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The Tamil Nadu Health Development Association (TNHDA), a prominent organization of healthcare professionals led by Dr. Rex Sargunam, former director of the Institute of Child Health (ICH) in Chennai, one of the premier paediatric institutions in India, has released a critical assessment of the state’s Drug Control Department following the Coldrif cough syrup tragedy.
The report, titled ‘Understanding our Drug Control Mechanism in the post Coldrif scenario’, details how Batch No. SR-13 of the cough syrup, manufactured by Sresan Pharma in Kancheepuram, was found to be adulterated with 48.6 per cent diethylene glycol (DEG). This toxic industrial solvent led to a wave of renal failure and subsequent child deaths in Madhya Pradesh and Rajasthan.
The book highlights a severe failure of oversight, revealing that the manufacturer had operated for 14 years without a single mandatory inspection by the state drug control authorities. Under the Drugs and Cosmetics Rules, inspectors are legally required to visit manufacturing units at least once a year to ensure compliance with safety standards and license conditions. The TNHDA notes that the Tamil Nadu health minister later admitted to these lapses, resulting in the suspension of two senior drug inspectors for negligence.
Internal audits conducted after the tragedy uncovered 364 critical and major lapses across the company's drug manufacturing chain. Investigators found that the facility operated in unhygienic conditions, with medicines stored in corridors and production areas lacking essential air handling units. Furthermore, the unit lacked purified water generation systems and proper cleaning procedures, with equipment found to be rusted and leaking.
A primary concern raised by the TNHDA is the fragmented nature of India's regulatory architecture, which complicates accountability. While the Central Drugs Standard Control Organisation (CDSCO) approves new drugs and clinical trials, the state departments are responsible for licensing manufacturing, sale, and distribution. The TNHDA argues that this divide creates a policy vacuum and leads to inconsistent enforcement across different state borders.
To address these structural weaknesses, the TNHDA has placed several formal demands before the government, starting with the release of a white paper. They insist that the Tamil Nadu government must provide a transparent account of Sresan Pharma’s long-term operations and the regulatory failures that allowed them to continue. Additionally, the association calls for the official publication of notifications under Rule 68A on the government website to ensure public access to licensing information.
The organization further advocates for a significant constitutional shift by moving ‘Drugs’ from the Concurrent List to the State List in the Seventh Schedule. The TNHDA maintains that since health is a state subject, drug control must be an integral and accountable part of state health services. This change would ensure that the state where a drug is manufactured remains fully responsible and accountable for the quality of every batch produced.
In its concluding remarks, the report emphasizes that manufacturers must be held strictly liable for the integrity of their raw materials and finished products. The TNHDA recommends the establishment of a dedicated all-India drugs control services cadre to shore up abysmally low staff strength in regulatory departments. They argue that only through such stringent reforms and increased pharmacovigilance can the prevailing issue of adulterated drugs be effectively halted.
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