Karnataka drugs control department sees the 90-day time-frame for clearance of samples with high performance liquid chromatography (HPLC) test method as a lengthy deadline. In fact, the state drugs control department’s laboratories revert with the final reports within 15 days and this duration could further be reduced with the induction of 52 junior scientific officers.
The latest guidelines issued by the health ministry has mandated 90 days for pharmaceuticals tests with HPLC instruments and those without HPLC to be approved within 45 days.
But in the case of state drugs control department it has already installed 42 HPLCs under a World Bank funded Karnataka Health System Development and Reform Project (KHSD&RP) assistance and has also recently recruited 52 junior scientific officers who are currently undergoing training and would be inducted into the labs in January 2013. This will only help us to further increase our speed of test report generation, Dr BR Jagashetty, drugs controller, government of Karnataka, told Pharmabiz.
Speeding up test reports is the way forward and is a portrayal of efficiency, responsibility and the capability of the lab. At our three labs in Bengaluru, Hubli and Bellary, we have been able to deliver the reports within a span of 15 days and therefore 90 days is a too long phase to test the drug samples if the lab is equipped with related range of reliable and fast instruments, he added.
There has always been a need to fix deadline for the drug sample reports because such matters cannot be delayed. There is need to take immediate action on the drugs found not-of-standard quality which are being circulated in the market. Until and unless we provide the reports we will not be able to issue the orders to withdraw the drugs from the market which is critical as the drugs off the shelf could continue to be prescribed by the physicians, stated Dr Jagashetty.
Incidentally since 2009, Dr, Jagashetty has been recommending for the need for Good Distribution Practices (GDP) to check the prevalence of substandard drugs as it could also result because of poor storage conditions across scores of pharmacy outlets in the country. He had also sent in a proposal to this effect to the then DCGI, Dr Surinder Singh.
While quick test reports are mandatory, there should also be clear-cut guidelines on medicine transportation, storage, trace and track to make sure faster recovery of drugs in transit if suspected to be substandard at any point of inspection, he noted.
Coming to the issue of the need for adequate funds availability for drawing more samples by the inspectors , Dr Jagashetty said that in Karnataka, the concerned pharmacy trade outlets issue a bill of credit and therefore there had been no issue on the same, he said.
But now if the government is keen to go ahead to create ample funds to draw more number of samples by the drug inspectors, the move can be appreciated.
On the point where Indian Pharmacopoeia Commission (IPC) would provide reference standards to the government testing labs within the next four-to-six months so that the labs can speed up the testing procedures, Dr Jagashetty said that the effort would only enhance efficiency levels.