Following WHO's red flag, India had immediately sent samples of the cough syrups for testing.
Days after Indian pharma company Maiden Pharmaceuticals was flagged by the World Health Organisation (WHO) following the death of 66 children in the Gambia, Haryana Food and Drug Administration has flagged lapses in the company's manufacturing facility for cough syrups.
Haryana state drug officials have listed out detailed 12 points of contraventions which were detected by officials during inspection of the manufacturing facility in Sonepat.
The state drug controller has issued show cause notice to Maiden pharmaceuticals as to why their manufacturing licence may not be cancelled.
The company has to reply to the show cause notice by October14.
Violations detected by the Haryana FDA at Maiden Pharma's factory
Missing log book: Maiden Pharmaceuticals failed to produce the log books of equipment and instruments regarding manufacturing and testing for the cough syrups in question.
Batch numbers of propylene glycol, sorbitol solution, and sodium methylparaben which were used in manufacturing of the drug in question were not mentioned.
Maiden Pharmaceuticals has not performed process validation and analytical method validation for the four cough syrups, which have been red flagged by the WHO.
Several drugs by the pharma company were earlier not found to be up to quality standards by four states of the country.
Vietnam had in 2011 banned the company.
Following WHO's red flag, India had immediately sent samples of the cough syrups for testing.
"Samples have been sent to a central pharmaceutical laboratory for testing," Anil Vij, Haryana's Health Minister, where Maiden has its factories, had told reporters. "Strict action will be taken if anything is found wrong."
