In an attempt to revive its anti-snake venom serum production, the King Institute of Preventive Medicine and Research, Guindy, is making an attempt to qualify for Good Manufacturing Practice (GMP) as specified by the World Health Organisation.
To this effect, the institute has submitted a proposal to upgrade infrastructure at the ASVS facility in the Guindy campus at a cost of Rs. 17 crore. “We want to bring our facility to meet all the GMP criteria as recommended by the WHO. Right from providing a uniflow to a separate sterilisation ante room, changing room, relaying the walls and flooring, we intend to adhere to all the norms,” S.Savithri, director, King Institute, told The Hindu .
There are about 180 standards that will have to be conformed to, if the GMP certification is to be procured. While old stocks of the anti-snake venom are being processed at the existing facility, production on new ASVS has been suspended.
V.K. Subburaj, Principal Secretary, Health, said the government was seized of the issue as a priority area. “We are trying to allot funds immediately. It is essential to use the existing skills and capacity at the King Institute to make the ASVS.” Meanwhile, the government has had to buy the ASVS vials from private manufacturers at a higher price, costing the exchequer much more than if the State was making its own anti-snake venom.
The current installed capacity for producing ASVS is 75,000 vials, Dr. Savithri said.
However, actual production depends on the availability of horses and the base plasma. Some years ago, the institute had sent a proposal to the Centre for funds for upgrade to meet GMP standards. However, that did not come through.
Already, the institute has procured GLP (Good Laboratory Practice) licence to make reagents, anti-sera, and antigens for laboratory diagnosis, she added.
“We have the know-how, skills and capacity. In the past, we did have issues with treatment of animals, but we now have a certification from the Committee for the Purpose of Control and Supervision on Experiments on Animals for our horses.”
