After WHO alert on its cough syrups, Haryana firm asked to halt production, faces licence cancellati
New Delhi/Chandigarh (PTI): The Haryana government has ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals, asking it to explain within a week "many contraventions" found during a recent inspection, or face suspension or cancellation of license.
The order to halt production came days after the World Health Organization (WHO) potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in African nation of The Gambia.
"We have ordered that all drug production at this unit be stopped with immediate effect," Haryana Health Minister Anil Vij told PTI over phone on Wednesday.
After the WHO alert, samples of the four cough syrups manufactured by the firm was sent to the Central Drugs Laboratory in Kolkata on October 6 for examination.
Vij said a joint team of the state and the Centre inspected the unit during which it found 12 violations or deficiencies. "Taking cognisance of this, the state government has ordered to halt the drug production in this unit."
He further said the report of the cough syrup samples are yet to arrive from the Central Drugs Laboratory in Kolkata. "Depending on what it says, we will take further action," he said.
According to a notice issued by the Haryana Drugs Controller following the inspection of the firm's plant, Maiden Pharmaceuticals Limited did not perform quality testing of propylene glycol, the raw material used for making one of the formulations.
"The firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol," said the notice.
The showcause notice issued on October 7 stated, "The inspection of your firm was conducted by a team comprising senior officials from CDSCO (Central Drugs Standard Control Organisation) and Haryana Drugs Controller Authority to conduct the necessary investigation for following drugs manufactured by you."
"During inspection many contraventions were detected. You are hereby served with the show cause notice rule 85(2) of drug rules, 1945 as to why your manufacturing license may not be suspended or cancelled," it said.
The state authority had asked the firm to respond within seven days, failing which it said ex-parte -- done with respect to or in the interests of one side only or of an interested outside party -- action will be taken against the company as per the drugs act.
Among the 12 "violations" highlighted by the state drugs regulator was that the batch number of propylene glycol, sorbitol solution and sodium methyl paraben used in the making of the drugs in question were not mentioned in the certificate of analysis report.
The firm has not performed process validation and analytical method validation for the drug products in question, according to the authority.
Besides, the complete plant is found under renovation and the firm failed to produce the log books of equipment and instruments regarding manufacturing and testing for the drugs in question, the notice read.
The batch number, manufacturer name and manufacturing date and expiry date were not found maintained on the purchase invoices of excipients including propylene glycol.
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Trump’s fresh threat to bomb Iran amid reports of deal to end war
Washington (PTI): US President Donald Trump on Wednesday threatened Iran with more bombing if it doesn't reopen the Strait of Hormuz, amid a report that the warring sides were nearing an agreement to end the war.
US media outlet Axios reported, quoting US officials and two other sources, that the US and Iran were getting close to a one-page memorandum of understanding to end the war and set a framework for more detailed nuclear negotiations.
The US expects Iranian responses on several key points over the next 48 hours, Axios reported, adding that nothing has been agreed yet. This was the closest the parties had been to an agreement since the war began.
"Assuming Iran agrees to give what has been agreed to, which is, perhaps, a big assumption, the already legendary Epic Fury will be at an end, and the highly effective Blockade will allow the Hormuz Strait to be OPEN TO ALL, including Iran," Trump said in a post on Truth Social.
"If they don’t agree, the bombing starts, and it will be, sadly, at a much higher level and intensity than it was before," Trump said.
According to Axios, the deal would involve Iran committing to a moratorium on nuclear enrichment, the US agreeing to lift its sanctions and release billions in frozen Iranian funds, and both sides lifting restrictions around transit through the Strait of Hormuz.
It said many of the terms laid out in the memo would be contingent on a final agreement being reached, leaving the possibility of renewed war or an extended limbo in which the hot war has stopped, but nothing is truly resolved.
