Indian-manufactured cough syrups have come under the scanner for the second time, with the Uzbekistan ministry linking the death of 18 children to excessive doses of Doc-1 Max cough syrup. The ministry alleged that the children had consumed excessive amounts of the syrup manufactured by the Noida-based pharmaceutical company Marion Biotech.
The administered drug was found to contain unacceptably high levels of ethylene glycol, a toxic contaminant. Prior to the Uzbekistan ministry's announcement, the deaths of about seventy children in Gambia were linked to the cough syrups manufactured by a Haryana-based Pharmaceuticals. With repeated such incidents being reported from other countries, the Indian medicine manufacturing unit's credibility has been put into question.
Dosage Administered Above Standard Limit
Initial lab investigations of the drug pointed toward high levels of ethylene glycol, a toxic contaminant that can prove fatal if consumed in high amounts. Based on further investigation, the ministry claimed that before being hospitalised, the children were given the syrup for about seven days in doses of 2.5 to 5 ml three to four times a day, which goes beyond the standard dosage. The parents administered the syrup as an anti-cold remedy on their own whim or upon the advice of local pharmacists.
After the reported deaths of 18 children, Uzbekistan withdrew all tablets and syrups of Doc-1 Max from sales across the pharmacies in the country. This is the second case that has linked children mortality with Indian-manufactured cough syrups.
The Uzbekistan health authorities have initiated a probe and have sacked seven employees who failed to analyse the situation in time to take necessary steps.
Indian Pharmaceuticals Under Radar
After the incident, the Indian drug regulator board looked into the issue and maintained that no contaminants were found in the control samples of the drugs in question. The Health Ministry in India stated that the samples from Maiden Pharma premises were those taken before the firm was closed for violating manufacturing practices.
According to their statement, 18 of 21 children suffering from acute respiratory disorder had consumed very high doses of Doc 1 Max syrup, which contains paracetamol. A report by the Tribune India quoted the ministry stating, "Since the syrup contains paracetamol, parents mistook it for an anti-cold drug and administered it to children three to four times a day for two to seven days, exceeding the standard dose for children."
A joint inquiry is in talks to be conducted by the teams of the Central Drugs Standard Control Organisation (CDSCO - north zone) and Uttar Pradesh Drugs Controlling and Licensing Authority to understand the issue better and send across a response.