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Peeling paint, cracks in the wall, water buildup, dirty drains and more—pharma company Morepen Laboratories was told to stop manufacturing and issued incidental notices after several glitches were noted.
As Baddi in Himachal Pradesh – India’s pharmaceutical manufacturing hub – is subject to the inspection of the Medicines Regulatory Agency, the famous Morepen Laboratories is one of the many companies that fail risk-based inspections.
BSE listed Morepen Laboratories, which is also the manufacturer of the popular Burnol brand, manufactures a variety of medicines and health supplements along with manufacturing blood pressure monitors, glucose meters, nebulizers, thermometers and other medical devices.
According to the letter sent by the Department of Health and Family Welfare on June 4, the company was required to stop manufacturing and show cause notices, describing the facility as “completely deficient” in compliance with Good Manufacturing Practices (GMP) and “the quality of medicines manufactured in this facility will be affected accordingly.” “.
The letter, seen by News18, said the inspection found two critical notes and 28 major and miscellaneous notes that could lead to bacterial contamination in drug products. The letter was written by Deputy Controller of Medicines Manish Kapoor to Morepen Laboratories.
While the company did not respond to a request for official comment on the matter, an official told News18 that all the loopholes had been fixed and, in fact, the company had resumed manufacturing after a re-inspection.
“We responded promptly to the issues highlighted in the inspection report,” he said, adding that “a re-inspection also took place followed by the resumption of manufacturing activity.”
‘Take immediate action’
According to the letter accompanying the 80-page risk-based screening report, “…a large number of drugs manufactured at this location have been declared not of standard quality by state and central drug testing laboratories.”
It added, “…an order may be issued to stop manufacturing immediately for this division/products and the Company may be directed to immediately take the necessary steps to comply with GMP standards… with respect to oral liquid dosage forms.”
The letter also stated: “Immediate administrative and regulatory measures such as revocation of product authorization for medicines falling under categories A and B of the Guidelines to take action on drug samples declared as counterfeit or not of standard quality in light of the increased penalties under the Medicines and Cosmetics Act.” 2008’s “May Be Taken”.
From peeling paint to mixing medicines
According to the inspection report, “Paint peeling, cracks in the wall, ceiling, gaps in doors, windows and floor joints, water build-up in primary treatment areas, damaged floors, and dirty drains were noted… It may lead to dirt build-up and bacterial contamination of the product.”
To highlight a critical error, the report also stated that “the company was processing three different products in a liquid manufacturing room simultaneously allowing room for cross-contamination and mixing…”
The report stated that at the time of the inspection, it was noted that “the tablet section is inoperable and a few machines were also found out of order such as pressing machines dumped in the area along with PET bottles, liquid solvents and other packaging materials”.
It also said that the inspection team found “no provision for temperature maintenance in the ventilation system in the oral fluids department”.
Also, “the company has been unable to provide any documentation regarding the quality of potable water used to prepare purified water that meets Schedule M requirements regarding the microbiological limit.”
From the GMP’s Checklist and Standards, the report concluded, “Several important and key observations have been made that the Company is not fully compliant with various Schedule M provisions under the Medicines Rules of 1945.”
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