The Drugs Control Administration (DCA) of Telangana has got its drug inspectors trained by the US Food and Drug Administration (USFDA).
It was part of an initiative by DCA to align itself and industry with the stringent regulatory regime of USFDA as Hyderabad has been the hub of drug exports to the US, Akun Sabharwal, Director of DCA, told BusinessLine here.
Over a dozen drug inspectors received training from the top global regulator in a special programme conducted in Bengaluru. They were trained in various aspects of good manufacturing practices in vaccines and bulk drugs, among others.
Global perspective “This is important because there is no training academy for drug inspectors and most of the learning is based on field trips and mentoring from seniors. We thought a formal training from a global perspective will make a significant difference,’’ Sabharwal said. This year too, DCA plans to seek training from FDA with special focus on data integrity issues. In total, 57 drug inspectors were recently trained in other national institutions such CDSCO so far.
Raising efficiency DCA has also taken a slew of measures to increase efficiency. It has put in place a flow chart based licence approval system and has been able to reduce time taken for approvals by 150 to 200 per cent.
“There are about 18 licences DCA has to issue and reduction in time has been helping industry to compete for global contracts/tenders,’’ the official said. An e-Lab has also been set up with advanced software to ensure the integrity of sample testing procedures.
“We have been shifting from e-monitoring to m-monitoring and a DCA Android App has been developed which is being used by the department for inspection of pharmacies, medicine/drug stores,’’ Sabharwal said.
States show interest In 2015, DCA issued 83 licences to the drug manufacturers and also booked 55 manufacturers for wrong practices.
Being one among the few drugs control departments in the country, the state DCA has been attracting the attention of other states.
The governments of Madhya Pradesh, Chhattisgarh, Maharashtra and West Bengal have shown interest in adopting some of these modernisation schemes and some teams had already visited the city for the purpose.