Over 3,000 drug samples declared not of standard quality in 2024-25: Nadda

New Delhi, Dec 3 (PTI) Of the 1.16 lakh drug samples tested in 2024-25, 3,104 were declared not of standard quality while 245 were found to be spurious or adulterated, Union Health Minister J P Nadda told the Lok Sabha on Friday.

Responding to a question, Nadda also informed that of the 1.06 lakh samples tested in 2023-24, 2,988 were not of standard quality and 282 were found to be spurious or adulterated.

In 2022-23, 96,173 samples were tested, of which 3,053 were not of standard quality, and 424 were spurious, the health minister said.

The Food Safety Standard Authority of India (FSSAI) and its regional offices, through the state and UT food safety departments, carry out regular surveillance, monitoring, inspection, and random sampling of food to ensure compliance with the quality and safety standards established under the Food Safety and Standards Act (FSS), 2006, and the rules and regulations made thereunder, he said.

As a part of quality monitoring and in order to assess the regulatory compliance of drug manufacturing premises in the country, the Central Drugs Standard Control Organisation (CDSCO), in collaboration with the state regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022, Nadda said.

Firms have been identified based on risk criteria such as the number of drugs declared as not of standard quality, complaints, criticality of the products, etc.

The CDSCO, along with the SDCs, conducted risk-based inspections of more than 960 premises since December 2022, and based on the findings, more than 860 actions, including issuance of show-cause notices, warning letters, stop production order and cancellation of licences, have been taken by the states and UTs as per the provisions of the Drugs Rules, 1945.

The list of drugs of various companies, which are declared not of standard quality/spurious/adulterated by the Central drug testing laboratories, is uploaded on the website of CDSCO under the heading ‘Drug Alert’ along with actions initiated as per the provisions of the Drugs and Cosmetics Act, 1940, and rules thereunder, Nadda told Lok Sabha.

To strengthen the drug regulatory system in the country, the Ministry of Health and Family Welfare has implemented a centrally-sponsored scheme – Strengthening of States' Drug Regulatory System (SSDRS) – Nadda stated.

The scheme envisages upgrading the existing state laboratories, state drug control offices, and setting up new drug testing laboratories.

Under the scheme, funds totalling Rs 756 crore have been released to the states and UTs as part of the Central share, 17 new drug testing labs have been constructed, while 24 existing labs have been upgraded in various states and UTs, Nadda said. PTI PLB ARI