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Lupin Q2 Net Down 35% On Slow US Sale

By CH Unnikrishnan Drug maker Lupin Ltd on Tuesday (October 27) posted 35 per cent drop in net profit at Rs 408 crore during the July-September quarter as against Rs 630 crore a  year ago. Its sales during the quarter at Rs 3178 crore grew just 2 per cent from the year-ago quarter's Rs 3116 crore. The slow growth was mainly on the back of less number of new launches in the US, the key revenue contributor to the company.  Reacting to the lower than expected growth in quarter results,  the share price of Lupin crashed 5.25 per cent to Rs 1,945.65 a unit on BSE on Tuesday. While, the bench mark index --Sensex was down only 0.40 per cent to 27253.44 points.  “Slowdown in approvals in the US and a lack of material launches continued to dampen growth. We continue to invest in research and remain upbeat on the pace of approvals and launches to pick up by the fourth quarter,” said Lupin managing director Nilesh Gupta in Tuesday statement.  Lupin's direct costs on input material, manufacturing, work force and research was also high during the quarter compared to the previous corresponding quarter, the company said. The D B Gupta promoted drug maker's US and Europe formulation sales stood at Rs 1,270 crore during July-September quarter. These markets together contributed some 40 per cent of its overall sales in the quarter. While, sales from India grew by 9.4 per cent  recording sales of Rs 873.8 crore for the quarter. Its another key market Japan also saw lower sales during the quarter at Rs 323.4 crore.    "Lupin’s US revenues have disappointed with a 9 per cent decline due to lack of new product launches and pricing pressure in a few key drugs in the US market. But, we expect new product launches in the US to improve in the second half and beyond on account of approvals in the recent past," said Ravi Shenoy, a sector equity analyst  with Motilal Oswal Securtities. 

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India Pledges $25 Mn Investment For 5-yr To Nurture Healthcare Innovation

World leaders adopted the Sustainable Development Goals or the Global Goals in September 2015 that aim to address problems like poverty, illiteracy, disease and overall lack of quality health care for all, among other key issues. In order to achieve these targets, it is crucial to intensify efforts to foster frugal innovation and research around the world. The Annual Grand Challenges meeting was held from 18-21 October in Beijing, China, served as a platform to discuss potential solutions centered on the power of research and development of innovative solutions to achieve the Global Goals.Grand Challenges India was jointly launched by the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) and the Bill & Melinda Gates Foundation in 2013 to promote scientific and technological advances in health through research and innovation, exclusively for Indian researchers. Under the initiative, the DBT and the Gates Foundation have pledged an investment up to US$25 million each, over the period of 5 years. Grand Challenges India seeks to promote and nurture innovations in vaccines, drugs, agricultural products, and interventions related to improving maternal and child health.In India, an estimated 1.27 million children die every year before completing 5 years. 81% of under-five child mortality takes place within one year of birth which accounts for nearly 1 million infant deaths and 57 per cent of under-five deaths take place within the first one month of life accounting for 730,000 neo-natal deaths every year in the country. Globally, India continues to be the country with the highest number of people (597 million people) practicing open defecation.Dr. Renu Swarup, Managing Director, Biotechnology Industry Research Assistance Council and Senior Advisor, Department of Biotechnology, Government of India said."We must recognize the need of innovation in developing societies. Encouraging innovation is of principal importance to tackle the problems of open defecation, child morbidity and mortality and malnutrition among mothers and children. The Bill & Melinda Gates Foundation and the Department of Biotechnology, Government of India, have come together to tap the vast potential available in India and drive health innovation in the country." said Mr. Trevor Mundel, President of the Global Health Division, Bill & Melinda Gates Foundation.The first two grants under Grand Challenges India focused on, 'Achieving Healthy Growth through Agriculture and Nutrition' and 'Reinvent the Toilet Challenge'. The latest grants under the initiative 'All Children Thriving' were awarded in 2015. Collectively there are 17 researchers and social entrepreneurs from across the country being funded under the partnership. The aim is promote innovation aligned with achieving the SDGs 2, 3 and 6, i.e., end hunger, achieve food security and improved nutrition and promote sustainable agriculture; ensure healthy lives and promote well-being for all at all ages; and ensure availability and sustainable management of water and sanitation for all.Dr K. Vijayraghavan, Secretary, Department of Biotechnology, Ministry of Science & Technology, Government of India and Chairman, BIRAC stated that "In the past two decades, we have witnessed major advances in science and technology which have transformed the lives of millions in the country. We need to continue to drive innovation and research to meet existing challenges in health care. There is a need to create an enabling environment for research and innovation; where creative confidence and inventiveness is praised and encouraged in order to harness the immense potential available in India. Through partnerships such as the Grand Challenges initiative, we can utilize our vast pool of knowledge and scientific talent to address the health challenges plaguing the country."

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Healthcare Industry In India Gets A New Edge With Coordinated Care

India is vigorously stepping ahead with giving new tangents to health care, diagnosis and medical services. New technology and emerging industry players are changing the dynamics of healthcare industry with making it more persistent and handy. Quality and affordability is becoming a new landscape for the development trajectory of India’s health system. The industry is going more towards the digital medium considering it easily accessible where technology is playing a very crucial role in rendering this shift.  Technology has changed the way doctors and patients interact. Information Technology enabled development of a “Next era” in medical sector of India by offering digital facet on medical consultation. Internet, mobile applications and web applications are playing an essential part to change patient’s experience of the industry.Lots of collaborations have been introduced through Internet that offers exclusive platforms for medical consultants and doctors. These platforms are able to allow doctors to take intense care of their patients and promote long distance communications. Technology enabled the embodiment of synchronized healthcare in health division of India.  Coordinated care is a collective approach towards bringing together two or more experts to provide medical aid to the patient for appropriate delivery of effective treatment. It is a prearranged care activity involving healthcare resources and personals managed through exchange of information between participants contributing to various aspects of care and treatment.Care coordination pays complete attention to all those activities that ensure contentment of patient’s needs and preferences. Primarily, care coordination enables smooth transition of information across experts, functions and geographical locations. Care coordination also helps in linking medical practitioners that helps in formulating an integrated health care system. The trend emerged from the US healthcare platforms such as Sermo and now has been shifting to India with doctors networking platforms such as Curofy.The fundamental aspect of care coordination is transition of information. Exchange of information between the medical entities aligned with patient’s treatment. This service is very important considering shift the patient from one health care aid to another in the system. There is a lot of information that goes along while transferring a patient, a series of information, interpretation of diagnostic reports and procedures needs to be transported to the other doctor. Even a minor gap in communication may lead to severe problems and the most crucial being wrong treatment. It’s the patient who will have to bear the ultimate consequences.Coordinated care primarily keeps a check on transferring the patient from one facility to another. It makes sure the transition is error free and easy. Most critical aspect of navigating a patient is clinical coordination. This involves the kind of information that is necessary, where to transfer, and how responsibility and accountability will be coordinated while the transfer.Sequencing of specialists, allocation of doctors, nurses, care managers and support systems need to be carried out through intensive coordination. The potential gaps in medical and informal support systems are met through coordination. Apart from these aspects, social, developmental, behavioral and educational needs of the patient are addressed in clinical coordination. Through intensive collaboration and information exchange, thus, coordination aims to achieve optimal health, wellness and positive outcomes from a treatment according to preference of the patient.Technology based platforms have given a major breakthrough to coordinated care. Web based platforms that allow extensive collaboration facilitated physicians to communicate seamlessly while transferring a patient from a care facility to another. As these platforms can be accessed via mobile devices, doctors can connect with their counterparts and exchange diagnostic reports, medical reviews and treatment procedures related to the patient with extensive ease and agility.These platforms have revolutionized the way healthcare industry functions. This has not only benefit patients, physicians and health care organizations but has given a new direction to the industry altogether. Mobile app based care coordination will definitely prove to be effective for betterment of public health management in the country. Effective utilization of care coordination can sideline the need of expensive procedures through timely delivery of intensive care and treatment.Care coordination ultimately takes care of an extreme management of well-informed doctors loaded with extensive download of the patient’s history. This is only possible because of the direct engagements of the experts and specialists. Ultimately, they aid patients with appropriate and timely treatment. These platforms also help in avoiding expensive procedure while providing the high quality services with the endless resources and efficient healthcare solutions.These platforms will benefit the present scenario of Indian Healthcare Industry immensely. The main aim of these technology driven platforms is to identify and engage the patients who require immediate attention, align specialized help, create effortless transition and optimize efficiency and revenue in the industry.Healthcare informatics, telemedicine, electronic health records, remote diagnostic and therapeutic tools have driven the first step for tech-enabled healthcare. Healthcare organization will require integrating their IT infrastructure will collaborative platforms for streamlined connection of physicians. This would enable international collaboration apart from national ones thereby bringing the sector on a par with the global healthcare industry.The author, Nipun Goyal, is Co-founder of Curofy

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Lupin Q2 Profit Lags Estimates On Fewer Drug Launches

Lupin Ltd, one of India's top five drugmakers by sales, reported second-quarter net profit much below market estimates, due to lower revenue from its largest market, the United States.Net profit for the July-September quarter slumped 35 per cent to Rs 4.09 billion ($62.97 million). That was much below the Rs 5.68 billion analysts on average estimated, according to Thomson Reuters data.US sales fell about 9 per cent to Rs 11.55 billion.Lupin's performance has been hurt in recent quarters by lower number of generic drug approvals by the US Food and Drug Administration."A lack of material (drug) launches continued to dampen growth" in the second quarter, Lupin's Managing Director Nilesh Gupta said in a statement on Tuesday (27 October).($1 = 64.9550 rupees)(Reuters)

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Rashtriya Arogya Nidhi: Govt Hospitals Can Now Grant Aid Up To Rs 5 lakh

By Haider Ali Khan The Centre has decided to enhance the financial powers delegated to designated Central government-run hospitals from Rs 2 lakh to Rs 5 lakh for providing financial help under Rashtriya Arogya Nidhi (RAN) in cases where emergency surgery is to be conducted. The RAN, set up in 1997 to provide financial assistance to patients living below poverty line and who are suffering from major life-threatening diseases related to heart, liver, kidney and cancer cases, provides for medical treatment at any of the super specialty government hospitals. "Revolving funds have been set up in 12 Central government hospitals/institutes and amounts up to Rs 50 lakh is placed at their disposal for providing financial assistance," the health ministry said in a statement.  For patients suffering from life threatening diseases, this would facilitate commencement of treatment of poor patients found prima facie eligible for assistance under the scheme by these hospitals. This would also enable to curtail the procedural delay for treatment, which would bring relief to thousands of patients annually.  The government also provides financial assistance through the Health Minister’s Cancer Patient Fund (HMCPF) set up for providing financial assistance to the poor patients suffering from cancer having treatment in 27 Regional Cancer Centres (RCC). Financial assistance is also available under the Health Minister’s Discretionary Grant (HMDG) to patients having family annual income up to Rs one lakh and below to defray a part of the expenditure on treatment in government hospitals, in cases where free medical facilities are not available.  These schemes have benefited 37,063 poor patients so far.

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Hilleman Lab In Talks With Indian Vaccine Makers For Tech Transfer

CH Unnikrishnan  Hilleman Laboratories, a global vaccine development initiative set up by UK-based biomedical research charity Wellcome Trust and US-drug multinational Merck and Co., is in talks with at least a couple of Indian vaccine manufacturers and government institutions to license out its technologies, including a low-cost Meningitis vaccine and heat-stable Rotavirus vaccine. The technology transfer deals, once signed and implemented, will make the Indian companies global supplier of these novel vaccines. The not-for-profit vaccine research institution, headquartered in India, was set up with an objective of creating new vaccines in areas of unmet need as well as developing existing vaccines for more effective delivery in low income nations. Currently it is working on  five different projects, which include a thermo-stable Rota virus vaccine, a low-cost vaccine to prevent Bacterial Meningitis, new vaccines for Cholera and E-coli induced diarrhea in children and a novel conjugate vaccine for Haemophilus Influenzae Type-b (Hib). “All our current projects, except Rotavirus and Cholera, are at the pre-clinical trial stage now and we have initiated talks with potential partners, including some of the leading private vaccine manufacturers and a couple of government organisations in India, for further development and commercial production," said Davinder Gill, chief executive officer, Hilleman Lab, in an exclusive interview with BW Businessworld on Monday (26 October). Hilleman Lab will take the diarrhea vaccines (Rotavirus and Cholera) up to clinical trial stage on its own and will license out to leading vaccine manufacturers for commercial production and marketing, Gill said.   Gill did not disclose the names of Indian companies with whom his organisation is in talks for licensing these technologies due to confidentiality reasons. The new Meningitis vaccine, which is at pre-clinical test stage, is a major breakthrough as it would reduce the cost of vaccination substantially. The currently available vaccines for preventing Meningitis, a deadly disease prevalent in many parts of the world including India, are quite expensive and not really accessible to people in the poor and developing countries. Hilleman’s new technology for this vaccine simplifies the development process and thus helps saving development and manufacturing cost,  The Hilleman model of low cost vaccine development through sustainable research is essential today as large commercial organisations are typically not interested in investing in such projects due to lack of commercial return. Therefore, access to live-saving vaccines for millions of people living in the developing world is affected. The World Health Organization estimates that 600,000 children under the age of 5 die annually due to Rota virus diarrhea and another two million are hospitalized. 90 per cent of these deaths occur in developing countries.  Hilleman Laboratories, established in 2009, had an initial funding of Rs 700 crore equally contributed by Wellcome Trust and Merck. According  to Gill, the institution’s model is to utilise this fund for its initial research projects and then to become self sustainable by transferring successful technologies to commercial organisations for making affordable vaccines. The Lab invests majority of its resources in the research and clinical assessment of vaccines against strains of diseases prevalent in the developing world, which bears 90 per cent of the global burden of disease. It also makes alliances with governments, policy makers, multilateral and international organizations including not-for-profit bodies, public-private sector, research and technical institutes among others to collaborate and exchange ideas to achieve this goal.

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Glenmark To Partner Celon For Seretide Generic

C.H. Unnikrishnan Research-focused Indian generic drug maker Glenmark Pharmaceuticals said on Friday (23 October) that its European subsidiary -- Glenmark Pharmaceuticals Europe Ltd -- has entered into a strategic drug development and licensing agreement with Polish drug maker Celon Pharma. The deal is specifically to develop and market a generic version of GlaxoSmithKline’s branded respiratory inhaler product Seretide Accuhaler.  GSK's branded inhaler with a combination of drugs such as fluticasone and salmeterol for the treatment of chronic obstructive pulmonary disease (COPD) is one of the most prescribed pharma brands in the European market. Seretide is among the top 3 pharmaceutical brands in Europe with sales of $2.24 billion for the financial year ended December 2014, according to pharma market researcher IMS.Health.  As per the terms of the agreement, Glenmark has obtained semi-exclusive marketing and distribution rights of the generic product, to be developed through the deal, across 15 European countries including UK, Germany, Belgium, the Netherlands, Italy, Sweden, Norway and Romania among others. While, Celon shall receive an upfront payment; followed by certain milestone payments during various stages of the product’s development from Glenmark, including royalties on sales. The distribution agreement was concluded for a period of 10 years, with an option of a two-year extension.  “The deal reinforces Glenmark’s growing capabilities in the respiratory segment and is a significant step forward towards building a strong respiratory franchise in Europe," said Glenmark chairman Glenn Saldanha.  "We are pleased to collaborate with Celon given their established track record with this inhaler product in Europe,” he added. According to Celon Pharma CEO Maciej Wieczorek, Celon has been investing heavily in developing technologies for inhalation drugs for sometime now.   "This agreement is yet another proof that the direction we have chosen is correct. The common experiences of both companies in the area of manufacturing, commercialisation and distribution of inhaled drugs will translate into greater availability of combination therapy in a DPI inhaler in many European countries,” Wieczorek said. Celon, which has two research laboratories and a couple of manufacturing units located near Warsaw, currently employs some 200 people including 50 scientists. While Glenmark, which has significant presence in branded and generic formulations across emerging economies including India, US and Europe, is also focused on the discovery of new molecules both new chemical entities( NCE) and new biological entities (NBE). It has several molecules in various stages of clinical development, mainly in the areas of inflammation, pain and oncology. 

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Bitter Pill | E-Pharmacies: Don't Open Yet Another Big Avenue For Counterfeiters Now

By CH Unnikrsihnan I met 27 year-old Dharmil Sheth, co-founder of PharmEasy, an e-pharmacy start-up based in Mumbai, over a coffee at the St. Regis hotel, on Wednesday. I was interested to meet him because of two reasons. First, the subject 'online pharmacy' is quite topical now and I was curious to know what’s different in his model from others, and secondly, how do these guys afford to give heavy discounts on the medicine prices when they deliver it at home.         As you know, online pharmacies have been the talk of the town in the last fortnight after the country’s 9,00,000 odd chemists closed shops on October 14 to protest the government move to appoint a committee for making a regulatory framework for e-pharmacies.  C H UnnikrishnanE-pharmacies are not new to Indian patients as scores of ads and promos of such online stores pop up on your browser every time you open one. Most of these online pharmacies, which offer nutritional products to sex enhancing capsules, including several prescription drugs,at huge discounts typically do not show the contact address or source of products that they offer to deliver.   There is no official statistics available as of now to show how many people lost their money or  how many patients got cured by taking the medicines delivered through these flashy websites and apps. But, since these sites have their servers based somewhere outside the country, Indian regulators can do nothing about it, to ban or allow.  But, when it comes to a dozen odd local e-pharmacies that have come up recently, the government should have some say. As a matter of fact, their models are not very different from the ones that is mentioned above except the access to the names and addresses of the promoters.  These new start-ups, which promise that the sales are purely prescription based, too talk about heavy discounts on medicine prices and delivery of the products at the patients’ doorstep. Now, the bigger dilemma that the Indian regulators are in at present is whether it’s time to recognise this model or not, and if yes, how to regulate them. India's Drugs and Cosmetics Act under which the pharmacy trade is regulated at present does not talk about this new model as this Act was drafted when the country did not even have a computer. The other the issue is the threat of strong protest from the offline trade, which argues that the online trade will lead to abuse of prescriptions and other ethical practices, though their real fear is the likely loss of revenue.  Dharmil Sheth explains that his model is ethical, safe and patient friendly and it asks for prescription as the patient needs to send a digital copy of the same when placing the order. . According to Sheth, the patients are offered a flat 20 per cent discount on their bills. His supply partners are the existing neighbourhood medical stores in every city that he operates and the delivery boy also cross check the prescription at the time of delivery.  According to Sheth, they are able to offer 20 per cent discount as they generate high volume of business for his supply partner. At this rate of discount, one should assume that the retail partner passes on his entire retail margin, if not more, to the buyer.  As per the industry data, the wholesale margin for drugs and pharmaceuticals in India is typically 8-12 percent. While, the retail margin is 15-17 per cent of the maximum retail price (MRP). But, one key issue in the online trade that the the e-pharmacy entrepreneurs, drug industry as well as the regulator are silent at this point in time is the inventory movement and the system to monitor this movement.    In the offline model, the medicines are sold and dispersed at a medical store, which is licensed by the drug authority. This helps the authority to inspect the place at any time during the business to ensure that the inventory stocked there are genuine and safe. The regulator also mandate the presence of a qualified pharmacist at the store and also specifies norms about storage conditions that is essential for maintaining quality, stability and efficacy of medicines. But, in the new model, neither the patient nor the regulator has any clue on where the medicines are sourced from and where are they kept. The patient also knows nothing about the delivery boy and whether the products that he brought were manufactured by a licensed drug maker.   I don't doubt Dharmil Sheth. But, there could be a black sheep in the trade.   So, should India--a market already known for rampant cases of drug counterfeits even with the existing licensed brick and mortar stores-- open up another big avenue for the counterfeiters without the required checks and balances?     

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