Deaths due to contaminated cough syrups have become painfully recurring. From fatalities in Mumbai in 1986 to deaths in Jammu in 2019 to casualties in Gambia, Uzbekistan and Cameroon in 2022 to now the tragic news of 14 children dying in Madhya Pradesh, the list of lives lost is long with no room to accommodate regulatory cold-feet. A link node running across has been the role of Diethylene glycol (DEG), an excipient (jargon for drug carrying medium or filler to lend acceptability to a drug).
While the investigations are now into the tragedy in Madhya Pradesh, the news hogging headlines is the cough syrup containing highly unacceptable concentration of DEG – as much as 48 per cent. Interrogate the internet and the permissible limit for this is less than 0.1 per cent.
The development and the long and telling travails with cough syrups over the past four decades has led several seasoned voices in the sector to seek a shift in focus to root cause analysis and away from mere temporary bans and suspensions.
With a deep understanding of the regulatory system and the manufacturing practices, most experts, not wanting to be named, felt, a root cause analysis must begin with the main culprit – the contamination in the syrups. Therefore, the starting point would have to be setting standards and norms for the use of DEG. There is also now a case arguably in favour of having DEG’s manufacturing brought under the scope of drug manufacturing licenses.
A root cause analysis that can trigger a solution-based response with systems in place for proactive policing must include a thorough review of the processes. In particular, those of joint inspections by the central and state regulators. This can help amplify the reasons that lead to lapses (products made to specifications that deviate from the prescribed standards and fall way beyond the permissible levels).
A closer examination of the role of the local regulator and the coordination with the central regulator will ensure deviations get prevented rather than revealed during a risk-based inspection. If a company is in operation for well over a decade then why should a tragic development trigger a regulatory check and only then have major observations dished out to the manufacturer. After all, as is often argued, disregard for Good Manufacturing Practices do not happen overnight. Huge lapses cannot occur if the incoming ingredients and out-going products are tested at every juncture. It is addressing these issues alone that can ensure proactive policing and a robust audit mechanism rather than a reactive regulatory response.