Published Oct 12, 2022 | 7:02 PM ⚊ Updated Oct 12, 2022 | 7:35 PM
The Karnataka drug regulator has asked manufacturers to test their products for solvents that could be fatal if taken beyond a certain limit. (Creative Commons)
The drug regulator of Karnataka has asked all drug manufacturers to test and analyse all individual containers and packs for glycerin and propylene glycol, and submit within 17 October a Certificate of Analysis of these solvents if they have been procured over the past year.
It may be noted that Kerala a week ago proactively asked for this analysis and even banned all the drugs sold in Kerala manufactured by Maiden Pharmaceuticals Ltd, whose four cough syrups were linked by the World Health Organisation (WHO) to the death of 66 children in the Gambia.
The Drugs Control Department of Karnataka issued its circular in this regard on 10 October.
The circular reiterated what the WHO had said about four cough syrups being contaminated with ethylene glycol and diethylene glycol, leading to acute kidney failure in 66 children, who then died in the African country.
“The products containing such contaminates are to be considered as adulterated drugs as per the provisions of Drugs & Cosmetics Act & Rules thereunder [sic],” the circular stated.
The Karnataka Drugs Control Department circular. (Supplied)
It may be noted that South First reported on violations found during the joint inspection by the CDSCO and the Haryana state drug regulators at the Sonepat manufacturing unit of Maiden Pharmaceuticals, and a show-cause notice was issued to it by the regulators.
The contaminants are dangerous and can even turn fatal. Therefore, to be on the safe side and “as a precautionary measure”, the Karnataka drug regulator has asked the drug manufacturers to not only procure the solvents directly from their makers but also comply with pharmacopoeial standards and submit a Certification of Analysis report, and also do the testing of their products.
The circular stated, “Therefore, all the manufacturers are herewith directed to procure solvents like glycerin and propylene glycol complying with pharmacopoeial standards, directly from the manufacturers as required under para 10 of schedule M of Drugs & Cosmetics Rules 1945. [sic]”
It also told the manufacturers: “As an abundant precaution, you are requested to sample and test or analyse all individual container/pack of Glycerin and Propylene Glycol. [sic]”
Meanwhile, the Haryana government, after finding violations at multiple levels by Maiden Pharma with the cough syrups under question, has decided that the total production of drugs shall be stopped.
Haryana Home and Health Minister Anil Vij told news agency ANI on Wednesday: “Keeping the flaws the joint inspection by Central and Haryana State drug departments found, it has been decided that the total production shall be stopped. Notice has also been given to the pharma company.”
“It has been decided to shut total production…” Haryana Minister on Maiden Pharma cough syrup plant
Read @ANI Story | https://t.co/tcagANUvJ9#MaidenPharmaceuticals #coughsyrup #WorldHealthOrganisation #Haryana pic.twitter.com/N6K7sQy3EV
— ANI Digital (@ani_digital) October 12, 2022
