Killer cough syrups and an indifferent system

India is facing yet another tragedy linked to adulterated cough syrups, exposing the deep flaws in the country’s poorly regulated pharmaceutical industry.

According to reports, at least 21 children have lost their lives in Madhya Pradesh, while several others are undergoing treatment for acute kidney injury (AKI).

This is the fifth cough syrup-related tragedy involving India-manufactured drugs in the last five years, following incidents in Jammu in 2020, Gambia and Uzbekistan in 2022 and Cameroon in 2023.

These four tragedies claimed the lives of around 160 children. There have been nine tragedies involving India-manufactured cough syrups over the decades, the first dating back to 1972.

The cause of death in most of these cases is acute kidney injury. Kidney failure occurs due to the contamination of the cough syrup with diethylene glycol (DEG), a chemical used in anti-freeze and brake fluid. It could be fatal for human beings, especially children, given their body mass.

Ideally, there should be no trace of DEG in propylene glycol (PG), an industrial solvent used to dissolve medicines required to make cough syrups. Manufacturers of cough syrups are required to use pharmaceutical grade PG and the law mandates that they test it for DEG contamination before formulating the syrup. However, in India, pharmaceutical manufacturers often skip this step and use untested PG procured from chemical traders.     

The only silver lining to this tragedy is the speed and candour of the Tamil Nadu Drugs Control Department (TNDCD), which rapidly inspected the manufacturer’s facility in Kancheepuram after receiving a communication from its counterpart in Madhya Pradesh.

Such candour marks a refreshing departure from the disgraceful, evasive and jingoistic response of the Drug Controller General of India (DCGI) in 2022, after the tragedy in The Gambia drew international attention.

Even more remarkable is that the TNDCD’s announcement came only a few hours after the Union Ministry of Health informed a news agency that the cough syrups had not tested positive for DEG.

It is a mystery as to how the Union Health Ministry made such a determination because it is now confirmed that Tamil Nadu knew on October 2 and Madhya Pradesh on October 3, that the cough syrup failed testing. It is unlikely that any bureaucrat will be held accountable for this brazen attempt to mislead the nation. Unfortunately, such grave incompetence has been a signature feature of the Union Health Ministry’s response to tragedies involving adulterated cough syrups. 

Even in the past, the bureaucracy has managed to escape scrutiny. For example, in December 2021, three children died and several others fell ill in a Delhi hospital after consuming a cough syrup. The Aam Aadmi Party government announced an inquiry but the final report was never made public. Repeated attempts to secure a copy of the report under the RTI Act failed due to a vicious circle of transfers by a bureaucracy acting in bad faith. As a result, we still do not know whether the cough syrup was responsible for those deaths.   

Effective recall

Now that it is confirmed that these cough syrups are contaminated with DEG, the immediate first step should be aimed at preventing any further deaths by conducting an effective public recall. 

As of today, India does not have a binding legal framework to conduct nationwide recalls of adulterated drugs. The issue of recalls has been discussed in numerous government committees since 1976 without any success. With drug regulation in India spread across 37 regulators, one for each state and union territory, plus the national regulator, the issue of coordination and accountability becomes crucial during a public health emergency. Given this fact, a national recall should be the responsibility of a national drug regulator who has the legal powers to operate across the country to conduct the required seizures of the adulterated stock.

Apart from identifying a central authority responsible for conducting recalls, the second component of a recall framework should aim at laying down a standard operating procedure outlining the scope of such recalls. For instance, after the tragedy in Jammu in 2020, it was the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, not the state drug controller, which alerted the public to the brand name of the cough syrup. A few months later another brand of cough syrup manufactured by the same company caused the deaths of two more children. Once again, we know of this only because PGIMER disclosed the details. These deaths could have been avoided had the state drug controller of Himachal Pradesh withdrawn all brands of cough syrup manufactured by the same facility from the market.

The logical extension of this argument is to also recall cough syrups manufactured by other companies who used the same batch of contaminated industrial solvent. This is an issue often ignored in India. Not once have we heard of drug regulators in the country tracing the source of the contaminated solvent and mapping out all possible recipients of the same. This is necessary to contain and limit further deaths among those who may have consumed cough syrups or other formulations produced using the same contaminated solvent, even though sold under different brand names.

The third component of any effective recall framework is a clear communication strategy to inform all stakeholders, especially patients and doctors, on the nature of the threat, precautions to be taken and a helpline number for those who require treatment after having consumed the contaminated cough syrup. This communication strategy should include press conferences by government doctors, multilingual advertisements in newspapers, and press releases. If the sales records for the contaminated cough syrup are available, all details of the distribution chain including names of distributors and pharmacies should be published in the advertisements.  

Separate from these steps, the government should consider putting together a rehabilitation and compensation package for those affected. Many of the children facing kidney failure due to the contaminated cough syrup will possibly require dialysis support for the long term. Their families will go bankrupt unless supported by the government.

Long-term reforms

As for long-term reforms aimed at preventing a recurrence of such tragedies, we are pessimistic that the state will enact any meaningful change. Our pessimism arises from the knowledge of the political economy of the pharmaceutical industry and its stranglehold over political power.

The public disclosure of electoral bonds revealed some of the links between national political parties and large pharmaceutical companies. Far more pervasive, we suspect, are the backroom deals between local politicians and the small and medium pharmaceutical companies that supply to state government procurement programmes and are responsible for most of these cough syrup scandals.

Together, the pharmaceutical industry wields such influence that they managed to convince the Ministry of Health to decriminalise some offences related to the manufacture of substandard drugs (the production of adulterated cough syrups can still be prosecuted) as part of the Jan Vishwas Act, 2023 in the immediate aftermath of the tragedies in The Gambia, Uzbekistan and Cameroon.

As winter sets in and the usage of cough syrups skyrockets, many of these tragedies will not even make it to newspapers as it is notoriously difficult to diagnose DEG poisoning. Prudence would dictate that both parents and doctors avoid cough syrups for children as far as possible.

(Dinesh Thakur & Prashant Reddy T are coauthors of The Truth Pill: The Myth of Drug Regulation)