According to a government report, India’s drug regulator discovered that a cough syrup and an anti-allergy syrup made by Norris Medicines are toxic, months after Indian-made cough syrups were linked to 141 children’s deaths worldwide.
The medicines were tainted with diethylene glycol (DEG) or ethylene glycol (EG), the same contaminants found in cough syrups that have killed people in Gambia, Uzbekistan, and Cameroon since the middle of last year.
Anti-allergy Syrup by Norris Medicines
The Central Drugs Standard Control Organization (CDSCO) has flagged any DEG and EG contamination in its monthly reports for the first time in at least two years.
As the country tries to crack down on its $42 billion drug industry, which is dominated by small players.
H.G. Koshia, commissioner of Gujarat state’s Food and Drug Control Administration, told Reuters on Wednesday that the agency had inspected Norris’ factory last month and ordered it to halt production and recall the drugs.
“The company failed miserably on compliance parameters of good manufacturing practices,” Koshia said.
“Adequate water system was not there. The air-handling unit was also not up to the mark. In the larger interest of public health, we ordered the unit to stop production.”
Outside of business hours, Norris Managing Director Vimal Shah declined to comment.
CDSCO Laboratory Test
According to a CDSCO laboratory test, the company’s Trimax Expectorant contained 0.118% EG, while allergy drug Sylpro Plus Syrup contained 0.171% EG and 0.243% DEG.
According to its August list of “not of standard quality/spurious/adulterated/misbranded” drugs. Norris used to export cough syrup, according to Koshia, but he didn’t say where.
According to the World Health Organization (WHO), the safe limit is no more than 0.10% based on internationally accepted standards.
“We are aware of the CDSCO report and have communicated with that agency to ascertain where the products… have been exported,” said a WHO spokeswoman.
“This information is pivotal when we consider whether – or not – to issue a medical product alert.”
It was unclear whether the Norris drugs had been recalled or if they had caused any harm. When it was checked, both medications were available from online pharmacies.
Manufactured by Fourrts Labs (India)
The CDSCO also discovered three batches of COLD OUT syrup contaminated with DEG and EG manufactured by Fourrts (India) Laboratories.
In August, the World Health Organization stated that a batch of COLD OUT sold in Iraq contained unacceptable levels of DEG and EG.
S.V. Veeramani, Chairman of Fourrts, did not respond to a request for comment.
According to Veeramani, the chairman of the government-backed Pharmaceuticals Export Promotion Council of India (pharmexcil), a recent “analysis of retention samples” of COLD OUT revealed “no contamination or toxins.”
“There is no report of any adverse effect or death due to the product,” he said in a WhatsApp message. “As a matter of abundant caution, we have voluntarily recalled the product in Iraq market.”
The toxic medicine alerts come at a time when the government is holding workshops for drugmakers across the country through pharmexcil to emphasize the importance of drug quality and patient safety.
The CDSCO list also included a glycerine batch made by Adani Wilmar, despite the fact that it contained 0.025% EG.
Which is within the WHO safety limit. Outside of business hours, Adani Wilmar did not immediately respond to a request for comment.
According to Indian pharmaceutical executives and regulators, it is common practice for some manufacturers in the country to use cheaper, commercial-grade ingredients when making cough syrups.
To read our blog on “Punjab ban locally made injection due to cause of blindness,” click here