NEW DELHI: The Indian drug regulator has identified two syrups, a cough syrup, and an anti-allergy syrup, manufactured by Norris Medicines as toxic. This revelation comes several months after Indian-manufactured cough syrups were linked to the deaths of 141 children globally.
For the first time in at least two years, the Central Drugs Standard Control Organization (CDSCO) has indicated DEG and EG contamination in its monthly reports. This development occurs as India plans to regulate its $42 billion (S$57 billion) drug industry.
H.G. Koshia, Commissioner of Gujarat state’s Food and Drug Control Administration, revealed on Wednesday that they had conducted an inspection of Norris’s facility last month and ordered an immediate halt to manufacturing due to the company’s significant non-compliance with good manufacturing practices.
Koshia stated, “The company failed miserably on compliance parameters of good manufacturing practices. Adequate water systems were lacking, and the air-handling unit did not meet the required standards. In the broader interest of public health, we mandated the suspension of production.”
Norris Medicines did not respond to emails and had inactive office phone numbers when contacted by Reuters news agency.
Additionally, the Central Drugs Standard Control Organization (CDSCO), the federal drug regulator, identified three batches of COLD OUT syrup manufactured by Fourrts (India) Laboratories as contaminated with DEG and EG, according to its August list of drugs categorized as “not of standard quality/spurious/adulterated/misbranded” on its website.
In August, the World Health Organization reported that a batch of COLD OUT sold in Iraq contained unacceptable levels of DEG and EG.
Fourrts Chairman S.V. Veeramani did not provide a response to Reuters’ request for comment. However, back in August, Veeramani, who also serves as the Chairman of the government-supported Pharmaceuticals Export Promotion Council of India, indicated that an analysis of retention samples of COLD OUT had shown no contamination or toxins. He asserted, “There is no report of any adverse effect or death due to the product,” in a WhatsApp message. “As a matter of abundant caution, we have voluntarily recalled the product from the Iraq market.”
WHO Warns Against Use of India-Made Cough Syrups
The World Health Organization (WHO) had issued a warning against the use of two India-made cough syrups after they were linked to the deaths of at least 20 children in Uzbekistan and 66 children in Gambia. The UN agency said that Indian-manufactured cough syrups were “substandard” and contained “unacceptable amounts of diethylene glycol and ethylene glycol,” chemicals often meant for industrial use.
