Indian Pharmaceutical Industry has witnessed a robust growth from US$ 11.4 billion in 2010 to US$ 13 billion in 2011 with a scorching pace of growth of 15%. The industry ranks 3rd in terms of volume and is 14th in terms of value globally. Showing tremendous progress in terms of infrastructure development, technology base creation and a wide range of products, the Indian pharmaceutical industry has established its presence and determination to flourish in the changing environment.

Indian Pharmaceutical Industry

The India Pharmaceutical summit 2012 brought together the leading delegates in the Pharmaceutical industry along with industry experts and thought leaders to discuss the current state and the projected growth in the India Pharmaceutical industry.

Mr Naresh Raisinghani, chairman for the event on day 1 and CEO & Executive Director, BMGI, spoke about how the Indian Pharmaceutical industry was poised for growth. He presented the point of view from both sides, articulating the dilemmas of the global innovators including declining R&D productivity, while also pointing out the pressure on the Indian Pharmaceutical industry, seeing as it is considered as the emerging Pharma market, and is being banked on by other markets as well. He ended his presentation by speaking about 5 key challenges that would need to be managed in order to unleash the growth potential in India.

Speaking on the need to keep a watch on quality as well, Dr Monir Islam from the World Health Organization, Regional office for South East Asia recounted experiences where a health worker allocated wrong medicine to use up the stock; or brushes with untrained doctors & nurses who can be dangerous to the patient. He cited a few other cases highlighting the dangers of poor stock management and general ignorance regarding the drugs being used by healthcare workers. His presentation also touched upon WHO’s activities in strengthening drug regulatory authorities, providing training and support and monitoring drug usage and implementation policies, and WHO’s global strategy and Plan of action, including promoting sustainable financing for developing countries. He ended by identifying the key challenges such as the large number of unorganized private healthcare providers and meeting the R&D challenge.

Dr PM Naik, Project Director, Zydus Cadilla spoke about the importance of creating world class infrastructure for GMP compliant facilities. He then mapped basic requirements for world class facilities for manufacture of potent drugs, steroids, OSD, Narcotics in detail before emphasizing that pharmaceutical organizations today need to look at Operational Excellence seriously as constant improvement gives competitive edge. He signed off urging the industry to “awake, arise and act in the right manner”

Mr Kenny Gregson, International Service Head of Germany’s Huber, took the delegates through a case study on temperature control in process chemistry. Giving an overview about Huber traversing through the company history and its’ product range progression through the years, Mr Gregson looked at the various influencers for efficient thermal transfer and the limitations & problems it would entail which includes losses due to poorly insulated surfaces.

Another eminent speaker at the summit, Mr Rahul Padhye - Head, Corporate Development, Reliance Life Sciences gave an overview of the Biotech sector in India. He spoke about the ample opportunities in India for Biosimilars and Regenerative medicine. The emerging landscapes, he predicted, promise more partnerships between organizations for P2P marketing deals or out-licensing deals. Mr Padhye closed by sharing the initiatives of Reliance Biotech in this industry to tap the opportunities especially in biopharmaceuticals and regenerative medicine segments.

Mr Aravindan Raghavan, General Manager, Corporate from Piramal Healthcare Limited shared the Operational Excellence Journey. Giving an overview of the journey, named “Manthan”, Mr Raghavan shared that it sought to counter high costs, varying cultures at different sites, high demand customers at its inception which provided an input to developing a model and a framework. The model reaped benefits that included increased employee engagement, external customer delight, facilitated better communication, reduced operational expenses and primarily improved yield and capacity.

Mr Daara B Patel, Secretary General of Indian Drug Manufacturers’ Association (IDMA) welcomed the delegates on Day 2 and spoke about India’s Generous Generics. He projected India joining the top 10 global Pharma markets in terms of sales by 2020 fostered by favourable economic policies, expiry of patents of blockbuster drugs and rising global healthcare costs. However the challenges of declining productivity, increased development costs and increase in clinical trial periods still exist. Plotting the global Pharma trends, Daara shared that the demand is towards low cost generic options from countries like India before encouraging Pharma companies to evaluate opportunities to procure medicines at affordable prices, reduce costs, improve pipeline and reduce the time to market. He rounded up with the initiatives taken by the Indian Government which include a decision to spend nearly 5 Bn USD to supply free drugs to patients and the assistance for a single window clearance to make India the destination for Generics.

Dr Albinus D’Sa, Deputy director India Office, U S Food & Drug Administration gave a complete breakdown of Health and Human services and presented data on the growth of generics while the funding for regulation has remained flat. This in turn leads to expanding backlog and increase in foreign API inspections significantly from India and China. Dr D’Sa explained the initiatives taken which include six public meetings and 16 negotiation sessions with 3 trade associations and gave the detailed break up for fees for ANDAs and DMFs. He also informed about the exemptions to the legislations.

Mr Subbi Reddy from Pharmaceuticals Export Promotion Council of India (Pharmexcil) made a presentation about India’s Pharmaceutical Exports, which is projected to be among the top five in 2013-14. He also shared that there is a lot of untapped opportunity as the major exports are to large countries and regulated markets as compared to small countries and unregulated markets. He concluded his presentation by outlining the generic industry’s growth drivers which include historically high levels of patent expiry, increasing healthcare demands for an aging world population and fewer new medicines reaching patients

Mr Sriram Akundi, Head of Quality & Regulatory Affairs from Biocon presented on “Harmonizing development through cooperation”. Mr Akundi began with the growth potential of the biotech market which will be propelled by the emerging markets. He added that while the patent cliff offers significant opportunity to markets like India, it is important to ensure there is an efficient and fast way of getting an entry into this. He concluded by stating that even if patent laws expire or regulatory reforms take place, affordable medicines will not be available for the patients and suggested partnerships are the way to go ahead to make medicines affordable.

Mr. Kaushik Desai, from the Indian Pharmaceutical Association (IPA) presented the Indian Pharmacy Education’s prospects and perspectives. He took the delegates through the history and outlined the activities of IPA that include conducting competitions for students and campaigns before explaining the challenges of the industry including Shortage of qualified trainers and a weak academia - industry interactions. He mentioned that the need of the hour is to think along the global lines and to make knowledge transferable from education to application, he added. He also proposed major amendments including introducing regulations for pharmacy practice, educational cut offs to ensure qualified healthcare workers and recognizing pharmacists and pharmaceutical scientists as experts in medicine and disease prevention

Noppen would like to thank our event sponsors, Peter Huber Kältemaschinenbau GmbH, Skypack India Pvt. Ltd and Reynders Label Printing India Pvt. Ltd. We would also like to thank our eminent speakers and delegates for participating in the summit and ensuring the success of the event