Bhartesh Singh Thakur
Chandigarh, October 21
The Haryana Medical Services Corporation Ltd (HMSCL), a state body that procures medicines for government hospitals and dispensaries, has blocked the orders placed with Sonepat-based Maiden Pharmaceuticals, which is under the scanner over the death of more than 66 children in Gambia.
A senior HMSCL official told The Tribune that this year's multiple orders of Maiden Pharmaceuticals had been blocked. "The stock of medicines, including several syrups, that was procured last year will also not be used," he said.
The decision was taken after the Food and Drug Administration (FDA), Haryana, ordered the firm to stop manufacturing operations. The World Health Organisation (WHO) had on October 5 issued an alert after four cough syrups of Maiden Pharmaceuticals were found contaminated with diethylene glycol and ethylene glycol.
Following this, a team of the Central Drugs Standard Control Organisation (CDSCO) inspected the firm's records and took samples of the syrups. The FDA issued a show-cause notice to the firm on October 7 under Rule 85 (2) of the Drug Rules, 1945.
It was found that the firm had not performed quality test on solvent propylene glycol for diethylene glycol and ethylene glycol. The batch number, firm's name and manufacturing and expiry dates were not mentioned on purchase invoices.
"The plant was found under renovation. The firm failed to produce log books of equipment and instruments used for manufacturing and testing drugs," said the notice, adding the firm had not performed process validation and analytical method validation for products in question.
Sources said Maiden Pharmaceuticals had not yet replied to the show-cause notice even as only seven days were given to it to file the reply. The CDSCO was yet to intimate the FDA about the lab report of the cough syrups, which was also unusual, they said.
Earlier, the Rohtak PGIMS had stopped the use of omeprazole 20 mg, manufactured by Maiden Pharma Ltd, Sonepat.
Firm yet to reply to show-cause notice
- Sources say Maiden Pharma has not yet replied to show-cause notice issued to it on Oct 7
- The FDA, which halted operations at Sonepat unit, had given firm seven days to file reply
- Besides, CDSCO is yet to share lab report of cough syrups, which is unusual, sources say
from The Tribune https://ift.tt/3BM8AJq
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