Suspend manufacturing at Maiden Pharmaceuticals Limited, orders Haryana Government

Geetanjali Gayatri

Chandigarh, October 11

In consultation with the Centre, the Haryana Government has decided to proceed against Sonepat’s Maiden Pharmaceuticals Limited and immediately suspend the manufacturing of drugs by the company.

The action comes after a joint team of the Centre and state found violations at the pharma unit during an inspection. While an order issued by the Health Department states that “necessary action” should be taken under the provisions of the Drugs and Cosmetics Act, sources said that after suspending operations, the unit was likely to be sealed and its licence cancelled or suspended.

Meanwhile, the test report of the samples collected from the unit and sent to the Central Drug Laboratory, Kolkata, was awaited.

Today’s action comes after a show-cause notice was issued to the pharma unit last week following a joint inspection team of the Central Drug Standard Control Organisation (CDSCO) and the Haryana Food and Drug Administration, which found a number of irregularities in the unit’s funtioning.

Sources said while the Health Ministry was monitoring the entire development in the case, Haryana Health Minister Anil Vij was overseeing the entire investigation in the state. The sources confirmed that action against the unit had been finalised at a high-level meeting this evening.

During the inspection regarding the cough syrup, the team found that the firm “had not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol”. The latter make the solvent toxic and it can be fatal when consumed.

The batch No., manufacturer name, manufacturing date and expiry date were found to be not maintained on the purchase invoices of the excipients, including propylene glycol.

While the plant was found to be under renovation, the pharma unit could not produce the proof of the testing of the raw material and its formulation. It was also pointed out in the inspection report that propylene glycol, with manufacturing date of September 2021 and expiry date of September 2023, was used in the four syrups in question, but their expiry date had been mentioned as November 2024.

The alleged “contamination” of the cough syrup formulated by the unit came to light after the WHO flagged the death of 66 children in The Gambia after its consumption.

Many irregularities, says inspection team

The action comes after a show-cause notice was issued to the pharma unit last week following a joint inspection team of the Central Drug Standard Control Organisation (CDSCO) and the Haryana Food and Drug Administration, which found a number of irregularities in the unit’s functioning.