India, Oct. 14 -- Earlier this month, at least 20 children died in Madhya Pradesh and Rajasthan after consuming Coldrif cough syrup, which tested positive for diethylene glycol (DEG) - a highly toxic industrial chemical known to cause kidney failure. This tragedy is not an isolated event. In 2022, dozens of children in The Gambia, Uzbekistan, and Cameroon died after ingesting India-made cough syrups (manufactured by Maiden Pharmaceuticals) that also contained DEG. To be the world's pharmacy is both an honour and a profound responsibility. India produces roughly one-fifth of the world's medicines and an even larger share of its generics. The pharmaceutical industry contributes nearly 6% of export earnings and provides essential drugs for citizens. Yet, drugs fail for two main reasons: Some are counterfeit, containing no active ingredients, while others are contaminated due to poor manufacturing practices. In the case of Coldrif, it is likely that the manufacturer used industrial-grade glycerin or propylene glycol already tainted with DEG, rather than the more stringently controlled pharma-grade version. A 2023 survey found that around 3% of drugs sold in India were substandard - but such cross-sectional surveys rarely capture episodic manufacturing failures that lead to tragedies like this one. Moreover, it is seldom that anyone connects deaths occurring in different locations to a single causal agent - a defective drug. The true risk of substandard medicines is, thus, likely far greater than the data suggest. India's system for regulating drug manufacturers dates back to the Drugs and Cosmetics Act of 1940 (and its 1945 Rules), a framework designed to ensure safety, efficacy, and quality. Authority under this law is shared: The Central Drugs Standard Control Organisation (CDSCO), led by the Drugs Controller General of India, oversees new drug approvals, imports, clinical trials, biologics, and enforcement coordination, while State Drug Controllers license most manufacturers and conduct inspections within their jurisdictions. In practice, this has created a race to the bottom. In competing for investment, some states relax oversight, knowing that drugs produced locally can be sold nationally. The result is that lax regulation in one state can endanger patients everywhere. India has an estimated 10,500 pharmaceutical manufacturing units, yet only about 1,300 comply with the WHO's good manufacturing practices (GMP). Gujarat alone hosts nearly 5,800 licensed manufacturers. By contrast, India has just 36 major licensed vaccine manufacturing facilities. Quality lapses in vaccine production are comparatively rare, and most are caught through batch testing or post-market surveillance before causing widespread harm. The lesson is clear: Having fewer, larger facilities that consistently meet global standards can reduce the risk of catastrophic failures. The pharmaceutical industry has long viewed limited government interference as essential to its success, operating on an unspoken pact - that self-regulation, driven by market incentives, would safeguard quality while exports and jobs benefited the nation. But as the recent tragedies show, this social contract is fraying. A handful of negligent players can damage the credibility of an entire industry. Calls for tighter government oversight are justified, yet regulation alone may not suffice in a system vulnerable to corruption. The profits are high, and smaller firms often cut corners - accepting the risk of penalties if disaster strikes. Arrests and shutdowns do little for the children already lost. What India needs is a national, industry-wide quality standard - a binding commitment to GMP, enforced at the central level. The state-by-state licensing system, created for an earlier era when it was difficult to inspect provincial manufacturing units from Delhi, is no longer fit for purpose. The solution is already in sight. The New Drugs, Medical Devices and Cosmetics Bill, 2023, awaiting passage, represents India's most ambitious effort to modernise the 1940 law. It introduces risk-based classification, centralised licensing for high-risk drugs and biologics, online approval, pharmacovigilance networks, and stricter penalties for spurious drugs. It preserves federal balance but empowers the Centre to reclaim regulatory authority where national or international interests are at stake. Its progress, however, has been slowed by disputes over online pharmacies, opposition from small manufacturers who fear tougher scrutiny, and resistance from a few drug-producing states reluctant to forgo licensing revenue. The government must act decisively. The Coldrif tragedy should be the last time a parent loses a child to a preventable regulatory failure. Passing the new Bill swiftly - and ensuring its rigorous enforcement - would honour both India's role as the world's pharmacy and its duty to protect every life that depends on it....