Drug standard watchdog inspects ‘suspicious’ manufacturing units across India

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The Central Drugs Standard Control Organisation (CDSCO) has started conducting joint inspection of identified drug manufacturing units along with state drugs control administrations in a risk-based approach, Union health ministry said today.

The joint inspections are being conducted all over the country as per the standard operating procedures and a committee of two joint drugs controllers has been set up at CDSCO to monitor the process of inspection, reporting and subsequent action so as to ensure compliance to the Drugs and Cosmetics Act, 1940 and its rules.

“This will ensure high standards of quality compliance with respect to drugs manufactured in the country,” said the ministry.

An action plan for a nationwide inspection of manufacturing units which are identified to be at the risk of manufacturing Not of Standard Quality (NSQ), adulterated or spurious drugs was made prior to carrying out of inspections.

The move comes about a month after detailed inspection at the drug manufacturing unit of Maiden Pharmaceuticals in Haryana was found to have several violations in the Good Manufacturing Practices (GMP). This drugmaker was named by the World Health Organisation as a supplier of four contaminated cough syrups that purportedly killed nearly 70 kids in Gambia.

The Indian government, however, recently said that it had not found any contamination in the batches of the drugs supplied to Gambia and dismissed concerns expressed by the WHO as “unfounded” in the absence of a causal assessment report.

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The objective of drug regulation is to ensure safety, efficacy and quality of the drugs available in the country, said the government, adding that the drug control administration is required to ensure that manufacturing units comply with the D&C Act its rules especially to the requirements of GMP.