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Waiver of local clinical trial requirements by CSDSO a well-deliberated move: Shweta Rai

Nandita Vijayasimha, Bengaluru
Wednesday, August 28, 2024, 08:00 Hrs  [IST]

Waiver of local clinical trial requirements is a well-deliberated move by the Central Drugs Standard Control Organization (CDSCO). This being for drugs already approved in well-regulated markets, will help bring medicines to patients with high unmet needs much quicker than before, noted Shweta Rai, managing director India and country division head South Asia, Bayer Pharmaceuticals.
 
This regulatory flexibility is expected to create a more efficient way for delivering essential medications to Indian patients. It opens up more positive possibilities for patients with specific health challenges like rare diseases and cell and gene orders. It will offer respite in health crisis and allow the introduction of medications that offer substantial improvements over existing treatments for varied conditions. Gaining access to these innovative drugs will expand the portfolio of treatments available for Indian patients and healthcare providers to choose from, she added.
 
The reduction in waiting time between the launch of a critical drug globally or in the country of origin, and access for patients on Indian soil speaks positively of the government’s focus on health. When it comes to patients, this move will help arrest or slow down the progression of the disease burden therefore offering brighter outcomes or improved economics, for many patients, who may have had to wait long durations for a drug to become available in India. The waiver also translates into access to best-in-class drugs and innovative therapies that can offer Indians even better health outcomes, Shweta Rai told Pharmabiz in an email.
 
Bayer has had an active clinical trials presence in India and this has helped secure the confidence of millions of patients over the years. We have often fast-tracked launch of critical drugs from our innovative global portfolio and this decision helps accelerate our mission of health for all, with a focus on catering to areas of high unmet needs with a first or best-in-class benefit.
 
Highlighting the trends, challenges and impact of this decision, Shweta Rai said: “The decision also helps pharma companies redirect energies and resources away from conducting local or Indian clinical trials, and towards ensuring better reach to patients across the length and breadth of the country through effective partnerships, education and awareness among HCP’s, patient assistance programmes and other efforts.
 
This waiver establishes the Indian government’s belief in the need for robust clinical trial processes and trust in the stringent regulatory standards in the select international countries of US, Britain, Japan, Australia, Canada and the EU that have a high focus on transparency, safety standards, and regulatory compliance.
 
We are confident this move will see great success and will further encourage the authorities to extend this waiver to a wider range of drugs, so that a larger pool of patients can benefit from faster access and quality drugs to depend on. It marks a significant advancement in India’s regulatory framework. This change is expected to accelerate the approval process for innovative therapies, potentially reducing the time needed for these treatments to reach the Indian patients, she noted.
 
We view this development as an opportunity to accelerate access to breakthrough treatments that can make a meaningful difference in patient care. The waiver will expedite the availability of orphan drugs, gene and cellular therapy products, drugs having significant therapeutic advance, and demonstrates government’s commitment to integrate innovative solutions into patient care more swiftly, stated Shweta Rai.

 

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