Drug Approval

Why in the News?
Recently, Baba Ramdev’s Patanjali Ayurved produced a series of medicines — Coronil, Swasari, and Anu Tel — that were advertised to be a cure for the ongoing pandemic. The company proclaimed that these medicines used in a particular manner would result in “100 per cent recovery from COVID-19 within 7 days”. During a press conference, Baba Ramdev himself quoted certain details from Patanjali’s clinical trials to showcase the medicines’ efficacy and scientific backing. However, it later came to light that the clinical trials conducted had not followed the due process prescribed, and that even the findings were hitherto unpublished. In violation of the Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954, the Ministry of AYUSH ordered Patanjali to desist from further advertisements, and the Jaipur Police filed FIRs against Baba Ramdev and a few associates based on the complaints received.

Truth Beyond Prejudice

In a country where scientific temper and scientific inquiry are prescribed as fundamental duties of its citizens, there should be no place for baseless magic and quackery. However, the proliferation of several kinds of spurious drugs and remedies across the length and breadth of the country have once again been brought to light by Patanjali’s latest contribution to the field. This is not a matter of prejudiced discrimination against traditional medicine systems in favour of the modern, but the forming a ground of credibility for the medical drugs and remedies in the country.

A Credible Means of Drug Evaluation

To maintain the public’s trust, the due process of scientific evaluation, in the form of clinical trials, must not be subverted to make way for opportunistic profit-making, especially during a pandemic. People repose their faith in the modern medical system for the credibility that comes from the empirical study and scrutiny of drugs, developed in accordance with
established scientific principles. Regardless of the system of medicine, to uphold the reliability and integrity of the medical sciences, it’s imperative that all drugs be subjected to clinical and scientific inspection before making their way into the general public. Randomised Clinical trials are based on these very principles. RCTs are one of the most effective and near-foolproof methods of evaluation currently known. For an RCT, a test group is created which is then divided into two sub-groups. The first sub-group is
administered the experimental drug that is being evaluated, while the second is given a placebo. The test subjects as well as the on-ground medical professionals are kept unaware about the identity of the drug being administered, ie whether it is the test drug or a placebo. This is done to maintain secrecy and foster unbiased scientific evaluation. The reactions and results of both the groups are constantly monitored, accurately recorded, and clinically compared to publish the findings which are peer reviewed by the scientific community. RCTs are highly effective in bringing out the benefits and side-effects of a drug. Despite the effectiveness, they are, however, time consuming and expensive to conduct.

Foolproof But Not India-proof?

It is important to note that the near-foolproof efficacy of the RCTs can be essentially undone by the somewhat opaque drug approval process in India. Take for example the recent granting of “accelerated approval” to Glenmark’s Favipiravir by the DCGI. The influenza drug, originally invented in Japan, garnered considerable attention for its repurposed use in Russia and China for treating COVID-19 patients. These usages were based on observational studies which are by no means an alternative to RCTs, as they can be biased and flawed. Although there were RCTs for Favipiravir, the findings cannot be conclusive due to the discrepancies in the due process. Favipiravir was supposed to be conducted in 12 different hospitals to see its efficacy compared to “standard care”, but the CTRI failed to define what constituted “standard care”. Also, only patients with “mild” symptoms were used for the trials. Experts argue that mild symptoms would have resolved on their own or with minimal medical care without the use of Favipiravir. Even more concerning is the lack of public data available on the evaluation of the external Subject Expert Committee that was supposed to examine the trial findings. It is not just Favipiravir that has seen such secretive approval but also the popular and controversial COVID drug Hydroxycholorquine (HCQ). Aside from drugs, even medical items like the PPE kits and diagnostic kits licensed to be used in the initial days following the lockdown were found to be either defective or of sub-standard quality. Such seemingly dubious approvals by the DCGI raises the question whether financial gain, on an individual or organisational level, outweighs the welfare and well being of the citizens in its decision making.

What Can be Done?

1) Drugs and remedies from all systems of medicine must be clinically evaluated before being permitted to be manufactured and sold to the public.
2) Increase transparency in the clinical trials.
3) Complete trial findings and Subject Expert Committee reports should be made public.
4) Stricter punitive action against any unethical practices or wilful clinical discrepancies.

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