The Indian pharmaceutical Industry is driven by knowledge, skills, low production costs, quality. Due to this, there is demand from both domestic as well as international markets. This has resulted in a robust growth of around 14% since the beginning of the 11th Plan in 2007 from about Rs 71000 crores to over Rs 1 lac crores in 2009‐10 comprising some Rs 62,055 crores of domestic market and exports of over Rs 42,154 crores.
Every 5th Tablet, Capsule and Injectable in generics drugs consumed anywhere in the world is manufactured in India. In fact, India manufactures 30% of the world requirement of Anti‐HIV drugs. All of this growth has been with affordable price to the common man – one of the lowest in the world.
Indian pharmaceutical industry is truly international with leading international manufacturers competing in Indian domestic market and several Indian pharma companies having a significant presence in international market, especially in the generic segment. However, the Industry is quite fragmented and comprises of nearly 10,500 units with majority of them in small sector. Of these, about 300‐400 units are categorized as belonging to medium to large organized sector with the top 10 manufacturers accounting for 36.5% of the market share.
For the achievement of these Goals, it is necessary for the Indian Pharmaceutical Industry to become globally competitive through world class manufacturing capabilities with quality and cost efficiency of production capacity and radical up gradation of research and development capabilities for new drugs and associated activities like clinical trials and contract manufacturing. There is need to develop world class support infrastructure both for production and research.
The preparation of the 12th Plan involved a detailed SWOT analysis of the Indian Pharmaceuticals Industry:
(a) Strong Low cost manufacturing sector
(b) Significant breadth and depth of product expertise
(c) Low cost of growing Human resources in the pharma sector.
(a) High emphasis on generics both for domestic and international markets have left little room for R&D on drugs development
(b) Inadequate R&D Infrastructure
(c) Poor Industry‐Academia linkage
(d) Lack of required high‐end product development capable human resources
(e) Lack of time driven regulatory infrastructure
(f) Poor SME base for high‐end manufacture.
(a) Global opportunity for increasing Generics and bio‐generics market both in developed and emerging countries due to pressure on budgetary limitations of these countries as well as emergent patent cliff due to off patenting of major high‐value drugs
(b) Low cost good skill destination for contract research and manufacturing and resultant opportunities in drug discovery as well as clinical trials
(d) High growth of domestic market attracting multi‐nationals both for brown field and green field investments in production and capacity building.
(a) Ever‐greening strategy of MNCs for denying and limiting the patent cliff opportunities with debatable recourse to TRIPs and FTAs.
(b) Increasingly stringent regulatory and non‐tariff barriers to generics markets in developed countries
(c) Increased competition for generics and bio‐generics production in terms of high capacity and production costs
(d) High‐entry barriers to enable market share in development of new drugs.
The present market size of Medical Devices and Equipments is around Rs 15,000 crores. The medical device Industry in India is very nascent and is largely import dependent. More than 65% of India’s requirement of medical devices and equipments are met through imports with domestic production being largely restricted to low technology disposable equipments.
India, at present is recognized as a leading global player and holds 3rd position in terms of volume and 14th the in terms of value of the production. Globally, in the overall pharmaceuticals space, with a turnover of US$21 billion in 2010, Indian Pharmaceutical Industry has a share of 2.4% in terms of value in global pharmaceutical industry which is having a turnover of US$ 878 billion in 2010.
Overall drugs manufacturing in India is up to 50% cheaper than in western industrial countries.
High end R&D was not a requirement and disease control was more an issue of access to public health infrastructure and low cost medicines. To that extent the Indian manufacturing model has served well from the manufacturing point of view. However now that India is poised for a greater role in the global economy in general and also in the pharma sector for reasons discussed earlier in terms of the growth drivers, the weakness in the system of poor R&D is quite evident. The industry’s total R&D budget is comparatively very small as compared to the global competitors.
Historically, it can be seen that when no private player was ready to invest in the capital‐intensive drug sector in fifties and sixties, Government of India invested huge capital in infrastructure of this sector establishing public sector units to make lifesaving medicines available at affordable prices for government health programs. This also substantially reduced dependence on imports saving the valuable foreign exchange when the country needed it most. Even when in eighties, when private players started entering this field, public sector helped the government to keep the prices of essential medicines under control. Even today the current scenario with respect to poverty and public health in India poses serious problems of affordability and availability of key medicines. Additionally, in cases like epidemics, natural calamities etc where emergency interventions are required, Public sector units are a vital tool in the hands of the government to make desired products available in volumes and at a reasonable price. While it is admitted that the share of Public Sector is minuscule in Pharma sector they can have some strategic importance. It could be useful to make these units competitive and self‐sustaining in the long run by providing the necessary fillip at this juncture.
Major Pharma companies:
Ranbaxy Labs, Dr Reddy's Labs, Lupin, Cipla, Sun Pharma,Wockhardt ,Jubilant Lifescience, Cadila Healthcare, Biocon, Glenmark Pharma, Stride Arcolab, Plethico Pharma, Piramal Healthcare, Divi's Labs, Aurobindo Pharma
2D Barcoding has been made a regulatory requirement for export of medicines by DGFT to prevent fake medicines and mis‐representation of Indian exports in the name of other countries like China etc.
Some Appreciation Please!