Centre Forms Committee to Revise Drug & Medical Device Pricing Framework

The committee has been specifically tasked with designing a price moderation framework for medical devices and emerging and precision therapies.

In a bid to overhaul the pricing process for drugs and medical devices, the central government has established a committee tasked with bringing about significant changes in the sector.

The committee, comprising key stakeholders from both the government and the pharmaceutical industry, is set to introduce reforms aimed at balancing the price and availability of essential medicines while fostering growth and exports.

The newly formed committee comprises three core members: the secretary and the senior economic advisor of the Department of Pharmaceuticals (DoP), along with the chairman of the National Pharmaceutical Pricing Authority (NPPA).

Additionally, two industry representatives, including the secretary-general of the Indian Pharmaceutical Alliance and the CEO of the Indian Drugs Manufacturers Association, have been included in the panel.

According to the official documents, the committee's terms of reference encompass several crucial objectives comprising institutional reforms within the NPPA.

This move seeks to maintain a balance between the price and availability of essential medicines and provide incentives to the pharmaceutical industry to sustain growth and enhance exports.

Focus on Medical Devices & Precision Therapies

The committee has been specifically tasked with designing a price moderation framework for medical devices and emerging and precision therapies.

This initiative aims to facilitate timely access to these vital medical interventions for needy patients. Notably, many medical devices and precision therapies currently need to be covered under existing pricing policies, such as the National List of Essential Medicines (NLEM).

Moreover, the government's decision to form this committee has been met with approval from various quarters, including the medical fraternity.

Commenting on the development, a senior doctor highlighted the significance of including medical devices and precision therapies in the pricing framework.

"Most medical devices aren't covered under the National List of Essential Medicines (NLEM). Similarly, precision therapies used in the treatment of diseases such as cancer aren't covered under any price fixation policy currently. The govt decision to form a committee to explore this option is a welcome move," the Dr stated.

The absence of coverage for such crucial treatments under existing policies underscores the necessity for reforms in this domain.

Timeline for Report Submission

The committee has been entrusted with the task of submitting its report within three months. This indicates a sense of urgency in addressing the pricing challenges faced by the pharmaceutical and healthcare sectors.

By streamlining the pricing process and ensuring equitable access to essential medicines and medical devices, the committee's efforts are poised to significantly impact healthcare affordability and availability in the country.

In another development for the medical device industry, just days back, the DoP announced a revision of production-linked incentive (PLI) guidelines to promote the manufacturing of bulk drugs and medical devices.

The latest revisions primarily focus on the scheduled commercial operation date (SCOD) and the invocation of bank guarantees, introducing measures to enhance operational efficiency and accountability within the schemes.

A decision by the Empowered Committee, the governing authority for the PLI schemes, followed this move during its June 9, 2023 meeting.