<p>New Delhi: As many as 3,104 drugs were found to be “not of standard quality” while 245 were found to be spurious out of 1,16,323 drug samples tested between April 2024 and March 2025, the Rajya Sabha was informed on Tuesday.</p>.<p>Responding to a query, Union Health minister J P Nadda said that 961 prosecutions were launched for manufacturing, sale and distribution of spurious/adulterated drugs during the same period, according to information received from the drugs controllers of various states and UTs.</p>.<p>Sharing details, Nadda said 1,06,150 samples were tested between April 2023 and March 2024 of which 2,988 were declared to be not of standard quality while 282 were found to be spurious.</p>.<p>He said 604 prosecutions were launched for manufacturing, sale and distribution of spurious/adulterated drugs during the same period.</p>.<p>The ‘counterfeit medicines’ terminology is not defined under the Drugs and Cosmetics Act, 1940, and the Rules made thereunder.</p>.<p>However, the Drugs and Cosmetics Act defines spurious, adulterated, and misbranded drugs, which include counterfeit drugs, Nadda said.</p>.<p>A nation-wide survey (2014-16) was conducted to assess the extent of ‘not of standard quality (NSQ)/spurious drugs’, for which 47,012 drug samples were drawn from both governments and private sources.</p>.<p>Manufacturing of spurious/adulterated/NSQ drugs is a punishable offence under the provisions of the Drugs and Cosmetics Act.</p>.<p>The Act empowers the concerned licensing authorities to take necessary legal action in such cases.</p>.<p>Furthermore, manufacturing, sale, and distribution of any prohibited or banned drug is also a punishable offence under the Act, and the licensing authorities concerned are authorised to initiate appropriate action in this regard, Nadda said.</p>.<p>Use of any spurious/adulterated/NSQ drugs, etc., is detrimental and may cause adverse effects on a patient's health.</p>.<p>Isolated complaints regarding such drugs as and when received are investigated along with the concerned licensing authorities for taking action, the health minister stated.</p>.Three held with drugs on Kanwar Yatra route in UP's Muzaffarnagar.<p>In case of drug samples declared as NSQ by the drug testing laboratories under CDSCO, the respective manufacturing firms are asked for immediate recall and stop further distribution of the not of standard quality drug in the market.</p>.<p>Further, based on investigation outcome, actions are taken by the licensing authorities concerned under the provisions of Drugs and Cosmetics Act and Rules made thereunder such as stop production orders, stop testing orders, licence suspensions/cancellations, warning letters and show-cause notices.</p>.<p>The government is also implementing a Strengthening of Pharmaceutical Industry (SPI) scheme in the country. The scheme has three components/sub-schemes.</p>.<p>The first component is Assistance to Pharmaceutical Industry for Common Facilities (APICF), which involves strengthening the existing infrastructure facilities by providing financial assistance to pharmaceutical clusters for creation of common facilities.</p>.<p>It also includes revamping the Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS) to facilitate and upgrade production facilities of the existing small and medium pharmaceutical companies having average turnover of less than Rs 500 crore, to attain the standards specified in the revised Schedule M to the Drugs Rules, 1945, and the World Health Organization – Good Manufacturing Practices (WHO-GMP); and Pharmaceutical and Medical Devices Promotion and Development Scheme (PMPDS).</p>.<p>Further, for strengthening the drug regulatory system in the country, the Ministry of Health and Family Welfare is implementing a Centrally sponsored scheme -- Strengthening of States’ Drug Regulatory System (SSDRS) -- with an approved outlay of Rs 850 crore.</p>.<p>The scheme envisages upgrading the existing state laboratories, setting up of new drug testing laboratories and upgradation of the existing state drug control offices in the country, Nadda said.</p>.<p>So far under the SSDRS scheme, funds totalling Rs 756 crore has been released to states and UTs as part of the Central share and 17 new drug testing labs have been constructed and 24 existing labs have been upgraded in various states and UTs.</p>
<p>New Delhi: As many as 3,104 drugs were found to be “not of standard quality” while 245 were found to be spurious out of 1,16,323 drug samples tested between April 2024 and March 2025, the Rajya Sabha was informed on Tuesday.</p>.<p>Responding to a query, Union Health minister J P Nadda said that 961 prosecutions were launched for manufacturing, sale and distribution of spurious/adulterated drugs during the same period, according to information received from the drugs controllers of various states and UTs.</p>.<p>Sharing details, Nadda said 1,06,150 samples were tested between April 2023 and March 2024 of which 2,988 were declared to be not of standard quality while 282 were found to be spurious.</p>.<p>He said 604 prosecutions were launched for manufacturing, sale and distribution of spurious/adulterated drugs during the same period.</p>.<p>The ‘counterfeit medicines’ terminology is not defined under the Drugs and Cosmetics Act, 1940, and the Rules made thereunder.</p>.<p>However, the Drugs and Cosmetics Act defines spurious, adulterated, and misbranded drugs, which include counterfeit drugs, Nadda said.</p>.<p>A nation-wide survey (2014-16) was conducted to assess the extent of ‘not of standard quality (NSQ)/spurious drugs’, for which 47,012 drug samples were drawn from both governments and private sources.</p>.<p>Manufacturing of spurious/adulterated/NSQ drugs is a punishable offence under the provisions of the Drugs and Cosmetics Act.</p>.<p>The Act empowers the concerned licensing authorities to take necessary legal action in such cases.</p>.<p>Furthermore, manufacturing, sale, and distribution of any prohibited or banned drug is also a punishable offence under the Act, and the licensing authorities concerned are authorised to initiate appropriate action in this regard, Nadda said.</p>.<p>Use of any spurious/adulterated/NSQ drugs, etc., is detrimental and may cause adverse effects on a patient's health.</p>.<p>Isolated complaints regarding such drugs as and when received are investigated along with the concerned licensing authorities for taking action, the health minister stated.</p>.Three held with drugs on Kanwar Yatra route in UP's Muzaffarnagar.<p>In case of drug samples declared as NSQ by the drug testing laboratories under CDSCO, the respective manufacturing firms are asked for immediate recall and stop further distribution of the not of standard quality drug in the market.</p>.<p>Further, based on investigation outcome, actions are taken by the licensing authorities concerned under the provisions of Drugs and Cosmetics Act and Rules made thereunder such as stop production orders, stop testing orders, licence suspensions/cancellations, warning letters and show-cause notices.</p>.<p>The government is also implementing a Strengthening of Pharmaceutical Industry (SPI) scheme in the country. The scheme has three components/sub-schemes.</p>.<p>The first component is Assistance to Pharmaceutical Industry for Common Facilities (APICF), which involves strengthening the existing infrastructure facilities by providing financial assistance to pharmaceutical clusters for creation of common facilities.</p>.<p>It also includes revamping the Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS) to facilitate and upgrade production facilities of the existing small and medium pharmaceutical companies having average turnover of less than Rs 500 crore, to attain the standards specified in the revised Schedule M to the Drugs Rules, 1945, and the World Health Organization – Good Manufacturing Practices (WHO-GMP); and Pharmaceutical and Medical Devices Promotion and Development Scheme (PMPDS).</p>.<p>Further, for strengthening the drug regulatory system in the country, the Ministry of Health and Family Welfare is implementing a Centrally sponsored scheme -- Strengthening of States’ Drug Regulatory System (SSDRS) -- with an approved outlay of Rs 850 crore.</p>.<p>The scheme envisages upgrading the existing state laboratories, setting up of new drug testing laboratories and upgradation of the existing state drug control offices in the country, Nadda said.</p>.<p>So far under the SSDRS scheme, funds totalling Rs 756 crore has been released to states and UTs as part of the Central share and 17 new drug testing labs have been constructed and 24 existing labs have been upgraded in various states and UTs.</p>