Currently, the NPPA follows the regulations which are outlined in the Drugs (Prices Control) Order, 2013 (DPCO-2013) for the prices of medical equipment and medications which are categorized as drugs. In 2012, the National Pharmaceutical Pricing Authority replaced the “cost-based” pricing system outlined in the Drug Policy of 1994 with a “market-based” pricing mechanism, which consequently led to the implementation of the Drug Price Control Order of 2013 (DPCO-13). These strategic adjustments are pivotal components of the ongoing India Drug Pricing Reforms, seeking to enhance healthcare affordability and access.
Medical device associations are advocating for a unique regulatory framework, highlighting the sector’s specific challenges and diverse product range. The demand stems from the need for regulations that account for the varying complexities and uses of medical devices, distinct from pharmaceuticals. While the NPPA regulates drug pricing, including setting caps for essential medicines and limiting price hikes for others to below 10% annually, this demonstrates a focus on affordability
On 12th March 2024, the Ministry of Chemicals and Fertilizers of India, through its Department of Pharmaceuticals (Pricing Division), announced the constitution of a committee to reform the pricing framework for drugs and medical devices through a gazatte reference number F. No.31026/23/2023-Pricing I/7704/2024.
The Government has decided to constitute a 3 core members and 2 special invitees as below to to oversee the pricing reforms for drugs and pharmaceuticals in India –
- Secretary, Department of Pharmaceuticals
- Chairman, National Pharmaceutical Pricing Authority
- Senior Economic Adviser, Department of Pharmaceuticals
- Secretary General, Indian Pharmaceutical Alliance (Special Invitee)
- Chief Executive Officer, Indian Drugs Manufacturers Association (Special Invitee)
Terms of Reference
The committee is anticipated to deliver its report within a span of three months. Their objectives include the following:
- Institutional Reforms within the NPPA
- Balancing price and availability of essential medicines whilst providing incentives
- Creating a framework for moderating prices of medical devices.
- Framework for emerging and precision therapies
- Drafting a new Drugs and Medical Devices (Control) Order
Conclusion
The efforts towards reforming the pricing framework for drugs and medical devices represent a critical advancement in India’s regulatory domain, aligning with global trends of ensuring healthcare affordability and accessibility. Morulaa stands ready to assist manufacturers and importers in navigating these new regulations, offering expertise in achieving compliance with the evolving regulatory requirements of the CDSCO. This support facilitates seamless market access for medical products, particularly when navigating the CDSCO’s registration processes for medical devices. For more information on how Morulaa can help you adapt to these regulatory changes in the Medical Device sector in India, contact us at [email protected] or click here to learn more about our services in the regulatory and registration spheres.