Kerala bans sale of all drugs by Sonepat firm

Tribune News Service

Bhartesh Singh Thakur  

Chandigarh, October 8  

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

Confirming the development while talking to The Tribune, Kerala State Drug Controller PM Jayan said, “We have issued orders for stopping the sale of all drugs manufactured by Maiden Pharmaceuticals. They have a few products in the market. We will draw samples and test each of these. Based on the results, we will allow the sale.” On the blanket ban, Jayan said the decision had been taken in view of the death of 66 children in The Gambia. The WHO has also said that laboratory analysis of samples of each of the four syrups manufactured by Maiden Pharmaceuticals confirmed that these contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

The four syrups which are suspected to be behind the deaths of 66 children in The Gambia are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

According to the Xtended Licensing, Laboratory and Legal Node website of the Centre, Maiden Pharmaceuticals’ metformin tablets, which are used to treat type-2 diabetes, failed the quality test in Ernakulum district in Kerala on September 28.  The remarks on the website say, "The sample does not conform to Indian Pharmacopeia (IP) 2018. This particular batch of the sample fails test Dissolution. Hence declared as not of standard quality."    

Another product by the same firm, Easiprin tablets, which is a gatro resistant aspirin, failed on June 30 in Kannur district (Kerala). It also didn't comply with IP standards and the product failed the “Descriptive part” and “test Salicyclic acid”. 

MAICAL-D tablets of Maiden Pharmaceuticals failed on March 24 in the content assay test. The samples were taken from Taluk Hospital, Attingal (Kerala), and were found of "Not Standard Quality".  

On March 19, Metformin tablets failed the test in Pallakad. The remarks said," The samples fail the test Dissolution and hence declared as not of standard quality." The same product of Maiden Pharmaceuticals failed the dissolution and assay tests on December 21, 2021, in Kollam.  

Regarding failed samples, Jayan said, “I can only comment about launching prosecution after seeing the file.”

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