DCA tightens noose on erring drug producers

Ambika Sharma

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Solan, June 7

Facing flak for cases of spurious and substandard drugs coming to fore in the state, the Drugs Control Administration (DCA) will now inspect such manufacturing premises every month.

In a bid to ensure quality drugs manufacturing in the state the Chief Secretary recently held a meeting with the officials of the DCA where he directed the agency to step up regulation. Directions were issued to enhance inspection in units found manufacturing spurious, adulterated and substandard drugs.

Monthly inspections

• Drugs Control Administration (DCA) will inspect such manufacturing premises every month
• The samples of about 20 units were found repeatedly figuring in the list of substandard drugs
• Such units now under the scanner of the DCA
• DCA has now directed the manufacturers to ensure their testing so that quality is assured

Category A offences, which pertain to manufacture of spurious and adulterated drugs, would attract additional regulation and their premises would be inspected every month. Samples would also be drawn to check the quality of drugs while such units would be annually reviewed according to the new directions.

Category B offences pertaining to serious defects which affect the quality of drugs owing to gross negligence or non-conformance to manufacturing norms will face quarterly inspections and drawing of samples. Such units will also be reviewed on an annual basis.

An analysis of monthly alerts issued by the CDSCO in 2023 revealed that of 76 drug samples from the state declared substandard this year, 51 either lacked assay content (active ingredient) or failed disintegration tests.

Though raw materials like active pharmaceutical ingredients and excipients fall under the regulation of the Drugs and Cosmetics, Act, there samples are rarely lifted for testing their quality. Use of substandard raw material hits the quality of drugs manufactured in the state.

The samples of about 20 pharmaceutical units were found repeatedly figuring in the list of substandard drugs issued by the apex drugs regulator CDSCO in 2022. Such units were now under the scanner of the DCA.

“The drug manufacturers have been directed to test every batch before their release and depute adequate staff vis-à-vis workload and the testing capacity of a unit. Mandatory adherence to Good Laboratory Practices has also been stressed apart from stepping up inspections for spurious, adulterated and substandard drugs,” informed Navneet Marwaha, State Drugs Controller.