New Delhi: In a major development, the Central Drugs Standard Control Organisation (CDSCO) and State Drugs Control Administration started a joint inspection of all drug manufacturing units across the country. The initiative was taken to ensure the safety, efficacy and quality of the drugs available in the country said officials.
The development took place after Union Minister for Health and Family Welfare and Chemical and Fertilizer Mansukh Mandaviya asked to conduct a joint inspection of identified drug manufacturing units as per a risk-based approach. The joint inspection is being conducted all over the country as per the Standard Operating Procedures (SOP).
A committee of two joint drugs controllers has been constituted at CDSCO headquarters to monitor the process of inspection, reporting, and subsequent action to ensure compliance with the Drugs and Cosmetics Act, of 1940 and the Rules there under. "This will ensure a high standard of quality compliance concerning drugs manufactured in the country," a senior government official said.
An action plan for nationwide inspection of manufacturing units, which are identified to be at risk of manufacturing Not of Standard Quality (NSQ), adulterated, spurious drugs, was made before carrying out the inspections. The drug control administration is required to ensure that manufacturing units comply with the Drugs and Cosmetics Act, of 1940 and the Rules there, especially to the requirements of Good Manufacturing Practices (GMP).
The action was taken weeks after a major controversy erupted following India-made cough syrup, locally produced by Maiden Pharmaceuticals was found to be linked to the death of 66 children in Gambia. However, following an examination of the syrup, India informed the WHO that the syrup was of standard quality.
