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CDSCO Waives Local Clinical Trials for New Drugs Approved in Developed Countries
Context:
The Central Drugs Standard Control Organisation (CDSCO) announced that it will waive local clinical trials for new drugs already approved in the United States, United Kingdom, Japan, Australia, Canada, and the European Union.
Key Highlights:
- The waiver has been granted under Rule 101 of the New Drugs and Clinical Trials Rules, 2019. This rule allows the Drugs Controller General of India (DCGI) to specify certain countries for considering the waiver of local clinical trials for the approval of new drugs.
The waiver covers five specific categories of drugs:
- Orphan Drugs for Rare Diseases: These are drugs intended to treat conditions affecting fewer than 500,000 people in India.
- Gene and Cellular Therapy Products: Innovative treatments that involve altering genes or cells to treat diseases.
- New Drugs Used in Pandemic Situations: Drugs that are crucial during pandemics to ensure rapid availability.
- New Drugs for Special Defense Purposes: Medications required for defence personnel.
- New Drugs with Significant Therapeutic Advances: Drugs that substantially improve existing treatments.
Implications:
- Faster Access to Latest Medicines: Patients in India will have quicker access to cutting-edge treatments for diseases such as cancer, rare diseases, and autoimmune disorders.
- It will reduce the costs associated with public procurement of drugs under various government schemes like Ayushman Bharat. It will also lower the expenses for pharmaceutical companies by eliminating the need for local trials.
- Both domestic and foreign drug manufacturers will benefit from an expedited approval process, facilitating faster access to essential medications for Indian patients.
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