Following the WHO red flag, India immediately sent samples of the cough syrup for testing.
New Delhi:
A week after the World Health Organization reported that 66 children in The Gambia could die from consuming India-made cough syrups, the Haryana government has stopped production, news agency ANI reported. Major irregularities in manufacturing have been found at the facilities of Haryana-based syrup maker Maiden Pharmaceuticals.
Haryana Health Minister Anil Vij told ANI, “Samples of 3 drugs mentioned by WHO of Sonepat pharmaceutical company were sent to Central Drug Lab in Kolkata. The report is not yet received, action will be taken after that.” In the joint inspection of the pharmaceutical departments of the Center and Haryana State, about 12 defects were found in the manufacturing.
Mr. Vij said, “Keeping in view which the decision has been taken to stop the total production, notice has been given.”
A show-cause notice issued to the company stated that the firm could not maintain a log book of the equipment and instruments used for manufacturing and testing the drugs.
The batch number of the potentially hazardous chemicals received for the manufacture of cough syrup is not mentioned.
Chemicals include propylene glycol, sorbitol solution and sodium methyl paraben.
The company has failed to validate the process and methods in manufacturing the syrup in question.
A batch of propylene glycol, which was analyzed by the company and declared to be of “standard quality”, failed in some cases.
No in-process test reports were provided to investigators of the cough syrup in question.
There are discrepancies in the date of manufacturing and the date the product is permitted.
The Haryana State Drug Controller has given the company 7 days to respond to its show cause notice, besides suspension or cancellation of the manufacturing license and further legal action.