Proposal to regulate prices of non-scheduled drugs under consideration

The DoP has been informed that a proposal to regulate the prices of non-scheduled drugs has been forwarded to them by the relevant authority for consideration.

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NPPA National Pharmaceutical Pricing Authority
NPPA

Last Updated on December 31, 2023 by The Health Master

Prices of non-scheduled drugs

The Department of Pharmaceuticals (DoP) is considering a proposal to regulate the prices of non-scheduled drugs, following similar measures to cap the prices of select anti-cancer medicines and regulate the prices of medical devices such as pulse oximeters and blood pressure monitoring machines during the COVID-19 pandemic.

This proposal, previously opposed by the pharmaceutical industry, is under review as it could affect the revenue and existence of small and medium scale firms in the sector.

Proposal Forwarded to DoP for Consideration

The DoP has been informed that a proposal to regulate the prices of non-scheduled drugs has been forwarded to them by the relevant authority for consideration.

In February 2019, the National Pharmaceutical Pricing Authority (NPPA) had already capped the trade margin of non-scheduled formulations of 42 select anti-cancer medicines under the “Trade Margin Rationalization” approach.

Following this, the prices of oxygen concentrators, pulse oximeters, blood pressure monitoring machines, nebulizers, digital thermometers, and glucometers were also regulated under the same approach in June/July 2021.

Now, the proposal to regulate the prices of non-scheduled drugs is under consideration.

NPPA’s Progress and Plans for 2023-24

The NPPA, established in 1997, has only been able to regulate the prices of 20 percent of drug formulations under scheduled drugs category, while 80 percent of non-scheduled drugs remain under a 10 percent annual ceiling price.

The Committee has observed that the NPPA should put in extra efforts to ensure access to affordable medicines and medical devices by the common man.

In the meantime, the NPPA is expected to initiate various steps in 2023-24, including exploring a new pricing methodology for rationalizing the high trade margin in selected drugs, exploring schemes for reducing litigation burden, and taking old cases to logical conclusions.

Challenges in Implementation of Drugs Price Control Order

The Committee also asked about the challenges faced by the NPPA when it comes to implementing the Drugs Price (Control Order) DPCO in the States and Union Territories.

The NPPA informed the Committee that PMRUs (Price Monitoring and Resource Units) are not fully operational in some States/UTs due to non-recruitment of staff or timely renewal of their contracts and yet to be established in others.

Continuous follow-up and meetings are being conducted with senior officials of the States/UTs to resolve these issues.

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