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ENFORCEMENT POWER TO NPPA

P A Francis
Wednesday, July 19, 2017, 08:00 Hrs  [IST]

A recent investigation by Maharashtra Food & Drug Administration has revealed that several private hospitals in Maharashtra are indulging in grave unethical practices such as reusing of medical devices and overcharging them while treating patients in their premises. The investigation is stated to have found that eight private hospitals reused 1,306 catheters on more than 1,000 patients and charged them as much as 77% of their retail prices. Catheters are used to clear obstructions or dilate a narrowed canal, duct or blood vessel as support devices in angioplasty procedures. The retail price of a balloon catheter is between Rs. 20,000 and Rs. 28,000 and that of a guiding catheter range from Rs. 5,000 to Rs. 10,500. The FDA report says while reusing the device is not illegal if they are sterilized but charging patients more than three-fourth of the cost of a new device is unethical. A number of medical devices used in private hospitals for various surgical procedures are cleaned and sterilised using ethylene oxide. As ethylene oxide is rather inexpensive chemical, the cost of sterilisation is negligible. In most of these cases, patients or their relatives are unaware of these unethical practices of the hospital managements. The state FDA has already approached the Department of Pharmaceuticals urging it to include catheters in National List of Essential Medicines so that this life saving device also can be brought under price control. In fact there is a need to regulate prices of all medical devices in the country as there is no transparency in the pricing of these products.
 
While price regulation of life saving products and essential medicines is necessary what is more important is how to ensure availability of these products under regulated prices to the patient community. Both in the cases of medicines and medical devices, rampant price violations are taking place in the country today. Take the case of cardiac stent pricing. National Pharmaceutical Pricing Authority brought these products under price control and fixed their prices on February 14 this year in a bid to curb huge profiteering in these products. But the benefit of the price capping of cardiac stents has not yet reached patients as most of the leading stent makers and hospital managements are finding ways to not to comply with the NPPA order. The fact is that NPPA has no enforcement powers or machinery to see that its order is complied with. Because of this dilemma, some of the state drug control administrations are taking up this responsibility on their own to implement the order. Same situation exist in the case of drug price fixation by NPPA. Hundreds of drug price fixations are challenged by the pharmaceutical companies in various courts and cases are pending for the last several years now. Therefore issuing orders of price fixation on these life saving products has no meaning without empowering NPPA or other government bodies enforce those orders effectively.

 

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