The Karnataka drugs control department’s is now on an aggressive mode to increase its drug testing capability to around 12,000 samples from the current 3,000 samples in a year.
“With the required drug test lab infrastructure in place at the three locations of Bengaluru, Hubli and Bellary, we would be able to achieve the target of 12,000 drug samples,” Dr BR Jagashetty, Karnataka drugs controller told Pharmabiz.
“Incidentally, inauguration of the Hubli lab by the Karnataka chief minister Jagadish Shivappa Shettar was planned for March 17, 2013. We are also sprucing up efforts to commission the new laboratory for testing biological drugs, vaccines, blood at Belgaum,” he added.
The department has also received its 42 High Performance Liquid Chromatography (HPLC) under a World Bank funded Karnataka Health System Development and Reform Project (KHSD&RP) assistance supplied by the global medical device major Shimadzu Corporation. The equipment have been installed at the three drug test labs located at Bengaluru, Hubli and Bellary.
In addition to the HPLC, the drugs control department has also received equipments covering UV Spectrometry, water purifier and dissolution test apparatus for the fourth lab.
“As part of the test equipment installation process, Shimadzu Corporation has trained the team of 42 senior and junior scientific officers at Singapore. The initiative would accelerate the speed of drug analysis in a systematic manner. Therefore, the new infrastructure and equipment would help us to strengthen our testing capability. We will be able to analyse more number of samples and revert with the final reports in a time-bound manner,” said Dr Jagashetty.
Meanwhile, the state drugs control department is also awaiting the National Accreditation Board for Testing and Calibration Laboratories (NABL) certification for its lab in Bengaluru as the audit is complete. The regional labs of Hubli and Bellary were approved to be set up in 2009. Initially the department received Rs.25 crore and received an additional Rs.9.5 crore from the department of health and family welfare. Now efforts are on to seek NABL certification for these two regional labs too, said Dr Jagashetty.
Last year, the state government approved the selection of 75 junior scientific officers out of the sanctioned 113 posts for the drug test labs. Filling up of vaccines of 30 officers is under process, said the Karnataka drugs controller.
The state drugs control department has been engaged in surprise inspections for not of standard quality and habit forming drugs. Now following the World Health Organisation (WHO) mandate to broaden the scope for drugs tests based on SSFFC (sub-standard, spurious, fake, falsified & counterfeit) model, the three labs along with its Intelligence Cell which is the core of regulatory activities, manned by five inspectors, at head office and one each in-charge of regional jurisdiction of Bengaluru, Mysore, Hubli, Bellary and Gulbarga to oversee the 30 districts, would enable surveillance of drug production and sale, said Dr Jagashetty.