Test Maiden Pharma’s albendazole samples at Kolkata lab: Haryana court

Bhartesh Singh Thakur

Chandigarh, September 2

A Sonepat court has ordered testing of 19 samples of albendazole tablets, manufactured by Maiden Pharmaceuticals, at the Central Drugs Laboratory (CDL), Kolkata.

During a recent hearing, Sonepat Chief Judicial Magistrate Arvind Kumar allowed the application of Drugs Control Officer, Sonepat, Sandeep Hooda, moved under Section 25 (4) of the Drugs and Cosmetics Act, 1940, in this regard.

Tablets failed quality check

• Samples of albendazole tablets, manufactured by Maiden Pharma, were found of “not of standard quality” by HMSCL-empanelled laboratories last year
• With the government lab not having the facility to carry out the ‘dissolution test’, the court was approached to test the samples at the CDL, Kolkata

Under Section 25 (4), the test report signed by or under the authority of the CDL director, is the “conclusive evidence of the facts stated therein”.

All 19 samples were put in a box that was sealed before being sent to the CDL.

On May 17, Haryana Medical Services Corporation Limited (HMSCL) barred Maiden Pharmaceuticals, Sonepat, for three years from participation in tenders of the state for albendazole 400-mg tablet. The action was taken as samples from 21 batches of albendazole tablets, given for parasitic worm infections, were found of “not of standard quality” by laboratories empanelled by the HMSCL. All 21 samples did not comply with the “dissolution test parameter of Indian Pharmacopoeia-2018 and addendum 2019”.

The Tribune had broken stories on November 1, 2022, and November 26, 2022, about albendazole failing the quality check. Soon after the results of the HMSCL-empanelled laboratory came, the State Drug Controller, Haryana, took the samples for testing at a state government lab as required under the Drugs and Cosmetics Act. However, the lab didn’t have the facility to carry out the dissolution test. So, it approached the court to test the samples at the CDL, Kolkata.

On July 15, 2022, the HMSCL had placed the order for albendazole tablets for supplying it to government hospitals and dispensaries.

The firm is also linked to four syrups that contained “unacceptable amounts of diethylene glycol and ethylene glycol” as contaminants in WHO labs in October 2022. These allegedly led to the death of 70 children in the Gambia. However, testing of control samples by the Central Drugs Standard Control Organisation didn’t find the syrups contaminated. But for violation of good manufacturing practices, all manufacturing activities of the firm were stopped.