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India Today
6 days ago
- Health
- India Today
Covid-19 cases rising: What is the status of India's vaccine stockpile?
As cases of Covid-19 show signs of resurgence, sources in the government have assured that India has enough vaccine stockpile for its citizens and support exports to other countries, if 1,010 active cases were recorded as of May 26, with new infections reported from Noida, Lucknow, Karnataka, Mumbai, Arunachal Pradesh, and Varanasi, raising concerns of another potential sources told India Today that there is an ample stockpile of Covid-19 vaccines ready for deployment. "We are fully prepared for any situation. We have enough stockpile to meet the requirements of our citizens. Moreover, if needed, we can even supply vaccines to other countries," the sources Most of India, nearly 1 billion people, have received at least one dose of Covishield or manufactured under licence from AstraZeneca by the Serum Institute of India (SII), ceased its production in December 2021 due to reduced Covaxin, India's first indigenous Covid-19 vaccine, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology, stopped production in early the halt in manufacturing, officials say that vaccine availability is not a concern. India's existing vaccines were not designed to target these newer subvariants. () While doctors attribute this surge to the unpredictable seasonal pattern of respiratory illnesses, global health authorities point to diminishing protection from previous infections and vaccinations that could be playing a role in regional India, the dominant strains currently in circulation are LF.7, XFG, and JN.1, alongside the new Omicron sub-lineage variants have overlapping symptoms that closely mimic the common flu: cough, runny nose, sore throat, low-grade fever, headaches, body aches, and, in some cases, gastrointestinal the seasonal behaviour of SARS-CoV-2 now mirrors that of other respiratory viruses, driven by periodic mutations, there's a main difference: India's existing vaccines were not designed to target these newer this, health experts maintain that those who have been previously infected or vaccinated, especially within the past year, are still expected to retain some degree of protection against severe illness, even if they contract a mutated version of the virus. Most of India, nearly 1 billion people, have received at least one dose of Covishield or Covaxin. () Whether India will require updated Covid-19 vaccines remains under evaluation. However, emerging research offers reassurance.A recent study by the University of Arizona Health Sciences, published in Nature Immunology, found that prior vaccination continues to provide strong immune protection, even against newer variants like Delta and it may reduce the body's ability to generate variant-specific antibodies, vaccinated individuals still mounted a more robust immune response compared to those who were never InMust Watch
RNZ News
25-05-2025
- Health
- RNZ News
What New Zealand could gain from India's booming pharmaceutical sector
Photo: 123RF Dr Chinthaparthi Prabhakar Reddy remembers the sleepless nights of March 2020. The World Health Organisation had just declared Covid-19 to be a pandemic, and the confirmed number of cases was steadily rising into the thousands. He would often wake up in a cold sweat, anxious about how life might unravel before his eyes. As the virus was spreading fast, one thing became imminently clear - the race for a vaccine had begun, and it was time for him to raise his hand to the challenge. A clinical pharmacologist and professor at Nizam's Institute of Medical Sciences in Hyderabad, Reddy volunteered to become a principal investigator for the phase three clinical trials for Covaxin - India's first indigenous Covid-19 vaccine. It was an inactivated virus vaccine or, in other words, a "killed" version of the virus that could trigger an immune response within patients without causing infection. Conducting the trials for such an important vaccine was a mammoth task, but when Reddy describes the process, it sounds almost simple. "We just needed to take the virus, grow it, kill it with chemicals, then package and administer it," he says. "This method has a well-documented safety history, so we were confident the side-effects would be minimal. Almost all vaccines today follow this process." Covaxin was India's first indigenous vaccine against Covid-19. Photo: 123RF Confidence in the science, however, didn't make the process any less grueling. Reddy and his peers faced an unprecedented challenge with Covid-19. Where the average vaccine development timeline can take anywhere from 10-15 years, Reddy had just 10-15 months. "Developing a fast-tracked vaccine at record speed was the challenge … any drug or vaccine development typically costs US$3 billion to US$4 billion and can take around a decade because of the sheer manpower involved. Dr Chinthaparthi Prabhakar Reddy Photo: RNZ / Jogai Bhatt "Pre-clinical trials on cells and animals can take up to six years, while clinical trials, which unfold in three phases and involve human participants, can take up to two years for each phase. "The first phase of clinical trials tests the safety of the vaccine on a small group of volunteers, which expands into larger and larger groups. By phase three, we see thousands of participants injected. "Only after these trials are over can manufacturers apply for approval, and that process itself can take up to six months. "In a pandemic, we didn't have that kind of timeline. Twelve years became 12 months. We were scared every day." Covaxin's phase one trials began in July 2020 and lasted just 96 days before moving into phase two. Reddy says emergency approval for the vaccine was granted in just two days, before the phase three stage was even complete. "Regulators, manufacturers, researchers, everyone was working day and night. So, years became months, months became days. It really was that fast." Manufacturers had begun producing Covaxin long before it was officially approved - which meant by the time regulators gave it the green light, there was already plenty of stock to distribute around the country. "Covaxin got approved very quickly, and it had high efficacy rates," Reddy says. "But each day was tense… By the time we reached phase three, there were around 26,000 participants across nearly 20 centres throughout India. Everyone worked incredibly hard for this." Reddy, now in his 70s, says he was exposed to somewhere between 100 to 200 trial subjects throughout the phase three stage of vaccine development. His own health was at risk every day, but he developed a personal litmus test to ensure he would be okay. "I used to walk six floors every day, up and down at the institute where we did the trials. If I could reach the top without breathlessness, I knew I was safe. If I got breathless, it was time to get admitted. "But all jokes aside, it was a very scary time for everyone. In the end, we were happy because Covaxin was safe, and it nearly saved our country, and we were also able to export it to around 25 countries." Photo: 123RF Although New Zealand ultimately relied on Pfizer for its vaccine rollout, Indian-made vaccines such as Covaxin played a crucial role in the global fight against Covid-19, even benefitting some of New Zealand's Pacific neighbours, including Fiji and the Solomon Islands. The Covaxin journey is a testament to India's prowess when it comes to vaccine development and distribution, with Hyderabad being considered the vaccine capital of the world. In recent years, it has also emerged as a global leader in generic medicines, supplying one-fifth of the world's medication by volume. As New Zealand restarted free trade negotiations with the South Asian nation, is it time to re-examine the potential for pharmaceutical trade? According to the Ministry of Foreign Affairs and Trade, pharmaceuticals are currently one of New Zealand's biggest imports from India, contributing a value of $131 million in 2024. The South Asian nation is currently New Zealand's sixth-highest medication provider overall, offering affordable, high-quality alternatives to brand-name drugs for the country's prescription market. By 2030, its pharmaceutical sector is expected to reach US$130 billion. Dr Shubhadeep Sinha Photo: RNZ / Jogai Bhatt It's a figure that doesn't surprise Dr Shubhadeep Sinha, senior vice president and medical director at Hetero Labs in Hyderabad. Sinha says India has cemented its position as the global leader in generic drugs. "It's the generic drugs capital of the world for a reason," he says. "We know that diseases don't differentiate, whether treatment is coming from an innovator company or a generic manufacturer. And neither do patients. "They need the products for their health, so when you have an equally good-quality product, available at a significant fraction of the cost, which is also accepted by the regulatory guidelines and laws, why not? "The need for generics is strong everywhere, and the kind of manufacturing volumes that we can do in India is significant." Generic drugs have been found to be just as safe and effective as brand-name ones and cost significantly less. However, New Zealand has stricter regulations on importing them. Before entering the New Zealand market, generics must be deemed bioequivalent to the original drug - meaning they need the same active ingredients, dosage form, strength and absorption rate - verified through rigorous Medsafe testing. A free trade agreement between the two nations would remove significant barriers to importing generics into New Zealand. According to MFAT, customs procedures would be simplified, tariffs on goods would be removed and there would be fewer unjustified restrictions on what can and can't be traded. Sinha says Hetero Lab's products could be beneficial to New Zealand's health system. His company currently manufactures generics for a range of Indian pharmaceutical companies, including Cipla, Lupin, Pfizer India and Dr Reddy's - the latter two of which already supply generic drugs to New Zealand's prescription market. Additionally, Hetero Lab's founder, B Partha Saradhi Reddy, was one of the original co-founders of Dr Reddy's itself. "He was instrumental in developing their manufacturing and research capabilities. So essentially the mind of Dr Reddy's had come and started Hetero, and a lot of companies have come out of that." Photo: 123RF Sinha says generic drugs are often unfairly maligned for being a mere copy - but there's a lot of effort that goes into developing them. "There's a lot of science behind the development of generic products, a lot of effort goes into synthesizing a compound, and a lot of high-quality development as well as manufacturing, which is a huge effort. "India's mastered that, and because we're able to massively provide high-quality products, the costs have come down significantly. Generics already come at a low cost, and with high volume production it's further gone down, so it helps everybody." Sinha questions what's stopping New Zealand from accepting generic drugs from India more freely. "Healthcare costs are rising everywhere, nobody has a tray of money to spend every time," he says. "Even with strong healthcare in New Zealand, the need for generics is there." High cholesterol, diabetes and heart disease are particularly prevalent conditions in New Zealand. Sinha claims Hetero Labs is a global leader in these areas and would happily supply generic drugs to New Zealand. "We do the largest of [cardiovascular and cholesterol medications] … we have all the antihypotensive drugs, that's the drugs that lower blood pressure, all the major classes for heart failure and anti-diabetic drugs. "We also manufacture anti-cancer drugs, not just chemical compounds but biologics. We're now one of the largest biological manufacturers in the world." Sinha believes a free trade agreement between New Zealand and India would be a game-changer. "New Zealand might currently rely on China for generics but even China is now depending on us," he says. "We have our own manufacturing facility in China, Russia, Egypt, the US. ... We're producing medicines worldwide, not only in India. "An FTA would definitely help [strengthen that relationship] with New Zealand, of course it will." * Jogai Bhatt travelled to India with support from the Asia New Zealand Foundation.
Hindustan Times
24-05-2025
- Business
- Hindustan Times
Indian pharma will be key to countering the next pandemic
India is uniquely positioned to lead the global response to health threats, provided timely investments are made in its pharmaceutical capabilities. The country's ability to produce affordable medicines at scale, coupled with its untapped potential for innovation, positions it to evolve beyond its role as the pharmacy to the world and into an innovation hub. Such a transformation can address the unmet needs of the Global South, which often lacks access to life-saving solutions like vaccines. India's pharmaceutical sector demonstrated unmatched agility during the Covid-19 pandemic. Producing over 60% of the global vaccine supply, including Covaxin and Covishield, India exported essential drugs and vaccines to more than 150 countries. According to the ministry of commerce, pharmaceutical exports surged to $24.62 billion in 2021–22, largely driven by pandemic-related supplies. Over 50% of Africa's generics, nearly 47% of the US's generic demand, and approximately 25% of the UK's medicine needs are met by Indian pharma, per the ministry of chemicals and fertilisers. Initiatives like Vaccine Maitri further highlighted India's commitment to health equity, supplying over 100 million vaccine doses to low- and middle-income countries. These efforts underscore the sector's potential to become an innovation hub capable of addressing global health challenges. While India's role as the pharmacy of the world is well-established, its next frontier lies in becoming a hub for pharmaceutical innovation. Fragmented ecosystems and insufficient research and development (R&D) investment have hindered progress. However, the pandemic revealed the sector's latent potential when supported by targeted policies and public-private collaborations. For instance, Covaxin's development exemplified how partnerships can spur innovation. The development of mRNA vaccines during the pandemic—hailed as rapid breakthroughs—was the result of decades of sustained investment and collaboration between governments, industry, and academia. India must adopt a similar model by fostering an ecosystem that integrates government support, private sector ingenuity, and academic excellence. Innovation thrives in robust ecosystems, not in isolation. The pandemic exposed the risks of over-reliance on a single source for drug raw materials, leading to shortages. Recognising this, India has launched initiatives like the Make in India programme for bulk drug production and established dedicated Bulk Drug Parks with state-of-the-art infrastructure. These parks aim to reduce costs, improve efficiency, and rebuild end-to-end drug manufacturing capabilities. The $2 billion Production Linked Incentive (PLI) scheme further boosts domestic production of key starting materials (KSMs) and active pharmaceutical ingredients (APIs). To maximise these initiatives, industry players must proactively invest in technology, upskill their workforce, and collaborate with academia and global counterparts. Effective execution could make India self-reliant in critical drug manufacturing within five years and position it as a viable alternative source for drug raw materials globally. India's pharmaceutical sector stands at a critical juncture. The achievements of the past—rooted in perseverance, innovation, and excellence—provide a strong foundation for a future where India leads not just in drug manufacturing but also in drug discovery. The decisions made today will determine whether we are prepared to meet tomorrow's health challenges. With coordinated efforts between the government and the industry, and a global vision, India can build an innovation-driven pharmaceutical sector. This sector would not only address domestic needs but also offer groundbreaking solutions to the world, ensuring readiness for the next health crisis. This article is authored by Anil Agrawal, former Member of Parliament, Rajya Sabha.
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Business Standard
21-05-2025
- Health
- Business Standard
Bharat Biotech's oral cholera vaccine Hillchol clears phase 3 trials
Bharat Biotech, the makers of Covaxin, on Tuesday said that their oral cholera vaccine Hillchol has demonstrated against both the Ogawa and Inaba serotypes of Cholera in both adults and children in a phase 3 clinical study across 1800 individuals. Cholera is an acute diarrhoeal infection caused by ingesting food or water contaminated with Vibrio cholerae bacteria. Studies have estimated that 2.86 million cases and 95,000 deaths occur annually. "Global demand for OCVs is close to 100 million doses a year, and given that only one manufacturer supplies them, there is a global shortage. Bharat Biotech's facilities in Hyderabad and Bhubaneswar have a capacity to produce up to 200 million doses of Hillchol," the company said. Sanofi India makes an oral cholera vaccine The double-blind, randomised phase 3 clinical trial was evaluating safety, immunogenicity and non-inferiority as well as a lot-to-lot consistency of single component oral cholera vaccine Hillchol in comparison to a comparator vaccine in an 1800 participant study across 10 clinical sites in India. In this study, participants were divided into three age groups: adults over 18 years, children aged 5 to under 18 years, and infants aged 1 to under 5 years. They were randomized in a 3:1 ratio to receive either Hillchol or a comparator above study findings have been published in the ScienceDirect, Vaccine journal. The primary endpoint focused on the proportion of participants achieving over 4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses. Bharat Biotech claimed that Hillchol demonstrated 4-fold rise in vibriocidal antibodies against both Ogawa (68.3 per cent) and Inaba (69.5 per cent) serotypes, proving non-inferiority to licensed vaccines. It also demonstrated a strong safety profile and was well-tolerated across all age groups including infants less than 1 year old. "This publication reaffirms our commitment to advancing vaccines built on rigorous research, thorough clinical trials, and reliable clinical data. It highlights our continued commitment to providing affordable, effective, and accessible vaccines for the populations who need them the most,' said Krishna Ella, Executive Chairman of Bharat Biotech. Dr. Ella added, 'Cholera is a vaccine-preventable disease that has faced a surge in outbreaks along with a huge shortage of vaccines. The new generation Oral Cholera Vaccine Hillchol, featuring a simplified single stable O1 Hikojima strain, inducing robust antibodies against both Ogawa and Inaba serotypes, aims to enhance production efficiency and affordability, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats.'
Scroll.in
17-05-2025
- Health
- Scroll.in
Indian academia is rife with research and publishing misconduct
In July 2021, the Bengaluru-based National Centre for Biological Sciences withdrew a paper published in Nature Chemical Biology, a premier journal, after discovering instances of data manipulation. The study, which announced a breakthrough in chemical biology, was withdrawn after being found to have manipulated images. In September 2024, the journal Drug Safety retracted a study conducted by researchers from Banaras Hindu University on the long-term safety of Covaxin, India's indigenous Covid-19 vaccine. The withdrawal was due to concerns that the reported adverse events could lead to ambiguous or incorrect interpretations regarding the vaccine's safety. In close to two decades now, faculty members from the premier Indian Institutes of Technology have retracted a staggering 58 papers, primarily due to plagiarism and duplication. As India strives towards Viksit Bharat 2047 – the goal of becoming a developed nation – strengthening research integrity, research funding and innovation ecosystems will be crucial. However, rising cases of research misconduct, including plagiarism, data fraud and fake peer review, pose a serious threat to this vision. Research misconduct refers to unethical practices in conducting, reporting or reviewing research. Such misconduct often leads to retractions. According to Retraction Watch, a global database, common reasons for retraction include fraud and misconduct, ethical violations, errors and mistakes, publication issues, and legal and policy violations. Such unethical practices not only damage the credibility of Indian institutions but also erode trust in research, affecting international collaborations and funding opportunities. Addressing these challenges requires urgent reforms in research evaluation, stronger institutional oversight and a shift towards quality-driven academic assessments. Research, rising retractions India's research output has increased rapidly over the past decade, with hundreds and thousands of papers published annually in reputed journals. Th National Science Foundation, 2022 report ranks India as the third-largest producer of science and engineering articles, after China and the United States. According to the scientific abstract and citation database Scopus, India has produced 3.67 million papers since 1867. Of these, 3,446 (0.09%) are retracted. While the growth of research is promising, the rising number of retractions is concerning. A study by this author shows primary causes of retractions are plagiarism, data fraud and fake peer review. Retractions due to these increased by 6.3% from 1991-2000 to 2001-2010. The upward trend has continued: retractions rose by 32% from 2001-2010 to 2011-2020. Quantity over quality When a scientist's survival is determined by impact factors, ethics becomes the privilege of a few who can afford to be ethical', said a scientist at the University of Pune, who was quoted in an article on research misconduct in India. Impact factor refers to the average number of citations to recent articles published in a journal, indicating the journal's influence in an academic field. Publishing in high impact factor journals translates into appointments, promotions, institution rankings and research grants. And here lies the root of the problem – evaluating scientific success by over-relying on impact factors, publication counts and rankings among organisations. This creates immense pressure, pushing researchers toward unethical practices. There are comprehensive guidelines of the Committee on Publication Ethics –a non-profit organisation that provides guidance to editors and publishers on all aspects of publication ethics, especially research and publication misconduct – and mandatory research ethics courses for students before they start PhD programmes. But whether the practices outlined by these efforts are genuinely practiced and embraced, or treated merely as formalities, remains a subject of debate. One of the primary reasons for the rising pressure on academics is the 'publish or perish' culture, where academic promotions and funding are heavily tied to publication volume rather than research quality. This intense pressure pushes some researchers toward unethical shortcuts, including plagiarism, fake peer review and data fabrication. This author's study revealed that fake peer review is the leading cause of retractions in India, accounting for 33% of total cases, followed by data fraud (17.2%) and plagiarism (14.8%). Among higher education institutions/universities, private institutions contributed to 60 percent of retractions, while public institutions accounted for 33.7%, and medical institutions made up 6.7%. Enforcing research integrity Without urgent and necessary changes in research evaluation and academic incentives, addressing research misconduct will remain a significant challenge. The presence of legally enforceable misconduct policies and a strong academic culture where research undergoes rigorous scrutiny from peers, mentors, and society, can serve as deterrents for such misconduct. Countries that offer cash rewards for publications may appear to encourage researchers, but ironically face a higher risk of misconduct. This suggests that such incentives might encourage negligence or unethical practices within the research community. Addressing research misconduct thus requires a multifaceted approach that respects the autonomy of researchers while establishing clear boundaries against unethical practices. In India, given the diverse research ecosystems and financial structures across Indian institutions, implementing a uniform national solution is challenging. The University Grants Commission recently discontinued the UGC-CARE (Consortium for Academic and Research Ethics) system of listing quality journals. The idea is to move towards a decentralised approach – empowering individual institutions to set their own criteria for journal selection, fostering academic freedom and encouraging more rigorous and context-specific evaluations. The reasons cited for the discontinuation include a number of poor quality journals and pay-and-publish or predatory journals which had found their way into the list, while several Indian language journals were left out. The new system allows for a broader range of journals – based on certain parameters – for the faculty to publish in. Indian institutions need to develop and enforce comprehensive research integrity policies, including mandatory training in research ethics. Establishing dedicated committees to oversee research conduct can also ensure adherence to ethical standards. Promoting open peer review processes and encouraging researchers to share data and methodologies can enhance transparency and accountability in research. Such practices deter misconduct by subjecting research to broader scrutiny. Kiran Sharma is Assistant Professor at the School of Engineering and Technology, BML Munjal University. She also leads the Center for Advanced Data and Computational Science. Her research integrates data science, the science of science, computational social science, machine learning and network science.
