DCGI asks WHO for more data on causality assessment of cough syrup deaths
The DCGI also asked the WHO to provide more details on autopsy reports of the children, samples of stools and biological samples from all children who presented with symptoms.
World Health Organisation’s claims of Maiden Pharma-manufactured cough syrup causing the deaths of 69 children in west Africa’s The Gambia was “inadequate to determine aetiology”, the Drugs Controller General of India (DCGI) said in a letter to WHO on Saturday.
Aetiology is the scientific study of the causes of disease or death.
In the letter, DCGI Dr VG Somani said that the Union ministry of health and family welfare’s committee of technical experts — formed on Thursday to examine and analyse the details of the report shared by WHO —in its first meeting concluded that the clinical features and treatment received by the children as shared by the WHO so far were inadequate to determine the aetiology.
“The details of illness, sign and symptoms, duration of anuria in the cases, results of laboratory investigations conducted including various markers and parameters, specific investigations for DEG (diethylene glycol) and EG (ethylene glycol) on clinical samples of the patients, treatment received before and after hospitalisation at the tertiary hospital in (The) Gambia, treatment received before and after AKI was suspected and reasons thereof, the names and brands of the drug formulations used in the treatment before and after hospitalisation, their manufacturers, their expiry and any other relevant information in each of the cases, are necessary,” read the letter.
The DCGI also asked the WHO to provide more details on autopsy reports of the children, samples of stools and biological samples from all children who presented with symptoms. Details of the test method adopted for testing samples were also requested in the letter.
WHO, in its briefing on October 5, issued a medical product alert over four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured and exported by Maiden Pharmaceuticals.
After the UN body’s alert potentially linking the medicines with acute kidney injuries among children that possibly led to 66 deaths in the west African country, the health ministry issued a statement that the central drugs regulator was investigating the matter in collaboration with the state regulator.
The WHO said in its 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.
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.
