NEW DELHI: The Supreme Court of India has agreed to hear a crucial Public Interest Litigation (PIL) concerning alarming cough syrup deaths among children in Madhya Pradesh and Rajasthan. This significant move highlights urgent calls for systemic reform in India’s drug safety mechanisms. The bench comprising Chief Justice B R Gavai and Justices Ujjal Bhuyan and K Vinod Chandran is scheduled to hear the plea on October 10. The incidents, allegedly due to consumption of toxic cough syrups, have brought India’s pharmaceutical regulatory framework into sharp focus.
The PIL specifically seeks a court-monitored investigation into these tragic incidents. It also urges the constitution of a National Judicial Commission or Expert Committee, to be headed by a retired Supreme Court judge.
This committee would ensure impartiality and accountability in the probe. Furthermore, the petition requests the transfer of all pending First Information Reports (FIRs) and investigations related to children’s deaths from toxic cough syrups across various states to the Central Bureau of Investigation (CBI). This aims to ensure fairness and uniformity in the investigative process, which fragmented state-level investigations often hinder. Such fragmentation reportedly leads to inconsistent accountability and allows hazardous formulations to persist in the market.
The plea also directs the central government to identify specific regulatory failures. These failures allowed substandard medicines to reach consumers. Moreover, it mandates toxicological testing for all suspect pharmaceutical products. These tests must occur through NABL-accredited laboratories before any further sale or export is permitted.
This proactive step is vital for safeguarding public health.
Reports from Madhya Pradesh and Rajasthan indicate that several children died after consuming a particular type of cough syrup. These incidents underscore a recurring problem in India. For example, the deaths of 14 children in Madhya Pradesh were linked to Coldrif cough syrup, found to contain diethylene glycol (DEG) at dangerously high levels. This toxic industrial chemical is banned for pharmaceutical use but is sometimes used as a cheaper substitute for propylene glycol. Tragically, this is not an isolated occurrence. India has a history of such incidents, including deaths in 1998, 2020, and international cases in Gambia and Uzbekistan linked to Indian-manufactured cough syrups.
India’s drug regulatory system faces significant challenges. The dual control system, with both central and state authorities, often results in fragmented oversight and inconsistent safety standards. Infrastructure gaps in state drug testing facilities further exacerbate these issues. Despite reforms like the New Drugs and Clinical Trials Rules in 2019, challenges persist regarding consistency and clarity in guidelines. There is also a notable absence of a robust drug recall mechanism, allowing substandard drugs to remain in circulation. The current crisis highlights a systemic collapse in India’s drug regulatory mechanism, amounting to a gross violation of the right to life under Article 21 of the Constitution.
The Supreme Court’s intervention represents a decisive moment for drug safety in India. The PIL seeks to ensure impartiality, transparency, and accountability, recognizing that preventable lapses deny constitutional rights. Key reforms are necessary. A unified regulatory authority, centralizing enforcement powers, could eliminate state-to-state variations in drug quality standards. Additionally, mandatory testing requirements currently applied to exports should extend to all domestically distributed medicines. Upgrading state drug testing laboratories with advanced instruments and trained personnel is also crucial. These steps aim to prevent future tragedies and restore trust in India’s pharmaceutical sector, ensuring medicine meant to heal never harms. Understanding drug safety protocols is essential for all medical professionals, particularly for those involved in prescribing and dispensing medications. For enhanced knowledge in this area, consider the Certification Course In Safe Prescribing.
