Gleneagles Hospital performs Mumbai’s first domino kidney transplant of the year for sensitized patients

 

A multidisciplinary team led by Dr Bharat Shah, Dr Shruti Tapiawala, Dr Pradeep Rao and Dr Jitendra Jagtap at Gleneagles Hospital, Parel, Mumbai, successfully performed the city’s first human leukocyte antigen (HLA) compatible, acceptable mismatch domino kidney transplant of the year. This extraordinary procedure involved six surgeries across hospitals and states, uniting three donors and three recipient families in a synchronized chain to save lives.

A domino transplant involves a chain of donors and recipients where each donor matches a different recipient, creating a life-saving chain. The procedure was essential for patients battling kidney failure and inability to get transplanted due to high risk of rejection with their available family donors.

Dr Pradeep Rao, director of urologist & kidney transplant, explained, “Kidney transplants for sensitized patients often require solutions beyond traditional donor-patient matching. Paired exchange or domino transplants, though legally and logistically challenging in India, are game-changers for such cases. Without these options, many patients would remain on dialysis indefinitely.”

Leveraging advanced transplant immunodiagnositics and acceptable mismatch techniques in HLA medicine, the domino transplant addressed the unique challenges of highly sensitized patients which is only 7-10% of transplant population, marking a new milestone in renal transplantation for our state and country.

Dr Bharat Shah, director of renal Science at Gleneagles Hospital, remarked, “This achievement exemplifies the power of teamwork, precision, and innovation in modern medicine. With domino transplants, we are creating a life-saving ripple effect for patients who once had no options. It is a privilege to lead such groundbreaking efforts that transform lives.”

Dr Shruti Tapiawala, consultant nephrologist, highlighted, “Sensitized patients, often due to prior transplants, pregnancies, or blood transfusions, face immense difficulties finding compatible donors. With the help of advanced transplant immunodiagnositics and acceptable mismatch techniques in HLA medicine, the domino transplant addressed the unique challenges of highly sensitized patients which is 7% to10 % of our population seeking transplants are highly sensitized, with antibodies increasing their risk of rejection to 30% to 35% even with desensitization protocols.

A 55-year-old lady from Hyderabad, with multiple donor-specific antibodies against multiple family donors, due to which she faced rejection risks from all her relatives, including her brother, aunt, husband, and maternal uncle.

A 17-year-old boy, whose first transplant failed during the Covid-19 pandemic, required specialized care to overcome sensitization from his earlier transplant and antibodies against his aunt and father precluding him from receiving a kidney from them.

An 18-year-old girl, previously lost a kidney due to infection and faced additional challenges due to congenital abnormalities and HLA antibodies against her mother who was her potential kidney donor.

Months and years of waiting to find an acceptably mismatched donor with whom the rejection risk would be minimal with lesser immunosuppression and cost, rigorous HLA matching and antibody profiling, virtual and physical cross-matching, and extensive counselling culminated in this life-saving procedure. On December 19th, three donors and three recipients underwent complex transplant surgeries lasting 18 hours.

One of the grateful recipients, a patient from Hyderabad, shared, “After years of waiting and failed attempts, I feel healthy and hopeful again. This would not have been possible without the expertise of Dr. Shruti Tapiawala and my nephrologist, Dr Anuradha, who collaborated to make this miracle a reality. I am immensely thankful to the donor for their selfless act.”

Dr Bipin Chevale, CEO of Gleneagles Hospitals, Parel, Mumbai, concluded, “This successful domino transplant is a testament to our hospital’s commitment to pushing boundaries in medical science.”

 

 

Molbio Diagnostics redefines molecular diagnostics with Truenat: Shiva Sriram, President of Molbio Diagnostics

In a world marked by significant healthcare disparities and the rising burden of infectious diseases, innovation is the need of the hour.

Molbio Diagnostics has redefined the landscape of molecular diagnostics with its flagship product, Truenat. This portable, battery-operated molecular diagnostic platform has not only transformed the detection of tuberculosis (TB) but has also evolved into a versatile tool for diagnosing multiple diseases, including Covid-19.

At COP29 in Azerbaijan, Molbio Diagnostics further demonstrated its commitment to global health equity by linking climate change and TB in a pioneering discussion. The company’s donation of innovative diagnostic tools to Azerbaijan reinforced its mission to support sustainable and decentralized healthcare solutions.

Shiva Sriram, President of Molbio Diagnostics, in an exclusive interview with Shardul Nautiyal, shares insights into Truenat’s success story, the challenges of healthcare access, and Molbio’s broader vision for the future.

“Truenat's journey exemplifies a mission to provide affordable, high-quality diagnostics to underserved populations, addressing the healthcare needs of lower- and middle-income countries. With its ability to deliver rapid results within an hour, even in resource-limited settings, Truenat is a testament to the power of innovation in bridging healthcare gaps,” he stated.

Excerpts:

India has a high TB burden, which was a key focus at our conference. Laboratories often take time to process and send results. Could you elaborate on molecular testing and benefits of using Truenat?

Truenat is a rapid, point-of-care molecular diagnostic platform that miniaturizes real-time PCR technology. Traditionally, molecular testing required centralized labs, complex infrastructure, and highly trained personnel, making it inaccessible in remote areas. With Truenat, we’ve addressed these barriers by creating a portable, battery-operated device that requires minimal training and infrastructure.

This innovation enables molecular testing at the primary care level, providing early diagnosis and intervention. Results are available within an hour of sample processing, allowing immediate, evidence-based treatment. This is a significant shift from using molecular diagnostics merely as a confirmatory tool to making them the first line of testing. Additionally, Truenat’s solar-powered option ensures functionality in areas with limited or no electricity.

 

Molbio Diagnostics is committed to bringing healthcare closer to people. Can you expand on this mission?

Our mission is to ensure that no individual, irrespective of their socioeconomic status or geography, is deprived of quality healthcare. Globally, around 80 per cent of the population in lower- and middle-income countries lacks access to basic diagnostics. By miniaturizing advanced diagnostic technology and decentralizing healthcare, we’re breaking barriers to access. Truenat’s deployment in underserved regions allows patients to receive timely and accurate diagnoses without traveling long distances.

 

At COP29, Molbio Diagnostics donated innovative diagnostic tools to Azerbaijan. Could you speak about this initiative?

Azerbaijan hosted COP29 in Baku, where the connection between climate change and TB was a focal point. Changing climate patterns exacerbate TB through increased malnutrition, migration, and population density. The "TB Go Green" campaign, adopted by Azerbaijan, aligns with this perspective.

Molbio donated the Truenat platform, ProRad ATLAS ultra-portable X-ray system, and Truelux solar charging station to support Azerbaijan’s decentralized healthcare initiatives. This donation helps transition the country from centralized microscopy to rapid molecular testing, ensuring early diagnosis and intervention. Such efforts reflect our commitment to enabling sustainable and climate-resilient healthcare solutions.

 

Could you elaborate on Molbio’s state-of-the-art facility and its approach to quality?

Manufacturing healthcare products demands the highest quality standards. At Molbio, we’ve implemented robust quality management systems to ensure product consistency and reliability. Our facilities are equipped with dedicated teams for R&D, manufacturing, quality control, and assurance. We also maintain a logistics network to ensure seamless delivery and provide extensive training for service providers to guarantee prompt maintenance and support.

 

What is the average lifespan of a Truenat device, and how do you handle equipment breakdowns?

Truenat devices have an average lifespan of five to seven years, with many operating beyond a decade. Their solid-state design minimizes breakdowns and eliminates the need for annual calibrations. In case of equipment issues, we have a global network of trained service engineers to ensure timely repairs. Training programs conducted in India prepare these engineers to provide comprehensive on-ground support.

 

What other innovative tools Molbio developing?

Beyond Truenat, we’ve introduced tools like the ProRad ATLAS, an ultra-portable digital X-ray system for mass TB screening, and Thermalytics, a touch-free, AI-driven breast cancer screening device. These innovations address critical gaps in healthcare. For example, Thermalytics provides a pain-free, radiation-free solution for early breast cancer detection, ensuring privacy and comfort for patients.

 

Truenat is a multi-disease platform. Could you expand on its versatility?

Truenat’s modular design allows it to test for a wide range of infectious diseases - from TB and Covid-19 to malaria, dengue, and hepatitis - using different cartridges. It supports multiple sample types, making it a comprehensive diagnostic tool that strengthens healthcare systems once deployed.

 

How does Molbio collaborate with universities and startups?

We’ve launched the EDGE programme to support startups and universities working on healthcare innovations. Through mentorship and financial support, we help bring their ideas to commercialization and scale. Additionally, we offer internship opportunities at our R&D facilities to foster collaboration and innovation.

 

How can science and innovation mitigate the effects of climate change on disease transmission?

The Covid-19 pandemic taught us that multi-stakeholder collaboration is essential. Governments, NGOs, civil society, and the private sector must work together to address healthcare challenges. With ongoing climate change, such collaborations are crucial for creating resilient healthcare systems.

Molbio Diagnostics exemplifies the transformative potential of innovation and collaboration in healthcare. By decentralizing diagnostics and making cutting-edge tools accessible to the last mile, the company is paving the way for equitable, sustainable healthcare solutions.

(Source: www.pharmabiz.com)

 

Odisha launches OPDC to transform state into India’s Pharmaceutical Hub

 

In a landmark initiative, the Odisha government has established the Odisha Pharmaceutical Development Cell (OPDC) under the direct supervision of the Chief Minister’s Office (CMO). Chaired by the Chief Secretary, OPDC aims to attract global investments, foster innovation, and position the state as a leading pharmaceutical hub in Eastern India.

Odisha has taken a significant step toward becoming a pharmaceutical powerhouse with the launch of the Odisha Pharmaceutical Development Cell (OPDC). Operating under the guidance of Chief Minister Mohan Charan Majhi and chaired by the Chief Secretary, OPDC is set to drive international investments, innovation, and industry growth in the state.

The state’s Chief Minister emphasized Odisha’s pivotal role in India’s pharmaceutical aspirations. “Odisha’s resilience during COVID-19 highlighted our dedication to the nation. With OPDC, we are creating opportunities for our youth while contributing to global healthcare, positioning our state as the pharmaceutical hub of Eastern India,” a statement from the CMO read.

Leadership and Objectives

Key appointments reflect the state’s commitment to structured leadership in the sector. Mamina Patnaik, Odisha State Drugs Controller, has been appointed as the Nodal Officer and Convener of OPDC, while Drugs Inspector Chandan Kumar Giri will serve as the Coordinator.

A senior official highlighted OPDC’s primary objectives like acting as a bridge between government and investors, driving collaborations and partnerships in the pharmaceutical sector, spearheading the Odisha Pharmaceutical Policy 2025, facilitating the development of a world-class Special Economic Zone (SEZ) for pharmaceuticals, infrastructure and policy developments

Under Chief Minister Majhi’s leadership, the state is aligned with Prime Minister Narendra Modi’s vision of making India the "Pharmacy of the World." The recent inauguration of the Central Drugs Testing Laboratory (CDTL) and a Sub-Zonal Office of the Central Drugs Standard Control Organisation (CDSCO) in Bhubaneswar underscores the state’s commitment to bolstering regulatory and testing infrastructure.

The Odisha Pharmaceutical Policy 2025, currently under development, is set to provide comprehensive support for investment incentives, research and development (R&D), and skill development.

SEZ Plans and Employment Goals

One of the highlights of the strategic plan is the creation of a world-class Pharmaceutical SEZ in the Khurdha-Balasore corridor. The SEZ is expected to create over 500,000 jobs by 2036 through skill enhancement and sustainable industrial growth.

The state also aims to attract Rs. 50,000 crore in investments, with the upcoming Pharmaceutical CEO Conclave positioned as a key platform for engaging national and international pharmaceutical giants.

Dr. Sunita Tandulwadkar takes over as 63rd FOGSI President, unveils bold vision for transforming women’s healthcare in India

 

Dr. Sunita Tandulwadkar, an internationally acclaimed infertility specialist, endoscopic surgeon, and gynecologist, was formally installed as the 63rd President of the Federation of Obstetric and Gynaecological Societies of India (FOGSI) in a historic moment during the 67th All India Congress of Obstetrics and Gynaecology (AICOG 2025) at the Jio World Convention Centre.

Dr. Tandulwadkar takes on this prestigious role with a steadfast commitment to tackling critical challenges in women’s health and advancing healthcare accessibility, education, and preventive care across India.

“It is both an honor and a responsibility to lead an organization as influential as FOGSI, which represents over 46,000 obstetricians and gynecologists across 277 societies in India,” said Dr. Tandulwadkar. “This presidency provides an unparalleled opportunity to launch initiatives that empower women with knowledge and resources, ensuring healthier lives and stronger communities. Through programs like Sampoorna: Swastha Janma Abhiyan, Know Your Numbers, and Do Teeke Zindagi Ke, we aim to create lasting change by prioritizing proactive health management and early interventions.”

India continues to witness significant challenges in women’s health, which must be addressed on priority. Despite progress, India still faces a high maternal mortality rate. Lack of awareness about pre-conceptional care and inadequate antenatal checkups are major contributing factors.

Non-Communicable Diseases (NCDs): Women in India are increasingly at risk of chronic conditions such as hypertension, diabetes, and anemia. Unawareness, poor lifestyle habits, and limited access to healthcare exacerbate these issues.

India has one of the highest rates of cervical cancer globally, largely due to limited awareness about preventive measures like HPV vaccination.

Access to Healthcare: Rural and underserved communities often lack access to quality healthcare services, with a significant number of women not having regular checkups or timely treatment for conditions like PCOS, fibroids, and reproductive health issues.

Many women lack access to basic education on reproductive health, often leading to late diagnoses of conditions such as endometriosis, ovarian cysts, and infertility.

Dr. Tandulwadkar’s initiatives address these challenges head-on, ensuring that women across India not only have access to vital health services but are empowered to take charge of their own health.

This nationwide campaign emphasizes the importance of pre-conceptional care to improve pregnancy outcomes and reduce maternal and neonatal mortality.

Over 1 million women will benefit from health camps and educational drives to promote planned pregnancies. By addressing health literacy and raising awareness about managing five key health indicators—weight, blood pressure, hemoglobin levels, blood sugar, and thyroid function—this initiative is expected to reduce maternal mortality rates by 20% in participating regions and improve neonatal health outcomes across the country.

A transformative health data collection initiative, Know Your Numbers aims to gather vital statistics, including weight, blood pressure, hemoglobin, and HbA1C levels, from over one million women across India.

By identifying early signs of chronic diseases like diabetes, hypertension, and anemia, this program is projected to reduce preventable health complications in 10 lakh women annually. The initiative will also provide valuable epidemiological insights, helping policymakers design targeted interventions tailored to the needs of diverse populations across India’s urban and rural landscapes.

Large scale project aimed at combating cervical cancer by increasing awareness about screening and HPV vaccination

With plans to reach 5 million women and girls through vaccination awareness campaigns, this initiative aims to increase HPV vaccination rates by 30% in key regions over the next year. By prioritizing education and accessibility, the program seeks to significantly lower cervical cancer incidence, ensuring a safer future for women nationwide.

FOGSI, representing over 46,000 obstetricians and gynecologists across India, is dedicated to enhancing women’s health through advocacy, education, and research. The ongoing AICOG 2025 conference serves as a vital platform for healthcare professionals and policymakers to share knowledge, discuss advancements, and foster collaborations in obstetrics and gynecology.

Dr. Sunita Tandulwadkar’s presidency marks a new chapter in FOGSI’s illustrious history. Her visionary initiatives aim to address pressing healthcare challenges, empower women, and build a healthier, more inclusive future for generations to come.

 

 

AiMeD calls for urgent action on overpriced imported medical devices to empower 'Make in India'

 

The Association of Indian Medical Device Industry (AiMeD) has called for stricter monitoring of the maximum retail price (MRP) of imported medical devices in India to ensure affordability for Indian consumers. In its pre-budget memorandum to the Finance Ministry, AiMeD highlighted that while the government’s efforts to reduce import duties on medical devices aim to lower costs, consumers are still paying 10 to 30 times the import landed price.

AiMeD has urged the government to withdraw concessional duty notifications that reduce import duties to 0 to 7.5%, advocating instead for a revised tariff structure of 5 to 15% on medical devices. According to Rajiv Nath, Forum Coordinator of AiMeD, such measures are necessary to promote domestic manufacturing and align with the “Make in India” initiative.

“Despite promises made in earlier Budget speeches, NIL and concessional duty exemptions continue to disadvantage Indian manufacturers, forcing many to turn into import traders. A predictable tariff policy with nominal protection is essential for fostering domestic production,” said Nath in a recent letter to Finance Minister Nirmala Sitharaman.

Challenges Facing Indian Manufacturers

India’s medical device industry has faced consistent challenges, including:

High Import Dependency: Over 70% of medical devices are imported, with imports exceeding Rs. 69,000 Crores in 2023-24—a 13% increase from the previous fiscal year.

Unfavorable Duty Structures: The current 0-7.5% basic import tariff, combined with GST benefits for importers, puts Indian manufacturers at a competitive disadvantage.

Manufacturing Disabilities: Indigenous manufacturers face a 12 to 15% cost disability due to factors like high infrastructure costs, limited R&D capabilities, and inadequate power supply.

AiMeD's Recommendations

To curb the growing reliance on imports and support domestic manufacturers, AiMeD has proposed the following measures:

Increase Import Tariffs: Raise basic import duties to 5-15% for finished devices and at least 5-7.5% for components.

Retain Low Duty on Raw Materials: Maintain a 2.5% concessional duty on raw materials and packaging for three more years to support local production.

Withdraw NIL Duty Notifications: Remove duty exemptions that undermine Indian manufacturing competitiveness.

Create a Favorable Ecosystem: Provide support similar to the mobile phone industry to nurture startups, MSMEs, and larger domestic manufacturers.

Impact on “Make in India”

AiMeD stressed that a robust domestic industry could adequately cater to the needs of India’s 1.4 billion population while reducing the country’s reliance on imports. The group emphasized that nominal tariff protection would incentivize manufacturers to expand capacity, enable exports, and create employment.

The association also pointed out the unintended consequences of the current duty structure. After the introduction of GST, imported devices became 11% cheaper, making it harder for domestic manufacturers to compete, especially in government tenders.

To address these disparities, AiMeD has requested the government to implement fair trade policies that protect ethical manufacturers and ensure medical security for India. By taking these steps, the government can not only strengthen India’s medical device industry but also make quality healthcare more accessible and affordable for its citizens.

AiMeD is an Umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical Devices including Consumables, Disposables, Equipments, Instruments, Electronics, Diagnostics and Implants.  With a Primary Membership of over 300 Manufacturers and additionally of over 200 Associate Members representing the interest of over 1200 Manufacturers of Medical Devices to address the manufacturer’s problems.

The aim behind forming AiMeD is  allow the Indian Government to access a single point of contact and provide various services to the manufacturers like Advocacy on policy issues, Information services, Regulations for Medical Devices, Education and Training, services, Testing Assistance and guidance for Quality Certification (ISO, CE, GMP), Lobbying for funding for R&D from the Government, encourage innovations from member units, Improve clinician and patient access to the modern, innovative and reliable Medical Device technologies through organizing and supporting Meeting, Seminars, Symposia, Exhibitions and Demonstrations and also, to promote global harmonization and respect for the  Indian Device Industry.

 

 

  

 

 

TechInvention partners with Ethiopia's Ministry of Health to advance vaccine manufacturing in Africa

 

In a significant step toward enhancing vaccine self-sufficiency and pandemic preparedness in Africa, TechInvention, an Indian biotech company, has entered into an agreement with Ethiopia's Ministry of Health. This initiative supports Ethiopia's goals under the African Union’s Agenda 2063 and the Partnership for African Vaccine Manufacturing (PAVM), both of which aim to strengthen healthcare systems and build resilience across the continent.

TechInvention will play a crucial role in this groundbreaking initiative by providing comprehensive technical and strategic support throughout the vaccine manufacturing project. This includes updating the feasibility study, developing the design of the manufacturing facility, conducting geotechnical investigations, and assessing environmental and social impacts. The company will also oversee the creation of technical specifications, prepare tender documents for contractor selection, develop bill of quantities, and offer support in product and process technology selection, acquisition, and transfer.

As part of its advisory role, TechInvention will guide the Ethiopian Ministry of Health and other stakeholders on project implementation, ensuring the development of a state-of-the-art vaccine manufacturing facility that adheres to international quality standards.

The official signing ceremony took place on December 26, 2024, in Addis Ababa, with Dr. Mekdes Daba, Minister of Health, Ethiopia, and Syed Ahmed, director and CEO of TechInvention, formalizing the agreement.

In her remarks, Dr. Mekdes Daba highlighted the strategic importance of local vaccine production, stating, "Producing vaccines locally is a key priority for ensuring the health of our population and for pandemic preparedness. This agreement signifies a major step for Ethiopia to produce vaccines locally, meeting not only international quality standards but also positioning Ethiopia as a supplier of vaccines to Africa and beyond. Preparations are already underway to begin construction and manufacturing in the coming months."

Syed Ahmed, director and CEO of TechInvention, expressed his enthusiasm for the partnership, "We are proud to collaborate with the Ministry of Health, Ethiopia, on this transformative initiative. By combining our technical expertise and experience, we are committed to supporting Ethiopia’s vaccine self-reliance and enhancing health security in Africa. This project will be a key step towards ensuring equitable access to vaccines across the continent."

TechInvention remains dedicated to advancing global health equity by empowering low- and middle-income countries (LMICs) to build robust healthcare infrastructures and establish sustainable vaccine manufacturing capabilities. This project represents a major step forward in promoting health security across Africa and contributing to the continent’s long-term pandemic preparedness.

TechInvention is an innovative biotech company that is committed to bringing greater health equity across the world and specially to LMICs. With a ‘One Health’ approach TechInvention has focused on making essential vaccines, diagnostics and biopharmaceuticals acceptable, affordable, and accessible in the developing world.

Techinvention offers expertise in project planning, project feasibility, technology licensing, WHO prequalification (PQ) support, design engineering, regulatory affairs, clinical research, and intellectual property (IP) support to pharmaceutical and biotech companies, governments, and investors, to make a difference to our shared world.

AIOCD raises concern over RailTel’s proposal to collaborate with online pharmacies

 

The All India Organization of Chemists and Druggists (AIOCD), representing over 12.40 lakh chemists and impacting the lives of more than 5 crore people across India, has strongly criticized the Ministry of Railways for endorsing what it calls "illegal online pharmacy operations." AIOCD has expressed deep concern over RailTel Corporation of India’s proposal to invite bids from online pharmacy platforms to facilitate doorstep medicine delivery.

In a joint statement, AIOCD President J.S. Shinde and General Secretary Rajiv Singhal asserted that the operation of e-pharmacies in India is unequivocally illegal. Referring to the Delhi High Court’s order dated December 12, 2018, the leaders highlighted that the court explicitly prohibited online pharmacy operations through its rulings in Dr. Zaheer Ahmad vs Union of India and South Chemists and Distributors Association vs Union of India. This prohibition remains in force, making RailTel’s proposal a blatant violation of the law.

RailTel's Proposal Raises Legal and Ethical Concerns

AIOCD pointed out that the Central Drugs Standard Control Organization (CDSCO) has admitted in its affidavit that the Drugs and Cosmetics Act, 1940, and its associated rules do not permit online pharmacy operations. The AIOCD stressed that as per the Act, the distribution of medicines is confined strictly to licensed premises, with door-to-door delivery allowed only under exceptional circumstances by local, registered pharmacies—not online platforms.

During the COVID-19 pandemic, the government had temporarily permitted door-delivery of medicines under strict conditions. However, AIOCD emphasized that this allowance was an emergency measure and should not be misinterpreted as a green light for the widespread operation of online pharmacies.

Public Health at Risk

“AIOCD is shocked and dismayed at RailTel Corporation’s disregard for legal norms and public health,” said Shinde and Singhal. They argued that online pharmacy platforms fail to adhere to critical regulations under Section 65 of the Drugs and Cosmetics Act, which mandates clear documentation of the prescriber’s signature, the seller’s name and address, and the date of delivery on prescriptions. These conditions make online pharmacy operations inherently non-compliant with Indian law.

AIOCD’s Stand and Call to Action

The AIOCD has demanded that RailTel Corporation withdraw its proposal immediately, warning that this initiative undermines the pharmaceutical sector and endangers public health. “This proposal is tantamount to circumventing the laws of our country and jeopardizing the safety of millions,” said Shinde.

Reaffirming its commitment to safeguarding the interests of citizens and the pharmaceutical sector, the AIOCD has called on the government to revoke its notification allowing limited door-delivery of medicines and take stringent action against any entities promoting illegal practices.

“Our organization stands united to protect public health and uphold the laws of the nation. We hope this decision was not made intentionally but urge RailTel to reconsider and act in the best interest of the country,” Shinde concluded.

Regulatory limbo surrounds methylcobalamin as union health ministry’s decision remains unofficial

 

The Union Ministry of Health’s decision to lift the ban on methylcobalamin, a critical Vitamin B12 derivative, has yet to be formalized, leaving its regulatory status in limbo despite scientific backing and growing demand for its use in treating conditions such as diabetic neuropathy. While the Government of India’s Scientific Committee approved the molecule's safety in 2019, the necessary gazette notification to officially lift the ban is still pending, raising concerns among health professionals and industry stakeholders.

Dr. Sanjay Agrawal, Scientific Advisor at Alkomex GBN USA has criticized the delay in formalizing the decision, highlighting the growing gap between regulatory approval and practical availability.

“Methylcobalamin is internationally recognized for its safety and efficacy, particularly in treating diabetic neuropathy. The molecule has been approved by the US FDA and is listed in the US Pharmacopoeia. Despite this, the Ministry of Health’s decision to lift the ban in 2021 has not been formalized through a gazette notification, leaving the regulatory framework unclear,” Dr. Agrawal stated.

The lifting of the ban was initially announced in 2021 following a thorough review by the Government of India’s Scientific Committee, which confirmed methylcobalamin’s safety profile. However, experts, including Dr. Agrawal, warn that the lack of formal notification creates uncertainty in the marketplace, affecting both manufacturers and consumers who rely on this vital nutrient for various health conditions, including diabetic neuropathy and neurological disorders.

Methylcobalamin has been lauded for its role in managing conditions such as diabetic neuropathy, where its neuroprotective properties help reduce nerve damage and alleviate pain. Despite its approval in other countries, including the US, where it is widely used as a dietary supplement, its delayed entry into the Indian market raises concerns among patients and healthcare providers.

The FSSAI's regulatory framework surrounding Vitamin B12 sources, including methylcobalamin, has also faced criticism for its lack of clear enforcement mechanisms. The FSSAI’s response to the Union Health Ministry outlined the legal framework for methylcobalamin, allowing its use under certain conditions. However, public grievances persist, particularly about the absence of a robust enforcement system and the potential for products exceeding safe limits of Vitamin B12 in the market.

Dr. Agrawal expressed frustration over the FSSAI’s response, noting that while the decision to allow methylcobalamin’s use under the 2022 amendment to the Food Safety and Standards regulations was a step forward, the absence of clear and enforceable regulations only adds to the confusion. “The delay in formalizing the lifting of the ban, combined with the lack of clear enforcement guidelines, leaves consumers vulnerable to substandard products,” Dr. Agrawal emphasized.

Health experts and consumer advocacy groups have called for urgent action to formalize the lifting of the ban and introduce comprehensive regulatory mechanisms for methylcobalamin. They stress the need for market surveillance, rigorous safety evaluations, and clear labeling to protect consumers.

As the debate continues, it remains to be seen whether the Union Health Ministry and FSSAI will take decisive steps to resolve the regulatory uncertainty surrounding methylcobalamin, ensuring that this essential nutrient can reach the market safely and effectively.

SunAct Cancer Institute ties up with Singapore’s CytoMed for Phase 2 Clinical Trials on innovative Gamma Delta T-Cell Cancer therapy in India

 

SunAct Cancer Institute is excited to announce the start of Phase 2 clinical trials on a groundbreaking treatment called Gamma Delta T-cell therapy. This trial, conducted in collaboration with CytoMed, Singapore, aims to bring hope to patients with difficult-to-treat cancers such as brain cancer, breast cancer, lung cancer, cervical cancer, colon cancer, renal cancer, liver cancer, lymph node cancer  and several others.

This is a cutting-edge cancer treatment that uses special immune cells called Gamma Delta T-Cells. These cells naturally fight cancer while protecting the healthy tissue. What makes this treatment unique is that it uses ready-made cells from donors, making it faster, easier, and less expensive compared to traditional therapies.

This trial marks a major collaboration between SunAct Cancer Institute in India and CytoMed, a leader in cancer treatments from Singapore. Together, they aim to offer world-class cancer care to patients in India.

SunAct stands out for world-class collaboration. It has partnership with CytoMed ensures access to advanced cancer treatment research.

It is focused on solid tumors. This trial tackles solid tumors, which are harder to treat compared to blood cancers. It offers accessible treatments. SunAct is committed to bringing advanced therapies to patients across India. It has an expert team.  SunAct’s top oncologists and researchers work to turn scientific discoveries into real-life treatments.

 “Our goal is to provide advanced and affordable cancer treatments to patients in India,” said Dr. (Prof) Vijay Patil, Founder of SunAct Cancer Institute. “Gamma Delta T-Cell therapy is a promising solution for solid tumors, and through this collaboration with CytoMed, we hope to improve the lives of many cancer patients,” he added.

CytoMed’s Chairman Peter Choo said, “CytoMed’s collaboration with SunAct is timely and complements our core focus of harnessing CytoMed’s proprietary off-the-shelf technologies to develop novel donor-derived cell-based allogenic immunotherapies for the treatment of various cancers at affordable cost. We are aligned with the foresight of our partner SunAct to provide affordable no-option cancer therapeutics and are excited to work with Dr. Vijay Patil in our strive to accelerate the therapeutic application of CytoMed’s patented allogenic gamma delta T-Cells in, an increasing population of cancer patients in India and around the world.”

The trial will begin in early 2025, and patients will soon be able to enroll. All candidates will be carefully screened to ensure safety. For more information about the trial and how to enroll, please contact +91 86553 13412.

SunAct Cancer Institute is a leading center for advanced cancer research and treatment. By combining innovation and excellence, the institute aims to transform cancer care in India and beyond.

CytoMed, based in Singapore, specializes in cellular therapies for cancer and immune disorders. Their cutting-edge technology places them at the forefront of cancer treatment innovation.

CRIUS Group emerges as India’s first CMO to adopt 100% AI-based project implementation

 

In a groundbreaking milestone for the global pharma industry, CRIUS Group has emerged as India’s first contract manufacturing organization (CMO) to adopt 100% AI-based project implementation. This transformative move leverages the NutrifyGenie Integrated AI platform, marking a world-first achievement in contract manufacturing and heralding a new era of innovation.

CRIUS Lifesciences, led by its visionary pharmacist-founder, Subba Rao Chinni, seized the opportunity to execute this AI-designed project. NutrifyGenie AI, a leading AI-driven platform, was integral in designing scientifically differentiated formulations for a multinational client. Beyond formulation, the platform mapped sourcing and development and identified contract manufacturers best suited to execute the project.

AI adoption is rapidly reshaping the contract manufacturing landscape. Studies suggest CMOs leveraging AI can achieve 40-50% process optimization, resulting in shorter manufacturing cycles, reduced waste, and lower production costs. Platforms like NutrifyGenie AI, Ingredients AI, and Pathway Formulator lead the charge, with NutrifyGenie distinguished by its peer-reviewed, high-impact research formulations.

Beyond its core functionalities, NutrifyGenie also supports businesses in accelerating their go-to-market strategies by 200%, fostering innovation in ingredient discovery and safety analysis through its proprietary databank of 3.6 million curated scientific data points.

Speaking about this achievement, Subba Rao highlighted the company’s pharma-based principles as its cornerstone for delivering quality production. "As a pharmacist owning a pharmaceutical plant, I’ve applied the same stringent principles to our nutraceutical facility. The integration of NutrifyGenie AI has been transformative, allowing us to focus on our world-class manufacturing strengths while AI manages the complexities of formulation, sourcing, and regulatory compliance."

The NutrifyGenie platform automates product design, ideation, sourcing, and regulatory processes, enabling CRIUS to shift its focus to process innovation and rapid production. "Winning business based on quality, rather than extensive sales and marketing, frees our bandwidth to innovate and ensure speed in manufacturing," added Subba Rao.

In addition to optimizing processes, NutrifyGenie builds bridges between academia, industry, and government, creating an ecosystem conducive to collaboration. Its impact-driven approach enables businesses to navigate regulatory complexities, ensuring faster and safer product commercialization globally.

CRIUS Group plans further investments to establish India’s most automated, innovative, and AI-powered contract manufacturing facility. "Curated AI engines is the future. After evaluating various solutions, we chose NutrifyGenie for its ability to streamline processes and handle end-to-end project execution," said Subba Rao.

As CRIUS Group sets a benchmark, the industry watches with keen interest. NutrifyGenie AI has proven that the fusion of technology and manufacturing can achieve new heights in efficiency and innovation. For contract manufacturers worldwide, the message is clear: AI isn’t just a tool for optimization—it’s the key to staying ahead in a rapidly evolving industry.

The Nutrify Today platform further amplifies this transformation by delivering measurable outcomes like higher ROI and expanded market access. With AI-driven innovations like NutrifyGenie, CRIUS is not just leading but setting benchmarks in responsible manufacturing practices, aligning with global health and sustainability goals.