What are the basic matters that have to be considered while framing the rules to regulate stents?

The device should go through safety animal data, human safety trials, efficacy trials and should be submitted to the regulatory authority seeking approval. The regulatory authority must check the data and decide whether the product should be approved or not. But it will take some time to prepare such norms independently. Since it is urgent to form some regulatory measures, I think, most probably the authorities should adopt the norms from US FDA and CE Mark. I personally feel this would be the best option.

One thing we have to keep in mind is, though the global market for DES is of approximately five million US dollars, only two companies have succeeded to get clearance certificate from US FDA. The same is the case in other countries. This shows that it is not easy to prove the efficacy of these drug eluting stents to attain approval. When we are ready with regulatory measures for such devices, we should make it sure that the indigenous stents should also go through various phases of trials. The phases of trials can be done in a very reasonable cost in India and if the Indian stents are found valuable, it would be a boon for the Indian patients because of the lower cost.

There are allegations that the manufacturers of DES are dumping the device to their distributors without sufficient trials and the dealers are using some shortcuts to distribute it to doctors. What do you think?

As I have said earlier, the question of trials is irrelevant as far as there is no regulatory authority and regulatory measures. I think the allegation about the dealers is also vague, as almost all the medical devices are directly distributed by the dealers to the hospital authorities.

Doctors like me will never buy a product without adequate data. I think most doctors are of the same opinion, since the matter is related with his patient. The central core of the matter is not whether the particular product is good or bad, but it is the reliability of the stent, which is enforced by adequate regulations. All the matters related to distribution and usages are secondary issues.

(Ref : Chronicle Pharmabiz September 15, 2005)