India sits at the centre of global healthcare. From HIV antiretrovirals that save lives across Africa to cancer drugs that make treatment affordable in Latin America and vaccines that protect millions in Southeast Asia, the country’s pharmaceutical industry has become indispensable. Today, India supplies around 20 per cent of global generic medicines by volume and nearly 60 per cent of the world’s vaccine demand, making it the backbone of treatment and prevention for much of the developing world. With pharmaceutical exports valued at nearly USD 28 billion during FY 2023–24, India is not merely a participant in global healthcare; it is one of its pillars.
At the same time, global reliance brings global scrutiny. Over the last five years, procurement agencies and regulators have begun examining not just what India manufactures but how consistently it guarantees quality. In a world where millions of patients depend on Indian medicines, internal regulatory supervision matters as much as supply. The international lens on India’s pharmaceutical ecosystem has sharpened not because India is less capable, but because the world can no longer afford uncertainty and suboptimal quality.
We are entering a new era — one in which trust becomes the most decisive ingredient of global healthcare leadership. Affordability and scale earned India its place; consistency and transparency will determine whether India can retain it.
The system is world-class in capability but stretched in supervision, allowing some unscrupulous players to operate. This has resulted in challenges to Indian-made drugs in multiple countries. This has been happening under the oversight of the regulatory bodies, both at the centre and the states.
India’s pharmaceutical success was built on scientific depth, competitive manufacturing, a vast talent pool and a regulatory architecture that enabled rapid expansion. However, over 10,000 manufacturing plants now operate across multiple states with uneven inspection capabilities. While the Central Drugs Standard Control Organisation (CDSCO) sets national norms, frontline oversight is state-driven, resulting in variability in manpower, laboratory capacity and enforcement.
The challenge is not intent; it is scale outpacing supervision. The global dependence on Indian medicines has grown faster than the regulatory capacity needed to monitor their manufacture.
The tragic deaths of children in Gambia and Uzbekistan linked to contaminated cough syrups were a turning point. In January 2023, the World Health Organization issued an alert noting that contaminated oral syrups distributed in several countries had been associated with “over 300 fatalities — the majority being children under the age of five.” In its October 2023 medical product alert, WHO described the flagged syrups as “substandard (contaminated) oral liquid medicines”, identifying toxic industrial solvents such as diethylene glycol (DEG) and ethylene glycol (EG) — chemicals that WHO warned “should never be found in medicines”.
Indian regulators’ response was largely cosmetic, and a strong association representing Indian manufacturers, the IPA, maintained radio silence.
The volumes were small, but the impact was enormous. For families, it was an unimaginable loss. For India’s pharmaceutical reputation, it was a global shock. Procurement authorities and regulators did not see a “cough syrup problem”; they saw a systemic risk signal. Following the alerts, several African and Southeast Asian governments temporarily delayed tenders involving Indian suppliers and began requesting plant-level audits rather than batch-level paperwork.
This was the lesson: while cough syrups do not define Indian pharma, they became an X-ray of its vulnerabilities. One failure, however isolated, reshaped global sentiment.
If quality inconsistencies recur, even infrequently, the consequences may include global procurement agencies shifting toward smaller but “lower-risk” suppliers, even if this raises treatment costs in low-income countries, and competitor nations using regulatory narratives — not pricing — to challenge India’s leadership in generics and vaccines.
This could damage not only India’s pharmaceutical sector but the global health architecture that relies on India for affordable, life-saving drugs.
The way forward is not defensive; it is structural and collaborative. The pharmaceutical industry has world-class players whose quality matches the highest global benchmarks. But the regulatory ecosystem must evolve to ensure that the strongest become the standard, not just the example. Pharma associations, big or small, have stakes in defending India’s reputation. The “it-is-not-my-monkey” approach will eventually impact each member.
A future-ready solution should include:
• Uniform regulatory standards across states, ensuring that inspection rigour does not depend on geography.
• A centralised digital audit and compliance registry, accessible to foreign regulators, which reduces repeated audits for compliant manufacturers and improves global transparency.
• A tiered quality-rating system for plants, encouraging SMEs to upgrade voluntarily and proactively rather than waiting for corrective inspections.
• Stricter penalties for repeat offenders, including suspension of export privileges, not merely batch recalls.
• Compliance-linked export facilitation for companies with clean records to reward good practice.
Such reforms do not burden the pharmaceutical industry; they protect it.
India should not assume that past incidents are forgotten or that the world will automatically separate isolated negligence from systemic capability. The families who lost their children will never forget. And global markets do not grade countries on intention; they grade them on assurance.
In sectors linked to life and death, trust is fragile. One mistake can overshadow a thousand contributions. A single contaminated batch can create suspicion around an entire category. The tragedy involving cough syrups showed the world that even small-margin products made in lesser-audited facilities can become global headlines.
India’s pharmaceutical sector has already done what no other country has: made advanced medicine affordable for much of the world. However, the next decade will not be defined by the number of medicines India exports; it will be defined by how reliably the world trusts them.
In the global pharmaceutical industry, quality is not just about compliance; it is the foundation of trust. And in the business of saving lives, trust is the most powerful export of all.
(Rakesh K. Chitkara is a corporate affairs and public policy professional specialising in regulation and trade)
