AI is transforming pharmacy by enhancing patient care and medication safety: Dr Steven Chen

 Artificial intelligence (AI) is revolutionizing the field of pharmacy, reshaping drug development, patient care, and medication distribution, states Dr. Steven Chen, Pharm D, FASHP, FCSHP, FNAP, associate dean for clinical affairs at the University of Southern California (USC) Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences while emphasizing the significant role AI is already playing in patient care.

“While much of the focus on AI in pharmacy has been on accelerating drug discovery—such as identifying new molecular entities, repurposing existing medications, and reducing overall costs—AI is also making a profound impact on pharmacy practice, improving patient safety and health outcomes,” Dr. Chen explains.

"When given sufficient data, AI is used to predict or identify patients at high risk for adverse health outcomes, requiring a commensurate level of care and intervention," says Dr. Chen. AI-driven Remote Therapeutic Monitoring and Remote Patient Monitoring are being increasingly utilized to analyse health trends, providing critical insights to both patients and healthcare providers.

Moreover, AI can assess social determinants of health—factors such as economic stability, education, and living conditions—to uncover social needs that impact a patient’s ability to achieve optimal health. "With sufficient data, AI can evaluate these determinants to ensure that underlying social issues are addressed, improving overall health outcomes," Dr. Chen explains.

Looking ahead, the integration of AI into digital therapeutics will provide real-time feedback to both patients and healthcare professionals. This innovation will help tailor treatment plans, optimize medication therapy, and improve patient adherence to prescribed regimens.

On the medication distribution side, AI enhances efficiency and safety, ensuring that patients receive the right medications faster. "Rather than replace the patient care role of pharmacists, AI will help pharmacists focus on the most challenging patient needs that require in-depth personalized evaluation, empathy, and patient-specific treatment plans," Dr. Chen notes. This includes making treatment adjustments, continuous monitoring, and providing education on self-management.

AI is essential in addressing the challenges posed by the US healthcare system, where high-quality, individualized medication therapy is crucial for improved patient outcomes. Additionally, in large countries such as India, where healthcare accessibility remains a concern, AI can play a transformative role in reaching patients who require better medication management and results.

As AI continues to evolve, its applications in pharmacy will expand, further strengthening the profession’s ability to deliver safe, effective, and patient-centred care. Dr. Chen underscores the importance of embracing AI in pharmacy: "AI in pharmacy is not just an innovation—it is a necessity to improve healthcare and medication outcomes worldwide."

“With AI-driven advancements, pharmacists will be better equipped to provide personalized care, ensuring patients receive the right medications at the right time while maintaining the human touch that is essential to patient-centred healthcare,” Dr Chen concludes.

Industry stalwarts discuss pharma industry's resilience, expectations from Union Budget 2025

 

As the Union Budget 2025 approaches, key leaders in the healthcare and pharmaceutical sectors have outlined their expectations for policy measures that could drive growth, innovation, and accessibility in India's healthcare landscape.

Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals, reflected on the industry's resilience and future opportunities. He stated that the Indian pharmaceutical industry has once again proven its remarkable resilience, navigating global challenges with agility. Initiatives such as Make in India and the PLI scheme have catalyzed growth, fostering an environment ripe for innovation. Looking ahead to 2025, our vision of 'A New Way for a New World' continues to fuel our drive to innovate, collaborate, and lead in addressing the world's most pressing healthcare challenges.

Nikkhil K Masurkar, CEO of Entod Pharmaceuticals, called for policy measures that would strengthen India's pharmaceutical ecosystem. He stated that enhanced support for research and innovation is crucial. Increased funding for R&D, particularly in next-generation molecules and AI-driven drug discovery, could drive investment and innovation. Strengthening the production-linked incentive (PLI) schemes for APIs and high-value pharma products can reduce import dependency, while better infrastructure support for MSMEs can spur innovation and job creation. Reducing customs duties on raw materials and lowering GST on essential healthcare products would make treatments more affordable and improve global competitiveness."

Chander Shekhar Sibal, vice president of the Medical Systems Division at Fujifilm India, stressed the need for a supportive regulatory environment. He explained, “To ensure access to quality care, we must work towards enhancing healthcare infrastructure. Investments in digital health platforms, telemedicine, and electronic health records can significantly improve healthcare delivery. The government should prioritize policies that encourage research and development, introducing incentives for both established companies and startups. Simplifying the GST structure to a uniform rate across all categories would significantly enhance affordability and strengthen domestic manufacturing capabilities."

Nirav Mehta, managing director & CEO of CORONA Remedies, emphasized the need for targeted policy interventions. He stated, "We are eager to see how the budget aims to boost the pharmaceutical industry through policy adjustments that foster sustainable growth and ensure widespread availability of essential medications. Boosting investments in research and development (R&D) can help solidify India's position as a hub for innovative products and environmentally friendly pharmaceutical production."

Kishore Karumanchi, CEO of Aciana, emphasized the need for higher exemptions on health check-ups and increased funding for research. He stated that AI is transforming healthcare with accurate diagnoses and personalized preventive treatments. Raising the exemption limit for health check-ups from Rs. 5,000 to Rs. 20,000 would encourage regular screenings and lower the disease burden. Additionally, allocating more funds to research in genomics, biotechnology, and AI diagnostics is vital for innovation. Tax breaks for healthcare startups and stronger public-private partnerships can accelerate the use of advanced technologies in healthcare. These steps will expand access to quality care for millions and position India as a global leader in healthcare innovation.

Bhanu Prakash Kalmath S J, partner at Grant Thornton Bharat, highlighted the importance of increasing healthcare expenditure to 2.5% of GDP. He stated, "Increasing healthcare spending to 2.5% of GDP is essential to strengthen infrastructure and expand access, particularly in underserved areas. Enhancing access through improved primary healthcare centers (PHCs) is critical for equitable healthcare delivery. Prioritizing investments in R&D and emerging technologies, such as telemedicine and AI-driven solutions, will further enhance service delivery and bridge accessibility gaps. Additionally, reducing the GST rate on health insurance premiums and hospital supplies will alleviate financial burdens on households."

Deepak Sharma, co-founder & CEO of MedLern, underscored the importance of workforce training. He said, “A well-trained workforce and robust infrastructure form the backbone of a resilient healthcare system. The budget should prioritize funding for healthcare-focused simulation-based training, e-learning platforms, and skill certification programmes. Investment in technology-driven solutions such as telemedicine hubs, AI-powered diagnostic tools, and digital health records can bridge the gap between urban and rural healthcare accessibility."

Ravi Hirwani, senior vice president of Bhailal Amin General Hospital, called for increased healthcare spending and infrastructure reforms stating, "The Indian healthcare sector is at a pivotal junction of growth. The government must increase healthcare spending to 3% of GDP, remove or reduce customs duties on medical devices and essential medicines, and grant the healthcare sector infrastructure status to attract private investments. Special incentives for hospitals in Tier-2 and below cities will help expand healthcare access. Additionally, introducing special packages for foreign nationals seeking treatment in India can enhance the country's position as a leading destination for medical tourism."

AIPAC in collaboration with MMC, SPDS, IPA, IDMA, Tamil Nadu Chapter hosts international symposium on dissolution science and drug development

 

This prestigious event brought together leading experts in the field of pharmaceutical science to discuss the latest advancements and research in drug development from USA, Europe & India. Shridhar, State Drug Controller inaugurated the Second AIPAC event at MMC, Chennai.

All India Pharmaceutical Association Consortium (AIPAC) in association with Madras Medical Pharmacy College (MMC), Society for Pharmaceutical Dissolution Science (SPDS), Indian Pharmaceutical Association (IPA - Tamil Nadu Branch), IDMA (Tamil Nadu, Pondicherry & Kerala) concluded an international symposium on dissolution science and drug development recently in MMPC Chennai auditorium.

This prestigious event brought together leading experts in the field of pharmaceutical science to discuss the latest advancements and research in drug development from USA, Europe & India. Shridhar, State Drug Controller inaugurated the Second AIPAC event at MMC, Chennai.

Renowned speakers Dr. Vinod P Shah, USA, Prof. Dr. Imre Klebovich, Prof. Emeritus, Semmelweis University, Budapest, Hungary, Prof. Dr. Romana Zelko, Full Professor & Director, Semmelweis University. Budapest, Hungary, Europe, Prof Padma V. Devarajan, President, SPDS & Professor at ICT, Mumbai and Suhas Yewale, associate director, Tecno Commercial, Sotax India delivered talk on various aspects of Dissolution Science and Drug Development.

The event also had a live demonstration of Sotax USP4 Dissolution Apparatus.

M N Sridhar, Director of Drugs Control (State FDA), Tamil Nadu was the Chief Guest of the event and Dr Kavitha, Vice President, MMC was the Guest of Honour.

The event is supported by Sotax, a global leader in dissolution testing, Tanipa and Tamil Nadu Pharmaceutical Sciences Welfare Trust.

During the event, the Dr. Vinod Shah, who is also an alumnus of MMC Pharmacy College (1957-59 B Pharm Batch) was felicitated by the MMC Alumni Association together with AIPAC, SPDS, IPA - Tamil Nadu Branch, IDMA (Tamil Nadu, Pondicherry & Kerala) through a citation which was read by Dr L Ramaswamy and presented by the Chief Guest.  Dr. Shah who was formerly with United States FDA is a renowned Pharmaceutical Consultant in USA and across the Globe.

Around 400 plus delegates from Industry and academia were part of this event as delegates.

Dr L Ramaswamy, Chairman of Sotax India Pvt Ltd, founder & National Convenor of AIPAC/Secretary General of SPDS, Dr J Jayaseelan, Chairman, Industry Division, IPA -Tamil Nadu Secretary, Tamil Nadu & Chairman – IDMA (Tamil Nadu, Puducherry & Kerala), Chairman, MMC Alumini Association Chennai have taken the major lead to organize this event with the full support of Prof R Radha & Dr Deattu Narayanan of MMC Pharmacy College.

This symposium promises to be an enlightening experience for all attendees, providing valuable insights into the future of drug development and dissolution science.

The topics presented includes Impact of Pharmaceutical Science on drug development, Advancing Pharmacokinetics and Drug Metabolism Research Through Different Radi Chromotographic Techniques, Nano Fibers Loaded with extracellular vesicles as promising platforms for Drug Delivery, In Situ Nanotechnology enabling Point of care Nanomedicine and Discriminating Dissolution Testing by USP 4.

 As AIPAC is committed to organise continuous training and workshops for MSME professionals to help them to produce good quality drugs. The 3rd workshop shall be at NIPER, SAS Nagar on March 4, 2024 in collaboration with SMPIC, SPDS, NIPER, SAS Nagar, and FOPE. The 4th is scheduled to be planned in Bengaluru in April or May 2025. The Central and State regulatory team will support the events through their participation and inaugural address.

Through dedicated efforts of Dr L Ramaswamy, AIPAC was able to get around 15 plus national level associations under one platform.

X-CIPLOG 2025 Reunion and Awards reflects industry excellence, resonates with Government Padma honour to Pharma industry

Delighted by the grand reunion, Cipla Veteran M.K. Hamied acknowledged the lasting bond and contributions of Cipla’s former employees. Expressing gratitude, he emphasized that Cipla’s current success is a testament to their collective efforts and dedication over the years.

The 6th X-CIPLOG Reunion Event 2025, held in Worli, Mumbai, celebrated the achievements of 12 distinguished professionals and three pharma institutions of international repute – Cipla, Serum and Zydus, from the pharmaceutical industry. Organized by Ex-Cipla employees, an association of over 500 ex-employees, the event honoured exemplary contributions and fostered industry-wide collaboration, innovation, and camaraderie.

Delighted by the grand reunion, Cipla Veteran M.K. Hamied acknowledged the lasting bond and contributions of Cipla’s former employees. Expressing gratitude, he emphasized that Cipla’s current success is a testament to their collective efforts and dedication over the years.

Dr. Vinay Nayak, founder and chief mentor of the X-CIPLOG Group and chairman of the IDMA Technical Committee, underscored the importance of such gatherings. He emphasized how these events strengthen industry relationships and promote thought leadership among professionals.

The event featured several insightful sessions, including Motivational Tech-Talks on emerging digital technologies, including gummies technology for drug delivery, particularly for ayurvedic and nutraceuticals medicines.

It featured a discussion on working with multiple companies and fostering a culture of leadership and also work-life balance – An engaging panel discussion on post-50s fitness journeys, including marathons, cycling, trekking and nature walks to maintain cognitive agility.

The award ceremony highlighted Cipla’s breakthrough in drug delivery through inhalation. A major milestone was Cipla’s approval from the Central Drugs Standard Control Organization (CDSCO) for Afrezza, an inhalable insulin developed by MannKind. This innovative solution provides a non-injectable alternative for diabetes management, aligning with Cipla’s mission to enhance accessibility and patient care in India.

It featured Innovation and Career Excellence Awards 2025 which conferred Innovation Award 2025 – Pharmaceutical Organizations like Serum Institute of India recognized for its leadership and innovation in vaccine technology and Zydus Cadila honored in acknowledgment of Pankaj Patel receiving the Padma Bhushan award from the Government of India.

This was followed by Career Excellence Awards 2025 – Pharmaceutical Industries. Geena Malhotra was awarded for her contribution in R&D and Tech Services, Preetish Toraskar – Founder Director & CEO, Koye Pharma for Marketing and Entrepreneurship, Sanjay Shetgar for Quality Assurance, Rajesh Ghangurde for Export Management, Deepak Dhuri for Supply Chain Management, P.P. Ramchandran for Human Resources, Anil Kumar for Manufacturing, Pradeep Surve for Research & Development, Dr. Prashant Dikshit for Quality Assurance, Dr. Suhas Mangaonkar for Microbiology, Dr. T.G. Chandrashekar for Technical Services and Dr. Anil Pareek for Medical Services.

Each awardee was honored for their outstanding contributions to the pharmaceutical industry, reinforcing the vision of “Together We Can Keep the World Healthy.” The event was convened with the active organising team of Sandeep Mankame, Sachin Ghosalkar, Davinder Singh, S. G. Belapure, Ram Gulwady, Satyasheel Desai, Vijay Kumar Maroo, Rajesh Ghangurde, Gayatri Khedekar, Sanjeev Bhale, Reshama, Isha Chaurasia, Sonia and S. N. Salgaonkar.

A Coffee Table Book - SHILPIIY- was also unveiled during the Award Ceremony to showcase the biodiversity, intellectual property, socio-economic and cultural diversity of the hill state – Uttarakhand authored by Dr. B P Nautiyal and Shardul Nautiyal.

“The X-CIPLOG Reunion serves as a catalyst for fostering innovation, leadership, and lifelong learning process. The event concluded with a renewed commitment to driving advancements in pharmaceuticals and healthcare for a healthier future,” concluded Dr. Nayak. 

 

Round Table Conference on RWE brings together eminent experts from India & Europe to discuss future of RWE

 

The Round Table Conference on “Real-World Evidence (RWE) and Post-Marketing Surveillance (PMS) Studies” brought together eminent experts from India, Switzerland and across Europe to discuss the future of RWE. The event, which concluded in Mumbai recently, addressed critical issues such as optimizing resources, reducing timelines, and enhancing regulatory compliance in the conduct of RWE & PMS studies.

Dr Chirag Shah, head of clinical operations at Raptim Research, emphasized the growing significance of RWE in modern drug development. He noted, “With regulatory agencies worldwide placing increasing emphasis on evidence-based research, it is imperative to streamline and scale RWE methodologies for more economical and efficient outcomes.”

Dr Shah further elaborated on the importance of RWE in bridging the gap between Indian and European regulatory landscapes. “India’s flexible and cost-effective regulatory environment and data management capabilities can complement Europe’s structured frameworks, ensuring faster and more reliable outcomes,” he added.

Recently Palbociclib in breast cancer and Abatacept in GVHD got an additional indication approval based on RWE data that demonstrated the power of RWE. These approvals underscore how real-world data can expedite drug development and regulatory decision-making.

Dr Shah informed that between January 2019 and June 2021, 136 new products were approved by the US FDA based on Real world evidence —a testament to the growing reliance on RWE. Real world data is proving instrumental in determining target populations and refining indications. However, concerns regarding data accuracy and reliability persist, especially in hospital-generated health data.

Key challenges in RWE implementation are data challenges – availability, integration, standardization, and real-time collection, regulatory and compliance issues – variability across regions, data privacy concerns, operational hurdles – investigator engagement, patient recruitment, resource constraints, study design complexities – bias, confounding factors, long study durations, technology gaps – interoperability issues, digital literacy limitations, budgetary concerns – high costs and cost-effectiveness concerns, stakeholder collaboration – aligning multiple stakeholders, ensuring patient-centric approaches, ethical and practical concerns – informed consent, ethical data, use.

On the occasion, Swiss-based Wemedoo unveiled its cutting-edge software, designed to optimize Real World Data (RWD) collection and analysis. “This innovative tool called as OOPUS and OOMNIA improves access to high-quality RWD, increases efficiency and cost savings, shortens study timelines, enhances data quality and integrity, supports innovative study designs, ensures compliance with global regulatory requirements and strengthens partnerships with healthcare institutions,” stated Dr. Nikola, oncologist & founder, Wemedoo, Switzerland and Dr Dhiraj Patel, director, Velocious Clinical Research.

The event witnessed active panel discussion moderated by Dr. Kamlesh Patel, head- medical affairs, clinical research & health tech, Lupin India, Mumbai along with other expert panellists from industry, Dr Santosh Taur, chair, RWE Council, Indian Society of Clinical Trials (ISCR) Mumbai, Dr Chintan Khandhedia, lead - clinical research, RWE, Sun Pharma, Ramneek Kour, global project manager, Abbott, Bengaluru, Dr Jyoti Bajpai, lead, medical & precision oncology, Apollo Hospital, Navi Mumbai. The list also included Dr. Chetan Gharat, head-medical services, Lupin Digital Health, Dr Hari Kiran Gellela, senior patient engagement and recruitment specialist, BMS, India and Veerababu Yegi, head biostatistician, Raptim Research, Mumbai, and Dr Rajen Shah, director, Raptim Research.

 Experts reiterated the urgency of adopting economical, scalable, and smart RWE solutions stating, “The real-world impact of RWE is undeniable. By harnessing technology, improving collaboration, and streamlining regulatory pathways, we can redefine the future of RWE & PMS studies globally.”

“With the pharmaceutical industry increasingly leaning towards evidence-based decision-making, RWE is poised to become the cornerstone of future drug approvals, ensuring better patient outcomes and more efficient healthcare systems worldwide,” Dr Shah explained.

Experts recommend travel and safety tips amid rising respiratory virus cases during Chinese Lunar New Year

 

A record-breaking nine billion inbound and domestic trips are predicted to take place in China during the 40-day travel rush for the Chinese Lunar New Year (Spring Festival) period. The official public holiday in China will run from 28th January to 4th February. Boosted by factors such as the recent expansion of the visa-free transit policy. This represents a nearly 7% increase year-on-year. Celebratory gatherings are also expected to attract crowds in major cities globally. To ensure the health, security and wellbeing of employees during this festive period, International SOS, is encouraging organisations to prioritise their workforce’s health and safety.

Dr Echo Li, medical director for China at International SOS said, “With the recent increase in the risk of infection from respiratory viruses, particularly given the upcoming holiday season and increased social gatherings, it is advisable for employees and their families to prioritise vaccination before travelling and to stay informed of health risks and medical alerts/travel advisories at their destination.”

Yingyan Zhang, senior travel risk manager at International SOS added, “While enjoying the Spring Festival celebrations worldwide, individuals should be mindful of the increased security risks associated with large crowds. Precautions such as safeguarding personal belongings and remaining vigilant against potential pickpocketing and scams are crucial. Additionally, it is essential to be aware of potential crowd surges, to adhere to crowd control measures and to maintain a heightened level of situational awareness throughout the festivities.”

To help organisations ensure the health and safety of their employees during the Spring Festival holiday period, International SOS has issued the following advice to communicate clear travel guidelines, regularly review and update travel safety policies and procedures to reflect evolving global health and security situations, provide specific guidance on avoiding overcrowded areas and emphasise the importance of adhering to local laws and regulations, address potential health risks.

It is crucial to be aware of potential health risks, particularly respiratory infections, as these can spread easily in crowded environments and during the winter months.

It has also advised to empower travellers with resources and decision-making tools, provide travellers with access to reliable travel information resources, such as government travel advisories, reputable news sources, weather alerts and local emergency contact numbers, equip them with the knowledge and tools to make informed decisions about their travel plans and to respond effectively to unexpected situations.

Gleneagles Hospitals, Mumbai launches advanced NICU and comprehensive obstetrics services

  

In a significant step towards advancing maternal and newborn healthcare, Gleneagles Hospitals, Parel, Mumbai has unveiled a high-tech Neonatal Intensive Care Unit (NICU) alongside state-of-the-art obstetrics services. The newly inaugurated facilities aim to deliver unparalleled care for neonates and expectant mothers, blending cutting-edge technology with a patient-centric approach.

The four-bedded state-of-the-art NICU is designed to care for neonates up to 30 days old, particularly those born prematurely with critical conditions or congenital issues. It features advanced ventilators, warmers, and neurodevelopment assessment tools to address a spectrum of challenges, including respiratory distress, infections, and growth concerns. The facility is staffed with highly trained paediatricians and nurses, ensuring 24x7 monitoring and expert care.

Dr Bipin Chevale, CEO of Gleneagles Hospitals, Parel, Mumbai, expressed his pride in the launch, "Our NICU and obstetrics services are a testament to Gleneagles’ continued commitment to delivering superior care with compassion. These facilities combine cutting-edge technology with personalized attention to ensure the best outcomes for newborns and mothers. This is a significant milestone in our journey to redefine healthcare standards in Mumbai."

Dr Fazal Nabi, senior consultant paediatric, highlighted the advanced features of the NICU said, "Newborns often face complex challenges, from respiratory distress to developmental concerns, requiring precise, round-the-clock care. Our NICU is equipped with the latest technology, including advanced ventilators and modern neurodevelopment tools, to support the physical and cognitive growth of neonates. Family-centred care is at the core of our approach, ensuring parents play an active role in their baby’s recovery and milestones."

Complementing the NICU is the hospital’s new comprehensive obstetrics services, which include a uniquely designed labour suite experience. Tailored for maternal comfort and holistic support, these suites offer the privacy of a personal room coupled with the capabilities of a fully equipped labour room, creating a seamless delivery environment for mothers.

Dr Anagha Chattrapati, senior consultant gynaecology, said. "Our new labour suites are designed to make childbirth a stress-free and memorable experience. With private spaces for mothers, advanced medical capabilities, and dedicated family areas, we ensure that every moment of this precious journey is supported with compassion and care."

This launch aligns with Gleneagles Hospitals’ mission to integrate technological innovation with emotional well-being, ensuring a brighter start for newborns and smoother journeys for mothers.

Lilavati Hospital collaborates with the Mayo Clinic, USA to further first-of-its-kind Nursing Excellence Programme in India

Lilavati Hospital has announced its collaboration with the Mayo Clinic, USA for the first ever Nursing Excellence Programme in India and the establishment of a new Cancer Care Institute, featuring a 300-bed hospital in Mumbai. This cutting-edge facility is set to revolutionize cancer treatment in India by providing access to the latest technology, advanced treatments, and global best practices in oncology.

Present during the #Lilavatiinitiatives programme were eminent personalities  Eknath Shinde, deputy chief minister of Maharashtra, Prakash Abitkar, minister of Public Health and Family Welfare of Maharashtra, Ashish Shelar, Minister of Information & Technology of Maharashtra, Pratap Sarnaik, Minister of Transport of Maharashtra, Dr Shrikant Shinde,  Member of Parliament, Biju Samkutty, chief operating officer, International and Enterprise Automation, Mayo Clinic, Charu Mehta, founder & permanent trustee of Lilavati Hospital, Rajesh Mehta, permanent trustee of Lilavati Hospital, Prashant Mehta, permanent trustee of Lilavati Hospital, Rajiv Mehta, permanent trustee of Lilavati Hospital.

The new Cancer Care Institute will offer tailored treatments based on patient-specific factors, ensuring that each patient receives personalized and effective care. The high-quality care provided locally will eliminate the need for patients to travel abroad for treatment, saving both time and costs.

In addition to providing exceptional patient care, the facility will create numerous job opportunities for healthcare professionals, researchers, and support staff. This significant investment in the community will boost the local economy and contribute to the overall development of the healthcare sector in Mumbai.

The Cancer Care Institute will introduce AI-driven diagnostic tools for early and accurate cancer detection, improving patient outcomes and survival rates. Furthermore, Lilavati Hospital will launch awareness campaigns to educate communities about cancer risks, symptoms, and preventive measures, fostering a culture of health and wellness.

Lilavati Hospital has collaborated with the Mayo Clinic to commence the Nursing Excellence Programme in India. This aims to enhance the skills and knowledge of our nursing staff through specialized training and development. The partnership covers various areas, including nursing excellence education, nursing quality and patient experience, patient and staff safety, nursing governance and leadership development, onboarding, orientation, and staff development & nurse competency.

Through this partnership, Lilavati Hospital will deliver training through observation, real-time best practice considerations, and structured sessions. Upon completion of the program, nurses will receive a certificate of completion from the Mayo Clinic, recognizing their dedication to excellence in patient care.

Rajesh Mehta & Prashant Mehta, The permanent trustees of Lilavati Hospital, stated, "We are thrilled to bring this state-of-the-art Cancer Care Institute to Mumbai and to collaborate with the Mayo Clinic to enhance our nursing staff's skills. This initiative reflects our commitment to providing world-class healthcare and improving the lives of our patients and community."

In a recorded video message from Davos, Switzerland, Devendra Fadnavis, Chief Minister of Maharashtra congratulated Lilavati Hospital and Mayo Clinic and said, "I am very happy that Lilavati Hospital and Research Centre Mumbai and Mayo Clinic, USA are collaborating for a nursing training programme. This will not only open a new journey in the healthcare sector but also towards the path of Seva to mankind. The launch of the nursing training programme which is the first of its kind in our country will revolutionize nursing education and set unparalleled standards of patient care.  This partnership exemplifies the spirit of collaboration that transcends borders bringing together expertise, resources, and shared aspirations to create a meaningful impact. Mayo Clinic is extending a technical partnership for the upcoming state-of-the-art hospital at Gandhinagar Gujarat, all these initiatives by the Mayo Clinic in bringing cutting-edge technology and world-class patient care in the healthcare sector in India for nurses, doctors, and healthcare professionals are the true champions of this initiative."

Eknath Shinde, deputy chief minister of Maharashtra congratulated Lilavati Hospital and said, “Lilavati Hospital has done a landmark collaboration with the world-renowned Mayo Clinic in the USA. I will refer to the cancer hospital being established by Lilavati Hospital and Mayo Clinic not just as a hospital, but as a ‘Health Temple’. The nurses are our ladki bahin (beloved sister) and will be given training by the Mayo Clinic.  I hope they will become the world’s best nurses with skills and techniques. Nursing staff is the soul of the hospital embodying critical importance in healthcare.  This type of nursing training is conducted for the first time in India. Lilavati Hospital is one of the advanced hospitals with the latest technology in Maharashtra and India and is world-recognized.  The hospital prioritizes its motto- “More Than Healthcare, Human Care” and is serving patients. Cancer cases are rising due to changing lifestyles and fast food consumption and this is a growing matter of concern. However, new cutting-edge treatments are available for treating cancer. I believe the cancer hospital being established by Lilavati Hospital will greatly benefit patients battling cancer. It is the government’s responsibility to strengthen health services in Maharashtra, and these services should reach remote areas too.   Our government is positive, practical, and cooperative for land allocation for the prestigious 300-bedded hospital and we will consider the appeal put forth by the Lilavati Hospital."

Centre seeks urgent pharma industry intervention on regulatory challenges

 

The apex Indian drug regulatory agency, the Central Drugs Standard Control Organization (CDSCO), has sought urgent inputs and feedback from the pharmaceutical industry stakeholders to identify current challenges within the existing regulatory framework. This urgent call is also to explore opportunities for streamlining processes without compromising the quality of medical products.

Pharmaceutical companies, research organizations, and healthcare professionals are encouraged to provide insights on the regulatory hurdles they face in areas such as drug approvals, compliance procedures, and market entry barriers. The objective is to refine regulatory processes to enhance efficiency while maintaining stringent safety and quality standards.

Industry representatives have long highlighted concerns regarding procedural delays, redundant compliance requirements, and regulatory bottlenecks that hinder timely patient access to essential medicines. CDSCO’s initiative seeks to address these issues and create a more dynamic and responsive regulatory environment.

A key focus of the consultation is on fostering homegrown innovation, particularly in cutting-edge fields such as gene and cellular therapy, stem cell research, and personalized medicine. With India emerging as a global hub for pharmaceutical manufacturing, CDSCO aims to strengthen support mechanisms for local innovators and research institutions.

Stakeholders are invited to share recommendations on policy enhancements, regulatory adaptations, and funding initiatives that could accelerate the development and commercialization of advanced medical technologies. The regulator is particularly interested in proposals that balance innovation with patient safety and ethical considerations.

CDSCO has urged industry members to submit their inputs at the earliest, emphasizing the importance of collective efforts in shaping a more robust and innovation-friendly regulatory landscape. The feedback received will inform future policy decisions and contribute to India’s positioning as a leader in pharmaceutical and biotechnological advancements.

Industry stakeholders are encouraged to reach out to CDSCO through its official communication channels.

The Indian pharmaceutical industry is undergoing a significant transformation with the adoption of the newly revised Schedule M guidelines. The move, spearheaded by the CDSCO, aims to enhance regulatory compliance, ensure high-quality manufacturing standards, and bolster India's reputation as a global pharmaceutical leader.

Industry experts view this transition as a critical step in aligning India’s pharmaceutical sector with global Good Manufacturing Practices (GMP), fostering competitiveness, and ensuring patient safety. However, stakeholders have highlighted several challenges and opportunities for streamlining the regulatory landscape.

Stakeholders from across the industry have pointed out various obstacles in the existing regulatory framework, including implementation gaps.  

Many small and medium-scale enterprises (SMEs) struggle with infrastructure and financial constraints in upgrading their facilities to meet new compliance requirements.

 

 

 

DGFT issues new guidelines for voluntary disclosure of SCOMET violations to boost pharma exports

 

In a significant move to bolster India’s export control framework, the Directorate General of Foreign Trade (DGFT) has issued a Standard Operating Procedure (SOP) for the voluntary disclosure of non-compliance and violations related to the export of special chemicals, organisms, materials, equipment, and technologies (SCOMET) items.

“The issuance of this SOP marks a crucial step in reinforcing India’s non-proliferation commitments while promoting ethical trade practices. Pharma exporters are encouraged to familiarize themselves with the guidelines and proactively disclose any inadvertent lapses to avoid stringent penalties,” DGFT said.

Santosh Kumar Sarangi, director general of foreign trade, emphasized the importance of voluntary disclosure in maintaining transparency and accountability in India's export ecosystem. "Transparency is key to strengthening export compliance. This SOP provides exporters with an opportunity to voluntarily disclose any inadvertent violations, ensuring corrective actions while mitigating legal consequences," he stated.

The newly issued SOP recognizes that responsible exporters may sometimes fail to comply with the export control provisions under various regulatory acts. The initiative aims to encourage voluntary disclosures, thereby raising awareness and minimizing non-compliance incidents.

The Inter-Ministerial Working Group (IMWG) within the DGFT will evaluate voluntary disclosures on a case-by-case basis, considering them as mitigating factors while determining administrative penalties, if any. However, the disclosure framework does not apply to violations involving SCOMET Category 0 and certain Chemical Weapons Convention (CWC) schedules.

The SOP lists several types of violations including unauthorized export of SCOMET-listed items without prior authorization, export to United Nations Security Council (UNSC) sanctioned entities, unauthorized access or transfer of technical data, failure to comply with reporting and record-keeping requirements and unauthorized site visits or access to sensitive documentation by foreign entities.

Despite voluntary disclosure, violations may still result in penalties or administrative actions, including potential criminal prosecution. The IMWG will evaluate disclosures based on factors such as intent, systemic lapses, prior violations, and the degree of cooperation with authorities.

Pharma exporters identifying a compliance breach are required to notify the DGFT immediately and submit all relevant documentation within 30 days. Required documents include Disclosure Proforma, licensing and shipping documents, end-user certificates and related agreements.

Failure to submit complete disclosures within the prescribed timeline may lead to the rejection of voluntary disclosure as a mitigating factor and could trigger further regulatory action.

All voluntary disclosures will be reviewed by the IMWG, which will recommend appropriate actions to the DGFT. These actions may include accepting the disclosure with no further action required, issuing a show cause notice (SCN) and imposing administrative penalties or other sanctions for serious violations.

Sarangi reiterated that the DGFT remains committed to ensuring national security while facilitating compliant trade. “We urge exporters to take proactive steps in maintaining adherence to SCOMET regulations. This initiative serves as a safeguard for responsible traders, ensuring compliance while maintaining India’s international trade integrity,” he remarked.