India says no problems found with cough syrup suspected in Gambia child deaths

The Gambian health ministry launched an investigation in July when the incident happened

India has told the World Health Organisation that cough syrup samples taken from Maiden Pharma comply with required standards. Reuters

India has said samples of cough syrup taken from a manufacturer blamed by the World Health Organisation for the deaths of 66 children in Gambia were found to be of “standard quality”.

The government began investigating Maiden Pharmaceuticals after the global health body issued an alert in October over four of the syrups produced by the Indian drug maker.

The WHO said the syrups led to the deaths and gave warnings that they could be linked to acute kidney injuries in the West African nation.

Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup were suspected to have been contaminated with diethylene glycol and ethylene glycol.

The chemicals are used in preparation of antifreeze, brake fluid, cigarettes, paints and some dyes, plastics, films and cosmetics.

But India's Minister of State for Chemicals and Fertilisers Bhagwanth Khuba informed the parliament on Thursday that samples of the drugs were found to be safe after an investigation.

“As per 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 EG,” Mr Khuba said in a written reply.

Authorities in India's Haryana state had ordered Maiden Pharmaceuticals to halt the production of cough medications, weeks after the WHO's alert following the Gambian Health Ministry’s investigation in July.

The warning against syrup paracetamol was issued on September 9, a month after investigators reported the death of at least 28 children aged five months to four years from acute renal failure.

The Drugs Controller General of India has also written a letter to Rogerio Gasper, director of Regulation and Prequalification saying that the WHO drew a “premature” link between the deaths of the children and cough syrups.

“It is clear that perhaps premature deduction was drawn … regarding the cause of death,” Dr Venugopal G Somani, the chief of DGCI, said in a statement. “Every subsequent alert or publication from the WHO only seems to be a reaffirmation of this deduction, without waiting for independent verification.”

He also said that the WHO’s statement has adversely affected the image of the Indian pharmaceutical products.

The South Asian nation is known as the “pharmacy of the world” in terms of its manufacturing volume worth $42 billion.

Africa is one of the top five destinations for the country's pharmaceutical exports.