Medicine maker Maiden Pharmaceuticals on Friday said it would seek permission to reopen its factory in Sonepat after India’s drug regulator found no contaminating chemicals in the four cough syrups linked to the deaths of 66 children in The Gambia, reported Reuters.
“I have full faith in Indian regulatory and judiciary processes,” Maiden Pharmaceuticals Managing Director Naresh Kumar Goyal told the news agency. “I have not done anything wrong. We will now try to request the authorities to reopen the factory. But I don’t know when that will happen. We are still waiting.”
On December 13, Drugs Controller General of India VG Somani wrote to Rogerio Gaspar, director (regulation and prequalification) at the World Health Organization saying that the samples of the cough syrups tested in government laboratory were found to be complying with specifications. Test reports also showed that the syrups were not contaminated with diethylene glycol or ethylene glycol.
The development came two months after the World Heath Organization, in October, issued a global alert for the cough syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – manufactured by Maiden Pharmaceuticals.
Authorities in the West African country had linked death of 66 children, most of them due to acute kidney failure, to these medicines.
The world health body had said that its laboratory analysis of the syrups confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
Soon after the alert issued in October, the Haryana government had suspended drug manufacturing at Maiden Pharmaceuticals’ Sonipat unit. The central and state drug departments had conducted a joint inspection and found 12 flaws in the medicines and their manufacturing process.
In its letter to the World Heath Organization on Tuesday, India said that it had sought details from the WHO about the causality relationship between drugs manufactured in India and the deaths in The Gambia but no information has been exchanged so far.
India’s drug controller also told the health body that its accusations had “adversely impacted the image of India’s pharmaceutical products across the globe, and caused irreparable damage to the supply chain of pharmaceutical products.”
However, on Friday Union Minister of State for Health and Family Welfare Bharati Pravin Pawar told the parliament that Maiden’s manufacturing operations will remain shut for now due to other violations, reported Reuters.
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