<p>Order of the Delhi High Court in the matter of Court on its Own Motion Vs Union of India & Others dated 16/04/2024.</p> <p>The Dr. S K Sarin Committee of doctors constituted by the Delhi HC submitted
R&D is a fast evolving segment of Indian pharmaceutical industry. Innovation, international partnerships, collaborations, inflow of funds, clinical trials partnerships and co-development deals are changing the landscape of R&D. However, the potential is far greater and to aid the harnessing of this potential, the Times Group organised the ET Bio-Pharma Development Summit in Mumbai. Dr Swati Piramal, director, Nicholas Piramal, was the chairperson of the forum, with the keynote speaker being Dr Ted Bianco, director, Wellcome Trust. The highlight of the event was the special address delivered by Kapil Sibal, union minister for science and technology and earth sciences. Dr Piramal delivered the opening address to a house full of delegates. She highlighted the need of innovation in R&D and how India can excel in the same. Her address was followed by an interesting speech made by Dr Ted Bianco, director, Wellcome Trust, UK. He provided an insight into early stage R&D through translational research funding and management of intellectual property arising thereafter. Then, it was time for Mr Sibal's speech. He termed the new disease pathogens the terrorists of the 21st century and said there was an urgent need to safeguard public health. He also made a strong case for growth of R&D in case of Indian pharmaceutical industry and how it could be harnessed in India to provide affordable cure. The minister stressed on the need for a forward-looking drug policy and government subsidies to boost innovation in the country. Malvinder Singh, MD and CEO, Ranbaxy Laboratories, the speaker for the second session, gave a address on the future of generics. He informed that the global bio-generic industry was worth $60 billion today. Indian pharma industry can capitalize on this opportunity and grow to become $100 billion industry in the coming years. He pointed out that having 50 NCEs being produced by 15-20 companies is not economically sustainable. Industry needn't duplicate infrastructure as it would be feasible to unite through partnerships and collaborations, he said. He also stressed upon the need for an enabling regulatory framework, which moves away from the price control regime. He pointed out that at present, R&D done internally by the companies alone qualified for weighted deduction under section 35(2AB) of Income tax act. He urged that the government to facilitate innovation by extending this benefit to outsourced R&D as well. The third session was a panel discussion providing an HR perspective on strategies for human resource management. Dr Ganesh Shermon, partner & country head, human capital advisory services, KPMG India, Rajorshi Ganguli, director, HR, Dr Reddy's Laboratories, Sanjay Muthal, president, HR, Nicholas Piramal and Shiv Raman Dugal, chairman, Instiute of Clinical Research of India, were the distinguished speakers forming the panel. Various strategies needed to drive excellence in research and cross-functional areas were discussed. The next session emphasising on what's next in Indian bio-pharmaceuticals was moderated by Utkarsh Palnitkar, national head of health and science industry, Ernst & Young, India. One of the speakers - Dr Ramani Aiyer, chief scientific officer, Actis Biologics - highlighted the new trends in bio pharma. He also delved into the concepts of angiogenesis, gene therapy, recombinant proteins and follow-on biologics. Kavita Khanna, president, Bharat serums & Vaccines, was the next speaker in the session and gave her views on the way forward in publicprivate partnerships. She presented a case study on 'Kala Azaar' (Leishmaniasis), to explain how public private partnership was being proposed to eradicate the disease by 2010. Adnan Naseemullah, a student of university of California, Berkeley, was one of the invitees to the session. He spoke about the growth and development of the Indian pharmaceutical industry and highlighted the variations in research strategies followed by the industry. The post lunch session was a two-speaker special session held by Dr S K Gupta, dean and director, Institute of Clinical Research of India (ICRI) and Dr Anand Bidarkar, VP, Siro Clinpharm India. They delved into the various clinical research strategies to maange research and development in India. Dr Gupta provided the statistical data on the infrastructure which is available for clinical research in India and how can India emerge as a world-class destination for conducting quality clinical research. Dr Bidarkar explained how MNCs were taking advantage of Indian clinical R&D to shorten their drug development timelines. He also highlighted how Indian companies could look at outsourcing to overcome their competitive disadvantages. The concluding session of the day was the CEO round table. Presided by Dr Piramal, with Pratibha Pilgaonkar, CEO, Rubicon Research, Dr Naveen Rao, MD, Merck India and Dr Ajit Dangi, president and CEO, Danssen Consulting, being the other participants in the discussion. Dr Piramal posed various questions to the panel relating to scope of R&D in India, possibility of doing a Nano in pharma and cost of innovation. Dr Naveen Rao, MD, Merck India, expressed the need for big pharma companies to look at India and its cost-effective resources. He also stated that partnerships offered an attractive method of risk and reward sharing. Ms Pilgaonkar pointed out that SMEs in Indian pharma industry at an early stage need the support and funding from big players in the industry to become agents of research and innovation. Dr Dangi stressed on the need for world class intellectual property (IPR) regime, lowering of transaction costs and a liberal price policy in the country. Strengthening of the infrastructure of Drug Controller General of India, approval of various protocols for clinical trials, framing of laws on cloning and neutraceuticals were other issues discussed by the panel discussion. Dr Piramal projected that by 2010, India would have discovered at least five new drugs . Her personal bet on the cost of innovation of a new drug in India stood at less than $50 million. The session concluded after a question and answer session where the audience put forth their questions to the panelists.
2.5 crore people likely to be affected by heart ailments due to diabetes Nearly 40,000 people lose their limbs every year due to the disease NEW DELHI: "Just the way the interests of 4 crore poor and marginal farmers have been protected by the Union Budget, Finance Minister P. Chidambaram should also have provided some relief to the 4 crore diabetes patients in the country who face the prospect of various serious ailments,' said Delhi Diabetes Research Centre president A. K. Jhingan in his reaction to the Union Budget on Friday. With diabetes likely to lead to heart ailments in about 2.5 crore of these people, renal or kidney failure in about 2 crore of them, loss of vision in about 1.2 crore, and with 40,000 people losing their limbs every year in the country due to gangrene caused by diabetes, Dr. Jhingan said there was a definite need for a fresh look at diabetes awareness, prevention and control. While the Union Government itself had admitted that diabetes had become a cause of national concern, it had done precious little to bring down the prices of drugs, testing equipment and test strips widely used by diabetes patients in the treatment and diagnosis of the disease, he added. Due importance "Just the way funds are allocated year after year for AIDS awareness and control, due importance should also be given for checking the spread of diabetes. But the Budget 2008-09 has remained silent on it,' Dr. Jhingan lamented. Pointing out that the reduction in excise duty allowed through the Union Budget some years ago had still not percolated to the consumers, Dr. Jhingan said a single diabetes test strip still costs over Rs.30 and insulin remains one of the most expensive available medicinal aids. As for the glucometer, he said, the prices still run into over a thousand rupees. "It is an irony that while the Centre provides glucometers free to those who have already lost their legs due to gangrene on account of diabetes, it has not tried to cut the prices so that such situations can be avoided,' he added.
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