Substantial cancer drugs beyond ambit of current price control mechanisms: Parliamentary panel

New Delhi: A Parliamentary panel has flagged that a substantial segment of cancer drugs are still beyond the ambit of current price control mechanisms and recommended measures to include the widest possible range of cancer drugs by expanding the scope of the Drugs Prices Control Order.

In its 163rd report presented on Wednesday, the Committee on Petitions, Rajya Sabha, headed by Narain Dass Gupta stressed that regular and comprehensive market assessments should be instituted to monitor prevailing drug prices and availability trends.

Though significant steps have been taken in recent years towards strengthening the regulatory framework for governing the pricing of cancer drugs and promote affordability, a substantial segment of such drugs still remain beyond the ambit of current price control mechanisms, it said.

The Committee noted that with the notification of NLEM, 2022, the number of anti-cancer medicines under price control has increased from 40 (in 2011) to 63 (in 2022). However, a significant number of oncology medications are not included under the Drugs (Prices Control) Order, 2013, and thus are not subject to any statutory price ceiling.

"This regulatory non-inclusion has led to excessive and often unaffordable pricing, thereby limiting access for a large section of the patient population," it stated. Furthermore, the government may consider establishing a robust, institutionalised oversight mechanism to periodically evaluate the effectiveness of the regulatory regime and identify systemic gaps.

"Implementation of these measures will significantly alleviate the financial burden on cancer patients and their families," the panel underlined.

The Committee also recommended that the quality of generic medicines available in the country should be monitored and sustained as many medical professionals are hesitant to prescribe these as they are not certified under the WHO-GMP.

The panel also noted that while provisions exist for accelerated access to new cancer drugs, regulatory delays, insufficient domestic research and development, and pricing constraints limit timely and equitable access.

It recommended that domestic research infrastructure should be enhanced, value-based approvals prioritised, regulatory pathways should be streamlined, and measures be taken to support indigenous development of novel oncology therapies.

The Committee also recommended that the government must encourage research in the private sector and pharmaceutical companies should be encouraged to invest in high level research in oncology.

There seems to be a lack of synergy between the private sector medical institutions and the Ministry of Health and Family Welfare regarding the procedures for approval of clinical trials in the country, it noted and stressed on collaboration between the two so that the maximum outcomes can be gained for the larger benefit of patients.

The Committee also advocated for the expedited deployment of field-ready technologies such as Magna-visualisers and the nationwide scaling up of gallbladder cancer risk mapping, particularly in underserved and high-risk regions.

Concurrently, investment should be significantly increased in region-specific prevention strategies and health literacy programmes, especially in high-incidence areas as the Northeast, it said.

Platforms like the India Cancer Research Consortium should be mandated to publish annual performance and progress reports, including documentation of the extent to which research outputs have translated into clinical practice.

Mechanisms to systematically track patient outcomes and evaluate the cost-effectiveness of adopted treatment guidelines must also be instituted to support evidence-based policy making, the panel suggested.

In view of the concerted efforts being undertaken to improve treatment outcomes in India, the Committee underscored the need for targeted system-wide enhancements to ensure effectiveness, equity, and responsiveness.

It recommended the institutionalisation of periodic audits and structured training workshops to enforce uniform adherence to standard operating procedures across diagnostic and research laboratories.

The Committee noted the roll out of the National Program for Palliative Care and recommended that the spread of the same should be expanded so as to reach the maximum numbers.

It highlighted the importance of tracking the efficacy of palliative care interventions and called for the introduction of robust outcome indicators to assess the impact of the National Programme for Palliative Care on patient's quality of life. Collectively, these measures will help establish a cancer care ecosystem that is data-driven, patient-centric, and outcome-oriented, it said.

Additionally, the Committee recommended enhanced utilisation of data from the National Cancer Registry Programme (NCRP) to form state-specific health policies and a centralised Clinical Trial Outcome Registry to facilitate informed decision-making, transparency and accountability.

The panel emphasised that continued coordination between central and state governments, public-private partnerships, and community participation will be critical to sustain momentum and ensure equitable cancer care for all citizens.

According to AIIMS, Jhajjar, the population-based screening for common cancers and opening of Day Care Centres are the positive aspects of the NPCDCS programme, the panel said.

However, to make it more robust there is a need to enhance district level facilities for early cancer diagnostics and referral linkage, integrate Cancer Registry Programme and NPCDCS for data driven planning and implementation of cancer services, focusing more on cancer awareness and behaviour change activities to remove the stigma attached to cancer, it highlighted.

Further, there is a need to decentralise radiotherapy centres in districts and Day Care Centres in a phase-wise manner and they may further be involved in cancer detection and its early management, it said.