Bhartesh Singh Thakur
Chandigarh, October 12
The investigations into Maiden Pharmaceuticals' cough syrups which led to the closure of manufacturing on the firm's premises on Tuesday have left many questions unanswered.
Despite it being a priority case, the results of the laboratory tests of syrups have not been revealed.
Unanswered questions
- Who is the supplier of propylene glycol and what action has been taken against it?
- Why other syrups produced by the same firm have not been recalled as these could be using the same propylene glycol under question?
- Why laboratory report has been delayed?
The joint investigation by the Central Drugs Standard Control Organisation (CDSCO)'s two drug inspectors, and a senior drugs control officer of the Food and Drug Administration, Haryana, found that the firm "had not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol".
The batch No., manufacturer name, manufacturing date and expiry date were not found maintained on the purchase invoices of the excipients, including propylene glycol. Propylene glycol is used as a solvent for preparing cough syrups.
According to the WHO, toxic effects of the adulterant diethylene glycol (DEG) and ethylene glycol can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.
First task should have been to catch supplier
The first task should have been to catch the supplier. It could have come from abroad or an Indian trader. The show-cause notice pointed out a number of deficiencies and 90% of the small-scale pharmaceutical industries would be having similar violations. —GL Singhal, Ex-state drug controller
As propylene glycol has been purchased from outside, the state regulator is tight-lipped over the name of the supplier and action against them.
The CDSCO is maintaining that the cough syrups in question were meant for export to The Gambia and were not sold in the country. But, as questions have been raised on the quality of propylene glycol, there is a possibility that it could have been used to make other syrups of the firm.
Public health activist and author of 'The Truth Pill: The Myth of Drug Regulation in India', Dinesh S Thakur, tweeted, "While they (other syrups produced by the firm) may not be selling cough syrup under the names they exported it to The Gambia, they are likely selling cough-syrup in Indiahellip;We found domestic trademark registrations for 'Kof-Total' (a syrup mentioned on the website of the firm) which likely means they are selling it in India." He pointed out that 'Macold Total', another syrup, has a domestic trademark registration too.
He pointed that eight months after the first wave of deaths due to diethylene glycol poisoning in Jammu in 2020, a two-year-old child Radhika died after taking digital vision syrup sold under a different name. He called for the need to recall all syrups, manufactured by Maiden Pharmaceuticals, from India.
As of now, only Kerala has banned the sale of all drugs manufactured by Maiden Pharmaceuticals.
The show-cause notice issued to the firm revealed that it had not performed process validation and analytical method validation for the drug products (syrups) in question, added the notice.
It has also come out that propylene glycol, with a manufacturing date of September 2021 and an expiry date of September 2023, was used in the four syrups in question, but their expiry date has been mentioned as November 2024.
"The first task should have been to catch the supplier. It could have come from abroad or an Indian trader. The show-cause notice pointed out a number of deficiencies and 90 per cent of the small-scale pharmaceutical industries would be having similar violations," said GL Singhal, former state drug controller of Haryana.
He added, "If the firm is producing other syrups too, same raw material could have been used there as well. Samples of all syrups produced by Maiden Pharmaceuticals should be taken for lab testing."
from The Tribune https://ift.tt/eIxj5no
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