|
The Central Drugs Standard Control Organisation (CDSCO) has released a comprehensive report detailing the quality surveillance of pharmaceuticals across India over the last five fiscal years.
The data reveals a massive scale of oversight, with nearly five lakh drug samples tested between 2020 and 2025. This surge in monitoring is part of a broader federal push to ensure the safety and efficacy of medicines distributed both domestically and internationally.
According to the official statistics, approximately 2.90 percent of the total samples analysed were declared ‘Not of Standard Quality’ (NSQ). While the volume of testing increased by 37 percent since 2020, surpassing 1.16 lakh samples in the most recent fiscal year alone, the rate of substandard drugs has remained relatively stable, hovering around the 3 percent mark. This consistency suggests that despite a much wider net being cast, the prevalence of low-quality medication is not increasing.
The report further highlights that the presence of ‘spurious’ or counterfeit drugs remains remarkably low. Over the five-year period, fake or imitation medications accounted for only 0.32 percent of all samples tested. In the 2024-2025 period, this figure dipped even further to 0.21 percent, representing just 245 samples out of more than 1.16 lakh. These figures underscore the high level of integrity maintained by the organized pharmaceutical manufacturing sector in India.
Reacting to the report, G. Koteshwar Rao, national president of the Drugs Control Officers India Welfare Association (DCOIWA), noted that these statistics reflect the continuous efforts of the regulatory system to safeguard public health. He emphasized that the testing of nearly five lakh samples demonstrates a firm commitment to ensuring only safe medicines reach the public. Rao pointed out that while a 3 per cent NSQ rate is stable, the extremely low proportion of spurious drugs, averaging around 0.3 per cent, indicates that the regulatory framework is largely effective.
The CDSCO has adopted more aggressive strategies recently, including the implementation of risk-based inspections starting in December 2022. This targeted approach has already covered over 960 manufacturing units across the country. Additionally, the government has ramped up legal consequences for offenders, in the 2024-2025 fiscal year, 961 prosecutions were launched for spurious or adulterated drugs, marking the highest number of legal actions taken in the last five years.
Despite these successes, the DCOIWA president cautioned that the presence of even a small percentage of substandard drugs cannot be ignored. Rao called for further strengthening of laboratory infrastructure and the filling of vacant drugs inspector posts to maintain this momentum. He noted that enhancing inter-state coordination and increasing stakeholder awareness are essential steps to evolving the current quality surveillance system into a foolproof shield for patients.
The report concludes by highlighting the ongoing vigilance of the CDSCO through its monthly ‘drug alerts’. In January 2026 alone, 240 samples were flagged as NSQ, proving that the machinery of oversight remains active year-round. As India continues to solidify its reputation as the ‘pharmacy of the world’, the DCOIWA reaffirms its support for these regulatory initiatives, stressing that ensuring drug quality is a collective responsibility vital for public health protection.
|