A sub-committee of the Drugs Consultative Committee (DCC) is examining the need for regulatory approval of drug eluting stents from the Drugs Control General of India. The committee has also been asked to give its recommendations to include more products under medical devices category which requires prior approval from the DCGI. The committee is yet to provide details on the same, it is learnt.
Currently, the drug eluting stents is not notified as a drug and hence it does not come under the purview of drugs control authority, Ramakrishna Gandhi, drugs controller, government of Karnataka told Pharmabiz.com Under the circumstances, the use of drug eluting stents will not be considered illegal in Karnataka or anywhere in the country, he added.
The DCGI has notified four medical devices under the Section 3 (b)IV of the Drugs and Cosmetics Act which needs formal consent for production and marketing. There was no mention of implants which includes drug eluting stents until the recent statement by the Maharashtra FDA. No drugs control department can enforce without the consent of DCGI and until the final decision on inclusion of implants in the D&C Act is taken, the State drugs control departments in the country will not be able to stop sales of stents which are used for life saving reasons, stated the Karnataka Drugs Controller.
When stents are drug coated, there is a presence of a chemical substance which needs authorization from licensing authority but since the DCC has taken a call on it, the matter is under scrutiny and a decision will be taken by them. The matter to be placed before the Drug Technical Advisory Board (DTAB) which would study the suggestions after which it will be issued for administration, he informed. In the best interest of the patients, it is vital that implants which are being embedded in the body, be it eye or ear or a cardiac stent, should necessarily require regulatory authority’s permission to ascertain quality parameters he expressed.