Clinical Trials

CDSCO eases NOC norms to speed up clinical research and pharma exports

India's drug regulator is withdrawing export NOC requirements for SRA markets and easing other low-risk approvals, even as it strengthens oversight of manufacturing quality

Miltenyi Biotec weighs local CGT manufacturing, eyes export potential

German biotech firm explores hospital-linked cell and gene therapy manufacturing in India while assessing long-term opportunities in regional CGT production, training and exports

Draft rules scrap provisional ethics committee registration stage

Health Ministry proposes removing provisional registration for ethics committees, shifting to single-stage approval to streamline clinical research and cut regulatory delays

MNC drugmakers push for 10-year exclusivity period for trial data

Global pharma companies represented by OPPI are urging the government to grant 10 years of exclusivity over regulatory trial data for first filers of novel drugs

Health ministry looks to reduce drug development, approval timelines

The Union Health Ministry has proposed amendments to NDCT Rules 2019 to reduce test licence timelines from 90 to 45 days and ease approvals for BA/BE studies

Japan's Takeda weighs India for global trials to speed up drug launches

Takeda is also open to partnering with local academia, healthcare providers and technology firms in India for innovation, Das said, without sharing more specifics

Biocon Biologics secures multiple market access coverage for Yesintek in US

Biocon Biologics' biosimilar Yesintek is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, and promises a cost-effective treatment

Eli Lilly's first weight-loss pill shows success in initial Phase 3 trials

Lilly CEO says if approved, drug could be manufactured and launched at scale globally

India should expedite efforts to become full ICH member: ISCR president

Policymakers should establish dedicated clinical research units within premier institutions like Aiims and NIPERs, regulatory authorities too would need support in developing their domain expertise

Alkem Laboratories eyes bigger pie of diabetes, weightloss market

Semaglutide, an active ingredient in drugs like Ozempic and Wegovy, is owned and produced by Novo Nordisk and is set to go off-patent in India in March 2026

Vaccine makers can add clinical trial sites through Sugam, says CDSCO

The recent notice brings applications for biological products such as vaccines and recombinant deoxyribonucleic acid (rDNA)-based drugs under the online ambit

Rewrite clinical trial rules to boost mkt share: Healthcare experts to govt

As of 2022, India held an 8% share in global clinical trials - which evaluate the safety and effectiveness of new treatments - compared to China's 29%

India on verge of becoming trials hub, says clinical research firm exec

The US-based company plans to boost its headcount in India by more than 2,000 over the next three to five years

Venus Remedies to co-develop antibiotic resistance blocker with UK firm

Clinical trials to start next year, and drug can be in market by 2031-32

Clinical trials of medicines often done in poor countries, says SC

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 .

Study shows severe Covid infection may shrink cancer tumours in mice

The implications of this study extend beyond COVID and cancer. It shows how our immune system can be trained by one type of threat to become more effectiCancerve against another

May look to bring Liraglutide via clinical trial waiver: Mazumdar-Shaw

Kiran outlines how being vertically integrated puts Biocon in a strong position

Clinical trial waiver only if drugs have greater benefits, says govt

A senior official in the health ministry said that the rule will help to make available essential drugs that have a significant therapeutic advance over the current standard care

Approval timelines for clinical trial applications back to pre-Covid days

During pandemic, process was faster and nods for Covid-19 trials came in 30 days

India premier destination for global clinical trials, says Harvard scholar

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