After a preliminary inquiry, the Central Drugs Standard Control Organisation (CDSCO) found on Thursday that the four cough syrups made by Maiden Pharmaceuticals, suspected to have caused the death of children in the Gambia, were exported only to the West African nation.
The World Health Organization (WHO) issued a warning on Wednesday.
“The Haryana-based manufacturer is licensed by the State Drug Controller to make the products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup for export only,” the Health Ministry said.
Controlled samples of the same batch manufactured by Maiden Pharmaceuticals have been taken and sent for testing to the Regional Drug Testing Lab, Chandigarh by the CDSCO, the Ministry said. The results will guide the further course of action and bring clarity on the WHO inputs. The CDSCO has requested the WHO to share at the earliest the report on establishment of the causal relation to death with the medical products in question, the Ministry added.
By the tentative results received by the WHO, four of the 23 samples tested have been found to contain diethylene glycol and ethylene glycol.
The All India Organisation of Chemists and Distributors (AIOCD) said none of the four syrups was available for sale in India. The group said it had assured the Drug Controller of India that in case these drugs were in the Indian market, their supply would be halted immediately.
The Union government will look at where else these medicines have been exported.
Despite multiple attempts by The Hindu, there was no response from the manufacturers.
“Maiden Pharmaceutical Limited has no presence in the Indian domestic market and they only export their products,” said Rajeev Singhal, general secretary, AIOCD. Mr. Singhal said Indian distributors had been alerted on Thursday to the adverse effect of the drug “and have been cautioned against any possible availability or distribution of these in any part of the country”.
The WHO mentioned that the syrups might have been distributed elsewhere and through informal markets.
“Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the WHO said in a medical product alert. The ingredients can cause abdominal pain, vomiting, diarrhoea, headache and severe renal injury, it added.
Pawan Kumar, paediatrician, Madhukar Rainbow Children’s Hospital, New Delhi, said diethylene glycol was used as an illegal adulterant in medications and could result in renal and neurological toxicity.
“Because of its toxicity, it is not allowed in food or drugs. But because of its solubility, some drug makers have inappropriately substituted it for non-toxic ingredients such as glycerine in pharmaceuticals such as cough syrups and acetaminophen. Acute kidney failure is the number one cause of death in poisoning cases, and it starts between eight and 24 hours after exposure to lethal doses of substance. If people don’t get treatment, symptoms progress to multi-organ failure in two to seven days,” he said.
