The Central Drugs Standard Control Organisation (CDSCO) has revealed that at least five batches of syrups, for cough and allergic rhinitis, from two Indian manufacturers have been found to contain contaminants.
The apex body in its report stated that the samples had higher than permissible levels of diethylene glycol and ethylene glycol, Indian Express reported.
According to a report by news agency PTI, these are among 48 drugs, samples of which were declared as “not of standard quality” and “spurious” by the Central Drugs Standard Control Organisation (CDSCO), out of a total of 1,166 samples tested in August.
It is noteworthy that 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, an official said, as quoted by PTI.
Samples from three batches of COLD OUT syrup having paracetamol, phenylephrine, and chlorpheniramine and used for relieving nasal congestion, runny nose and fever, etc., manufactured by Tamil Nadu-based Fourrts (India) Laboratories, were also found to have both the contaminants — ethylene glycol 1.9 per cent and diethylene glycol 0.14 per cent.
WHO maintains that the safe limit, based on internationally accepted standards, is no more than 0.10%.
In August this year, the World Health Organization (WHO) had 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), said, as quoted by PTI, Norris Medicines Ltd. was asked to suspend production at its Ankleshwar plant a month ago.
He said central and state government agencies have been on a mission for the last three months to ensure that India’s name in the pharma sector does not get tarnished on the world stage because of some companies, as per PTI.
According to Koshia, a team of the FDCA had inspected the plant in Ankleshwar industrial area of Bharuch district and found several critical and major compliance issues, which could lead to health issues among the public.
“Thus, we issued a show-cause notice and ordered the company to stop the production with immediate effect a month ago. The plant is still not functional,” Koshia said.
He added that the company will be given permission to restart production only after it complies with the norms as prescribed by the FDCA.
According to a CDSCO report, 1,166 samples were tested at various statutory laboratories authorised by it, of which 48 were found “not of standard quality” and spurious.
A report by news agency Reuters reveal that this is the first time in at least two years that the Central Drugs Standard Control Organisation (CDSCO) has flagged any DEG and EG contamination in its monthly reports as the country tries to crack down on its $42 billion drug industry dominated by small players.
The alerts on the toxic medicines come at a time when the government, through pharmexcil, is organising workshops for drugmakers across the country to stress the importance of drug quality and patient safety.
The CDSCO list also named a glycerine batch made by Adani Wilmar, despite it containing 0.025% EG, within the WHO safety limit, as per Reuters.
Indian pharmaceutical executives and regulators have told Reuters that it is common practice among some manufacturers in the country to substitute cheaper, commercial-grade ingredients when making cough syrups.
Moreover, the WHO had previously told The Indian Express that 20 such products by 15 different manufacturers had been flagged, with drugs originating from two countries — India and Indonesia.
