CIPLA is a known name. However, only a few remember that CIPLA used to be Chemical, Industrial and Pharmaceutical Laboratories once upon a time. This November, CIPLA received a warning letter from the US Food and Drug Administration saying that the company’s drug manufacturing facility in Indore violates the current good manufacturing practice regulations for finished pharmaceuticals. This being CIPLA, the issue will be resolved.
There is a Roman god named Janus, after whom the month of January is named. Janus being the god of beginnings, endings, gates and duality, he had two faces—one that looked towards the future, the other towards the past. . India has a pharma success story, even in markets subject to stringent regulation. To quote from the pharmaceuticals department’s annual report for 2022-23, “The sector offers lower cost without compromising on quality as is reflected by the fact India has the highest number of US Food and Drug Administration approved pharmaceutical plants outside the US and also a significant number of World Health Organization good manufacturing practices-compliant plants as well as plants approved by the regulatory authorities of other countries.” That’s true, of course, and it is this face of Janus that looks towards the future.
But let’s contrast this with the other face of Janus that looks towards the past. In July 2023, in response to a question in the Rajya Sabha, we were told that between April 2021 and March 2022, 88,844 drug samples were tested. More than 2,500 were sub-standard and 379 were spurious. Along with state-level drug control administration, the Central Drugs Standard Control Organisation (CDSCO) has been inspecting drug-making units. Roughly, 15 percent of samples were sub-standard. Many firms have been sent showcause notices and about a third were issued orders to stop manufacturing.
Let’s take a step back and quote from the Mashelkar Committee report of 2003. “There has been a wide-ranging national concern about spurious/counterfeit/sub-standard drugs. The Supreme Court of India, the National Human Rights Commission and members of parliament have time and again expressed concern about improving the drug regulatory system in the country. The Drugs and Cosmetics Act has not been reviewed in a comprehensive manner since its inception although the rules have been amended from time to time. The government of India, in the past, had constituted several committees that had examined the issues and had made many recommendations. These recommendations have been implemented to some extent, but the core issues have remained unresolved.” The core issues remain unresolved because we didn’t take them seriously until there was global flak about Indian cough syrups leading to children’s deaths in Gambia, Uzbekistan and Cameroon. Recently, there was a news report on cough syrups, that said the CDSCO found that 54 firms were manufacturing sub-standard cough syrups.
They will not be allowed to export. Does that mean they will be allowed to sell in India? There was another report that, in Gujarat, five people died because of an ayurvedic cough syrup that was chemically adulterated. More of us should read a book by Dinesh Thakur and Prashant Reddy titled, The Truth Pill, The Myth of Drug Regulation in India published in 2022. In 2019, many children from Jammu died. They had been given a cough syrup called Coldbest. This cough syrup tested positive for diethylene glycol (DEG), which is a powerful industrial solvent used in making anti-freeze and brake fluids. “It is never used in medicines and can be fatal to humans who consume it,” states Dinesh Thakur and Prashant Reddy’s book. It further says that India has a uniquely depressing record of having had at least five major DEG poisoning events—Chennai in 1972, Mumbai in 1986, Bihar in 1988, Gurgaon in 1998 and Jammu in 2019.
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If the rest of the world has woken up to the dangers of DEG poisoning, what’s our problem? “The simple answer is that Indian pharmaceutical companies quite often fail to test either the raw materials or the final formulation before shipping it to the market. This is despite good manufacturing practices as prescribed in Indian law requiring mandatory testing of both the raw material before it is used in production and the final formulation before it is shipped to the market… In many of these disasters, traders responsible for supplying chemicals such as propylene glycol have either mislabelled DEG as propylene glycol by mistake or alternatively, have adulterated propylene glycol with DEG either on purpose to reduce costs or by mistake due to poor quality control measures,” the book states.
This raises a broader issue about the role of the law and the regulator. There will always be errant companies and is impossible for a regulator like CDSCO to do a census. Therefore, what should be done is a survey. What happens when there is an errant company, not only for cough syrups but for other drugs too? “As we discovered to our utter astonishment, this case, which was filed in December 2014, had not proceeded to trial as of March 2022.” This case concerned the company, Alfred Berg. In another case, the chief judicial magistrate hearing the case decided that it would be adequate punishment to sentence the guilty in this case, to “simple imprisonment till the rising of the court” along with a paltry fine of Rs 70,000.
The broad point is a simple one. Especially for something like drugs and health; once someone is found guilty, the punishment should be punitive so that there is a deterrent effect against future malpractices. In contrast, there is a low probability of investigation and prosecution. Once prosecuted, there is a low probability of conviction. Once convicted, the punishment is hardly a deterrent. On the other hand, the gains from mala fide acts are high. Therefore, in that one face of Janus, we care little about human lives and health. The problem arises because the other face looks towards the global market, where anything sub-standard and counterfeit will not suffice. Whether we like it or not, that is the truth pill, though we might find it difficult to swallow. After a few deaths and a few days of outrage, our interest moves on to something else.
(Views are personal)
Bibek Debroy
Chairman, Economic Advisory Council to the Prime Minister
(bibek.debroy@gov.in)