Solan, October 9
Himachal lacks a fully equipped drug testing laboratory, even as it hosts Asia’s largest pharmaceutical center in the Baddi-Barotiwala-Nalagarh (BBN) industrial belt.
The rate at which a new laboratory is being installed since 2017 speaks volumes about concerns to promote quality drug manufacturing.
lab in preparation
A new laboratory is being set up in Baddi which will be equipped with all modern testing facilities. Navneet Marwaha, State Drug Comptroller
The Composite Testing Laboratory (CTL) in Kandaghat is the only drug testing laboratory in the state serving 690 pharmaceutical units and 5,500 outlets.
The lack of facilities to test injections, microbiology-related tests, as well as those using sophisticated equipment, is a major handicap for the Drug Enforcement Administration (DCA) in maintaining effective quality control. These tests are outsourced to other states. The laboratory that was established in 1992 did not achieve any appreciable improvement in equipment and personnel, which hampered the work of DCA officials.
According to the conclusions of the Mashelkar Committee, which had conducted a comprehensive review of drug regulatory issues at the national level, good laboratory practices should be mandatory for all drug testing laboratories and should be accredited by the Board National Accreditation for Testing and Calibration. Laboratories.
The Union Ministry of Health and Family Welfare had provided Rs 30 crore to the state Department of Health in 2017 to establish a new lab as part of the 12 Five-Year Plan. But it has not yet become functional.
“A new laboratory is being set up in Baddi which will be equipped with all modern testing facilities. It is being established with central assistance where 90 per cent of the funds have been raised by the union government. Once it is set up, new staff will be hired to make it work,” reported State Drug Controller Navneet Marwaha.
The need to improve infrastructure facilities is the need of the hour with a multi-million rupee bulk drug park being established in the Una district. But such planning is not visible in the Department of Health.
Since the Central Drug Standards Control Organization imposes strict conditions, such as bioequivalence and stability data for each product, this laboratory will be of great help to the industry. Setting up a stability chamber and related facilities is a costly affair for small manufacturers, a pharmaceutical manufacturer opined.
Another drug testing laboratory being set up by industries in Baddi has not appeared since 2014. The civil work was completed at a cost of Rs 3.25 crore at least five years ago, but it did not become functional.
The project was sanctioned under the Central Government’s Program of Assistance to States for the Development of Export Infrastructure and Related Activities and funds worth Rs 8.9 crore were supposed to be received. However, the scheme was discontinued in 2014 and only Rs 3.25 crore was made available for this lab.