The Central Drugs Standard Control Organisation (CDSCO) has reported that five batches of cough and allergic rhinitis syrups from two Indian manufacturers have been found to contain higher than permissible levels of diethylene glycol and ethylene glycol.
Out of a total of 1,166 samples tested in August, 48 drugs were declared as “not of standard quality” and “spurious” by the CDSCO.
Samples from a batch of cough syrup and another batch of anti-allergy syrup manufactured by Gujarat-based Norris Medicines Limited were found to be not of standard quality, containing 0.118 percent ethylene glycol and 0.171 percent ethylene glycol and 0.243 percent diethylene glycol, respectively. Norris Medicines Ltd was asked to suspend production at its Ankleshwar plant a month ago.
Samples from three batches of COLD OUT syrup, manufactured by Tamil Nadu-based Fourrts (India) Laboratories, were also found to have both contaminants — ethylene glycol at 1.9 percent and diethylene glycol at 0.14 percent. The safe limit for these contaminants, based on internationally accepted standards, is no more than 0.10 percent.
In August, the World Health Organization (WHO) raised an alert over a batch of contaminated COLD OUT cough syrup supplied in Iraq and manufactured by the same company.
H G Koshia, Commissioner of Gujarat’s Foods and Drug Control Administration (FDCA), stated that central and state government agencies have been on a mission for the last three months to ensure that India’s reputation in the pharmaceutical sector is not tarnished on the world stage due to some companies. A team from the FDCA had inspected the plant in Ankleshwar and found several critical and major compliance issues, leading to the suspension of production. The company will be allowed to restart production only after complying with FDCA norms.
According to a CDSCO report, out of 1,166 samples tested, 48 were found “not of standard quality” and spurious. This marks the first time in at least two years that CDSCO has flagged diethylene glycol and ethylene glycol contamination in its monthly reports, as India attempts to crack down on its $42 billion drug industry dominated by small players.
The alerts regarding toxic medicines come as the government organizes workshops for drugmakers across the country to emphasize the importance of drug quality and patient safety through pharmexcil.
The CDSCO list also mentioned a glycerine batch made by Adani Wilmar, despite it containing 0.025% ethylene glycol, within the WHO safety limit.
Indian pharmaceutical executives and regulators have reported that some manufacturers in the country commonly substitute cheaper, commercial-grade ingredients when making cough syrups. The WHO has previously flagged 20 such products by 15 different manufacturers, originating from India and Indonesia.