Chennai: More than six months after contaminated cough syrup Coldrif killed more than 20 children in Madhya Pradesh, Tamil Nadu health development association, led by senior paediatrician Dr C S Rex Sargunam, former director of Institute of Child Health, demanded state govt release a white paper detailing the operations of Sresan Pharma, the Kancheepuram firm behind the toxic batch.The state earlier said the product, manufactured at a unit in Kancheepuram, was contaminated and contained high levels of industrial solvent diethylene glycol. High court advocate P B Suresh Babu prepared a report, signed by association president Dr Sargunam and secretary N Gnanaguru, ‘Prevention of Adulterated and Spurious Drugs’, calling for reforms in the drug regulation system in India, which will be released on Saturday by Justice D Hari Paranthaman, former Madras high court judge. The report, which details the measures to be taken for better monitoring and prevention of manufacturing and sale of injurious drugs, was prepared by high court advocate P B Suresh Babu, and signed by association president Dr Sargunam and secretary N Gnanaguru.“It’s time to shift drugs from the concurrent list to the state list in the Constitution’s Seventh Schedule, alongside public health,” Dr Sargunam said. “When health is on the state list, why are drugs on the Concurrent List? States must ensure manufacturers strictly follow Rule 71 of the Drugs and Cosmetics Rules, 1945, and set up their own independent testing labs for drug quality. In the cough syrup case, TN and MP officials must be held accountable for the deaths from contamination of Coldrif,” said Dr Sargunam, adding, “Since drugs are on the concurrent list, the Centre blames the states and the states blame each other. There is no accountability. No govt official was held accountable for the contamination or children’s death.”India, he said, received complaints from organisations such as World Health Organisation about substandard drugs that lack adequate potency to treat bacterial infections and cancer, and added, Central Drugs Standard Control Organisation (CDSCO) must be responsible for drugs exported to other countries. “Since drugs are on the concurrent list, the Centre blames the states and the states blame each other. There is no accountability. No govt official was held accountable for the contamination or children’s deaths,” he said.The report also accuses authorities of opacity, adding that the state must share a key list: the notification under Rule 68A — the long-elusive notification under Rule 68A of the Drugs and Cosmetics Rules, 1945, a list of which drugs require Central licensing approval. “The notification is long, elusive and not accessible online,” he said.Experts propose a unified national enforcement agency — All-India Drugs Control Services modelled after IAS/IPS, with trained officers posted nationwide for inspections, licensing, and accountability. The association will meet state health officials to press its demands, and take the report to political parties to lobby to move drugs to the state list, he added.
