India US FDA India Office Director Sarah McMullen discusses the importance of maintaining India’s role as a global supplier of low-cost generics while also navigating the complexities of innovating and producing more complex pharmaceutical products. She notes that increased product complexity will inevitably lead to more regulatory challenges, emphasizing the need…
Africa Nigeria has become the first country to roll out a new meningitis vaccine. The product, a shot able to protect against the five causes of meningococcal meningitis, was developed by the Serum Institute of India (SIIPL) and health equity non-profit PATH. With more meningitis vaccine-based projects in the pipeline, stakeholders…
India Dr Suresh Advani, director of the department of Medical Oncology at Jaslok Hospital and Research Centre reviews the progress of medical oncology in India and talks over the significant contribution of the hospital to the field with its involvement in large international clinical trials, particularly phase I trials. He laments…
India President of India’s Diabetes & Obesity Centre, Dr Brij Mohan has an extensive background in the field of diabetes, having served on the board of Diabetes India and as president of the Research Society for the Study of Diabetes in India (RSSDI). He outlines the significant diabetes burden in a…
India A pioneer in caster oil-based chemicals and pharmaceutical-grade products, Jayant Agro-Organics accounts for some 35 to 40 percent of the global castor oil market. Chairman Abhay V. Udeshi explains the audit process the company maintains to meet the standards of local and international regulatory bodies and Jayant’s sustainability efforts, including the…
India India’s National Chemical Laboratory (NCL), one of the most well-established labs in the wider Council of Scientific and Industrial Research (CSIR) network, has made some major contributions to improving the country’s manufacturing processes for pharmaceutical intermediates and APIs. Director Dr Ashish Lele outlines the approaches the lab is pursuing, such…
India Sanjay Bhutani of Bausch & Lomb outlines why the medical devices sector in India is poised for substantial growth, bolstered by increased government support and a higher healthcare budget. He also explains how the 2023 National Medical Device Policy marks a significant shift towards recognizing the distinct needs of the…
India Regular contributor Brendan Shaw gives his informed take on how best international stakeholders can engage with India’s attempts to transform into a global pharma innovation powerhouse, Our greatest ability as humans is not to change the world, but to change ourselves Mahatma Gandhi The secret to success in India…
India Dr Santosh Indraksha serves as Deputy Drugs Controller (India) for the Central Drugs Standard Control Organisation (CDSCO) under the Indian Ministry of Health and Family Welfare. As a representative of India’s main regulatory body for pharmaceuticals, tasked with overseeing the organisation’s international cell, Dr Indraksha outlines the key upgrades in…
India Clinical trials will be a pivotal part of India’s attempts to scale the global pharmaceutical value chain. Following a series of well-publicised scandals in the early 2010s, the country tightened up its clinical research regulations and saw a significant drop in trial numbers. However, with a revised regulatory landscape, a…
India Dr Viranchi Shah of Saga Lifesciences and the Indian Drug Manufacturers Association (IDMA) outlines the Indian pharmaceutical industry’s potential for growth and its role in global health initiatives. He highlights IDMA’s focus on scaling operations, affordability, accessibility, quality, and compliance to drive positive change across the sector. Dr Shah also…
India Drawing on a unique background in both medicine and law, Dr Milind Antani today leads the pharma and healthcare practice at Nishith Desai Associates, covering everything from regulatory work to corporate transactions, intellectual property matters, and dispute resolution. Dr Antani highlights the dynamic M&A landscape in Indian healthcare and pharmaceuticals…
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