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Shardul Nautiyal, Mumbai October 15 , 2016
Health ministry will soon set up a mini drug testing lab at Ahmedabad airport as a part of its mandate to control exports and imports of spurious drugs. The lab will be set up at a strategic location in an area of minimum 3,000 sq ft and will be equipped with analytical modalities like AAS, GC, HPLC, IR and NIRS among others for effective detection, analysis and reporting on drug quality.

This will enhance the capability to analyse and detect spurious, NSQ drugs and counterfeit medicines which are ready to be exported at the airport in less than 40 seconds time without any manual intervention, according to a senior CDSCO official.

As per official sources, two of the eight mini- labs are also expected to come up at Nhava Sheva at Jawaharlal Nehru Port Trust (JNPT) in Navi Mumbai and Mumbai Airport.

Other five labs would come up at Kolkata, Hyderabad, Bengaluru, Delhi and Chennai.

Estimated to cost around Rs.25 crore for which funds have already have been sanctioned, the mini-lab at Ahmedabad airport will be manned by a team of nine technical personnel led by a senior scientific officer. To ensure quality of drugs supplied to over 200 countries from India, Central Drugs Standard Control Organization (CDSCO) is also in the process of training its drug inspectors on Good Manufacturing Practices (GMP) and risk based assessment.

Headed by the Drug Controller General of India (DCGI), Government is also keen on expanding CDSCO’s capacity by 2020 by adding a total of 20 mini drug-testing labs at the port offices of the drug regulator.

Central government has allocated Rs.900 crore for enhancing manpower and capacities of mini labs at port offices and mobile labs at CDSCO level. A total of additional 1,195 posts were also sanctioned for the upgradation of manpower and labs under the 12th five year plan.

Currently, there are seven drug-testing labs 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).

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 had 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.

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