New Delhi : In a significant move, the Drug Controller General of India (DCGI) has announced the waiver of local clinical trial requirements for certain new drugs from the USA, UK, Japan, Australia, Canada, and the EU. The announcement, detailed in order file No. DC-DT-15011 (11)/85/2024, was made on 7th August. The waiver applies to orphan drugs for rare diseases, gene therapy and cellular therapy products, new drugs used in pandemic situations, drugs for special defense purposes, and new drugs offering significant therapeutic advances over current standards of care.
This government order is expected to facilitate quicker access to critical medications for patients with rare diseases and other urgent medical conditions. The decision has been warmly welcomed by various stakeholders, including the Organization for Rare Diseases India (ORDI), a prominent advocacy group dedicated to improving the lives of people with rare diseases.
Mr. Prasanna Shirol, Co-founder & Executive Director of ORDI, expressed his gratitude towards the Government of India, the DCGI, the Ministry of Health and Family Welfare (MoHFW), and all the organizations involved in this decision. He stated, “This Government Order will not only allow easy and faster access to critical drugs required for Rare Diseases patients but also encourage and attract Global Pharmaceutical companies and Clinical Trial Companies to India.”
Background on ORDI
The Organization for Rare Diseases India (ORDI) was established in February 2014 as a Section 25 non-profit company. It operates as a patient-centered organization with a mission to enhance the health and well-being of patients with rare diseases across India. ORDI’s activities encompass awareness, advocacy, patient support, scientific research, drug development collaborations, and information dissemination.
Over the past decade, ORDI has become the collective voice for patients with rare diseases in India, influencing government policy to address the unique challenges faced by this community. The organization collaborates with national and international experts and key opinion leaders to design and implement innovative programs benefiting stakeholders in India.
Impact of the Waiver
The waiver of local clinical trials is expected to significantly impact the availability of new treatments for rare diseases in India. It will enable faster entry of drugs that have already been approved in developed markets, reducing the time and cost associated with bringing these treatments to Indian patients. This is particularly crucial for patients with rare diseases, who often face limited treatment options and long waiting periods for new therapies.
Moreover, this move is anticipated to make India a more attractive destination for global pharmaceutical and clinical trial companies. By reducing regulatory hurdles, the country can become a hub for advanced medical research and development, ultimately benefiting patients and the healthcare system.
Conclusion
The decision to waive local clinical trial requirements for specific new drugs is a landmark move by the Indian government. It aligns with the broader objective of improving healthcare access and outcomes for patients with rare diseases and other critical conditions. The Organization for Rare Diseases India (ORDI) and other stakeholders have praised this initiative, recognizing its potential to transform the treatment landscape in India and provide much-needed relief to patients.
For more information, please visit [www.ordindia.in](http://www.ordindia.in) or contact ORDI at +91 8892 555 000 or via email at contactus@ordindia.in.
