Significant number of cancer drugs don’t fall within price control mechanisms, says report

A substantial number of cancer drugs are beyond the ambit of current price control mechanisms, the 163rd report of the Committee on Petitions observed earlier this week in its report of recommendations placed in Parliament.

With the notification of the National List of Essential Medicines 2022, the number of anti-cancer medicines under price control increased from 40 in 2011 to 63 in 2022. Nevertheless, a significant number of oncology medications are not included under the Drugs (Prices Control) Order (DPCO), 2013, and are thus not subject to any statutory price ceiling, the report said.

“This regulatory non-inclusion has led to excessive and often unaffordable pricing, thereby limiting access for a large section of the patient population,’’ it said. 

The government should undertake urgent measures to expand the scope of the DPCO to include the widest possible range of cancer drugs, the Committee on Petitions has recommended in its report. Additionally, regular and comprehensive market assessments should be instituted to monitor prevailing drug prices and availability trends, it said.

The quality of generics available in the country should be monitored and sustained since many medical professionals hesitate to prescribe generics as they are not certified under the World Health Organization’s Good Manufacturing Practices, the report said.

While provisions exist for accelerated access to new cancer drugs, the report said, regulatory delays, insufficient domestic R&D, and pricing constraints limit timely and equitable access. 

“Domestic research infrastructure should be enhanced, value-based approvals prioritised, regulatory pathways should be streamlined, and measures should be taken to support indigenous development of novel oncology therapies. The committee also recommends that the government must encourage research in the private sector and pharmaceutical companies should be encouraged to invest in high level research in oncology,’’ the report saidy.

There seemed to be a lack of synergy between private sector medical institutions and the Union Ministry of Health and Family Welfare on the procedures for approval of clinical trials in the country, report said. Therefore, the committee recommended in its report, there should be collaboration between the two so that the maximum outcomes can be gained for the larger benefit of patients.

Platforms, including 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 policymaking,’’ the report said.