Bengaluru: Karnataka’s Food Safety and Drugs Administration (FDA) has urged the Centre to regulate prices of essential medical devices to reduce patients’ out-of-pocket expenditure, proposing a national framework to identify essential devices and cap their prices.FDA commissioner Srinivas K, in letters dated Sept 18 to Drug Controller General of India (DCGI), department of pharmaceuticals and national pharmaceutical pricing authority (NPPA), proposed a National List of Essential Medical Devices (NLEMD) on the lines of the National List of Essential Medicines.The proposal covers 24 categories, including devices used in cardiovascular care, respiratory treatment, neurology, obstetrics and gynaecology, ophthalmology, oncology, radiotherapy and kidney care.The move comes amid a pricing controversy in Maharashtra, where the state FDA has flagged wide gaps between procurement costs and MRPs of commonly used hospital consumables and sought Centre’s intervention.Karnataka, however, had raised concerns weeks earlier. In an Aug 4 letter to DCGI Rajeev Singh Raghuvanshi, Srinivas had sought systematic regulation of medical-device pricing and recommended bringing approved devices under the Drugs (Prices Control) Order (DPCO) framework “to prevent unfair trade margins and protect public interest”.The letter also flagged pricing disparities in medicines, noting that several formulations were being sold at discounts of 30% to 50% from printed MRPs.For the proposed NLEMD, Karnataka suggested criteria including clinical importance, public-health relevance, frequency of use, availability of alternatives, risk classification and affordability.FDA said only a limited number of medical devices currently have specific price-control provisions and sought a wider framework to make essential devices more affordable and accessible to patients.
