|
The Central Drugs Standard Control Organisation (CDSCO), along with the State Drug Controllers have taken more than 860 actions based on the risk-based inspections conducted in more than 960 premises since December, 2022, according to the Union Ministry of Health and Family Welfare.
As a part of quality monitoring and in order to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO, in collaboration with state regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022.
"Firms have been identified based on risk criteria like number of drugs declared as not of standard quality, complaints, criticality of the products etc," said Union Minister of State for Health and Family Welfare, Anupriya Patel, in a written reply in the Rajya Sabha.
"As of now, CDSCO along with SDCs have conducted risk-based inspections of more than 960 premises since December, 2022 and based on findings, more than 860 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses, warning letters have been taken by the States/UTs as per the provisions of the Drugs Rules 1945," she said.
Also, more than 1100 cough syrup manufacturers and 380 blood centres have been subjected to intense audits in coordination with State authorities. Increased market surveillance sampling of syrup formulations by Central and State drugs regulators has also been done.
The drug regulators across the country have tested nearly five lakh samples in five years, to ensure safe medicines.
According to the data from the Ministry, a total of 1,16,232 drug samples were tested in 2024-25, of which 3,104 samples were declared as Not of Standard Quality (NSQ), while 245 were declared as spurious or adulterated. This is compared to 1,06,150 samples tested in 2023-24, of which 2,988 samples were declared as NSQs, and 282 samples as spurious or adulterated.
The results for 2024-25 marks a growth from 84,874 samples tested in 2020-21, almost five years back, out of which 2,652 samples were declared as NSQs and 263 as spurious or adulterated.
In order to strengthen the drug testing infrastructure and enhance laboratory capacity across the country, the Ministry of Health and Family Welfare has implemented a Centrally Sponsored Scheme 'Strengthening of States’ Drug Regulatory System (SSDRS). The scheme envisages upgrading existing State laboratories, setting up of new drug testing laboratories and upgradation of existing State drug control offices in the country.
Under the SSDRS Scheme, funds totalling Rs. 756 Crore has been released to States/UTs as part of the Central Share and 19 New Drug Testing Labs have been constructed and 28 existing labs have been up-graded in various States/UTs, said the Minister.
Further, Food Safety Standard Authority of India (FSSAI) and its regional offices through the State/UT Food Safety Departments, carry out regular surveillance, monitoring, inspections, and random sampling of food to ensure compliance with the quality & safety standards established under the Food Safety and Standards Act (FSS), 2006, and the Rules and Regulations made thereunder, she added.
|