As India emerges as a major healthcare centre, an advanced and expensive surgical tool called bio-sealant, that helps surgeons join pieces of liver or heart without sutures, has made its debut in the Indian market.
With the permission from the Drugs Controller General of India (DCGI), world’s leading manufacturer of bio-sealant Baxter launched its fibrin sealant, tisseel, in India in May.
This would be useful in cardiac, liver, neuro and ENT operations, said Baxter’s business manager Sumit Kumar. Tisseel was the first commercial fibrin sealant approved by the US Food and Drug Administration in 1998.
Bio-sealants are surgical tissue adhesives derived from human and animal blood products. The ingredients in the sealants interact among themselves to control the bleeding, speed up wound healing and seal off hollow body organs or cover holes made by standard sutures. The interaction leads to the formation of a stable blood colt made out of fibrin protein.
“The sealants are used in cases where the suture line will not hold. They reduce the post-operative stress and hospitalisation stay. Earlier, only a handful of doctors used sealants as the company procured it specially for them. Now it will be available widely, which is welcome,” Dr A S Soin, a liver surgeon at Sir Gangaram Hospital here told Deccan Herald.
Baxter, which has invested $ 200,000 in the Indian market, targets to sell the sealants for one to two lakh surgeries in premiere hospitals like All India Institute of Medical Sciences (AIIMS), Gangaram in Delhi and Manipal Hospital in Karnataka. According to the estimate, every year, around 35 lakh surgeries take place in India.
The main advantage of bio-sealant is that it is devoid of synthetic chemicals and derived from human and bovine blood products. Though both types products are manufactured in Baxter’s plants in the US and Vienna, keeping the Indian cultural sensitivity in mind, the company has decided to sell only human blood derived products in India. However, cost is the biggest bottleneck for the sealant’s wider acceptability as one ml vial costs Rs 5000 and a two-ml vial is priced at Rs 8000. “That’s why we are targeting only the high-end and complicated surgeries,” said Mr Kumar. Besides Baxter, one more company sells bio-sealants in Indian market.
Theoretically, the sealants always carry the risk of rejection by the body. “But I have used sealants in about 1000 operations and have not seen a single case of rejection,” added Dr Soin.