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Clinical Trials
Observing clinical trials of medicines and vaccines were often carried out in poor countries, the Supreme Court on Wednesday allowed a petitioner to file submissions and objections to the rules framed by the Centre on the issue. A bench comprising Justices Hrishikesh Roy and S V N Bhatti considered the submissions of Centre's additional solicitor general Archana Pathak Dave who said rules for new drugs and clinical trials were framed in 2019. "We know that the clinical trials are conducted in poor countries," the bench said. Following the rules, Dave said New Drugs and Clinical Trials (Amendment) Rules were notified in 2024 to streamline the approval process for clinical trials and new drugs in India which aimed to improve patient safety protocols and ensure compliance with global standards. Senior advocate Sanjay Parikh, appearing for NGO Swasthya Adhikar Manch, which filed a PIL in 2012 alleging large-scale clinical drug trials across the country by multinational pharmaceutical .
India has emerged as a premier destination for conducting global clinical trials, an Indian bureaucrat who is also a Harvard scholar has said, asserting that the pharma industry must recognise the country's intrinsic value as a primary location rather than relegating it to a secondary backup role. Speaking at a recent Bio-Pharma summit in Boston, Dr Mrinalini Darswal, an Indian diplomat who is currently a PhD scholar at Harvard University, said that India "boasts a robust infrastructure, a cadre of seasoned investigators, and cost-effectiveness, collectively rendering it an appealing choice for such endeavours. The present aspirational India under the strong and transformative leadership of our Prime Minister Narendra Modi has emerged as a premier destination for conducting global clinical trials, having streamlined its regulatory framework and elevated its compliance standards to align with international good clinical practices, Darswal said. This starkly contrasts larger economies
Over the past 10 years, clinical trials in India have become easier, more accessible and accelerated, experts from the pharma sector have said as top multinationals are increasingly looking at the country as their base for clinical trials. Data from 2017 to 2023 shows that phase two and phase three clinical trials are growing at about 15 per cent to 18 per cent in India. This is primarily because of the 10 modifications done to the Drugs and Cosmetics Act of 1940, according to Badhri Srinivasan, head of Global Clinical Operations, Novartis. Novartis is one of the largest pharmaceutical companies in the world and was the fourth largest by revenue in 2022. Given where we are, given what the landscape in the international community has happened, the regulators in India are starting to move and make changes to it. Since 2013, there have been 10 modifications to that act to try to make clinical trials easier, more accelerated, more accessible, et cetera, Srinivasan said at the 18th Annua