UP News: FDA, Central Team Conduct Risk-Based Inspections Of Cough Syrup Manufacturers Following Child Deaths

A joint team from the Food and Drug Administration (FDA) and the central government has begun inspecting cough syrup manufacturing companies to ensure compliance with drug safety standards. The inspections will assess manufacturing records, product returns, past inspections, and quality testing, with a focus on high-risk drugs as per guidelines issued by the Central Drugs Standard Control Organisation (CDSCO).

Following reports of child deaths linked to cough syrup, inspections have already been carried out in six states. Drug Controller Shashi Mohan stated that a surprise inspection was conducted at Omni Pharma in Hapur, where samples were collected and sent to the central laboratory for testing. Documents related to the company’s drug manufacturing practices were also obtained.

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If any violations of standards are found, authorities may initiate proceedings, including issuing a show-cause notice, halting production, or cancelling the company’s licence. The risk-based inspections examine production methods, product quality standards, and drug supply chain records.

In the state, inspections were triggered after child deaths in Madhya Pradesh and Rajasthan. A total of 17 cough syrup manufacturing companies were identified, four of which had stopped production without informing the FDA. For companies still manufacturing cough syrup, samples of raw materials and finished products have been collected, totalling 913 samples from both pharmacies and manufacturing units. So far, test reports for 63 samples have shown no irregularities.

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Authorities have stated that inspections of other manufacturing units will continue under the same guidelines to ensure public safety.