Karnataka Drugs Control Department’s constant checks and surprise inspections has now led to a drastic decrease in the number of samples categorized under the not-of- standard quality(NSQ) drugs manufactured by pharma companies in the state.
In August end, Union government Ministry of health and family welfare had released details of a study stating one in three drugs to be NSQ and Karnataka accounted for 7.2 per cent of sub-standard drugs. However the Karnataka state drugs control department said that during their regular and surprise inspection spree of pharmacy outlets, where drug samples are collected, the number of Karantaka companies reporting NSQs was miniscule.
Providing the details of the three years of inspection, the drugs department said that of total 5,270 drug samples analysed at its three drug test labs (DTLs) at Bengaluru, Hubli and Bellary, the NSQ drugs detected were only by four companies in 2011-12 as compared to 11 companies in 2010-11 and six companies in 2009-10. According to the Central Drugs Standards Control Organization (CDSCO) report, Karnataka ranks second after Maharashtra in the number of samples assessed for NSQ.
In 2009-10, of the total 3,542 drug samples analysed, the percentage of NSQ of samples by Karnataka manufacturers was a mere 0.17 per cent. In 2010-11 out of 3,896 samples tested, it was 0.28 per cent. For 2011-12, of the total 5270 samples analysed, it was 0.076 per cent.
“Therefore as per our information, the NSQ drugs are currently less than one percent in Karnataka which proves it is the lowest. Manufacturers here adhere to high production standards together with surprise inspections have helped to achieve this,” Dr BR Jagashetty, Karnataka Drugs Controller, told Pharmabiz.
Total samples received from Karnataka manufacturers in 2009-10 was 448, where DTL at Bengaluru analysed 368 drugs, 31 were tested at the Hubli DTL and 49 samples assessed at the Bellary facility. Out of these six were declared as NSQ. In 2010-11, of the 631 samples, 546 were tested from Bengaluru, 20 from Hubli and 65 from Bellary, of which 11 were NSQ. Similarly in 2011 -2012, out of 922 samples, 740 tested at Bengaluru, 88 at Hubli and 94 at Bellary of which only four were NSQ.
The analysis has further indicated that the maximum number of NSQ drugs detected are from pharma companies outside Karnataka, he said.
Meanwhile initiatives like computerization- networking, presence of the Intelligence Cell to inspect and keep tabs on spurious, adulterated and unlicensed manufacturers, inclusion of public and non-governmental organizations during random sample checks, makes Karnataka companies alert about NSQ products. Recently, under a World Bank supported Karnataka Health System Development and Reform Project (KHSD&RP) scheme, 42 High Performance Liquid Chromatography (hplc) were installed. The National Accreditation Board for Testing and Calibration Laboratories (NABL) certification is under clearance for DTL Bengaluru. All these factors are expected to strengthen the testing of NSQ drugs at a faster pace, said Dr Jagashetty.