Jun 30 2017 : The Times of India (Chennai)
Govt goes slow on price control due to US concerns
Rupali Mukherjee
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Despite state Food and Drug Administration's of Maharashtra and Odisha investigations and hard evidence submitted to the government months ago pointing to unregulated prices and hefty margins on medical devices including orthopaedic implants, intraocular lenses and catheters, it is yet to take any decision on fixing caps. Even after multiple discussions on the issue with stakeholders, drug prices regulator, NPPA has not moved ahead on the matter, the most recent one held on Thursday , raising skepticism. The government's “go slow'' on capping medical devices' prices could be due to concerns expressed by US on ceiling prices of stents, an issue which was officially raised before Prime Minister's US visit, industry experts say .Facing months of delay , thousands of patients are forced to pay exorbitant medical bills, while hospitals and distributors continue to pocket fat margins, ranging from 40-600% on these devices.
A key proposal suggested by health activists and doctors is to include all medical devices under the definition of `scheduled drugs' under the Drugs and Cosmetics Act.“We have been asking the government to notify medical devices as scheduled drugs (to be eligible for price control) and include them in the NLEM (National list of Essential Medicines), and fix 1520% margins on their landed price (imported price)“, RPY Rao, from Society for Awareness of Civil Rights, told TOI.
Once these devices are in cluded in the NLEM, the NPPA can further notify them as scheduled drugs, and bring them under price control. The state bodies have proposed regulating prices and trade margins under the Drug Prices Control Order (DPCO) either through addition to NLEM, or use of public interest provisions contained in Paragraph 19 of the Act.
“Given that medical devices are critical, unavoidable components of healthcare, this situation of free pricing represents a massive undue burden on patients“, All India Drug Action Network (AIDAN), a group of public health activists and doctors, said.
In Thursday's meeting held on orthopaedic implants, Alliance of Doctors for Ethical Healthcare, said profit margin should not be over 10% for wholesaler, and 20% for retailer, which is already in practice. No other profit should be given to the health provider facility“.
The FDA reports provide hard evidence providing details of hefty margins at each step of supply chain and document business practices, designed to give super normal profits to hospitals, distributors and companies. In fact, original investigative reports on coronary stents (Odisha FDA, 2014 and Maharashtra FDA, 2015) provided the impetus for price control, which led to capping their prices in February this year, following years of prodding by health activists, MPs and even a public interest litigation in the Delhi high court.
A key proposal suggested by health activists and doctors is to include all medical devices under the definition of `scheduled drugs' under the Drugs and Cosmetics Act.“We have been asking the government to notify medical devices as scheduled drugs (to be eligible for price control) and include them in the NLEM (National list of Essential Medicines), and fix 1520% margins on their landed price (imported price)“, RPY Rao, from Society for Awareness of Civil Rights, told TOI.
Once these devices are in cluded in the NLEM, the NPPA can further notify them as scheduled drugs, and bring them under price control. The state bodies have proposed regulating prices and trade margins under the Drug Prices Control Order (DPCO) either through addition to NLEM, or use of public interest provisions contained in Paragraph 19 of the Act.
“Given that medical devices are critical, unavoidable components of healthcare, this situation of free pricing represents a massive undue burden on patients“, All India Drug Action Network (AIDAN), a group of public health activists and doctors, said.
In Thursday's meeting held on orthopaedic implants, Alliance of Doctors for Ethical Healthcare, said profit margin should not be over 10% for wholesaler, and 20% for retailer, which is already in practice. No other profit should be given to the health provider facility“.
The FDA reports provide hard evidence providing details of hefty margins at each step of supply chain and document business practices, designed to give super normal profits to hospitals, distributors and companies. In fact, original investigative reports on coronary stents (Odisha FDA, 2014 and Maharashtra FDA, 2015) provided the impetus for price control, which led to capping their prices in February this year, following years of prodding by health activists, MPs and even a public interest litigation in the Delhi high court.
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