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Maharashtra: Bring medical devices under Packaged Commodity Rules, says controller of Legal Metrology

The distributors have also been told to explain the difference between qualities of products sold and the variation in the MRP for different products, officials said.

Written by Rashmi Rajput | Mumbai |
February 26, 2017 1:41:14 am

NEARLY A month after the Controller of Legal Metrology (LMD) raided eight city hospitals for allegedly selling medical and surgical devices, such as stents, without printing details related to maximum retail price (MRP), the LMD has told the Department of Consumer Affairs to bring such devices under the purview of the Packaged Commodity Rules (PCR).

“Our recent raids have established that the medical devices, such as stents and other surgical equipments, were sold at different MRPs. With the government now ordering a cap on them, the idea of bringing them under the realm of PCR was recently discussed with the joint secretary, civil supplies of the department of consumer affairs. We are positive that the PCR will be amended,” Amitabh Gupta, additional director-general, LMD, who heads the department, told The Indian Express.

Once the rules are amended, the LMD would be able to take action against the violators, he added. In January, the LMD had raided eight hospitals, including Breach Candy, Kokilaben Dhirubhai Ambani, Lilawati, Fortis, Hiranandani, Asian Heart Institute, after the controller found a wide variation between the MRP printed on the packages, the one charged by the suppliers to the hospitals and those billed to the patients at hospitals.

In some cases, the department has also found that the devices were sold at four times the price charged by the supplier, without any value addition in services. The packaged commodities, included stents, balloon device, angiography catheter, euretic euroworld, fabric natural fiber, IV catheter, guide wire, breathic circuit, limbo single limb anesthesia, gloves and blood collector.

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The raids by the LMD also helped flag off the issue, prompting the regulators — the National Pharmaceutical Pricing Authority, or NPPA — to take note of it. The regulators have fixed the ceiling price of drug-eluting stents (DES)s and bioresorbable stents at Rs 30,000, and that of bare metal stents at Rs 7,500. The notification on the prices came into effect on February 14.

In its letter to the NPPA, the LMD had written that, “It came to our notice that the hospitals were charging different prices for stents. It varies from Rs 1.05 lakh to Rs 1.90 lakh…It is pertinent to note that the cost of import stent be much less than Rs 45,000. Also, same or similar stents were branded differently and sold at different MRP, which is not allowed.”

The agency had identified five distributors — Meril Life Science Pvt Ltd, Abbott Vascular, Bostan Scientific, Medtronic Pvt Ltd and Sahjanand Pvt Ltd. To find out the irregularities and cost escalation, the agency has sought explanation from these five, seeking details of the MRP of the products three years ago and also at the time of launch.

The distributors have also been told to explain the difference between qualities of products sold and the variation in the MRP for different products, officials said. The distributors have also been told to enlist the hospitals they supply the items to and also foot their bills of imports.

“In one case, the details of import and price of stents accessed by us revealed that, while the items were bought at Rs 40,000, they were sold to the Rs 1.30 lakh each. In few cases, we found distributors visiting the hospitals to provide the stents to the doctors, who were about to conduct a surgery. In other cases, we found that the charges of stents were 65 per cent of the actual value of the product. A patient who doesn’t have any alternative, but to buy these products, were being fleeced ,” said an LMD official.

Other than distributors, the LMD will also probe the hospitals. It has written to all the eight hospitals, seeking details on the types of stents being used, the price band for each quality of stent and the name of the supplier along with the priced charged.

“We suspect that the pricing by the hospital is not MRP. If that would have been the case the importer wouldn’t haven’t be charged one-third of the amount, as he has to foot the customs duty, which would have been high if the products were sold by them at the prices they are being sold to the patients. The prices have been inflated subsequently,” added the official.

“The patient is charged for the items used by the surgeons, who charge for the services they offer. There is no value addition in the product and it reaches in the same condition, as been shipped by the importer. So, there is an anomaly on the price by various hospitals,” said the official.

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