Spurious cough syrups kill; labels can play a preventive role

The Indian pharmaceutical industry has once again made headlines, but for all the wrong reasons. Diethylene glycol (DEG) has led to the deaths of children in Madhya Pradesh and Rajasthan. This exposes the lapses in the state regulatory system, as state regulators are often short-staffed or lack the resources to carry out inspections and audits.

Dr Cyriac Abby Philips, aka TheLiverDoc, on X said, "12 children in Rajasthan died because their cough syrups were contaminated with toxic DEG made by Kayson Pharma. 11 children died in Madhya Pradesh after consuming contaminated cough syrup made by Shreesan Pharma." He added, "This was proven through lab testing by Madhya Pradesh (MP) and Tamil Nadu government labs. But the Ministry of Health, India, told people that the cough syrups were clean, and then one mother who gave the cough syrup to her child in Rajasthan was jailed, and a doctor who prescribed cough syrup in MP was arrested." He stated, “No one from the company that manufactured these killer syrups was arrested or jailed. One manufacturer, Kayson Pharma, was already blacklisted in 2023 for poor-quality drugs. Why were they let back into the contract?”

The issue isn’t new, as similar incidents occurred in Gambia, Uzbekistan, and Cameroon (70 deaths in Gambia, 18 in Uzbekistan, and 12 in Cameroon) a few years ago. The deaths were caused by the consumption of contaminated cough syrups manufactured by Indian pharmaceutical companies.

The culprits were industrial solvents, specifically DEG and ethylene glycol (EG). The toxic chemicals were used as a cheap substitute for propylene glycol, a legitimate solvent in liquid medicines. Ingesting DEG and EG can cause acute kidney injury, multi-organ failure, and death, especially in children. The World Health Organisation (WHO) in its investigation found "unacceptable amounts" of diethylene glycol and ethylene glycol in the products. The global acceptable standard for DEG set by the WHO is 0.10%.

The Central Drugs Standard Control Organization (CDSCO), following the international incidents, implemented stricter export regulations for all Indian-made cough syrups, making it mandatory for exporters to have their products tested at government-approved laboratories before shipping.

Following the incidents in Madhya Pradesh and Rajasthan, Dr Rajeev Singh Raghuvanshi, the DCGI, issued an advisory for strict compliance with the Drugs Rules, 1945, for the testing of raw materials and finished formulations.

The advisory mentions that, as per the Drugs Rules, including Rule 74 (c) and Rule 78 (c) (ii), the licensee shall test each batch or lot of the raw material used for manufacture, as well as each batch of the final product, either in its own laboratory or in any laboratory approved by the licensing authority. The licensee shall also maintain records or registers showing the particulars of such tests as specified in Schedule U.

Dr Raghuvanshi said, “All the State/UT Drug Controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitizing the manufacturers through circulars, etc. Further, it shall also be ensured that the manufacturers have a robust vendor qualification system in place and use raw materials, including excipients, from reliable and approved vendors only.”

India is termed the ‘pharmacy of the world,’ with about 40% of drugs sold in the USA and 90% of drugs in Africa being exported from India. However, some loopholes are being exploited, and the end-users of these spurious drugs are paying the price.

However, the moot question remains, as these incidents are not one-offs or isolated: Who is responsible, and where does accountability lie? A healthcare practitioner prescribing these drugs cannot be held accountable, as they are not the ones manufacturing them. They are only prescribing medicines that are available in the market and have been approved by the CDSCO.