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Move to relax clinical trial norms will cut Indian pharma's human studies cost, lower drug prices for patients

Nandita Vijayasimha, Bengaluru
Friday, August 23, 2024, 08:00 Hrs  [IST]

The recent regulatory developments to relax clinical trial norms in India are poised to have a significant impact on the pharmaceutical industry and drug pricing. By easing regulations, Indian pharma could see a reduction in the costs associated with human studies. This, in turn, could lead to lower drug prices for patients, making medications more affordable.

Gaurav Gupta, vice president, engineering and head of healthcare & life sciences, GlobalLogic said, the waiver of clinical trials for specific drug categories is expected to bring several advantages for Indian pharma. It will enable faster market entry for innovative drugs. This can attract more foreign pharmaceutical companies to invest in India, leading to technology transfer, job creation, and boost the overall healthcare ecosystem. It will strengthen India's position as a global pharma hub.

While this waiver offers significant benefits, it also comes with responsibilities. The industry and regulatory bodies need to ensure robust post-market surveillance to monitor the safety and efficacy of these drugs, he added.

Drug manufacturers will need to establish robust systems to monitor safety and efficacy of drugs once they enter the market, including collecting and analyzing adverse event reports.

There will be a need to implement comprehensive risk management plans to identify and mitigate potential risks associated with the drug. Besides, adherence to good manufacturing practices (GMP) and other quality standards is crucial, Gupta told Pharmabiz.

From a regulatory authority perspective, information dissemination is key to provide clear and timely information to healthcare professionals and patients about the benefits and risks of these drugs. The enforcement action should be stringent against companies that violate regulations or compromise patient safety, he noted.

Safety and efficacy for Indian patients is critical because of the genetic, environmental, and lifestyle differences between Indian and western populations. Local trials have traditionally been crucial in identifying these variations.

Gupta also noted that the new policy might hinder the growth of India’s burgeoning clinical research industry, which has been steadily building a robust infrastructure. Moreover, solely relying on foreign clinical trial data might not align with India’s ethical and safety standards. Ensuring informed consent and safeguarding patient interests need to be a priority.

With different countries have varying regulatory standards, it is essential to ensure that only drugs meeting the highest safety and efficacy standards are approved in India without local trials.

While the waiver might reduce drug costs, it could also increase competition from foreign manufacturers, impacting the market share and profitability of domestic pharmaceutical companies, he said.

All said this policy shift could indeed mark a new era for the Indian pharmaceutical industry, but it demands careful execution and vigilant monitoring to ensure it truly benefits Indian patients and the broader healthcare system, said Gupta.

Stating that GlobalLogic has an Intelligent Clinical Trials’ platform, Gupta said that advent of artificial intelligence (AI) is reshaping the medical research landscape, especially in clinical trials, by addressing two challenges: patient recruitment and data management. The platform helps extract ideal patients within an EMR (electronic medical record) system or other recruitment databases and match them with complex clinical trial criteria, thus minimizing the effort spent on numerous outreach events like calls and physical exams and saving time and money. Automated data collection produces usable, real-time information through wearable devices, sensors, video capture, etc. Chatbots allow patients to ask questions and get answers instantly.

 

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