New Delhi: The Centre has directed states to strictly enforce drug testing regulations, specifically for raw materials and finished products, after the deaths of more than a dozen children were linked to toxic cough syrups.
The directive, issued on 7 October by the Drugs Controller General of India (DCGI) , orders all state and Union territory drug controllers to ensure that pharmaceutical manufacturers rigorously test every batch of ingredients to prevent a recurrence of the tragic events that have claimed the lives of children in Madhya Pradesh.
The DCGI’s order comes in the wake of the deaths of at least 14 children in Chhindwara, Madhya Pradesh, who died of renal failure after allegedly consuming a contaminated cough syrup.
The directive noted that during investigations into manufacturing facilities, it was observed that some drugmakers were not carrying out the mandatory testing of each batch of excipients and active pharmaceutical ingredients, in direct violation of the Drugs Rules, 1945.
The document highlights these lax practices as a critical loophole that led to the proliferation of substandard drugs on the market, directly endangering public health.
In-house laboratory mandated
To address this systemic failure, the DCGI has directed that all licensees must have an in-house laboratory or an approved external facility to test every batch of raw material and the final product.
Additionally, manufacturers are required to maintain detailed records and registers of all such tests, as specified under the Drugs Rules, 1945.
The directive also emphasizes the need for a robust vendor qualification system to ensure that raw materials are sourced only from reliable, approved suppliers.
This is being done to ensure that contaminated or substandard ingredients never enter the manufacturing pipeline in the first place.
The urgency of this directive stems from the severity of the Chhindwara tragedy.
Recently, a government doctor was arrested for allegedly prescribing the cough syrup, which was found to contain an alarming 48.6% concentration of diethylene glycol (DEG), a toxic industrial solvent.
Reports suggest that this concentration is hundreds of times higher than the permissible limit and is known to cause acute kidney failure, particularly in children.
The specific syrup in question, Coldrif, was manufactured by Sresan Pharmaceuticals, a Tamil Nadu-based firm. Investigations into the company’s factory revealed hundreds of critical and major violations, including filthy premises, damaged equipment, and the use of non-pharma grade chemicals.
The company’s licence had reportedly remained unscrutinized for over a decade.
By tightening the grip on quality control at the source, the government aims to rebuild trust in India’s pharmaceutical industry, which is a major global supplier of generic medicines.
government doctor, cough syrup, diethylene glycol, pharmaceutical industry, toxic cough syrups
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