'Half Of The Drug Eluting Stents Used In India Lack Adequate
Trial Data'
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.
Continued
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