Mumbai/New Delhi: As part of a global withdrawal, CoStar, an advanced heart stent from Conor Medsystems LLC, a recently acquired unit of Johnson & Johnson, which has been sold in India for the last three years, will be pulled from hospitals in the country.
But some 9,000 heart patients estimated to have had the tiny plastic-and-chromium pipe inserted into their clogged cardiac arteries will have little recourse under Indian law, which remains largely silent on the issue of control and monitoring of medical devices.
On Monday, J&J announced that it was withdrawing an application for approval of CoStar from the US food and drug administration after the stent failed to meet trial benchmarks. J&J said it would pull the product from overseas markets as well. Conor was acquired by J&J in February for $1.4 billion.
J&J said that 11% of patients with the stent had a heart attack or a repeat procedure or died within eight months, compared with 6.9% for Boston Scientific Corp.’s ‘Taxus’ device. Both devices, used to prop open diseased arteries, dispense paclitaxel, a medicine that suppresses scar-tissue growth surrounding the area the stent has been placed.
Medical specialists recommended monitoring patients implanted with the CoStar stent. “Hospitals and doctors who implanted the stent will have to track the patients, call them in and examine for any side effects. We have to be careful not to create panic among the patients. After all, product recalls do not mean that people on the device are going to collapse; it just means that some corrective steps might be required,” said Praveen Chandra, interventional cardiologist with Max Heart Institute in New Delhi.
Drug-coated stents were believed to be a major improvement over the traditional stent devices as they prevented future blockages in the same artery but recent studies have shown that they can lead to clot formation within the device. CoStar was supposed to be a breakthrough product as it emitted the drug from tiny reservoirs rather than through a coating.
CoStar, short for Cobalt chromium Stent with Antiproliferative for Restenosis, is marketed in India by Interventional Technologies Private Ltd, a marketing company based in Mumbai. It will be formally withdrawn soon, a senior J&J Asia executive said. “The company is likely to stop marketing the device in Asia and corporate information to this effect is expected soon. We may, in turn, ask the marketing partner to withdraw the inventory from domestic market,” said the executive who did not want to be quoted by name because Conor and J&J’s integration was still not completed.
Interventional Technologies spokesman George Kurien said his company had written to Conor seeking direction. But, as of late Tuesday, its marketing manager Sushil Tambe said it had not “heard anything from our principal or from the regulatory authorities here.”
“The product is approved and we have been selling it,” Tambe said, declining to comment how may CoStar stents had been sold in India. But a health-care industry analyst, requesting anonymity, estimated between 8,000 and 9,000 patients had been implanted with the Conor stent.
India’s regulator for medicine quality promised action. “We will call for a clarification from the company and no further marketing may be allowed. There is no way something like this can go on,” said M. Venkateswarlu, drug controller general.
Asked about the options for patients implanted with CoStar stents, he said it was outside the purview of Indian law that governs the regulator. “The patients can sue the company directly,” he told Mint.
Stents and other advanced devices are not covered by the Drugs and Cosmetics Act, 1940, the main law that governs pharmaceuticals and medical devices. Affected consumers will have to depend on “common law,” which is non-statutory in nature. “The original manufacturer is liable for product liability whereas the prescribing doctor may be liable for having prescribed a drug-coated stent that has not fulfilled the safety standards,” said Anand Grover, who heads the Lawyers’ Collective, a group of advocates fighting public health issues.
The issue illustrates a serious gap in Indian medical law and inaction on part of the health ministry. A 2003 report by the Mashelkar Committee had noted that “it is the responsibility of the government to regulate and assure the quality of any product marketed in the country. In the case of medical devices, which have potential health risks, this responsibility becomes even greater.” The panel recommended that “a suitable policy and a proper mechanism should be established in the office of the Drug Controller to regulate and control the quality of medical devices available in the country.” The recommendations of the panel have largely languished with little action taken by the ministry. The number of annual procedures that use stents is 75,000 in India—less than 40% of which use drug-coated stents.