MicroPort entered the market on Feb 15 and its stent was used in a Mumbai hospital.
The Shanghai-based MicroPort Scientific Corporation has entered the Indian market within days of the National Pharmaceutical Pricing Authority imposing a cap on prices of coronary stents.
This is in contrast to global giants like Abbott, which are finding it difficult to maintain their premium biodegradable stents in the market, according to distributors.
The NPPA on February 13 capped the prices of bare metal stents at Rs 7,260 and those of drug eluting stents, used in about 90 per cent of angioplasty procedures, at Rs 29,600.
The more advanced biodegradable stents introduced in India in the last two years were also capped at a price of Rs 29,600.
These include Abbott’s fully dissolvable stent, which does not leave any residue in the heart. This stent was at a little under Rs 2 lakh before imposition of the price ceiling and its import price is Rs 42,125.
MicroPort entered the market on February 15 and its stent was used in a Mumbai hospital, marking its first clinical use in the country.
“The firm has a free sale certificate in Germany and the Netherlands, and the Central Drug Standards Control Organisation has issued it approval for sale in India,” said a drug safety official.
Sale of medical equipment in India needs prior approvals from drug regulators in the US, Europe, Australia or Japan. MicroPort is eyeing a much bigger market because its stent releases drugs only to specific areas for faster healing.
“Studies undertaken on target eluting stents suggest the healing time is four months while other drug eluting stents take around one year to heal a blockage,” said a MicroPort executive. Doctors have been apprehensive about the quality of Chinese stents.
“We need a more effective system of accreditation in India. The benchmarks should be US-approved stents,” said Vivek Jawali, chairman of the department of cardiovascular sciences at Fortis Hospitals.