The Hindu Business Line : HC orders DCGI to regulate medical devices in 3 weeks

THE Bombay High Court has directed the Drug Controller-General of India (DCGI), the central regulatory authority, to come out with a notification regulating the segment in three weeks.

In the absence of a drug licensing authority that gives permission for medical devices, how is it that stents are being used in India, asked the Chief Justice of the Bombay High Court, Mr Dalveer Bhandari, repeatedly expressing his surprise that critical devices such as heart valves, stents, etc., were unregulated in the country.

The Divisional Bench comprising Mr Chief Justice Bhandari and Mr Justice S. Vazifdar also directed the Maharashtra Food and Drug Administration (MFDA) to process the applications of two domestic stent manufacturers, Shruti Medi-Science Pvt Ltd and Vascular Concepts.

Both the DCGI, Mr Ashwini Kumar, and the MFDA Commissioner, Mr Ramesh Kumar, were present in the court.

The Chief Justice's observations and the subsequent directives were issued during a hearing on petitions filed by Mumbai-based Shruti Medi-Science and Bangalore-based Vascular Concepts against a Maharashtra FDA order banning the sale of drug-coated stents in the State.

The MFDA's contention was that drug-coated stents needed to get a drug licence from the DCGI.

However, with its notification regulating the segment still be issued, the DCGI was of the opinion that drug-coated stents were medical devices and did not require drug licences.

Stents are thin steel wires inserted into blood-vessels to remove blockages and drug-coated stents prevent the blockages from recurring.

The issue had been stirred up in the first place when the MFDA banned Shruti Medi-Science from selling the drug-coated stents that it imported from a Netherlands-based company.

In the interim period, when stent manufacturers were waiting for clarity from the DCGI on whether they had to get a drug licence or not, the MFDA allowed the sale of drug-eluting stents that had USFDA or European CE certification, so that patients would not be inconvenienced.

Subsequently, Shruti and Vascular Concepts independently resorted to legal recourse to be allowed to locally sell the product again.

The case will next be heard on October 14.

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