Major irregularities have been found at the facilities of Maiden Pharmaceuticals, the Haryana-based manufacturer of syrups.
New Delhi: A week after the World Health Organisation reported that as many as 66 children in Gambia may have died after consuming Indian-made cough syrups, the Haryana government has stopped all drug production at a manufacturing plant linked to it.
Major irregularities have been found at the facilities of Maiden Pharmaceuticals, the Haryana-based manufacturer of syrups.
“Samples of 3 drugs mentioned by WHO of Sonipat’s pharmaceuticals company were sent to Central Drug Lab in Kolkata. The reports are not in yet, action will be taken after that,” Haryana Health Minister Anil Vij was quoted saying by news agency ANI, adding that, however, a joint inspection by the Central and Haryana state drug departments found around 12 flaws in manufacturing.
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“Keeping this in mind, it has been decided that the total production shall be stopped,” Mr. Vij added.
A show cause notice issued to the company says the firm could not produce a log book of equipment and instruments used to manufacture and test the drugs in question.
Batch numbers of potentially dangerous chemicals that were acquired for the manufacture of cough syrups have not been mentioned.
The chemicals include Propylene Glycol, Sorbitol Solution, and Sodium Methyl Paraben. The company has failed to validate processes and methods in the manufacture of the syrups in question.
A batch of propylene glycol, which was analyzed by the company and declared of “Standard Quality” failed in certain respects.No in-process testing reports were provided to investigators of the cough syrups in question.
There are discrepancies in the date of manufacturing and the product permission that was given. The Haryana State Drugs Controller has given the company 7 days to respond to its show cause notice, barring which the manufacturing license may be suspended or canceled and further legal action taken.
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