Tamil Nadu Health Association Demands White Paper on Deadly Cough Syrup Manufacturer
In a significant move, a health development association in Tamil Nadu has called on the state government to release a detailed white paper concerning the operations of Sresan Pharma, the Kancheepuram-based firm responsible for a toxic batch of cough syrup. This demand comes more than six months after the contaminated product, known as Coldrif, led to the tragic deaths of over 20 children in Madhya Pradesh.
Contamination and Accountability Issues
The state authorities previously confirmed that the cough syrup, manufactured at a facility in Kancheepuram, was contaminated with dangerously high levels of diethylene glycol, an industrial solvent. Despite this finding, no government officials have been held accountable for the contamination or the resulting fatalities, highlighting a severe lack of oversight in the drug regulation system.
Dr C S Rex Sargunam, former director of the Institute of Child Health and president of the Tamil Nadu health development association, emphasized the urgent need for reform. "It's time to shift drugs from the concurrent list to the state list in the Constitution's Seventh Schedule, alongside public health," he stated. "When health is on the state list, why are drugs on the Concurrent List? This overlap allows the Centre to blame states and states to blame each other, creating a vacuum of accountability."
Report on Drug Regulation Reforms
A comprehensive report titled 'Prevention of Adulterated and Spurious Drugs' has been prepared by high court advocate P B Suresh Babu and signed by Dr Sargunam and association secretary N Gnanaguru. This document outlines critical measures for enhanced monitoring and prevention of harmful drug manufacturing and sales. It is scheduled for release on Saturday by Justice D Hari Paranthaman, a former judge of the Madras High Court.
The report advocates for several key reforms:
- Transferring drugs from the concurrent list to the state list to clarify jurisdictional responsibilities.
- Ensuring strict adherence to Rule 71 of the Drugs and Cosmetics Rules, 1945, by state governments.
- Establishing independent state-level testing laboratories to verify drug quality.
- Creating a unified national enforcement agency, modeled after the IAS/IPS, with trained officers for nationwide inspections and licensing.
Opacity and International Concerns
Dr Sargunam also criticized the authorities for their lack of transparency, particularly regarding Rule 68A of the Drugs and Cosmetics Rules, 1945. This rule mandates a list of drugs requiring Central licensing approval, but the notification is described as "long, elusive, and not accessible online," hindering effective regulation.
Furthermore, he highlighted international issues, noting that India has faced complaints from organizations like the World Health Organisation about substandard drugs that fail to adequately treat conditions such as bacterial infections and cancer. He stressed that the Central Drugs Standard Control Organisation (CDSCO) must take responsibility for drugs exported to other countries to maintain global trust.
Next Steps and Advocacy
The association plans to meet with state health officials to press for these demands and will also present the report to political parties to lobby for moving drugs to the state list. This initiative aims to prevent future tragedies by strengthening India's drug regulation framework and ensuring accountability at all levels of government.
