Heart stents from US push costs up

Experts say flawed govt policies favour foreign medical companies

Heart attacks are increasing at an alarming rate in India with estimated deaths of around 24 lakh people every year. However, the management and treatment of heart ailments are not in the reach of the common man.

The major reason for the high cost is that most of the medical devices and implants like stents, and balloons which are used to treat the blockages during heart attack are still imported from  the US and European countries, the despite presence of many Indian companies.

Experts blame this on a biased approach against Indian products by insurance companies. Central Government Health Scheme (CGHS), which is the largest medical treatment reimbursement agency in India, has differential pricing for different stents.
In October 2011 it revised the ceiling rates for coronary stents. A stent is a small mesh tube that is used to treat narrow or weak arteries.

After the revision stents approved by United States’ Food and Drug Administration are at Rs 65,000 each. Similarly, European Commission’s CE approved are reimbursed at Rs 50,000 and stents approved by Indian Drugs Controller General of India is reimbursed at Rs 40,000.

“This makes the Indian companies lose their deserved market share. If a person knows that the stent will be reimbursed, he will obviously go for the costliest one. This is a favourable condition for American manufacturers,” said Dr K K Aggarwal, cardiologist associated with Moolchand Medcity.

CGHS is a prime body that fixes the rate for reimbursement which is followed by most of other reimbursement and insurance bodies. In India, over 70 per cent of the drug eluting stents are still imported from the United States and Europe.

Aggarwal said Indian stents are as efficient as the imported stents and there is no reason to discourage them through policy measures like this.

“Ideally the criteria for approval should be clinical data associated with products and not any country specific approvals. Indian stents which are equivalant with the American drug eluting stents should be put in the same category as US FDA approved,” he added.

He said in China, over 80 per cent of such stents used are locally manufactured.
This is majorly because of various policies of the Chinese government which favours domestic manufacturers and wants to be completely self-reliant for treating cardiac diseases with local products in the next 2 to 3 years.

US FDA approval is given only to those companies who want to launch their products in USA. Technologies by non-US companies which don’t intend to launch in US markets do not go for US FDA approval.

Also all US FDA products are not equal. There are some old generation US FDA approved mesh tubes which are still being used in India but are withdrawn in other countries. This is because US FDA approval once granted remains for the lifetime of the product despite availability of better technologies.

An Industry spokesperson said, “CE mark is a fair quality criteria and it is accessible by Indian companies. CE mark is non-discriminatory unlike US FDA and Indian companies can also get it by improving their manufacturing and quality standards.”

It is also important to mention that drug eluting stents are priced higher in India than rest of the world .The prices of these tubes are fast degrading in the world market.