India’s reputation as the “pharmacy of the world” is facing a growing crisis, not from counterfeit medicines as commonly feared, but from a far more insidious threat: substandard drugs. As highlighted in a recent analysis by Frontline India, the country’s fragmented regulatory system, weak enforcement, and lack of transparency are enabling the circulation of medicines that fail to meet basic safety and quality standards—sometimes with deadly consequences.
Public discourse around drug safety in India has long been dominated by concerns about counterfeit or “spurious” medicines. Yet official data from the Union Ministry of Health and Family Welfare paints a very different picture. A nationwide survey conducted between 2014 and 2016 found that spurious drugs accounted for just 0.0245 per cent of the market, effectively rendering the problem negligible. The real danger lies elsewhere—in drugs that are legally manufactured but fail to comply with mandatory quality standards.
These substandard drugs can be ineffective at best and lethal at worst. Over the past five years, nearly 200 children have died after consuming contaminated cough syrups produced by Indian pharmaceutical companies. These tragedies have occurred not only within India, in regions such as Jammu and Madhya Pradesh, but also internationally in countries including The Gambia, Uzbekistan, and Cameroon. Such incidents have cast a long shadow over India’s global pharmaceutical standing.
The culprit in many of these cases has been diethylene glycol (DEG), a toxic industrial chemical commonly used as an antifreeze agent. DEG contamination occurs when manufacturers fail to adequately test propylene glycol, a solvent used in syrup formulations. Despite clear legal requirements mandating such testing, lapses continue to occur. The consequences are particularly severe for children, whose developing organs are highly vulnerable to the toxin’s effects on the liver and kidneys.
This is not a new problem. India has witnessed multiple DEG-related tragedies dating back decades, with more than 50 deaths recorded between 1972 and 1998 alone. The persistence of such incidents underscores systemic failures in enforcement rather than gaps in knowledge or regulation.
The issue extends beyond cough syrups. In 2024, contaminated ringer lactate solution—used to rehydrate patients—was linked to the deaths of several young mothers in Karnataka and West Bengal shortly after childbirth. Investigations revealed the presence of bacterial endotoxins in the fluid, which should have been sterile. Similarly, eye drops manufactured in India and exported to the United States have been implicated in fatalities and severe infections due to contamination with multidrug-resistant bacteria.
While such high-profile cases capture public attention, Frontline India points to another equally troubling trend: declining confidence in generic drugs. Generics, which are intended to be affordable equivalents of branded medicines, have become a source of concern among medical professionals. In 2023, the National Medical Commission’s attempt to mandate the prescription of drugs by their generic names triggered significant backlash from doctors.
The rationale behind the policy was straightforward—reduce costs for patients by encouraging the use of cheaper alternatives. However, many doctors resisted, citing inconsistent quality across generic drugs available in the domestic market. Reports of patients not responding as expected to certain generics have further eroded trust, prompting physicians to continue prescribing more expensive branded medications.
This lack of confidence has serious implications for a country where affordability is a critical factor in healthcare access. It also raises uncomfortable questions about the reliability of India’s pharmaceutical supply chain, especially given its role as a major exporter of generic medicines worldwide.
At the heart of the problem lies a deeply flawed regulatory framework. The Central Drugs Standard Control Organisation (CDSCO), India’s national drug regulator, operates as an administrative body under the Directorate General of Health Services. Key policy decisions are made by bureaucrats within the Ministry of Health and Family Welfare, reflecting an outdated governance model that lacks autonomy and efficiency.
Compounding this issue is the fragmentation of regulatory authority between the central and state governments. While the central government oversees drug imports and approvals, state authorities are responsible for issuing manufacturing licences and conducting inspections. This division has resulted in a patchwork of 37 separate regulators across the country, creating inconsistencies and enforcement challenges.
The consequences of this fragmented system are evident in cases where substandard drugs cross state boundaries. If a drug manufactured in one state fails quality tests in another, the affected state has limited authority to take action beyond notifying its counterpart. It cannot inspect the manufacturing facility, revoke licences, or halt distribution. Such jurisdictional limitations weaken accountability and delay corrective measures.
Efforts to centralise drug regulation have been proposed for years, drawing on models used in other federal systems. A unified national regulator could ensure consistent enforcement and enable parliamentary oversight. However, these proposals have faced stiff resistance from segments of the pharmaceutical industry, particularly small and medium enterprises that benefit from negotiating with state-level authorities.
Even if structural reforms are implemented, they will have limited impact without addressing the pervasive lack of transparency within the system. As Frontline India notes, Indian regulators provide minimal public information about their activities. Unlike their counterparts in developed countries, they do not routinely publish inspection reports, scientific justifications for drug approvals, or detailed records of enforcement actions.
This opacity has far-reaching consequences. Procurement officials in both public and private sectors often lack reliable data on the quality of drugs and manufacturers, leading to inefficiencies and duplication of efforts. Some state agencies have resorted to conducting their own inspections, increasing costs and administrative burdens.
Greater transparency could serve as a powerful tool for accountability. Publicly available inspection reports and test results would enable independent scrutiny by नागरिक groups and researchers, ensuring that standards are consistently applied. It would also incentivise regulators to perform thorough inspections, knowing their findings are subject to public review.
Despite the urgency of these issues, reform efforts have repeatedly stalled. Industry lobbying has delayed the adoption of stricter standards aligned with global benchmarks, while recent legislative changes have weakened enforcement mechanisms. The Jan Vishwas Act of 2023, for instance, has diluted penalties for manufacturers found guilty of producing substandard drugs, raising concerns about deterrence.
Meanwhile, the bureaucracy has shown limited appetite for meaningful change, often resorting to superficial measures such as outsourcing inspections without addressing underlying structural flaws. Critics argue that such approaches fail to tackle the root causes of the problem and may even exacerbate existing vulnerabilities.
The stakes could not be higher. Substandard drugs not only endanger lives but also undermine public trust in the healthcare system and damage India’s credibility as a global pharmaceutical leader. As Frontline India emphasizes, holding the industry accountable is no longer optional—it is imperative.
Without decisive action to strengthen regulation, improve transparency, and enforce existing laws, the silent crisis of substandard medicines will continue to grow. For millions who rely on affordable healthcare, the cost of inaction may be measured not just in rupees, but in lives lost.
