An implication of this regulatory update is the tying of drugs listed within the DCA to the Essential Commodities Act, which means that the DCGI will be able to implement price controls for these medical devices.
The Drug Technical Advisory Body, the country’s highest drug advisory body, has approved the proposal of the Union health ministry to include nebulisers, blood pressure monitoring devices, digital thermometers and glucometers under the purview of the Drugs and Cosmetics Act (DCA). The decision will enable the Drug Controller General of India (DCGI) to regulate the prices, supply, import, manufacture and sale of these devices under the Medical Devices Rules of 2017. An implication of this regulatory update is the tying of drugs listed within the DCA to the Essential Commodities Act, which means that the DCGI will be able to implement price controls for these medical devices. It is unclear as to the profit margins generated by sellers of these devices, or their manufacturing cost, but capping the prices of medical devices, indeed any product, is a bad idea since its eventual result is the lowering of supplies.
By way of example, it has been nearly two years since the price of cardiac-stents was price-capped by the government and a report shines light on how the enforced price control did not, in fact, lead to greater accessibility for patients. 80% of the government hospitals surveyed in the study reported no change in the number of angioplasties while, in the remaining 20%, the increase was limited to a low 2-5%. More important, as an expose by The Indian Express showed, there are huge lacunae in the quality of stents and other medical devices—like hip and knee replacements; so while the government was focusing on only prices, the greater problem was the near absence of any type of effective quality control. The cap possibly also drove out top-notch devices from the market, like Abott did with two of its stents post the government notification. In an ideal situation, the government should focus only on strict quality control, and in cases when it feels the prices are too high, either negotiate with suppliers for bulk discounts to government hospitals or, in case there are no alternatives, give a cash subsidy to poorer patients.