Kerala bans sale of all drugs by Sonepat firm : The Tribune India


Tribune press service

Bhartesh Singh Thakur

Chandigarh, October 8

Kerala has banned the sale of all drugs manufactured by Sonepat-based Maiden Pharmaceuticals. Earlier, the World Health Organization (WHO) issued an alert over four syrups from the firm on October 5 after 66 children died in The Gambia.

Confirming the development in a chat with The Tribune, Kerala State Drugs Comptroller PM Jayan said: “We have issued orders to stop the sale of all drugs manufactured by Maiden Pharmaceuticals. They have a few products on the market. We will take samples and test each one. Based on the results, we will authorize the sale. Regarding the blanket ban, Jayan said the decision was taken in view of the death of 66 children in The Gambia. The WHO also said laboratory analysis of samples of each of the four syrups made by Maiden Pharmaceuticals confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

The four syrups suspected of being responsible for the deaths of 66 children in The Gambia are Promethazine oral solution, Kofexmalin baby cough syrup, Makoff baby cough syrup and Magrip cold syrup NOT.

According to the Centre’s Xtended Licensing, Laboratory and Legal Node website, Maiden Pharmaceuticals’ metformin tablets, which are used to treat type 2 diabetes, failed the quality test in Ernakulum district of Kerala on September 28. . The remarks on the website read, “The sample does not comply with the Indian Pharmacopoeia (IP) 2018. This particular batch of the sample fails the dissolution test. Therefore, declared as not of quality standard.”

Another product from the same firm, Easiprin tablets, which is an gastro-resistant aspirin, failed on June 30 in the district of Kannur (Kerala). It also did not comply with the IP standards and the product failed the “descriptive part” and the “Salicylic acid test”.

Maiden Pharmaceuticals’ MAICAL-D tablets failed the content assay test on March 24. The samples were taken from Taluk Hospital, Attingal (Kerala), and found to be of “non-standard quality”.

On March 19, metformin tablets failed the test in Pallakad. The remarks said “The samples fail the dissolution test and are therefore declared not to be of standard quality.” The same product from Maiden Pharmaceuticals failed dissolution and dosage tests on December 21, 2021 in Kollam.

Regarding the failed samples, Jayan said, “I can only comment on the filing of lawsuits after seeing the file.”

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