India Pharmaceutical Summit 2012, Mumbai

BMGI Presents the Elixir for Transforming Indian Pharmaceutical Industry to become the top Pharmerging Market
As the key knowledge partner for India Pharmaceutical Summit 2012, held in the Hilton Mumbai International Airport Hotel, Mumbai on 12th & 13th July, BMGI presented the ‘elixir’ for making India the top Pharmerging market in the world. The event was organized by Shanghai based Lnoppen that facilitates business through events and market research across Asia & Europe. With over a hundred participants including Mylan, Ranbaxy, FDC, Neogen and Midas Pharma, the event saw speakers from thought leaders from the industry and regulatory/institutional entities like the World Health Organization (WHO), Indian Drug Manufacturers’ Association (IDMA), Indian Pharmaceutical Association (IPA), Pharmaceuticals Export Promotion Council of India (Pharmexcil) and organizations like Biocon, Reliance Life Sciences, Lupin Bioresearch Center, Global Pharma Tek, Jubilant Life Sciences, Zydus Cadilla, Piramal Healthcare Limited to name a few. Mr Naresh Raisinghani, chairman for the event and CEO & Executive Director, BMGI, in a brief presentation, articulated how Indian Pharma was poised for growth. He presented the polarity for India, where on one hand the global innovators’ dilemmas – the patent cliff, the declining R&D productivity leading to thin pipeline of new drugs, the pressures on pricing – are causing worry and on the other, markets are banking on India for generics as it is one of the Pharmerging markets. He illustrated that India has the opportunity to be Mr Naresh Raisinghani, CEO & Executive Director, BMGI at the epicentre of the generics revolution with the rise in population (set to grow to 1.35 billion by 2020) and coupled with increasing life style diseases together with higher disposable income levels enables it to spend more on healthcare. Leveraging the low cost manufacturing India offers coupled with the increased spending by the Government on healthcare infrastructure and providing 100% FDI for health & medical services, the Indian Pharmaceutical narrative is only set to expand. This will provide lucrative opportunities for the global Pharma industry to focus on India with the landscape already changing with various mergers and acquisitions / licensing such as Ranbaxy, Piramal Healthcare, etc., Mr Raisinghani added. Reinforcing Mr Raisinghani’s estimates, Mr Subhi Reddy, Pharmaceuticals Export Promotion Council of India (Pharmexcil) shared that India’s Pharmaceutical Exports is projected to be among the top five in 2013-14. Mr Reddy added that India is the largest exporter of formulations by volumes with a 14% market share and that there is a lot of untapped opportunity. Plotting the trend of the Indian industry, Mr Naresh Raisinghani recounted from the time where most drugs sold were only MNC based, and the first game changer came with the India Patent Act leading to the birth of the booming generics industry. The second major change came when India decided to become globally competitive and the Patent Law being aligned with global norms in 2005, opening the doors for Exports and Indian firms being considered for CRAMS giving a new dimension

Corporate Development. both Mr Rahul Padhye. He signed off urging the industry to “awake. if an organization chooses not to comply with GMP. API.01% of GDP on government funded R&D to meet the health needs of developing countries. The Ex-President of Indian Pharmaceutical Association (IPA) firstly described the various reasons for a pharmaceutical organization to go for a new facility that included growth. Regional office for South East Asia elaborated on a recent analysis by the WHO in seven countries in SE Asia which reveals that only a few countries know what drugs they are using and cautioned the industry to keep a watch on quality. Mr Padhye shared that. enhancing medical insurance coverage as a hedge towards distributed medical expenses and strengthening IPR laws as we moved more from Patent Challenge to Patent Protect era. Dr PM Naik. He elaborated on WHO’s Global Strategy & Plan of Action (GSPA) . Mumbai to India as a Pharma destination. Mr Akundi urged the industry to look at Biosimilars which is a product that is equivalent of a generic in Pharma. Reliance Life Sciences and Mr Sriram Akundi. Project Director. was to get all countries to commit spending at least 0.India Pharmaceutical Summit 2012. WHO. Mr Kenny Gregson of Huber and . he stated. Director. Dr Naik mapped basic requirements for world class facilities for manufacture of potent drugs. constraints in capacity or even a regulatory requirement or tax benefits. One of the recommendations from the report. steroids. Health Systems Development. skilled labour availability and dichotomy of price controls. Head of Quality & Regulatory Affairs from Biocon shared that affordable medicines will not be available for the patients and the way to make this was through partnerships or out-licensing deals. he predicted. arise and act in the right manner” Looking at exports as a percentage of sales and being in a generic market.a. Zydus Cadilla spoke about the importance of creating world class infrastructure for GMP compliant facilities. Biocon India which include rural reach. The future wave would not only look at India as the generics headquarters. Mr Daara B Patel. Biosimilars and Clinical trials. Mr Raisinghani signed off by identifying 5 key challenges that need to be managed to unleash the potential for high growth in Mr Sriram Akundi. Secretary General of Indian Drug Manufacturers’ Association (IDMA) supported this by sharing that every third tablet consumed in the world is “Made in India” Illustrating the patent cliff and the Indian opportunity for Bio Similars as mentioned by Mr Naresh Raisinghani. would its profits not be optimised? The discussion on this and other important questions confronting the Indian pharmaceutical industry was moderated by BMGI’s Mr Naresh Raisinghani and the panellists included Dr Naik.this includes promoting sustainable financing mechanisms for developing countries on Public Health Innovation and Intellectual Property which seems as a direct countermeasure to the challenges outlined earlier by the Chairman of the event. at least 50% of the Biopharmaceutical market is contributed by the Indian Biosimilars market that is growing at 20% p. in detail before emphasizing that pharmaceutical organizations today need to look at Operational Excellence seriously as constant improvement gives competitive edge. etc. but would show a shift towards co-holders of development of Innovator Drugs. Dr Monir Islam.

Mr Banerjee said adopting the Six Sigma way would enhance process consistency & reliability and this would directly seek to make processes more capable. production lead time by over 60%. Almost . lack of harnessing market potential by focusing on product and not the outcome. adhering to GMP prevents the practice of conclusion being made on the entire batch to be released from the sample that is tested. Mr Easwar opined GMP enables low process variability leading to high quality products. less efficient supply chain leading to high cost and lack of consistency in the process outcome – Mr Banerjee charted out key strategies for finding the elixir that will address these issues. Nirmalya outlined the rapid innovation strategy for exponential growth by expanding the window of focus not just to include the expectations of the customer but the “Job To Be Done”. BMGI presented the elixir for transforming the Indian Pharmaceutical Industry. Mumbai Mr Easwar. Mr Gregson stated that it will be very dangerous to work in an approach where there is no focus on quality and end up damaging the reputation. how would the Indian Pharmaceutical Industry counter them? Mr Nirmalya Banerjee.India Pharmaceutical Summit 2012. Senior VP. Mr Easwar & Mr Kenny Gregson in end and tablets obtained at the other in a a panel discussion with Mr Naresh Raisinghani span of 6 hours where it takes 365 days today. All this is possible only if one has the understanding of the process. lower inventory turns. Contrasting the R&D Spend by Pharma companies with the number of approved products. productivity and right design. unit cost of conversion by 20% and increase the direct labor productivity by over 40%. Business head & Senior Principal Consultant. Dr Naik supported the thought and said the principles of Six Sigma allow one to control quality and recounted the horrors of working with variation where one batch had a lower impurity level than other two batches. the business head for the Pharma industry vertical suggested Design for Six Sigma approach that has a success rate more than 3 times of the conventional approach. Given the challenges that have been recounted so far. Describing the key chronic issues the industry faces today that include lesser success rate yet high lead times of R&D. does Lean and Six Sigma help in Pharma kind of business? Mr Easwar felt there is a paradigm shift taking place where an organization is working on a concept where raw material is fed at one Mr Ravisekhar Kasibhatta. Ranbaxy. Urging the industry to Innovate to Breakthrough. Mr Gregson felt that Six Sigma and lean system are practices where in you look to improve and continuously look to raise the bar. increased customer satisfaction. adopting a Lean way in moving from batch to flow would be the strategy to be adopted which has the potential to reduce in process inventory by 35%. Naresh probed the panellists with his second question: Lean comes from the auto industry and Six Sigma popularized by GE. Dr Naik stated that if one is making a ton of product. He added that the notion that it costs money is a misplaced one and further stressed that it is about the right blend of process technology. To facilitate a rapid & an efficient supply chain and increase inventory turns. He urged the industry to integrate the 4 strategies for higher revenue growth. faster & efficient processes and a satisfied customer.

The opportunity could be made possible through websites but that is the best that could be done. external customer delight. Safety & Efficacy. Mumbai The importance of a framework for operational excellence and business growth. Quality Function Deployment and Design of Experiments to name a few. supply chain transformation and sales force effectiveness. reduced operational expenses and primarily improved yield and capacity. US Food & Drug Administration gave a complete breakdown of Health and Human services and the detailed break up for fees for ANDAs and DMFs . Business Excellence from Jubilant Life Sciences spoke about the business turnaround for the Pharmaceutical unit. Corporate from Piramal Healthcare Limited shared the Operational Excellence Journey where the process improvement parameters are under a business excellence model named “Manthan” that sought to counter high costs.50%. Deputy director India Office. While it was felt that therapies available make people vulnerable to effects of nonstandard practices by physicians and Mr Padhye felt it would not be possible for the industry to reach out to the people and educate them as it would be unethical. senior Vice President & Global Head. He further added that slowly Piramal is moving towards Organizational Excellence before sharing a case study on energy management where the expenditure on energy was reduced by 14% using lean and six sigma principles. Dr Kasibhatta explained the process of comparing a generic product and an innovator product is called a Bio Equivalence study and it is important there be uniformity in standards in terms of Quality. Dr Albinus D’Sa. Mr Aravindan Raghavan. shop-floor development. He established that Pharmacokinetic-Pharmacodynamic Studies is a better tool during development as it has the potential to shrink the size of clinical trials since the conventional BE studies become impossible to establish safety & efficacy. How will we know if a generic product is as good as the innovator product? This question was answered by Dr Ravisekhar Kasibhatta who is the Vice President –CR in Lupin Bioresearch Center in his eloquent talk on Bioavailability/Bio Equivalence Studies in India. Mr Padhye and Mr Kasibhatta. Outlining Jubilant’s business excellence strategy he shared a case study where the market demand grew suddenly for formulation & API business.India Pharmaceutical Summit 2012. While Mr T V Narayana. that helped reduce the development time by 40 . varying cultures at different sites. Mr Gupta recounted several problems the team faced and explained the various process improvement tools that were used which included principles from New Product Development. General Manager. He stressed the importance of a focused structure and a framework for improving operations and hence the business. Vice President. As if reinforcing the importance of strategy for operational excellence. the role of a Pharma firm in investing in educating the country’s population was probed by Dr Islam. Mr Kulbhushan Gupta. The BMGI supported initiative at Piramal had two models: culture development and profit development which led to major initiatives that included ideation. a Pull based system – Kanban. The model reaped benefits that included increased employee engagement. energy & solvent management. high demand customers at its inception which provided an input to developing a model and a framework. facilitated better communication. Chairman Education Division from the India Pharmaceutical Association (IPA) urged improvements in education in Pharmacy in India with increased academia-industry interactions.

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