Himachal lacks a fully equipped drug-testing laboratory even as it houses Asia’s biggest pharmaceutical hub in the Baddi-Barotiwala-Nalagarh (BBN) industrial belt.
The pace at which a new lab is being set up since 2017 speaks volumes about the concerns to promote quality drug manufacturing.
The Composite Testing Lab (CTL) at Kandaghat is the lone drug-testing lab in the state which caters to 690 pharmaceutical units and 5,500 sale premises.
The absence of facilities for testing injections, microbiology-related tests as well as those using sophisticated equipment is a major handicap for the Drug Control Administration (DCA) in maintaining effective quality control. These tests are outsourced to other states. The lab which was set up in 1992 has failed to get any appreciable enhancement in equipment and staff, adversely hitting the working of the officials of the DCA.
According to findings of the Mashelkar Committee, which had undertaken a comprehensive examination of drug regulatory issues at the national level, good lab practices should be made mandatory for all drug-testing laboratories and those should be accredited by the National Accreditation Board for Testing and Calibration Laboratories.
The Union Ministry of Health and Family Welfare had provided Rs 30 crore to the state Health Department in 2017 to set up a new lab as part of the 12th Five-Year Plan. But it is yet to become functional.
“A new lab is being set up at Baddi which will be equipped with all modern testing facilities. It is being set up with central assistance where 90 per cent funds have been pooled by the union government. Once it is set up, fresh staff will be recruited to make it functional,” informed State Drugs Controller Navneet Marwaha.
The need to enhance infrastructure facilities is the need of the hour with a multi-crore bulk drug park being set up in Una district. But no such planning is visible in the Health Department.
With the Central Drug Standard Control Organisation imposing stringent conditions such as bio-equivalence and stability data for every product, this lab will be of great help to the industry. The creation of a stability chamber and related facilities is a costly affair for small manufacturers, opined a pharmaceutical manufacturer.
Another drug-testing lab which was being set up by the industries at Baddi has failed to come up since 2014. The civil work was completed at a cost of Rs 3.25 crore at least five years ago, but it failed to become functional.