Many Cancer Drugs Outside Price Control: Parliamentary Committee Report
The 163rd Report of the Committee on Petitions, tabled in Parliament, has highlighted that a large number of anti-cancer medicines remain outside the ambit of statutory price control, resulting in high and often unaffordable costs for patients.
Key Observations
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Increase under NLEM 2022:
The number of cancer medicines under price control rose from 40 in 2011 to 63 in 2022 with the updated National List of Essential Medicines (NLEM). -
Still outside DPCO coverage:
Despite this, many oncology drugs are not included under the Drugs (Prices Control) Order, 2013 (DPCO, 2013) and therefore lack any statutory ceiling price. -
Affordability issue:
Exclusion has led to excessive pricing, limiting access for a large section of patients.
Committee Recommendations
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Expand scope of DPCO: Cover the widest possible range of cancer drugs.
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Regular market assessments: Continuous monitoring of drug prices and availability.
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Generics quality: Ensure generics meet WHO Good Manufacturing Practices (GMP), since many doctors hesitate to prescribe uncertified versions.
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Accelerated access: Address regulatory delays, limited domestic R&D, and pricing barriers that restrict timely availability of new oncology drugs.
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Strengthen domestic R&D: Enhance research infrastructure, promote indigenous development of novel cancer therapies, and encourage private sector investment.
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Regulatory reforms: Streamline approval pathways, adopt value-based approvals, and incentivize high-level oncology research.
- The National Pharmaceutical Pricing Authority (NPPA) is the government body responsible for regulating drug prices.
- The National Pharmaceutical Pricing Authority (NPPA) is a government regulatory agency responsible for controlling the prices of pharmaceutical drugs in India.
- It was constituted on 29 August 1997 through a Government of India Resolution as an attached office of the Department of Pharmaceuticals (DoP), under the Ministry of Chemicals and Fertilizers.
- Functioning as an independent regulator, the NPPA’s primary role is to fix and regulate the prices of drugs and ensure their availability and accessibility to the public at affordable rates.
- Drugs are categorized as scheduled (subject to direct price control) or non-scheduled (regulated through other mechanisms, like trade margin limits)