EXCLUSIVE: Maiden Pharma puts the ball in Indian govt's court; says will recall products when govt orders

The Indian drug regulator Drugs Controller General of India (DCGI) has asked the World Health Organization (WHO) to provide the exact “certificate of analysis” on the basis of which it has linked the deaths of at least 66 children in Gambia to consumption of cold and cough syrups exported by the Indian firm Maiden Pharmaceuticals. Caught in the eye of a storm, the Delhi-based pharma major, for the time being, is waiting for instructions from the Indian government for further action and has indicated that it may recall the products following the government directions.

“We have not received any information or directions from the Indian authorities. We are waiting for the analysis results from the Indian government. We will take further actions accordingly. No death reported in WHO report. It’s our defamation without any cause,” Vivek Goyal, director, Maiden Pharmaceuticals, told BT.

Sources in DCGI have also told BT that it has asked the apex global public health body to share at the earliest with Central Drugs Standard Control Organisation (CDSCO) the report which establishes the causal relation between the children's death with the medical products in question, photographs of labels/ products, etc., which, the Indian government affirmed, is still awaited.

Because the drug in question was manufactured at Maiden's facility in Sonepat in Haryana, after intimation, the Indian government launched a detailed investigation into the matter, in collaboration with Haryana's state drugs controller, which is the concerned state drug control authority.

“From the preliminary enquiry, it has been made out that Maiden Pharmaceutical Limited, Sonepat, Haryana is a manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products. The company has manufactured and exported these products only to Gambia so far,” an official source, on the condition of anonymity, told BT.

“It is a practice that the importing country tests these products on quality parameters, and satisfies itself as to the quality of the products before their release for usage in the country,” added the source.

According to Maiden Pharmaceuticals' website, it is a WHO-good manufacturing practices (GMP) and ISO 9001-2015 certified pharma company, which started its operations November 22, 1990. The company has two manufacturing plants, one based in Kundli in Haryana and the other in Panipat, in Haryana. The company's corporate office is at Netaji Subhash Place, Pitampura, Delhi.

The company has two directors -- Naresh Kumar Goyal and Vivek Goyal -- and it manufactures capsule, injectables, liquid syrup, ointments and tablets. Apart from domestically supplying its products to the local markets, the company also exports the products to majorly developing or under-developed countries in Asia, Africa and Latin America. Maiden Pharma has total revenue of Rs 38.95 crore and net profit of Rs 5.82 lakh for FY21.
 
The WHO on September 29 informed the DCGI, the national drug regulator of India, that it is currently providing technical assistance and advice to Gambia, where the significant contributing factor leading to the death of children was suspected to be the use of medicines which may have been contaminated with diethylene glycol or ethylene glycol. On Wednesday, the global health body said that the deaths in Gambia could be linked to contaminated cough and cold syrups which were manufactured by Maiden.

The official source said that as per the tentative results received by WHO, out of the 23 samples tested, 4 samples have been found to contain diethylene glycol/ ethylene glycol, as indicated.  “It has also been informed by WHO that the certificate of analysis will be made available to WHO in near future and WHO will share it with India. At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of Labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products,” said the government official.

The WHO on Wednesday in a medical product alert said, "The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products."

Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions, said the WHO advising, if someone has these substandard products, they should not use them.

Also read: Toxic cough syrup probe: Haryana drug controller takes samples of medicines exported to Gambia

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