Introduction:

India’s pharmaceutical industry, long known as the “pharmacy of the world,” is again under scrutiny after toxic cough syrups were linked to child deaths in Madhya Pradesh and Rajasthan. Laboratory tests revealed dangerously high levels of diethylene glycol (DEG), an industrial chemical used in antifreeze, in syrups. The incident has triggered state bans, factory inspections, and renewed debate over the safety and accountability of India’s drug manufacturing system.

This follows earlier international tragedies in The Gambia, Uzbekistan, and Iraq, all involving India-made syrups.

Pattern of Recurring Cough Syrup Tragedies:

India has repeatedly faced incidents of DEG contamination in pharmaceuticals over the past century, reflecting systemic failure rather than isolated error.

Historical incidents: Major poisoning events were reported in Chennai (1973), Bihar (1986), Gurugram (2020), Jammu (2019), and internationally in The Gambia (2022) and Uzbekistan (2022), leading to hundreds of deaths, most of them children.
Common pattern: In each case, toxic solvents were substituted for pharmaceutical-grade compounds to cut costs, exposing the absence of strict supplier verification and testing.
Regulatory aftermath: Investigations typically result in temporary bans and arrests but rarely in structural reform, allowing recurrence.
Root cause: Weak coordination between central and state regulators, underfunded laboratories, and an enforcement system that reacts after fatalities rather than preventing them.

Toxic Component: Diethylene Glycol (DEG)

Nature: A clear, sweet-tasting industrial solvent used in brake fluids, antifreeze, and plastics manufacturing.
Why it appears in medicines: It is sometimes misused as a low-cost substitute for propylene glycol or glycerine in pharmaceutical syrups.
Toxicity: Even small doses can cause severe abdominal pain, vomiting, metabolic acidosis, kidney failure, and death.
Permissible limit: Only 0.1% is allowed in drugs; recent tests found over 46%, indicating gross manufacturing negligence.
Historical precedent: Global awareness of DEG poisoning dates back to the 1937 U.S. “Elixir Sulfanilamide” disaster, which killed over 100 people and led to the creation of the U.S. FDA’s modern drug laws.

How are Medicines regulated in India?

Legal framework: Governed primarily by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
Authority structure:
- The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health regulates imports, new drugs, and quality standards.
- State Drug Control Authorities license manufacturing units and monitor local sales.
Implementation challenge:
- Fragmented responsibilities lead to uneven enforcement and duplication of work.
- While CDSCO issues guidelines, states often lack testing infrastructure or manpower to ensure compliance.
- Public health being a state subject further complicates central supervision.
Testing requirements: Manufacturers must verify both raw materials and finished formulations, but this is rarely enforced or independently audited.

Regulatory and Structural Gaps:

Weak coordination: No integrated digital system links state and central regulators to track licenses, test results, or violations.
Inspection failures: Many small and medium-sized drug firms operate without periodic inspection or third-party audits.
Resource deficit: State drug labs often face staff shortages, outdated testing equipment, and minimal budgets.
Penalties too lenient: Adulteration and misbranding attract limited imprisonment or fines, offering little deterrence.
Lack of global alignment: India’s domestic quality standards often diverge from those used by WHO or international regulators, creating dual regimes for export and domestic markets.

How such incidences impact India’s global credibility?

International scrutiny: Following deaths in The Gambia and Uzbekistan, the World Health Organization (WHO) issued global alerts on India-manufactured syrups.
Export restrictions: Several importing countries now demand independent quality certificates before allowing entry of Indian pharmaceuticals.
Erosion of trust: India’s image as a low-cost, high-quality medicine supplier is undermined by repeated safety lapses.
Diplomatic and economic cost: Quality scandals threaten a $25 billion export industry that supplies over 50% of global vaccine demand and a major share of generic drugs to Africa, Latin America, and Southeast Asia.

Way Forward:

Centralised surveillance: Create a national digital platform integrating manufacturing, testing, and licensing data across states.
Independent quality audits: Mandate third-party verification of raw materials, excipients, and solvents used in formulations.
Stronger penalties: Introduce criminal liability for executives in cases of fatal contamination.
Laboratory strengthening: Upgrade all state drug testing labs with modern equipment and accredited quality management systems.
Export accountability: Require WHO-GMP certification for all export-bound and domestic drug batches alike.

PYQ Relevance:

[UPSC 2024] The case study focuses on a senior scientist, Dr. Srinivasan, working on a new drug, facing pressure to expedite trials and resort to unethical shortcuts, such as manipulating data to exclude negative outcomes and selectively reporting positive results.

The questions posed specifically asked the aspirant to:

• Examine options and consequences in light of the ethical questions involved.

• Discuss how data ethics and drug ethics can save humanity at large in such a scenario.

Linkage: The core issue involves the provision of quality healthcare and social services. The crisis highlights the vulnerability of populations, both domestically and internationally, to unsafe drug manufacturing practices. Questions can focus on the mechanisms, laws, and institutions designed for the protection and betterment of vulnerable sections (like consumers of essential medicines).

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