The Central Drugs Standard Control Organisation (CDSCO) along with State Drugs Controllers (SDCs) have conducted Risk-Based Inspections.
NEW DELHI: The Centre on Tuesday said India’s drug regulator has conducted risk-based inspections in over 1,000 premises since December, 2022, following which strict action has been taken against erring pharma companies, including suspension and cancellation of licenses.
In a written reply in the Rajya Sabha, Minister of State for Health and Family Welfare, Anupriya Patel, said that more than 1,100 cough syrup manufacturers have been subjected to intense audit in coordination with state authorities.
“Increased market surveillance sampling of syrup formulations by central and state drugs regulators has also been done,” she added.
“The Central Drugs Standard Control Organisation (CDSCO) along with State Drugs Controllers (SDCs) have conducted Risk-Based Inspections beyond inspections of more than 1040 premises since December, 2022,” she said.
She added that based on the findings, more than 950 actions like issuance of show cause notices, stop production orders, suspension, cancellation of licenses /product licenses, and warning letters have been taken by the state licensing authorities.
Patel said the manufacture, sale and distribution of drugs are primarily regulated in the country under the provisions of the Drugs and Cosmetics Act, 1940 and Rules thereunder through a system of licensing and inspection by State Licensing Authorities (SLAs) appointed by respective state governments.
As per the provisions of the Drugs Rules, 1945, drug manufacturing premises are inspected periodically to verify compliance with the requirements of Good Manufacturing Practices (GMP) prescribed under Schedule M.
“Further, with respect to the number of non-compliant units and action taken in each case, CDSCO zonal offices forward the inspection report along with recommendations to the concerned SLA, who are legally empowered to take actions like issuance of show-cause notices, stop-production orders, suspension, cancellation of licenses /product licenses, warning letters, including launching of prosecution in an appropriate Court of law,” she added.
