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The Drug Controller General of India (DCGI) will soon put in place a multi-level
complaint redress mechanism including a grievances box to be manned and opened
personally, in a bid to mitigate the irritants of the industry players to the
best possible extent.
As part of streamlining the functions vis-à-vis addressing the grievances of the
industry, a senior official will be designated to handle the queries and
problems every day for a greater time and if needed a whole day in a week.
Time-frames for clearing of each application will be fixed and displayed so that
applicants can seek justification for delays. ``If still there is any complaint
about the delay in clearance or anything else, and was not addressed at
different levels, anyone can drop the complaint in the grievances box which will
be placed soon in the FDA Bhavan. I will personally open and address the problem
listed in it,'' DCGI Dr Surinder Singh informed a gathering of manufacturers
recently.
He also assured the industry that they would be consulted through regular
workshops before making any major decision on key areas like clinical trials and
would meet the representatives of the companies once a month to personally to
take the feedbacks.
Faced with shortage of manpower, the immediate effort was to fill up the vacant
posts in the CDSCO. Already nine persons have been promoted as assistant drug
controllers and advertisement was given to select four deputy drug controllers.
Besides, 31 technical assistants are being appointed soon, he disclosed.
Looking forward to a smooth system on par with world-class standards once the
E-governance is being fully implemented, the DCGI said the drug inspectors in
the North Zone were already given laptops to send reports immediately from the
field itself. It would now be extend to the West Zone also, he added.
(Ref: Chronicle Pharmabiz dated 07 July 2008)
GE Sensing & Inspection Technologies has developed the Labwatch monitoring
system with real time temperature, pressure and humidity data controls. The
system equipped with RF ValProbe offers significant economies of scale as it
does not require wiring.
The changeover downtime is eliminated, as the hardware can be quickly converted
from monitoring into temperature mapping. The system finds extensive application
for monitoring installations in stability rooms, freezers, refrigerators,
incubators, cold rooms, water baths, clean rooms, laboratories and warehouses of
the pharmaceutical and biotech industries.
Labwatch is widely acknowledged as a labour-saving system for monitoring,
alarming and reporting on environmental status in the pharma and biotech
sectors. It provides the information needed for internal analysis and for
documentation to comply with regulatory requirements, specifically with those of
FDA regulation 21 CFR Part 11. It also maintains a secure archive of monitored
values from all sensors and creates an audit trial of alarms and actions taken
by the system and system operators. Typical monitored parameters include:
pressure, temperature, humidity, light, both visible and UV, airflow, CO2 and
the open/shut status of doors.
The incorporation of the RF ValProbe into the Labwatch system now allows users
greater flexibility, significant time saving and reduced risk of data analysis
errors.
RF ValProbe system consists of RF wireless loggers, a base station and
appropriate software. The loggers provide high accuracy measurement of
temperature, pressure and humidity. Data is collected from many loggers over a
wide area. Mesh networking technology ensures that no data is lost, by
permitting loggers to route data to another logger for subsequent forwarding if
the direct path to the base station is blocked. It is the integration of
exceptionally reliable and robust RF Mesh technology with the advanced measuring
capabilities. The software and data reporting features that accompany the RF
technology provide regulatory-compliant text and graph reports. It eliminates
the need to download data to an Excel spreadsheet. Encryption guarantees data
protection.
(Ref: Chronicle Pharmabiz dated 05 July 2008)
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