Last Updated on August 17, 2024 by The Health Master
Drug Approval
In a landmark decision aimed at accelerating drug approval process, India’s Central Drugs Standard Control Organization (CDSCO) has announced a significant relaxation of clinical trial requirements for certain drugs.
This move, approved by the central government, is expected to revolutionize the healthcare landscape in the country.
Waiver of Local Clinical Trials
Under the newly amended New Drugs and Clinical Trial Rules, 2019, drugs approved in select, highly regulated markets can now bypass local clinical trials in India, subject to specific conditions.
This expedited drug approval process applies to drugs manufactured in the United States, United Kingdom, Japan, Australia, Canada, and the European Union.
Prioritized Drug Categories
The CDSCO has identified five key categories of drugs eligible for this accelerated drug approval:
- Orphan Drugs: Medications for rare diseases that often face significant development challenges.
- Gene and Cellular Therapies: Cutting-edge treatments with the potential to cure previously incurable diseases.
- Pandemic-Related Drugs: Medications urgently needed to combat public health emergencies.
- Defense-Specific Drugs: Drugs developed for use by the armed forces.
- Drugs with Superior Therapeutic Advancements: Medications offering significantly better treatment outcomes than existing options.
A Boon for Patients and Industry
Anil Matai, Director General of the Organization of Pharmaceutical Producers of India (OPPI), has lauded the government’s decision.
He believes this move will significantly benefit both domestic and foreign pharmaceutical companies by streamlining the drug approval process.
Ultimately, it will lead to faster access to life-saving medications for Indian patients.
Industry Calls for Broader Scope
While welcoming the initiative, OPPI also emphasizes the need for expanding the waiver to a wider range of therapeutic areas.
By doing so, India can further enhance its position as a global healthcare hub and improve patient outcomes.
Additionally, the industry seeks clarity on the criteria for determining drugs with “significant therapeutic advancements.”
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
CDSCO approval granted for Beyfortus in India
India seeks new Head for Drug Regulators CDSCO
DCGI announces Stringent Measures and Digital Transformation Plans
Latest Circulars, Notices & Guidelines: CDSCO, DCGI
CDSCO Panel approval granted for this Anti Cancer Drug
DCGI approval granted for this new Antibiotic Drug Combination
Gujarat FDCA Launches Crackdown on Fake Drugs: Special Flying Squads Formed
Govt Job: For Pharmacists in Indian Railways – 246 posts
USFDA warns of Quality Issues with Chinese Plastic Syringe
Data integrity is the biggest issue in Pharma Industry: USFDA official
USFDA issues OAI Classification to Aurobindo Pharma Bhiwadi Facility
Indian Pharma industry urges NPPA for stable drug pricing policy
IPHEX 2024: Your Gateway to Indian Pharma Market
Indian Govt implements Pharma PLI scheme worth Rs 15,000 Cr
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
