Maharashtra FDA’s recent decision to ban Drug Eluting Stents (DES) without international quality certifications stirred up a controversy in the country on the safety and quality aspects of DES used in the country. Incidentally, the issue forced the central government to start the process of bringing medical devices under the regulatory ambit of Drugs & Cosmetics Act, 1940.

Dr S. Ajith Mullasary, Senior Consultant Cardiologist, Institute of Cardio Vascular Disease, Madras Medical Mission, Chennai, was among the few prominent cardiologists who raised concerns over the lack of laws to regulate medical devices and associated with a New Delhi based NGO’s national campaign to regulate DES.

In an interview with Gireesh Babu of Pharmabiz, he discusses the various aspects of the issue. Excerpts:

The Drug Eluting Stent issue has caused to widely discuss about the lack of laws in the country to regulate medical devices. The drug regulatory authorities are planning to introduce regulations for all sterile medical devices now. What is your opinion on this?

It is extremely good to get all medical devices under a regulatory act for quality control. Unless there are some regulatory norms, it is impossible to predict the quality of the products we are using in our patients.

I can talk about the issue with my own experience on DES. It is the most useful device to curb restenosis in coronary artery. The chances of recurrence have decreased from 20-25% to 5-9% by this device. The chances for sub-acute thrombosis are also minimized to less than 1%. The cases referred to bypass surgery have decreased by 50% in US and by 25% in India due to the DES. But as it is a device used in human being, we cannot install it without knowing its trial data. The devices approved by US FDA and CE Mark authorities are products with adequate trial data.

You have mentioned that DES is the most effective device available for reducing recurrence in angioplasty. What is the market situation of DES at present?

The picture of market situation is not precise at the moment. The only available statistics is National Angioplasty Registry Data, and since all institutions may not submit the data to the registry, the available statistics may not be correct. Roughly, about 50,000 to 60,000 angioplasty are done in the country per annum. Half of the stent used in this angioplasty are unapproved stents. The usage unapproved stents means the devices that are not approved by US FDA or the European regulatory authority. Cypher of Johnson and Johnson and Taxus of Boston Scientific are the US FDA approved stents. DES of about 20 companies is used in India at present. Among these, US FDA approves two DES and the European drug regulatory authority, CE Mark, approves three or four stents.

It is alleged that DES manufacturers are conducting unauthorized trials to generate adequate data to support their claims. What do you think about this?

There is nothing like unauthorized trials at present in India. A trial can be marked as unauthorized only if there is an authorized regulatory system to evaluate it. First there should be a regulatory body and norms. Then you can pressurize the companies to obey the rules. Meanwhile, all the other 16 DES in the market should undergo continuous clinical trials and input their date to the regulatory authority for approval. As far as I am concerned, I will not prefer to use stents without adequate data. The DES should undergo various phases of trials and the data should be made available for scrutiny by the public and authorities. Framing of regulatory rules and implementing it effectively is the need of the hour.

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.