AiMeD Demands Separate Pricing Policy for Medical  Devices Industry

This assertion comes in response to the DoP forming a committee to draft a price control order encompassing drugs and medical devices.

The Association of Indian Medical Devices Industry (AiMeD) has underscored the necessity for a distinct pricing mechanism and regulatory framework for the medical devices sector.

This assertion comes in response to the Department of Pharmaceuticals (DoP) forming a committee to draft a price control order encompassing both drugs and medical devices.

Regarding the industry’s stance, Rajiv Nath, forum coordinator, AiMeD, said, "The domestic medical devices industry wants a separate regulatory framework and a separate pricing mechanism distinct from how drugs are regulated in the country."

Elaborating further on the industry's proposal, Nath advocated for price regulation based on trade margin monitoring instead of price control.

He proposed a graded, non-disruptive regulatory rationalization at the initial point of entry into the supply chain, applicable to imports and ex-factory prices.

Additionally, Nath highlighted the industry's desire for a level playing field with overseas manufacturers, emphasizing the distinction between Indian manufacturers and importers of foreign medical devices.

Formation & Mandate of the Committee

The DoP has taken proactive steps by constituting a committee tasked with reforming the pricing framework for drugs and medical devices in the country.

Headed by Arunish Chawla, secretary, DoP, the committee includes core members such as Kamlesh Kumar Pant, chairman, the National Pharmaceutical Pricing Authority (NPPA), and Awadhesh Kumar Choudhary, senior economic advisor, DoP.

Additionally, the committee comprises two special invitees from the industry, representing the Indian Pharmaceutical Alliance (IP Alliance) and the Indian Drugs Manufacturers' Association (IDMA).

The committee is entrusted with several crucial objectives, including institutional reforms for the NPPA, ensuring a balance between the price and availability of essential medicines, incentivizing industry growth and exports, and designing a price moderation framework for medical devices.

Furthermore, the committee aims to facilitate the timely availability of emerging and precision therapies to patients in need.

Parliamentary Standing Committee's Recommendations

In a related development, the Department-related Parliamentary Standing Committee on Chemicals and Fertilizers recommended the inclusion of medium and high-end medical devices used for critical patient care under the National List of Essential Medicines (NLEM).

The committee highlighted the importance of listing devices essential for critical patient care, stressing the need for price control measures to ensure accessibility and affordability.

Furthermore, Parliament’s Department-related Standing Committee on Chemicals and Fertilizers recently proposed measures to support domestic manufacturing of medical devices.

The recommendations include reducing GST rates, providing short-term custom-duty concessions on imported components, and extending the Phased Manufacturing Programme (PMP) to cover a broader range of medical devices.

The call for a separate pricing mechanism and regulatory framework for the medical devices industry reflects the sector's unique needs and challenges.

As the committee appointed by the DoP delves into reforming the pricing framework, it is imperative to consider the diverse perspectives of stakeholders to ensure equitable and effective regulations.

The recommendations put forth by industry bodies such as AiMeD underscore the importance of fostering an enabling environment conducive to innovation, affordability, and accessibility in healthcare.