Tag Archives: FDA

Maharashtra and Odisha FDA Reports showcase huge profits in medical devices

In a widely celebrated move that was expected to benefit heart patients, the National Pharmaceutical Pricing Authority (NPPA) capped the prices of coronary stents in February 2017. Unfortunately, prices of all other medical devices with the exceptions of condoms and IUDs remain unregulated.  

Given that medical devices are critical, unavoidable components of healthcare, this situation of free pricing represents a massive undue burden on patients. A recent spate of media reports confirm widespread financial exploitation of patients with respect to commonly used devices such as intraocular lenses, catheters, orthopedic implants and surgicals.  

In the last month the NPPA has undertaken an exercise to gather data for 19 medical devices that are classified as ‘drugs’ under the Drugs and Cosmetics Act, 1940, in order to monitor their prices. However these data have not yet been made public.       

A lesser known fact is that the Food and Drugs Administrations (FDAs) of Maharashtra and Odisha states have carried out multiple investigations into the pricing and marketing of medical devices over the last several years. In fact, original investigative reports on coronary stents (Odisha FDA, 2014 and Maharashtra FDA, 2015) provided the impetus for price control. 

In the interest of increasing transparency and making the data and findings of these investigations available to the public, we are publishing the reports of the state FDAs. 

We are thankful to Mr. R. P. Y. Rao, Society for Awareness of Civil Rights, Mumbai for the reports of the Maharashtra FDA which were obtained through RTI requests.

The documents

The FDA reports are replete with data for a wide spectrum of devices including coronary and peripheral stents, intraocular lenses, cochlear implants, pacemakers, catheters, syringes and needles. The studies provide hard evidence of hefty margins at each step of the supply chain and document business practices designed to give super profits to hospitals, distributors and companies. 

On the basis of these studies, the FDAs have repeatedly sent recommendations to the Central Government aimed at increasing affordability of medical devices and curtailing the extortion of patients. A key proposal has been to bring in more medical devices under the definition of ‘drugs’ under the Drugs and Cosmetics Act which would further permit regulation of their prices. The state bodies have proposed regulating prices and trade margins under the Drug Prices Control Order (DPCO) either through the route of addition to the National List of Essential Medicines or the use of public interest provisions contained in Paragraph 19.  

Maharashtra FDA

Recommendations based on Study Report on Pricing of Balloon Catheters and Guiding Catheters, June 2017

Study of surgical equipments/instruments, medical devices not under the purview of DPCO, 2013 and proposal to Central Government to notify them as ‘drugs’ and bring them under the DPCO (2013), June 2017

Enquiry report on pricing of stents, May 2015

Proposal to notify certain medical devices as ‘drugs’ under Drugs and Cosmetics Act (1940), August 2011

Note on Life Saving Medical Devices & Anticancer drugs, Antibiotics & Anticoagulants which are sold at exorbitant prices

Odisha FDA

Recommendations based on Detailed Survey Report on Medical Devices, December 2014

The documents mentioned above can be accessed at the Dropbox hosted folder available here: https://www.dropbox.com/sh/db1f6q4l8fh07my/AAB2no7wf5m2NfGxDdFz8hqBa?dl=0 

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