Clinical Trials

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

India becoming attractive for clinical trials, says pharma industry leaders

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

Veeda Clinical Research buys European CRO Heads for an undisclosed sum

Veeda expands its footprint across major regions and will gain expertise in late-stage oncology trials

AstraZeneca to import critical drugs to India, focus on cancer therapies

AstraZeneca is currently conducting 50 clinical trials in India

IIL launches first indigenously developed Hepatitis A vaccine, 'Havisure'

Hepatitis A is a viral infection primarily spread through the fecal-oral route, meaning that it is transmitted through the ingestion of contaminated food or water

China health ministry for more fever clinics to combat mystery illness

Both SARS and Covid-19 were first reported as unusual types of pneumonia

Russia's loss can be India's gain in clinical trial shift, say experts

India's contribution to global clinical trials has been around 4 percent in the last decade while it's the second most populous country in the world, and has one-fifth of the global disease burden

'Malaysia, Korea are preferred to India as global clinical trial sites'

There is intense competition to have these studies on advanced or complex unmet medical needs in a country

R21/Matrix-M malaria vaccine: What it is, and when will it roll out?

The R21/Matrix-M malaria vaccine is an easily deployable vaccine that can be manufactured at a mass scale with a modest cost

Bharat Biotech plans to invest Rs 3,000-4,000 crore in post-Covid shift

Not thinking about an IPO as of now, says chairman