India, long regarded as the pharmacy of the world, faces yet another challenge as its drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has flagged over 50 widely used drugs as substandard or counterfeit. This is a significant blow to the credibility of an industry responsible for supplying a substantial portion of the global pharmaceutical market. Among the drugs flagged are popular antacids, paracetamols, painkillers, antibiotics, vitamins and anti-diabetic drugs, which form an integral part of everyday medical care in India.
The issue, however, extends beyond these specific cases, underscoring deeper concerns within the drug regulation and manufacturing framework. The findings raise questions about the robustness of India’s quality control processes, both at the manufacturing and regulatory levels. While India has earned global recognition for producing affordable medicines, incidents such as these highlight gaps in the system that must be addressed. These latest revelations come on the heels of international controversies, where Indian-made medicines were linked to fatalities in countries like Gambia and Uzbekistan.
Although these are distinct cases, the cumulative effect on the perception of Indian pharmaceuticals cannot be ignored. One of the pressing issues is the presence of counterfeit or spurious drugs, which not only endanger the health of consumers but also erode trust in the entire supply chain. While the CDSCO’s monthly lists are a step toward greater transparency, more rigorous oversight is required to ensure that substandard drugs do not reach the market in the first place. The fact that major pharmaceutical companies have themselves alerted the regulator about counterfeit batches indicates a systemic problem that affects both manufacturers and consumers.
The recall of substandard drugs after they have already been distributed is reactive and far from ideal. It exposes the weaknesses in premarket surveillance, where more stringent measures could prevent such batches from entering circulation. Moreover, the manufacturers’ responsibility to conduct their own tests on leftover samples to confirm the authenticity of these drugs adds another layer of post-incident control, but it does little to reassure the public. Greater cooperation between regulatory bodies, manufacturers, and distributors is essential to create a more proactive, preventive approach to drug safety.
India’s reputation as a leading drug exporter has been under increasing scrutiny, particularly in light of recent scandals involving contaminated medicines linked to deaths of children overseas. This latest episode of substandard drugs in the domestic market further complicates efforts to restore confidence, both internationally and at home. At a time when gastrointestinal and anti-diabetic drugs are driving significant market growth, such incidents are particularly damaging.
Moving forward, the Indian pharmaceutical industry and regulators must prioritise rigorous quality assurance processes, from manufacturing to distribution. Strengthening the drug regulation system, implementing stricter compliance checks, and enhancing transparency across the supply chain are critical steps toward restoring trust. It is also essential that the CDSCO collaborates more closely with international regulators to ensure that drugs produced in India meet the highest global standards. Consumers, both in India and abroad, deserve safe, effective medicines.