The decision of the Maharashtra FDA to insist on US FDA approval for manufacture of drug eluting stents (DES) and on trade licences from the state drugs control department to market them is illogical. This will only create shortage of stents, push up prices and create a monopolistic situation in the market, according to leading cardiologists in Bangalore.

Though cardiologists said there was no uniform standard in the country to ascertain the quality and safety of medical devices, they said there was no logic in using the US FDA as a yardstick to determine the quality of stents.

“US FDA is no longer the torchbearer for certifying drugs and medical devices. If all drugs had to be US FDA certified, then more than 80 per cent of them would be off the shelves,” said Dr. B G Muralidhara, chairman and chief of cardiology, Trinity Heart Hospital Private Limited, the largest user of stents among small private hospitals in Bangalore. On an average, Trinity uses between 75 and 100 stents on 60 patients a month.

“Stem cell therapy is still being debated in the US but has been accepted in the UK. Further, AIDS drugs worth millions of dollars promoted by the Bill Clinton Foundation are not US FDA approved. Making them US FDA approved would make them grossly unaffordable,” Dr Muralidhara opined.

Moreover, even advanced countries like Japan and those in Europe do not follow US FDA instead they have a stringent regulatory mechanism. Similarly, in India, the Drugs Controller General of India has to decide on the standards.

The two popular stents used in India are Taxus by Boston Scientific and Cypher by Johnson and Johnson, which are both approved by US FDA. Though there is little clinical difference between these stents and those without US FDA approval, the former costs Rs 50,000 more, making them unaffordable to most Indian patients. Over 90 per cent of the stents are not US FDA approved and the impact on healthcare and the stent market will be serious. The stents also do not justify the high cost since they are primarily scaffolding devices with the mechanical aspect constituting 95 per cent of their functioning and the clinical component a mere five per cent.

Importantly, Dr Muralidhara said stents are used for fixing the artery after angioplasty and cannot be removed. Hence, the Maharashtra FDA’s contention that used stents were implanted into patients has no basis.

Cardiologists suspect the Maharashtra FDA decision could be politically motivated and has no scientific basis. "Pharmaceutical drugs and medical devices including DES should be treated as one entity and approved by the DCGI because it should be relevant to our clinical practices," they said.

Cardiologists also opined that the move would also make it difficult to procure stents of the right length and diameter. This could force cardiologists to compromise on the quality of the procedure, averred Dr Muralidhara.

According to Dr Jay Ranganath, consultant cardiologist and paediatric cardiologist of Manipal Hospital, the Maharashtra FDA’s decision will bring down non-invasive cardiac procedures by 20 per cent and there will be an increased number of surgeries like bypass and open heart. Manipal Hospital uses between 220 and 250 stents a month and is the largest user in the corporate hospital segment.

Sources from Sri Sathya Sai Institute of Medical Sciences, Narayana Hrudayalaya, Sri Jayadeva Institute of Cardiology, a State Government-owned hospital and Mahaveer Jain Hospital stated that the Maharashtra FDA decision would seriously affect treatment of cardiac disorders, the most common complaint among Indians.