should have no place in such debates. As the saying goes, nationalism is the last refuge of the scoundrel, more so when it is raised in context of drug regulation. Beware of those who wave this flag of nationalism when it comes to the safety and efficacy of medicine that you intend to give your children. The only silver lining in these times are the voices of the many doctors, scientists and journalists who have called the regulator out on its arbitrary decision-making process.