Spurious drugs: Maiden Pharma blacklisted, all contracts cancelled

Bhartesh Singh Thakur

Chandigarh, March 23

Haryana has blacklisted Maiden Pharmaceuticals Ltd, based at Sonepat, for three years, thereby debarring the firm from participating in state tenders. All rate contracts issued to the firm have also been cancelled.

Public safety

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Though the HMSCL policy is to blacklist a firm only if more than three products fail quality tests, it decided to act in the case of Maiden Pharma in view of public safety and after receiving the CM’s approval.

Haryana Medical Services Corporation Ltd (HMSCL), which procures medicines for government hospitals and dispensaries, has taken action against the firm after its three different products failed the quality test.

Labs, empanelled by HMSCL, declared 21 batches of albendazole tablet (400 mg) as “not of standard quality”. It was The Tribune that broke the story of the quality failure of albendazole tablets on November 1 and November 26, 2022.

The testing also proved three batches of ibuprofen tablet (IP 400 mg) as “not of standard quality”. In the case of azithromycin suspension (40 mg/ml), 16 batches failed the test and were declared “not of standard quality”. These products were supplied against purchase orders in 2022 and 2023. Clause 12 (Liquidated damages and other penalties) of the terms and conditions of the rate contract says, “If more than three products of a firm are debarred/blacklisted, the firm will not be eligible to participate in the tendering process of Haryana for the next three years for any item.” In the blacklisting order, HMSCL MD Vivek Aggarwal pointed out that as per media reports, Maiden Pharmaceuticals had supplied cough syrups to the Gambia which led to the death of 66 children and the sample testing by the Gambia government showed excessive toxins which led to acute kidney injury and consequently deaths. The World Health Organization had issued an alert about the cough syrups too.

The order added that the firm had been a serial offender in quality control in the previous years. It pointed out that after investigation on the premises, the State Drug Controller, Haryana, had by an order dated October 11, 2022, stopped all its manufacturing activities. The Kerala Government had found five drug formulations while the Himachal Pradesh Government had found one drug formulation as ‘not of standard quality’, the order added.

The HMSCL MD said the Bihar Government had blacklisted the firm in 2011. Also, Central Drugs Standard Control Organization (CDSCO) received information from the Vietnam government regarding the blacklisting of Indian pharma companies, including Maiden Pharmaceuticals.

A Sonepat court had convicted two of the firm’s directors in the substandard ranitidine hydrochloride tablet case. HMSCL’s policy lays down the blacklisting of a firm for three years for all tenders if more than three products failed quality tests, but here three items were found to be ‘not of standard quality’. The performance bank guarantee of the firm has also been forfeited.