Gambia deaths: Maiden Pharmaceuticals told to halt drug production, Centre forms expert panel

Updated on Oct 13, 2022 04:38 AM IST

The halting of drugs manufacturing was directed through a joint order issued by the central and state drugs regulators. HT has seen a copy of the order.

A health department team at Maiden Pharmaceuticals Ltd unit in Sonepat on Thursday. (PTI)
A health department team at Maiden Pharmaceuticals Ltd unit in Sonepat on Thursday. (PTI)
ByRhythma Kaul and Hitender Rao, New Delhi

All drug production at the Sonepat unit of Maiden Pharmaceuticals has been halted, even as the Centre on Wednesday set up a four-member committee to investigate allegations that the firm used contaminated raw materials to manufacture four cough syrups that potentially led to the deaths of 66 children in The Gambia, people aware of the matter said.

Authorities in Haryana have issued a show-cause notice to the company to explain within a week “many contraventions” found during a recent joint inspection by central and state drugs regulators, as reported by HT on Wednesday.

The halting of drugs manufacturing was directed through a joint order issued by the central and state drugs regulators. HT has seen a copy of the order.

“During the investigations as per Drugs and Cosmetics Act and Rules thereunder, it is observed that the firm has been manufacturing and testing drugs without adhering to and in contravention of the various GMP (Good Manufacturing Practice) requirements of Schedule M and Schedule U of the Drugs Rules. The firm has not maintained and not produced complete records of manufacturing and testing as per rules,” the order said.

The World Health Organization (WHO) said in a recent alert that two toxic contaminants, diethylene glycol and ethylene glycol, were found in four cough syrups manufactured and exported by the Delhi-headquartered firm to the West African nation.

“In view of the seriousness of the contraventions observed during the investigation and its potential risk to the quality, safety and efficacy of the drugs being produced, all the manufacturing activities of the firm is being stopped with immediate effect,” the order, dated October 11, said.

Haryana health minister Anil Vij said that the authorities in the state ordered “that all drug production of this unit be stopped with immediate effect”.

A central technical committee, chaired by Dr YK Gupta, vice chairperson, standing national committee on medicines, and comprising Dr Pragya D Yadav from the National Institute of Virology, Dr Arti Bahl, division of epidemiology, National Centre for Disease Control, and AK Pradhan, joint drugs controller of India, Central Drugs Standard Control Organisation (CDSCO) will examine the issue, the health ministry said on Wednesday.

“The committee will, after examining and analysing, adverse event reports, causal relationship and all related details shared by WHO, suitably advise and recommend the Drugs Controller General of India about further course of action. The committee may co-opt any other technical experts as deemed necessary,” a senior government official said, asking not to be named. “WHO has not yet made available certificate of analysis. It has informed us that the same will be made available in near future. The exact one-to-one causal relation of death has not yet been provided by WHO to CDSCO, though CDSCO has requested WHO twice,” the official added.

An analysis of the show-cause notice issued to the pharma company on October 7 showed that discrepancies linked to manufacturing and product permissions for the four pediatric cough syrups were found during a joint inspection of the manufacturing facility by the Haryana drug authorities and officials of the Central Drugs Standard Control Organisation (CDSCO).

They pertained to date of manufacturing as per product label, date of manufacturing as per batch manufacturing record (BMR) and product permission.

All the four syrups under investigation have drug product labels mentioning the manufacturing date as December 2021, whereas the commencement dates in BMR and date of completion of manufacturing are of 2022, according to the notice.

WHO issued a medical product alert last Wednesday over four medicines – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – made by Maiden Pharmaceuticals.

After the UN body’s alert potentially linking the medicines with acute kidney injuries among children, the Union health ministry issued a statement that the central drugs regulator was investigating the matter in collaboration with the state regulator.

“The results of tests on the cough syrups are awaited,” another senior official aware of the matter said, asking not to be named. “A lot will depend on what WHO shares as it is important to establish the causal relationship,” the official added.

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