Inferior trials on Indian stents make them less reliable: Docs
According to a study, the reason for the lower popularity of Indian-made stents is the inferior trials on the products compared to foreign stents that are product tested to prove better safety.mumbai Updated: Apr 13, 2015 19:37 IST
Three international pharmaceutical and device manufacturing companies claim more than 50% of the national market share in stents used in cardiovascular surgeries such as angioplasty. According to a study, the reason for the lower popularity of Indian-made stents is the inferior trials on the products compared to foreign stents that are product tested to prove better safety.
The annual reports for 2013 and 2014 released by the National Interventional Council (NIC) and the Cardiological Society of India (CSI) showed the market share of the international manufacturers grew in 2014.
According to experts, the reason for the huge gap between international companies and the Indian is because of poor Indian regulation standards and lack of clinical data with regards to the efficacy of Indian-made stents.
“A key reason why stents by reputed international companies remain a preferred choice of surgeons is that the products are studied maximally. Their efficacy and safety are supported by huge data that is reassuring for any surgeon,” said Dr Praveen Chandra, president, NIC.
In 2013, the total market share of three international manufacturing companies stood at 58.94% and the rest of the market share was split among more than six Indian manufacturers. The market share of the foreign companies in 2014 grew to 59.3%. In this period, a couple of Indian companies did show an increase, but not substantial enough to claim a larger market share. Doctors said Indian-made stents are at least 15% cheaper than the foreign ones.
The Indian regulatory body requires Indian companies to prove safety of stents over six month in 100 cases, while an international company takes a trial with sample size upwards of 2,000 cases and over two to four years.
“This kind of data and trial result gives surgeons confidence. It’s not that Indian stents are not safe, but the focus on trial is poor and negligible investment is done for research and development. We just copy what others have already worked upon. We need to adopt a more scientific approach,” said Dr Ashok Seth, vice-president, Asian Pacific Society of Cardiology.