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.