Opinion Cough syrup deaths: India’s drug regulator must stop treating public health crises as public relations problems

India has a tumultuous history of DEG contamination in medicines. Between 1972 and 2020, India has seen at least five mass DEG poisonings in Chennai, Mumbai, Bihar, Gurgaon and Jammu. The incident in Gurgaon led to the death of 33 children and the incident in Jammu of at least 11 children. The final reported toll in such cases is definitely an undercount because it is notoriously difficult for doctors to diagnose such deaths and attribute them to adulterated medicine.

The immediate public health response in these cases of DEG contamination should be aimed at limiting further deaths. This means tracing the origins of the contaminated industrial solvent used to manufacture the syrups. Given the physical proximity of the manufacturers implicated in the Gambian and Uzbekistan cases, there is a very high possibility that the same batch of contaminated industrial solvent was used by both companies.

After the tragedy in Gambia was reported, we had called upon the government to swiftly make public the names of the chemical traders and manufacturers implicated in that case so that the rest of industry can be warned against using these chemicals. Regrettably, the government did not heed our request until two weeks ago, when it released its communications with the WHO and even then denied that those intermediate chemicals were adulterated despite the WHO’s test reports providing irrevocable proof of DEG and EG contamination.

Unfortunately, such lethargy and denial is a pattern with drug regulators in India. In August 2020, about eight months after the DEG-related deaths of the children in Jammu were first reported by PGIMER, Chandigarh, the same hospital reported that another two-year-old child from Baddi had died in its facility after consuming a different brand of cough syrup manufactured by the same company that was responsible for the deaths earlier in Jammu. This was a death that could have been easily avoided if the regulators had conducted and published a thorough root cause analysis after the Jammu incident and followed it up by a nationwide recall of all cough syrups manufactured at the same facility. This never happened.

The question now is whether the Ministry of Health and the Central Drugs Standard Control Organisation (CDSCO), the national regulator, have learnt their lessons from these previous incidents.

We are not too optimistic. The present government is likely to handle this crisis as yet another “public relations” crisis instead of a “public health” crisis. We say this based on our observation of the official response from the government to the tragedy in Gambia. Far from condoling the deaths of 72 Gambians, the initial press release from the Ministry of Health gaslit the Gambians by accusing them of not testing the cough syrups before prescribing them to patients. This was an absurd allegation because nobody tests drugs that are purchased before releasing them for patient use, even in India. The presumption is that the drug regulator is doing its job to ensure quality control.

Once they were done with the Gambians, the government’s information czars went after the WHO. The first step of this PR strategy was to keep leaking to journalists that the WHO was not co-operating with the information requests made by an expert committee set up by the Government of India to investigate the deaths in Gambia. This despite the government fully knowing that the responsibility of investigating the deaths lay not with the WHO but with the sovereign authorities in Gambia. After an adequate number of leaks over a span of two months, the government on December 16 made public a coarsely worded, condescending communication from the Drug Controller General of India (DCGI) to the WHO accusing it of reaching “premature” conclusions and of indirectly causing harm to the “image of India’s pharmaceutical products across the world”.

Similarly, both of us received a legal notice at 6 PM on a Saturday evening, merely 30 minutes before the launch of our book on the failures of India’s drug regulatory system, because of certain statements we made about the Gambian tragedy in a press interview. About that interview, the CDSCO said, we were “undermining the trust and faith of the public on the Indian drug regulatory system and to bring it into disrepute”. We were then told by the CDSCO that it would “not hesitate to exhaust every available recourse including all possible legal options to take action to dissuade” us from repeating similar allegations.

The common thread running through these events is a communications strategy aimed at denial and intimidation. There is rarely a mention of sympathy for lives lost or a commitment to protect public health. An iron fist in a titanium glove is the best way to describe the government’s response to any allegations of quality issues afflicting the Indian pharmaceutical industry. Even China does better than us. In 2007, when a Chinese chemicals manufacturer was implicated in the deaths of 365 people in Panama who consumed cough syrup manufactured with an adulterated industrial solvent, the Chinese arrested the manufacturer and publicly promised to punish him.

Over the last few years that we have been advocating for reform in drug regulation, we have come to realise that the primary challenge is to convince the Indian establishment — and this cuts across the political spectrum — to accept the fact that there is a major quality problem with the Indian pharmaceutical industry. In the UPA years, when the Ranbaxy scandal first broke, the ruling establishment claimed that the USFDA was acting as a proxy for the American pharmaceutical industry that allegedly could not compete with the Indian industry. In the NDA years, the enemy has morphed into the WHO. Perhaps once the job of responding to public health crises is left to public health professionals and not information czars, we can have a meaningful conversation on actual regulatory reform.

The writers are co-authors of The Truth Pill: The Myth of Drug Regulation in India