In yet another red flagging of India-made medicines, the World Health Organization (WHO) on Monday banned a batch of contaminated common cold syrup, manufactured by an Indian company. India has already been warned about substandard medicines by the apex health body earlier.
The United Nations agency said the batch of the syrup, that goes under the brand name Cold Out, sold in Iraq, was manufactured by Fourrts (India) Laboratories for Dabilife Pharma, and had higher than acceptable limits of contaminants diethylene and ethylene glycol.
The batch had 0.25 per cent of diethylene glycol and 2.1 per cent of ethylene glycol, when the acceptable safety limit for both is up to 0.10 per cent, WHO said in its medical product alert.
The agency added the manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product. The companies did not immediately respond for comments.
At least five of the syrups under scrutiny involve Indian manufacturers.
Cough syrups made in India were linked to deaths of at least 89 children in Gambia and Uzbekistan last year. Indian authorities also found violations at Riemann Labs, whose cough syrup was linked to deaths of children in Cameroon.
Months back, Sri Lanka too banned India-made eyedrops of a particular brand after quality concerns that led to infections, loss of eyesight and even deaths following their use in that country.
Late last year, Nepal had also banned the import of medicines from 16 Indian companies for failing to comply with the World Health Organization’s (WHO) good manufacturing practices.
The US Food and Drug Administration has sent out dozens of notices to Indian pharmaceutical companies post-pandemic. Many of these firms are accused not only of negligence, but of deliberately ignoring warnings.
A public interest writ petition was moved in the Gujarat High Court months back, seeking an immediate ban on the sale and manufacture of low-quality, health-threatening drugs and products. Drug Controller General of India (DCGI), Food and Drug Control Department of the Government of Gujarat have been joined as parties in the petition.
Also Read: CBI Books Ahmedabad Firm For Alleged Fraud Of Rs 46 cr
