Reforming India's Pharmaceutical Regulation: Addressing Structural Gaps and Ensuring Drug Safety

Deepak Paliwal

Abstract: India's pharmaceutical industry remains a global manufacturing powerhouse, yet recurrent episodes of substandard and contaminated medicines-culminating in recent paediatric cough syrup tragedies at home and abroad-have exposed critical regulatory weaknesses that threaten public health, export credibility, and diplomatic influence. This article synthesises evidence from national surveillance data, high-profile contamination incidents, and policy debates to map the structural causes of failure: fragmented central?state governance, chronic inspector and laboratory shortages, weak legal deterrents, opaque loan-license and contract-manufacturing practices, and lagging digital traceability. It examines the international fallout in export markets and soft-power costs, and evaluates recent reform efforts, including mandatory GMP alignment and the proposed Drugs, Medical Devices and Cosmetics Act, 2025. Drawing on comparative best practices, the paper proposes a nine-point reform agenda that prioritises centralised oversight, rapid independent batch testing for high-risk products, expansion and accreditation of laboratory capacity, stronger liability for brand owners using contract manufacturers, mandatory serialisation and real-time recalls, reinforced pharmacovigilance, and restored legal deterrence for deliberate or repeat offences. The article argues that decisive structural reform, technological adoption, and transparent enforcement are essential to restore trust, protect vulnerable populations, and secure India's long-term role in global pharmaceutical supply chains.

Keywords: India's pharmaceutical regulation, Substandard and spurious medicines, Diethylene glycol contamination, Pharmacovigilance, Batch testing and laboratory capacity

How to Cite?: Deepak Paliwal, "Reforming India's Pharmaceutical Regulation: Addressing Structural Gaps and Ensuring Drug Safety", Volume 14 Issue 10, October 2025, International Journal of Science and Research (IJSR), Pages: 1297-1304, https://www.ijsr.net/getabstract.php?paperid=SR251024134018, DOI: https://dx.doi.org/10.21275/SR251024134018