In the first week of June, the Union health ministry exercised its powers under the Drugs and Cosmetics Act, 1940 to prohibit 14 fixed-dose combinations (FDCs) that have been on the market for 30 years. These were originally a part of 300 FDCs that were first banned in 2016 by the health ministry using its power under Section 26A of the Drugs & Cosmetics Act, but were later rescued by the Supreme Court (SC) in 2017 on a procedural technicality connected to the fact that these 14 drugs were approved prior to 1988. The court left it to the government to conduct a fresh study to prohibit these drugs. The fresh study was completed on April 1, 2022, but the final prohibition orders were passed only in June 2023.
It is time for doctors and citizens to ask the health ministry to put in place a cogent policy to tackle this issue of dubious drugs ((REPRESENTATIVE IMAGE))
SC never clearly mentioned the significance of 1988 in its verdict, but we presume that particular year was important because it was when India amended its law to create, for the first time, a mandatory mechanism to be followed before approving a new drug. This included the requirement to provide clinical data demonstrating the safety and efficacy from three phases of clinical trials. Until 1988, pharmaceutical companies were not required to submit such data in order to seek approval to sell their drugs in India. The new law brought in a more rigorous approval mechanism — which required safety and efficacy data collected through clinical trials — but it was surprisingly silent on how regulators were to tackle existing drugs that were approved earlier, without having to demonstrate any therapeutic efficacy and safety.
Other countries typically put in place transitory mechanisms to ensure drugs approved under an old law are weeded out unless they meet standards under the new law. For example, when the United States (US) moved to a similar approval process in 1962, it required a study of all existing drugs approved prior to 1962. Called the Drug Efficacy Study Implementation (DESI), this mechanism removed all the drugs that did not meet the new standards of safety and efficacy under the 1962 amendments.
Unlike the US in 1962, India never conducted such a systematic study in 1988 while moving to a new regulatory regime. Instead, the health ministry followed an apparently arbitrary approach to removing older FDCs and other drugs by issuing orders under Section 26A. This is why it was not until 2016 that some of these FDCs — approved more than 30 years ago at that point — were first identified for removal. Since July 23, 1983, when the first order was issued under Section 26A, the health ministry has prohibited the manufacture and sale of 518 different drugs, mostly FDCs.
This whack-a-mole approach to drug regulation, which is mostly concentrated on FDCs, is too haphazard to even qualify as a policy. We suspect that many problematic drugs may not be identified and removed because of this chaotic approach. For example, one drug that popped up in our research is Buclizine, which was approved as an anti-histamine in the 80s but has since faced questions on its continued usage and is no longer sold in countries such as the United States. In India, an expert committee was supposed to study the underlying data for this drug and submit recommendations, but its report was never made public. There is another government report dated March 26, 2013, saying that the original approval file for Buclizine was missing. Such an approach can allow pharmaceutical companies to continue to legally make money selling drugs that are of doubtful efficacy to unsuspecting patients.
It is time for doctors and citizens to ask the health ministry to put in place a cogent policy to tackle this issue of dubious drugs that continue to be available despite lacking adequate safety and efficacy data to justify their use. Any such policy should begin by making public, preferably on the internet, the original files that formed the basis of approval of all these drugs in India. This is not going to be easy since many of these files may have gone missing.
For the remaining drugs, the pharmaceutical industry may resist disclosure on the grounds that their trade secrets could be jeopardised. But this is an outdated argument. Most drug regulators across the world, including those in the US and Europe, make available all drug approval files, albeit with some redactions to protect confidential information.
We hope that drugs for which government files are still available are made accessible, and academics from the fields of medicine and pharmacology can work together to review them and identify problematic drugs, which can be weeded out by the government. For any of this to happen, the culture of secrecy apparent at the national regulator — the Central Drugs Standard Control Organisation (CDSCO) — must end. It is only the health ministry which can force CDSCO to adopt a culture of transparency. Until this happens, India will continue to be a market for drugs of doubtful safety and efficacy.
Dinesh Thakur, a public health activist and Prashant Reddy T, a lawyer, are co-authors of The Truth Pill: The Myth of Drug Regulation in India. The views expressed are personal
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