Himachal Regulatory Authorities Halt Production in 13 Pharma Units Over Quality Concerns
Nov 7, 2024
Source: Tribune News Service
Share:
In a bid to ensure adherence to quality standards in drug manufacturing, the Central and Himachal state drug regulatory authorities have directed 13 pharmaceutical companies in Himachal Pradesh to halt or partially suspend their production. These companies, located across key industrial clusters in Baddi, Nalagarh, Solan, and Sansarpur Terrace, were found violating quality protocols during recent inspections.
The inspections, conducted by state regulators and the Central Drugs Standard Control Organisation (CDSCO), were part of a risk-based audit of 42 units since May 2024. Of the 13 firms facing action, seven risk a full suspension of licenses, while six others face partial suspension. Key issues identified included inadequate maintenance of critical equipment and non-functional air handling units, both of which are essential for drug quality and safety.
Manish Kapoor, the State Drug Controller, stated that this initiative focused on companies frequently listed in monthly drug alerts for non-standard quality products. “Units failing to meet quality benchmarks are subject to immediate regulatory action, including partial or complete halts in production,” he said. Kapoor emphasized that affected firms will only be allowed to resume operations after corrective actions are verified by officials.
October’s monthly alert highlighted 25 drug samples, including 11 injectables, that failed to meet quality standards. These inspections not only aim to uphold drug quality but also to encourage manufacturers to maintain rigorous operational protocols.
Read Next
Copyright © 2024 Pharmacy Pro. All rights reserved.
Copyright © 2024 Pharmacy Pro. All rights reserved.
Copyright © 2024 Pharmacy Pro. All rights reserved.
Source: Tribune News Service
In a bid to ensure adherence to quality standards in drug manufacturing, the Central and Himachal state drug regulatory authorities have directed 13 pharmaceutical companies in Himachal Pradesh to halt or partially suspend their production. These companies, located across key industrial clusters in Baddi, Nalagarh, Solan, and Sansarpur Terrace, were found violating quality protocols during recent inspections.
The inspections, conducted by state regulators and the Central Drugs Standard Control Organisation (CDSCO), were part of a risk-based audit of 42 units since May 2024. Of the 13 firms facing action, seven risk a full suspension of licenses, while six others face partial suspension. Key issues identified included inadequate maintenance of critical equipment and non-functional air handling units, both of which are essential for drug quality and safety.
Manish Kapoor, the State Drug Controller, stated that this initiative focused on companies frequently listed in monthly drug alerts for non-standard quality products. “Units failing to meet quality benchmarks are subject to immediate regulatory action, including partial or complete halts in production,” he said. Kapoor emphasized that affected firms will only be allowed to resume operations after corrective actions are verified by officials.
October’s monthly alert highlighted 25 drug samples, including 11 injectables, that failed to meet quality standards. These inspections not only aim to uphold drug quality but also to encourage manufacturers to maintain rigorous operational protocols.
Share:
Read Next
Read Next
Copyright © 2024 Pharmacy Pro. All rights reserved.
Copyright © 2024 Pharmacy Pro. All rights reserved.