Multiple violations found during inspection at Sonepat drugs firm
Bhartesh Singh Thakur
Chandigarh, October 9
After the World Health Organisation (WHO) flagged four syrups produced by Sonepat-based Maiden Pharmaceuticals, a joint team of the Food and Drug Administration (FDA), Haryana, and Central Drug Standard Control Organisation (CDSCO), North Zone, Ghaziabad, found violations on multiple accounts during an inspection at the firm, including missing batch No., manufacturer name, manufacturing date and expiry date on the invoices of propylene glycol, which is used in cough syrups.
Propylene glycol is used as a solvent in pharmaceutical drugs like syrups. If contaminated with diethylene glycol and ethylene glycol, it can cause death.
During the inspection regarding the syrups, it has been found that the firm “has 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 excipients, including propylene glycol.
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.
“Complete plant is found under renovation. The firm failed to produce the logbooks of equipment and instruments regarding manufacturing and testing for the drugs in question,” said the notice. Batch numbers of propylene glycol, sorbitol solution, and sodium methyl paraben in the certificate of analysis (CoA) reports have not been mentioned.
The firm has not performed process validation and analytical method validation for the drug products (syrups) in question, added the notice.
“The firm submitted six-month real-time and accelerated stability data of the drugs in question. However, at the time of the investigation, none of above said products were found charged in the stability chamber,” said the show-cause notice.
It has come out that the 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 firm failed to produce the in-process testing report of the products in question,” said the show-cause notice.
Reply sought in 7 days
After finding contraventions, a show-cause notice under Rule 85 (2) of Drug Rules, 1945, dated October 7, has been issued to the firm as to why the manufacturing licence may not be suspended or cancelled. The firm has to reply in seven days.
Types of discrepancies
- Batch No., mfg, exp dates missing on invoices of propylene glycol, says show-cause notice
- Firm also didn’t do quality testing of propylene glycol for diethylene glycol and ethylene glycol
