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Key Statistics
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Total drug samples tested (Apr 2024–Mar 2025): 1,16,323
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Drugs ‘not of standard quality’ (NSQ): 3,104
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Spurious drugs detected: 245
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Prosecutions launched for spurious/adulterated drugs: 961
More than 3,000 drug samples tested across India over the past year were found to be “not of standard quality”, with nearly 250 confirmed as spurious, Union Health Minister J. P. Nadda informed the Rajya Sabha this week. The data, compiled from state and union territory drug controllers, covers samples tested between April 2024 and March 2025.
In the previous period (April 2023–March 2024), authorities tested 1,06,150 samples, of which 2,988 were found to be of subpar quality and 282 were identified as spurious. Legal action remains a priority, with over 1,500 prosecutions initiated over the past two years.
Regulatory Response and Legal Measures
The Drugs and Cosmetics Act, 1940 defines spurious, adulterated, and misbranded drugs, all of which encompass the idea of counterfeit medicines. While “counterfeit medicines” is not a legally defined term under the Act, offenses related to manufacturing, sale, and distribution of non-standard or spurious drugs are punishable and attract legal action. Licensing authorities may take actions such as:
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Immediate recall and halting further distribution of affected drugs.
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Issuance of stop production/testing orders.
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Suspension or cancellation of licenses.
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Issuance of warning letters and show-cause notices.
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Initiation of court prosecutions.
Measures to Strengthen Drug Quality Standards
Authorities are taking a multi-pronged approach to safeguard public health:
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Quality Recalls: Manufacturers must immediately recall ‘NSQ’ drugs as declared by accredited laboratories.
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Legal Enforcement: Licensing authorities enforce stop orders, suspensions, and initiate prosecutions based on investigation findings.
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Surveys and Monitoring: A national survey (2014–2016) previously examined the prevalence of NSQ/spurious drugs, testing 47,012 samples from government and private sources.
Strengthening the Pharmaceutical Industry
The government’s Strengthening of Pharmaceutical Industry (SPI) scheme includes:
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Assistance to clusters for building shared infrastructure.
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Technology upgrades to help small and medium enterprises comply with national and WHO-GMP standards.
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Promotion and development of pharmaceutical and medical device industries.
Additionally, the Strengthening of States’ Drug Regulatory System (SSDRS) aims to upgrade laboratories and regulatory offices across India. So far, Rs 756 crore has been allocated, 17 new labs constructed, and 24 existing labs have undergone upgrades.
Public Health Implications
Consumption of spurious, adulterated, or NSQ drugs carries significant health risks. The government emphasizes the importance of prompt investigations and collaboration with state licensing bodies to minimize patient exposure to unsafe medications.
Disclaimer
This report is based on information provided by the Indian Union Health Minister to the Rajya Sabha and collated from various government sources. Figures and policies cited reflect government statements as of July 2025. Readers should consult the original sources and relevant authorities for the latest updates and details regarding pharmaceutical regulations and enforcement in India.
