Last Updated on January 6, 2024 by The Health Master
11 Pharma companies told to shut operations
Solan: The Drugs Control Administration (DCA) Himachal Pradesh has recently taken action against several pharmaceutical firms operating in Baddi-Barotiwala-Nalagarh, Sirmaur, and Kangra districts.
Following risk-based inspections, critical flaws related to Good Manufacturing Practices (GMP) have been identified, leading to the DCA’s order to halt manufacturing operations.
This article provides an overview of the situation and highlights the key issues faced by the pharmaceutical industry in the region.
DCA’s Inspection Results:
The DCA, in collaboration with the Central Drugs Standard Control Organisation (CDSCO), conducted inspections of 29 firms during the second phase of its recent operations.
Out of these, 11 companies have been instructed to cease their manufacturing activities due to critical flaws concerning Schedule M of the Drugs and Cosmetics Act, 1940.
Additionally, show-cause notices have been issued to the remaining 18 firms, prompting them to rectify the identified flaws.
Certification Process and Duration:
To regain their manufacturing status, the companies must undergo re-examination once they have addressed the observations made during the inspection.
DCA officials will review the rectifications, and upon certification, the manufacturing operations can be restored.
The duration of this process varies from 20 days to two months, depending on the severity of the observations.
Identified Critical Observations:
While specific details regarding the observations and causes behind the enforcement actions have not been disclosed by the authorities, it has been learned that certain critical flaws were detected during the inspections.
Notably, non-functional air handling units and dysfunctional lab equipment in micro-labs were among the issues found in these firms.
Furthermore, the validation of machinery is being closely examined, as inadequate maintenance practices have been identified, resulting in a negative impact on drug quality.
Monitoring of Firms with Substandard Drugs:
The DCA has been actively monitoring companies that frequently appear on the list of monthly alerts for substandard drugs.
This initiative aims to address recurring issues and ensure that appropriate actions are taken to rectify the situation.
Alarming Substandard Drug Statistics:
In a concerning development, 76 samples of drugs from Himachal Pradesh units have been declared substandard this year, compared to a national figure of 275 samples.
This is particularly worrisome considering that one in every three drugs sold in India is manufactured in the pharmaceutical hub of Baddi-Barotiwala-Nalagarh.
To address this issue, the government has implemented strict regulations, including the suspension of licenses after two lapses and the sealing of units after three lapses.
Conclusion:
The recent order to cease manufacturing operations for 11 pharmaceutical firms in Baddi-Barotiwala-Nalagarh and surrounding districts reflects the strict enforcement of Good Manufacturing Practices.
With critical flaws identified during inspections, it is crucial for the companies to rectify the observed issues promptly.
The DCA’s ongoing monitoring efforts and the government’s regulations demonstrate a commitment to ensuring the production of high-quality drugs in the region’s pharmaceutical industry.
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