Spurious drugs: Apex drug regulator, state regulators start joint inspection of firms
Aditi Tandon
New Delhi, December 27
The Central Drugs Standard Control Organisation (CDSCO) has started conducting joint inspection of identified drug manufacturing units along with state drugs control administration as per risk-based approach close on the heels of the WHO global alert with respect to products manufactured by Sonepat-based Maiden Pharma.
The joint inspections are being conducted all over the country as per the standard operating procedures.
“A committee of two Joint Drugs Controllers has been constituted at CDSCO headquarters to monitor the process of inspection, reporting and subsequent action so as to ensure compliance to the Drugs and Cosmetics Act, 1940, and Rules thereunder. This will ensure high standards of quality compliance with respect to drugs manufactured in the country,” the government said.
An action plan for nation-wide inspection of manufacturing units which are identified to be at the risk of manufacturing (Not of Standard Quality/adulterated/spurious drugs) was made prior to carrying out inspections.
“The objective of drug regulation is to ensure safety, efficacy and quality of the drugs available in the country. The drug control administration is required to ensure that manufacturing units comply with Drugs and Cosmetics Act, 1940, and Rules thereunder especially to the requirements of good manufacturing practices,” the officials said.
