After capping the price of stents and knee implants, the government is now planning to further regulate the medical devices industry in the next five years. The government is now working on a proposal to formulate a pricing policy for over 6,000 medical devices like pacemakers, hearing aids, glucometers, and blood pressure instruments.
The proposal has been prioritised in the Department of Pharmaceutical’s (DoP) current five-year vision plan. The DoP is the apex body under the Ministry of Chemicals and Fertilisers that governs laws related to drugs and medical devices. The policy is placed under the ‘strategic initiatives under the price regulations’ section. According to a senior official of the DoP, the pricing control aimed to check a loophole in the import of the medical devices.
“The foreign companies sell their products directly to hospitals under institutional sales where these imported devices do not carry the maximum retail prices,” explained the DoP official. “It is one of the biggest loopholes in our system that allows hospitals to charge as much as they want for the device.”
The official added that the government hopes the policy will benefit local players. “The policy is expected to boost the sales of the domestic device makers, who have been bearing the brunt of a strong lobby between foreign companies and hospitals,” the official added. “It will also provide a boost to the Prime Minister’s Make in India campaign.”
The new policy will take into consideration some of the recommendations that a task force formed in 2014, had concluded with regard to capping prices of the medical device. For now, the discussions have just begun and they may soon reach out for stakeholder suggestions. One of the key recommendations of the 2014 task force was that medical devices should not be classified as drugs and instead called for them to be included in the Essential Commodities Act and regulated under a separate medical devices price control order (MDPCO). But its recommendations were never acted upon. Currently, the medical devices are notified as ‘drugs’ after the Modi government in 2014 announced to regulate these devices under the drug pricing and control order (DPCO).
The medical devices sector has been seeking for rationalised price regulations. “The drug policy is not useful for devices as it doesn’t address the huge price disparity in MRP for similar products nor does it discourage Indian and overseas manufacturers from using exorbitant trade margins to induce hospitals and retailing chemists from pushing their products,” said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AIMED).
“Unlike consumer products, patients do not usually have a choice on which brands of devices are used on them and hospitals usually decide this,” he added. “This decision should be based on a combination of quality and buying price of hospital and not on the basis of margins to be made for pushing a particular brand onto the hapless patient,” he said.
Source: The Print