Health ministry to set up six mini drug-testing labs across major ports and airports in the country
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Shardul Nautiyal, Mumbai
September 27 , 2016
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In order to monitor the standards of imported and exported drugs, the
Union Health Ministry is planning to set up six mini drug-testing
laboratories across major ports and airports in the country. Two of the
six mini labs are expected to come up at Nhava Sheva at Jawaharlal Nehru
Port Trust (JNPT) in Navi Mumbai and Mumbai Airport.
Other four
labs would come up at Kolkata, Hyderabad, Bengaluru and Ahmedabad.
Procurement of equipment for the mini labs is currently being done and
land has also been identified for the same, said a senior CDSCO
official.
Central government has allocated Rs.900
crore for enhancing manpower and capacities of minilabs at port offices
and mobile labs at CDSCO level. A total of additional 1,195 posts were
sanctioned for the upgradation of manpower and labs under the 12th five
year plan.
Currently, there are seven drug-testing laboratories
in the country in Kolkata, Mumbai, Chennai, Hyderabad, Guwahati,
Chandigarh and Kasauli and state drugs testing labs at Gujarat,
Karnataka, Maharashtra with an autonomous lab at Indian Pharmacopoeia
Commission (IPC), Ghaziabad for drug testing and analysis.
As a
step forward, CDSCO has already concluded the process of recruiting 147
drug inspectors which will enhance inspections of manufacturing units in
line with current Good Manufacturing Practices (cGMP).
To ensure
quality of drugs supplied to over 200 countries from India, CDSCO is
also in the process of training its drug inspectors on Good
Manufacturing Practices (GMP) and risk based assessment.
CDSCO
had in the past started deputing drug inspectors as observers to carry
out joint inspections on an event of inspection from an international
regulator. The exercise done in coordination with state drug regulators
was meant to monitor manufacturing plants on GMPs and equip drug
inspectors on enforcing its compliance across the country. Following
which, around 80 drug inspectors have been recruited at the CDSCO in
2014
In August 2015, the cabinet committee on economic affairs
approved a proposal to strengthen the country’s drug regulatory system
at an estimated cost of Rs.1,750 crore.
The proposal envisaged the setting up of testing labs and a training
academy for regulatory and drug-testing officials at the central and
state levels. It also envisaged additional manpower for regulatory
structures.
The onus for the country’s drug regulation rests with
the Central Drugs Standard Control Organization (CDSCO). Headed by the
Drug Controller General of India (DCGI), one of the targets to expand
CDSCO’s capacity by 2020 is to set up 20 mini drug-testing labs at the
port offices of the drug regulator.
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