Drugs Pricing Reforms in India: In a strategic move, the Centre expands industry participation to enhance decision-making and fairness in drug pricing.

Department of Pharmaceuticals Broadens Committee by Including More Industry Groups to Ensure Pricing Balance, Availability of Essential Medicines, and Growth Incentives

NEW DELHI (India CSR): In a significant move aimed at reforming the pricing of drugs and medical devices, the Department of Pharmaceuticals (DoP) in New Delhi has issued an order to expand its committee by including a broader range of industry representatives. This expansion aims to create a more inclusive decision-making framework that balances drug pricing, ensures the availability of essential medicines, and fosters industry growth and exports.

Addressing Industry Concerns

The decision to broaden the committee’s composition follows feedback and requests from numerous industry associations questioning the initial exclusivity of representation. Previously, the core committee predominantly included representatives from a single pharmaceutical body, which raised concerns about adequate representation. The recent order dated April 22 has extended invitations to seven additional industry associations, marking a move towards a more equitable representation within the committee.

New Inductees Joining the Committee

The expanded committee will now include high-level executives and representatives from several key associations including:

Organisation of Pharmaceutical Producers of India (OPPI)
US-INDIA Strategic Partnership Forum (USISPF)
Medical Technology Association of India (MTaI)
Confederation of Indian Industry (CII)
US India Business Council (USIBC)
Federation of Indian Chambers of Commerce and Industry (FICCI)
Association of Indian Medical Device Industry (AiMED)
Federation of Pharma Entrepreneurs (FOPE)
AdvaMed
Association of Diagnostic Manufacturers of India (ADMI)
Bulk Drugs Manufacturers Association of India (BDMAI)
ASSOCHAM

These additions are aimed at diversifying the perspectives and expertise within the committee, thus enhancing the deliberations on drug pricing and regulatory reforms.

Drugs Pricing Reforms in India: Committee’s Key Responsibilities and Goals

The primary objective of the newly formed committee is to establish a fair balance between the pricing and availability of essential medications. This involves multiple tasks:

Reforming the operations of the National Pharmaceutical Pricing Authority (NPPA)
Creating a price moderation framework for medical devices
Providing incentives to reduce import dependency
Developing pricing frameworks for emerging and precision therapies to facilitate timely patient access
Overseeing the drafting of a new Drugs and Medical Devices (Control) Order that aligns with these objectives

The Role of NPPA and Current Regulatory Framework

The committee will work closely with the NPPA, which currently operates under the Drugs (Prices Control) Order, 2013 (DPCO-2013). This framework moved away from the cost-based pricing model of the Drug Policy of 1994 to a market-based approach. The committee will assess the efficacy of current regulations and propose necessary adjustments or overhauls to meet the evolving needs of the healthcare sector and patients.

Industry Response

The inclusion of diverse industry groups has been welcomed by the stakeholders, with many expressing gratitude for being recognized as pivotal players in the reform process. Anil Matai, Director General of OPPI, emphasized the importance of a balanced approach to price review. He stated, “Achieving a balanced approach to price review within the pharmaceutical and medical device sectors requires the participation of a diverse range of stakeholders in the decision-making process. As advocates of patient-centric solutions, we remain steadfast in our commitment to emphasizing the importance of striking a balance between affordability and innovation, ensuring that patients have access to life-saving treatments while incentivizing continued research and development.”

Conclusion

By involving a wider array of industry representatives, the committee is poised to make impactful decisions that will ensure the affordability of essential medicines while promoting innovation and growth within the pharmaceutical and medical device industries.