New Delhi: The Central Drugs Standard Control Organization (CDSCO) and state drug regulatory authorities have intensified drug safety crackdown as substandard and spurious medicine cases have risen during the last five years.
Amid increasing concerns over medicine quality and patient safety in India, there has been a significant increase in enforcement actions against manufacturers and distributors involved in the sale of substandard, spurious, and adulterated medicines.
The figures, compiled from reports submitted by State and Union Territory Drug Controllers, reveal that over 3,100 medicines have failed quality tests in 2024-25 alone based on the growing scale of surveillance being undertaken under the provisions of the Drugs and Cosmetics (D&C) Act, 1940 and the D&C Rules, 1945.
In 2024-25, drug testing reached its highest-ever level at 1,16,323 samples. Regulators identified 3,104 NSQ samples and 245 spurious or adulterated medicines. More significantly, prosecutions jumped dramatically to 961 cases, marking the highest level of enforcement action in the five-year period and signalling an increasingly uncompromising stance by regulators against violations.
The figures reflect the growing concern among policymakers and health authorities regarding medicine quality and patient safety in a country that plays a central role in the global pharmaceutical industry. India supplies a substantial share of generic medicines worldwide, and any concerns regarding drug quality have implications not only for domestic healthcare but also for international confidence in Indian pharmaceutical exports.
Authorities have reiterated that all medicines manufactured in India, whether intended for domestic consumption or export markets, are required to meet the same quality standards prescribed under Indian law. In addition to complying with national regulations, exporters are also obligated to satisfy the regulatory requirements laid down by importing countries, reflecting India’s dual responsibility as both a domestic healthcare provider and one of the world’s largest pharmaceutical suppliers.
During the financial year 2020-21, authorities tested 84,874 drug samples, of which 2,652 were declared “Not of Standard Quality” (NSQ), while 263 samples were identified as spurious or adulterated. Enforcement agencies launched 236 prosecutions related to the manufacture, sale, and distribution of fake or adulterated medicines during the same period.
In 2021-22, the number of samples tested rose to 88,844. Although the NSQ count marginally declined to 2,545, the number of spurious or adulterated drugs detected increased sharply to 379. Regulatory action intensified substantially, with prosecutions surging to 592 cases, more than double the previous year’s figure.
The trend continued in 2022-23, when testing operations crossed the 96,000 mark, reaching 96,713 samples. Authorities found 3,053 medicines to be below standard quality, while 424 samples were declared spurious or adulterated, which is the highest such figure in the five-year dataset. Enforcement agencies launched 663 prosecutions during the year, reflecting heightened scrutiny and tougher legal action against offenders in the pharmaceutical supply chain.
The financial year 2023-24 witnessed another expansion in surveillance activity, with regulators testing 1,06,150 drug samples nationwide. Of these, 2,988 were declared not of standard quality, while 282 were classified as spurious or adulterated. Legal enforcement remained robust, with 604 prosecutions initiated against entities allegedly involved in manufacturing or distributing unsafe medicines.
In response to these concerns, the CDSCO and the Union health ministry have undertaken a series of regulatory measures aimed at strengthening oversight of drug manufacturing and imports. Authorities have increasingly relied on risk-based inspections, coordinated surveillance drives, upgraded testing laboratories, and stricter prosecution mechanisms to identify violations and remove unsafe medicines from circulation.
Industry experts have stated that India’s pharmaceutical credibility in international markets depends heavily on the effectiveness of these regulatory interventions.
