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Health ministry to upgrade manpower and drug testing infrastructure across country
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Shardul Nautiyal, Mumbai
October 27 , 2015
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The Union health ministry has recently recruited around 31 assistant
drug inspectors at Central Drugs Standard Control Organisation (CDSCO)
and sanctioned another 470 technical staff posts as a part of manpower
upgradation programme. An amount of Rs.
1,750 crore has already been sanctioned for upgradation of manpower at
the CDSCO and state level. As a part of the plan, drug testing
infrastructure in the country will also be upgraded.
According to
a senior CDSCO official, " Around 80 drug inspectors were recruited at
the CDSCO last year as a part of the process." While State drug control
departments have been allocated Rs. 850 crore, CDSCO has been allocated Rs.
900 crore for enhancing manpower and capacities of minilabs at port
offices and mobile labs. A total of additional 1195 posts were
sanctioned for the upgradation of manpower and labs under the 12th Five
Year Plan, as per official sources.
In order to monitor
manufacturing plants on GMPs and equip drug inspectors on enforcing its
compliance across the country, CDSCO had also started the exercise of
deputing drug inspectors as observers to carry out joint inspections in
an event of inspection from an international regulator.
An
official said that the manpower is expected to double both at the centre
and states by the end of 2017. Talking about the increasing global
requirement for evolving regulatory compliance in regulated and
unregulated markets, deputing drug inspectors as observers through joint
inspections has been able to help augment our knowledge on continuing
good manufacturing practices. It will also be helpful for manufacturers
in adopting global practices followed in other countries where our
medicines are consumed.
A total of 100 drug inspectors with
equal representation from CDSCO and state drug regulatory bodies from
across the country are also participating in workshops on GMP and data
integrity to be held in Bengaluru and Ahmedabad between November 16 and
19, 2015. Workshops on GMP and cGMP compliance conducted by CDSCO and US
FDA's jointly for the first time in four cities of India last year in
May was well received as over 60 pharma companies participated in the
workshop.
The US FDA CDSCO workshops were held in Hyderabad, Goa,
Chandigarh and Ahmedabad covered relevant topics for regulatory
requirements like process validation, enforcements and computer system
validation based on specific information.
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