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Economic Times
30-07-2025
- Health
- Economic Times
Civil society organisations urge govt to scrap animal testing in biosimilar development
New Delhi: Civil society organisations have approached the health ministry, seeking to remove animal studies to speed up biosimilar development. In their representation to the government, which is working on a set of guidelines for biosimilars, the Working Group on Access to Medicines and Treatment stated that by eliminating these tests, India can lower production costs, speed up biosimilar development and uphold ethical standards. This, said the network that works on affordable healthcare, will also make biosimilars more affordable for patients. "We strongly urge you to eliminate unnecessary animal studies" and establish "clear conditions" for comparative clinical trials in order to prioritise affordability without compromising safety and efficacy, KM Gopakumar and Jyotsna Singh, co-convenors of the working group, wrote in a letter dated July 18 to the health secretary. The government is giving final touches to a revised set of regulations to set stringent quality standards for research and manufacture of biosimilar drugs, which are emerging as a mainstay for treatment of cancers and autoimmune diseases among others. In the letter, the group also urged the ministry to engage with civil society, patient groups and healthcare advocates before finalising the guidelines. The US Food and Drug Administration recently announced a plan to phase out animal testing requirements for monoclonal antibodies (biotech drugs) and other therapies, replacing it with potentially more effective methods. Biosimilars are medicines based on living cells and are very similar, but not identical, to originally invented biological drugs, or biologics. In India, biosimilars is an emerging segment with sales reaching close to $867 million in 2024. The market is expected to grow at around 17% annually, according to industry estimates. "In India, where many struggle to afford basic healthcare, these drugs can transform lives," the group said in the letter. "The draft guidelines are progressive as they have simplified the approval process, but we believe additional changes can make biosimilars even more accessible, ethical, and affordable, while maintaining safety and quality," it under consultations, the 'Guidelines on Similar Biologics' are closely aligned with regulations followed by global regulatory bodies, people aware of the development said. This is the second comprehensive overhaul of biosimilar guidelines, which were first released in 2012 and revised in 2016. The proposed guidelines seek to restrict the use of animals in testing. The draft stresses on in-vitro (lab-based or not in animals) studies. The industry has long been demanding that animal toxicology studies be waived for biosimilars where robust global clinical data and analytical comparability already exists.
ITV News
26-07-2025
- Business
- ITV News
UK-India trade deal sparks fears over access to cheap medicines for millions
A newly signed trade agreement between India and the UK has triggered concerns that millions of poor Indians may lose access to affordable life-saving medicines. Civil society groups and health experts say the UK-India Free Trade Agreement (FTA), finalised between two countries, tilts the balance in favour of multinational pharmaceutical corporations and threatens to erode long-standing protections that have allowed India to produce low-cost generic drugs. 'This is not just about trade. It's about whether a person living on ₹200 (£2) a day can afford cancer treatment or survive tuberculosis,' said Jyotsna Singh, co-convenor of the Working Group on Access to Medicines and Treatments. At the heart of the controversy are the agreement's intellectual property (IP) provisions, which activists say may restrict the Indian government's ability to issue compulsory licences—legal tools that allow domestic companies to manufacture patented drugs at reduced prices during public health emergencies. India used this provision in 2012 to dramatically cut the price of sorafenib, a cancer drug sold by Bayer under the brand Nexavar. Generic versions slashed the monthly cost by nearly 97%, from ₹2.8 lakh (£2,600) to around ₹8,800 (£80), making it affordable to thousands. 'By discouraging compulsory licensing and promoting voluntary licences, the deal hands over control of access to medicines to the market,' said Prof Biswajit Dhar, a trade expert and former professor at New Delhi's Jawaharlal Nehru University. 'Voluntary licences often come with strings attached and don't bring the same price reductions.' Weakening India's Patent Safeguards Under the FTA, companies will no longer need to report annually how their patents are being 'worked'—or used—in India. Instead, disclosures can be made every three years, and some information can be kept confidential. Activists say this undermines transparency and makes it harder to prove that a drug isn't available to the public, a key step in applying for a compulsory licence. There are also concerns the deal could open the door to 'evergreening'—a tactic in which companies make minor changes to existing drugs and claim new patents. Indian law currently limits this practice under Section 3(d) of the Patents Act, but experts warn the FTA's emphasis on 'harmonisation' of IP standards with Western countries could override such protections. 'This is effectively a backdoor entry for TRIPS-plus provisions,' said K.M. Gopakumar, co-convenor of the Working Group. 'It would push India to grant unnecessary patents, prolonging monopolies and delaying cheaper alternatives.' The Indian pharmaceutical industry supplies more than 60% of global vaccines and a significant share of affordable generics to low- and middle-income countries. Critics say the FTA may limit this capacity and ultimately have consequences well beyond India's borders. Government response The Indian government has promoted the FTA as a landmark deal that will boost exports and attract UK investment in manufacturing, services, and digital trade. Officials insist that India has preserved its ability to protect public health. But rights groups remain unconvinced. 'You cannot negotiate away access to life-saving drugs in the name of free trade,' said Gargeya Telakapalli, a public health campaigner based in Hyderabad. 'The poorest Indians—those with cancer, HIV, diabetes, or TB—are being quietly sacrificed.' Broader implications The deal follows a similar agreement India signed last year with the European Free Trade Association (EFTA), which also faced criticism for diluting IP safeguards. Observers say the trend may reflect a shift in India's trade policy as it seeks closer ties with Western economies. But for many in India's healthcare and legal communities, the question remains: how much access to medicine is the country willing to give up for a better trade balance? From Westminster to Washington DC - our political experts are across all the latest key talking points. Listen to the latest episode below...
The Hindu
25-07-2025
- Business
- The Hindu
The UK-India FTA tilt the balance in favour of patent owner and undermines access to medicines: experts
The U.K. -India Free Trade Agreement (FTA) provisions on patents tilt the balance in favour of the patent owner and undermines the access to medicines, said experts on Friday at a discussion on the agreement's implication for access to medicines. Expressing their concerns over provisions in the recently signed agreement that could impact access and affordability of medicines in India, experts noted that certain intellectual property (IP) and regulatory clauses may delay or limit the production of life saving generics, impacting patients in India and across the Global South. 'There is a progressive movement towards accepting the demands of FTA partners, which systematically debasing the public interest safeguards available in the Indian Patents Act,'' warned professor, Centre for Economic Studies and Planning, JNU (Retd), Biswajit Dhar, explaining that the preference on voluntary licenses leaves the access to medicines in the hands of market forces and undermines the role of the government in facilitating access to medicines. 'Often voluntary licenses contain onerous conditions on the licensee and fail to bring sharp price reduction compared to the compulsory licenses,' he said. He further said that under the Indian Patents Act every year the patent holder must submit details of working of patents in India. The annual submission information will now be submitted once in three years and the confidential information contained in the submission shall not be made available in the public domain. Added Jyotsna Singh, co-convenor of the working group on Access to Medicines and Treatment: ``This effectively compromises the ability of potential compulsory license applicants to prove unmet demands, which constitute a ground for compulsory license. It clearly tilts the balance heavily in favor of the pharmaceutical transnational corporations allowing them to easily get away by hiding the denial of access to medicines due to high prices on access. ' 'There are also provisions in the IP chapter which can potentially undermine the safeguards preventing evergreening of patents,'' said K. M. Gopakumar, co-convenor of Working Group on Access to Medicines and Treatment adding that though couched in best endeavor language there are provisions 'facilitate the sharing and use of search and examination work of the Parties'. 'The implementation of this provision would lead to the harmonization of patentability criteria and undermine safeguards against evergreening such as Section 3 (d) of the Patents Act,'' he said. Meanwhile, Sanjaya Mariwala, executive chairman and managing director of OmniActive Health Technologies welcoming the move said that India's exports to the UK went up by 12.6% last year, and this deal gives us a chance to build on that growth. 'But it's not just about trade volumes—what stands out is the scope it opens-up in healthcare. With regulatory barriers coming down, Indian healthcare companies will find it easier to operate in the UK, and that can lead to more affordable services and better collaboration between the two systems. That's a space worth watching. At the same time, we can't lose sight of the fact that Free Trade Agreement (FTAs) only work well when businesses at home are strong. As more of these agreements are signed, we need to back our local entrepreneurs and MSMEs with the right support—finance, infrastructure, policy clarity,'' he said. Adds Bhavin Mukund Mehta, director, Kilitch Drugs: 'The India UK FTA by formalising zero duty access for nearly 99% of Indian pharmaceutical and medical device exports, provides long term clarity and a much needed boost for the Indian pharma industry. With the UK's pharma market projected to grow from about $45 billion now to $73 billion by 2033, and India's generics segment already crossing $910 million in exports in FY 24, this agreement will strengthen India's presence in UK drug stores and broader supply chains. For niche, high quality manufacturers that align with global standards, this is truly a game changer.'' Previously the Commerce Ministry had said that zero tariff provisions under the FTA are expected to significantly enhance the competitiveness of Indian generics in the UK market, which remains India's largest pharmaceutical export destination in Europe. Currently, India exports $23.31 billion globally and the UK imports nearly $30 billion, but Indian pharma accounts for under $1 billion. The pharma sector has 56 tariff lines, which is just 0.6 per cent of the total, the document stated. Despite the small representation, the pharmaceutical sector holds high value and strategic importance, especially in global trade, the document added. India's pharmaceutical industry is the world's third largest by volume and 14th largest in terms of value. The sector's exports rose 10% year-on-year to $30.5 billion in FY 2024-25. The industry is leading in the manufacture of high-quality generic drugs at competitive prices over the last 30 years. India is the largest supplier of generic medicines with a 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.
Time of India
13-06-2025
- Business
- Time of India
Fish boom: Local entrepreneurs thrive as output triples in state
Patna: Women and small-scale entrepreneurs in Bihar are reaping the benefits of the state's fisheries initiatives with fish production tripling over the past two decades. Jyotsna Singh from Pura village in Samastipur district has become self-reliant through fish seed production and now employs 20 people. She received a grant of Rs15 lakh in 2023 from the fisheries department to set up a hatchery, which proved highly successful. Similarly, Laxmi Sahni, Sheela Devi, Pramod Kumar Sahni, Rani Kumari and Seeti Devi from Raipur village in Sarairanjan block are engaged in fish farming over approximately eight hectares. They produce 10-15 tonnes of fish annually, earning Rs13 to Rs18 lakh. A state govt report released on Friday revealed that fish production in Bihar rose from 2.68 lakh metric tonnes in 2005 to 8.73 lakh metric tonnes in 2023-24, a threefold increase over 19 years. Officials said this growth was driven by several schemes under the state's agriculture road map, including the Chief Minister Integrated Wetland Development Scheme, Reservoir Fisheries Development Scheme, Private Pond Renovation Scheme, the River Restoration Programme and the centrally sponsored Pradhan Mantri Matsya Sampada Yojana. Under the Wetland Development Scheme, 461 hectares have been converted for fish farming. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Giao dịch vàng CFDs với sàn môi giới tin cậy IC Markets Tìm hiểu thêm Undo Model-based pond construction in districts with abundant wetlands is rapidly increasing output. To support fish traders, 30 fish markets are being established across selected blocks. Also, modern techniques like biofloc and RAS (recirculating aquaculture system) technologies are being adopted. So far, 439 biofloc units and 15 RAS units have been established. To further enhance production in rivers such as the Ganges, Gandak, and Burhi Gandak, 61.81 lakh fish seeds were released during the current financial year. Follow more information on Air India plane crash in Ahmedabad here . Get real-time live updates on rescue operations and check full list of passengers onboard AI 171 .
