As 2015 comes to a close, Frost & Sullivan experts and thought leaders gather together to predict the top 10 trends to expect during the coming year.
The government has been contemplating to bring some price control on critical medical devices in the country from last year in the context of repeated complaints of overcharging of these products by the patient groups. The MNCs have been freely importing and selling medical devices either directly or through their agents at exorbitant prices and making huge profits with the support of hospital managements and medical professionals as hardly 30 per cent of this class of products are indigenously produced. As a first step to have some regulatory control on this class of products, the government had classified 14 medical devices like cardiac stents, drug eluting stents, orthopaedic implants, etc. as drugs and placed them under Drugs & Cosmetics Act some time ago. But these products still remained outside any price control. And only in last April, a Task Force, set up by the Department of Pharmaceuticals (DoP), recommended framing of a separate price control order for medical devices and placing them under the Essential Commodities Act. The Task Force also recommended to formulate a Medical Device Regulatory Act, to treat these products distinctly from drugs and make a separate chapter for medical devices in the D&C Act. And the action on these proposals from DoP has been rather slow all these months.
Now as a first step towards bringing price control on medical devices, DoP had called a meeting of all stakeholders last month. In the meeting the government objective was conveyed to the industry and made it clear that imported medical devices would be brought under price control first on account of their very high prices. At the meeting, the officials directed all importers and manufacturers to submit their maximum retail price to the National Pharmaceutical Pricing Authority (NPPA) by November 30 and to ensure that all packs of medical devices carry the MRP. After submission of the price lists NPPA will decide the price caps on each of these devices on the basis of a formula which is being worked out. It is important that some kind of price parity of indigenously made medical devices and imported products is maintained through this exercise so that the patients are not fleeced. For this a transparent labelling policy for these products with display of MRP inclusive of all taxes needs to be adopted. An unethical practice has been existing in this industry by way of putting removable stickers with MRP on shelf packs and that was being substituted by traders. There is a need to eliminate this illegal activity from the trade by way of regular inspection of these products at the trading points by the officials. Apart from monitoring prices, the health departments in the states have to be also vigilant about the quality of materials used in the manufacture of medical devices and their manufacturing processes. For this, standards and specifications for these materials need to be laid down and enforced.
A small, experimental wearable device has moved a step closer to helping patients who rely on kidney dialysis, according to a report.
For patients with kidney failure, the common treatment is to be hooked up to a dialysis machine at a hospital or clinic several times a week. In addition to the inconvenience, patients develop buildup of fluids and minerals between dialysis sessions, which can result in high blood pressure and breathing problems and require severe dietary restrictions.