NEW DELHI: The Central Drugs Standard Control Organisation (CDSCO) has started conducting a joint inspection of identified drug manufacturing units along with State Drugs Control Administrations in a risk-based approach, the Union Health Ministry said on Tuesday.
The move comes a month after a detailed inspection at the drug manufacturing unit of Maiden Pharmaceuticals in Haryana found several violations of Good Manufacturing Practices (GMP).
Maiden Pharmaceuticals, which has two manufacturing units in Sonepat, Haryana, was named by the World Health Organisation (WHO) as a supplier of four contaminated cough syrups that allegedly killed nearly 70 children in Gambia. The WHO raised a global alert in October concerning the company’s four cough syrups and said they are "potentially linked with acute kidney injuries" and deaths among children.
According to the Union Health Ministry, joint inspections are being conducted all over the country as per the standard operating procedures. A committee of two common drugs controllers has been set up at CDSCO to monitor the process of inspection, reporting and subsequent action to ensure compliance with the Drugs and Cosmetics Act 1940 and its rules.
"This will ensure high standards of quality compliance concerning drugs manufactured in the country, " said the ministry in a statement.
The step was taken under the direction of Union Minister of Health and Family Welfare and Chemicals and Fertilizers, Dr Mansukh Mandaviya.
An action plan for nationwide inspection of manufacturing units identified to be at risk of manufacturing Not of Standard Quality (NSQ)/adulterated/spurious drugs was made before carrying out assessments. The ministry, however, did not name the manufacturing units identified for the inspection.
"The objective of drug regulation is to ensure the safety, efficacy and quality of the drugs available in the country. The drug control administration must ensure that manufacturing units comply with the Drugs & Cosmetics Act, 1940 and Rules thereunder, especially to the requirements of Good Manufacturing Practices (GMP), " the statement further added.