Global trust vs domestic safety gaps

India has earned global trust as the pharmacy of the world. Yet, at home, quality gaps continue to expose patients to preventable risks, highlighting the urgent need for stronger safeguards.

Strengthening inspections, enforcing accountability and tightening surveillance are key to restoring confidence in drug safety, even as manufacturers race to meet this month’s deadline to comply with the revised Schedule M or India’s good manufacturing practices code.

History lingers

Little seems to have changed since 1986, when 14 patients who were recovering at Mumbai’s JJ Hospital suddenly died after receiving a routine drug contaminated with industrial glycol, a toxic chemical that attacks the kidneys. The landmark Lentin Commission, one of the major documented probes to lay bare the rot within India’s healthcare system, exposed a web of corruption and gross negligence, pointing to a nexus between unscrupulous manufacturers, traders, laboratories, even the Food and Drugs Administration.

The scourge of `killer syrups’ and toxic formulations has persisted over the decades with diethylene glycol-tainted syrups linked to children’s deaths in Gambia (2023), Uzbekistan (2019–2020) and Jammu (2020). Earlier, in 2014, adulterated Ciprofloxacin was dispensed to women in Chhattisgarh. These episodes expose deep fault lines in quality oversight over the years.

Adulteration often stems from inadequate testing of excipients (binders, lubricants, solvents) and raw materials that are critical links in the supply chain. For instance, pharma ingredients like glycerine and other raw materials must be tested to ensure the absence of toxic diethylene glycol (DEG) and ethylene glycol (EG).

Growing cost pressures, from price controls to rising competition, may tempt certain manufacturers to cut corners. Regulations should mandate clear labelling at the point of sale to distinguish medicinal from industrial-grade excipients, for preventing use of cheaper non-pharma grade substitutes.

Quality under scrutiny again

The most recent incident emerged in Madhya Pradesh, where at least 25 children died after consuming an adulterated cough syrup made by a Tamil Nadu firm, Sresan Pharma.

Investigators found 350-plus violations including rusted equipment, dirty equipment, filthy floors and non-pharma grade chemicals. Such units often operate in make-shift facilities with no standard operating procedures (SOPs) or quality controls.

At the core of the issue lies Schedule M, notified in December 2023, meant to bring uniform quality across factories. Two decades on, implementation remains uneven, especially among small and medium-scale firms that supply much of rural India.

Only about 2,000 of the country’s 10,500 drug units are fully GMP-certified, and with the revised Schedule M set to take effect from January next year, compliance remains chequered, particularly among smaller units below Rs 250 crore in annual turnover, which face potential shutdowns.

The new rules, aligned to global benchmarks, emphasize robust quality across the entire product lifecycle, tighten norms, demand validated processes and stricter documentation.

But rules alone will not fix gaps that stem from inadequate inspection and poor surveillance.

Monitoring, surveillance and enforcement gaps

Parliamentary committees and expert panels have long highlighted structural flaws in India’s drug regulatory system: weak infrastructure, limited testing facilities, a chronic shortage of inspectors, and uneven enforcement.

Health being a concurrent subject creates overlaps and inconsistencies between the national regulator CDSCO (Central Drugs Standard Control Organization) and state drug authorities.

Further, a culture of soft enforcement, minimal penalties and low convictions for serious offences, erodes deterrence.

Despite Mashelkar Committee recommendations (2003) – one drug inspector per 50 manufacturing units, and one for every 200 distribution outlets, remain largely unmet two decades later. With over 750 districts and domestic drug sales of over Rs 2.2 lakh crore annually, a severe manpower crunch continues to hamper effective regulatory oversight.

An independent USFDA-style national regulator for licensing, inspection and public disclosure of errant companies could help foster accountability and transparency. Along with stronger regulation, mandatory batch-testing before inter-state distribution, and routine checks of both excipients and final products should be enforced.

Traceability through technology can ensure swift coordinated recalls to counter delayed or inconsistently implemented withdrawals of ‘not of standard quality’ drugs.

A comprehensive surveillance system, with accredited laboratories, stringent SOPs, and transparent reporting, is essential to detect substandard products early, and to build a credible and contamination-proof supply chain.

Export standards, domestic reality

A stark disparity persists: plants exporting to regulated markets like the US meet stringent norms set by their regulators and are audited regularly. Those producing for Indian patients face far fewer checks, with enforcement varying across companies and states.

The divergence raises an uncomfortable question: if the industry can meet global standards for exports, why should medicines sold in India be held to a lower bar?

The road ahead 

Ensuring quality at every stage from raw materials to retail shelves is essential to deliver safe, reliable medicines for every Indian and safeguard the country’s reputation as a global pharmaceutical hub.

Equally critical is robust pharmacovigilance to monitor adverse effects, ensuring end-to-end testing, tech-enabled traceability and faster recalls, and investments in testing labs, inspector training, and consumer education to close existing gaps.

Only a bold, independent national regulator, with foolproof audits, inspections and surveillance is key to make that happen.

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