Gambian children’s death: Maiden Pharma’s cough syrups of standard quality, no contaminants found, says govt

The Indian government said four cough syrups manufactured and exported by Maiden Pharmaceuticals that allegedly caused the deaths of 66 children in The Gambia were tested and found to be of standard quality.

Control samples of the four cough syrups were analysed by the Regional Drug Testing Laboratory in Chandigarh, Bhagwanth Khuba, minister of state for chemicals and fertilisers, said in a written reply in the Rajya Sabha.

The samples of Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup were tested and also assessed for the presence of diethylene glycol (DEG) and ethylene glycol (EG).

Also read: Gambia Cough Syrup Deaths | Data received is inadequate to determine aetiology: DCGI tells WHO

Consumption of DEG and EG beyond a limit can cause symptoms including acute kidney failure and may be fatal, especially for children with low body weight.

“As per the report of the government analyst, the samples have been declared to be of standard quality. The said samples were also found negative for both diethylene glycol and ethylene glycol,” Khuba said.

Vivek Goyal, director of Sonipat-based Maiden Pharmaceuticals, welcomed the government test lab reports and said that the drugs produced by his company weren’t adulterated.

“We are happy to hear this. We always said that there was no problem in the drugs produced by Maiden Pharma,” Goyal told Moneycontrol.

Not sold in India

The government’s reply was to a question by Rajya Sabha Congress lawmaker Jebi Mather Hisham on measures to ensure safety, quality, and standards in pharma manufacturing. Hisham asked if the government had double-checked that the cough syrups were not sold in India.

The minister said in his reply the four drugs weren’t licensed for manufacture and sale in India and that they weren’t marketed or distributed in India. The death of the children in The Gambia didn’t impact India’s pharma business in the international market, the government informed parliament.

Also read: Post-Gambia deaths, CDSCO and state regulators start testing cough syrups sold in market

“There have been reports, both in domestic and international media, on the incident. There is no observable impact on Indian pharma exports in the past few months that can be attributed to this incident,” Khuba added.

The Centre had set up a committee chaired by YK Gupta, vice chairperson of the standing national committee on medicines, and comprising Pragya D Yadav from the National Institute of Virology, Arti Bahl from the division of epidemiology at the National Centre for Disease Control, and AK Pradhan, joint drugs controller of India, Central Drugs Standard Control Organisation (CDSCO), to examine the issue.

The government has updated the World Health Organization, which said on October 5 that lab analysis of the four cough syrups confirmed they contained unacceptable amounts of DEG and EG as contaminants.

“We have written to the WHO as well as the Gambian authorities on a case-wise status update on the children’s deaths. We are still awaiting a reply from them,” an official of the committee told Moneycontrol.

Maiden Pharmaceuticals was asked to stop all manufacturing at its Sonipat plant in October after the Haryana drug authorities and CDSCO officials found several flaws at the facility during a joint inspection. A show-cause notice issued to the company reviewed by Moneycontrol highlighted several discrepancies linked to manufacturing and product permissions for the four pediatric cough syrups.