Pune: The Maharashtra Food and Drug Administration (FDA) has seized cough syrup stock worth Rs.13 lakh from Rednex Pharmaceuticals in Pune after samples collected in Gujarat reported high levels of diethylene glycol(DEG), a toxic chemical known to cause liver and kidney failure.
Following a tipoff, the Joint Commissioner for Drugs at FDA Pune, Girish Hukare, launched a drive to inspect local cough syrup manufacturers.
“Gujarat government’s samples revealed high levels of diethylene glycol in products from Rednex Pharmaceutical and Shape Pharma… In Pune, we have seized the stock of Rednex Pharma worth Rs 13 lakhs… Additionally, a drive has been initiated to inspect local manufacturers to ensure compliance with standards with surprise visits planned. Legal actions will be taken against those who violate these,” Hukare told ANI.
Precautionary measures
Due to the death of 20 children, mostly in Madhya Pradesh’s Chhindwara district and a few in Rajasthan, authorities have been taking precautionary measures to ensure compliance with stringent quality control measures. Doctors, pharmacists and stockists have been put on high alert, with the local units of the FDAs analysing random samples and conducting surprise raids.
Last week, reports came in of children succumbing after consuming the ‘Coldrif’ cough syrup that contained DEG. An analysis of samples confirmed the presence of DEG in the medicine manufactured by Tamil Nadu-based Sresan Pharmaceuticals, whose owner, Ranganathan, is on the run.
Developments post cough syrup deaths
Following the reports, Tamil Nadu, Puducherry, Rajasthan and Chhattisgarh have also banned the sale of Coldrif, while the medical shops in Chhindwara have launched an indefinite strike to protest against inaction by the authorities against medical shops that sold the syrup.
The District Chemists Association in Madhya Pradesh’s Chhindwara insists that this strike is to urge the authorities to punish only the guilty chemists, not all of them.
“Our strike is indefinite and it will continue until the administration accepts our demands. If our demands are accepted now, we will reopen our shops immediately. We had met the SDM last night; he had assured us of a discussion this afternoon, but so far we have not received any call or communication. Our demand is that the action being taken by the administration against our fellow chemists is unfair. Action should be taken only against those who are actually guilty. Our chemist colleagues are not manufacturers of medicine but only sellers, so such action against them is unfair.” Santosh Chaure, the Chhindwara president of The Districts Chemists Association, told ANI.
This development has shown the lax attitude of the FDA and the Central Drugs Standard Control Organization (CDSCO), which hasn’t been able to enforce the stringent regulations required to ensure safety and boost efficacy of leading drugs.
Not the first time, will it be the last?
India has been at the centre of such a scandal in 2023, after almost 70 children died in Africa due to adulterated cough syrup manufactured in India. India is a major manufacturer of affordable generic drugs for developing countries, accounting for almost 20% of all supplies.
The increasing demand for affordable drugs, coupled with the high trust placed by doctors on some brands and the overburdened work load of regulators have given criminals fertile grounds to sell fake medicines. The CDSCO and FDA have to do far more than just knee-jerk reactions to ensure such incidents don’t occur again, even as the authorities use technologies like holograms and RFID tags to keep a watch on the supply chain.
