India has emerged as hub of cost effective medicines for not only developing countries, but also for highly regulated markets like USA, Canada and Europe. The cost content of medicine prices are determined by countries regulatory agency National Pharmaceutical Pricing Authority (NPPA), International agencies like USFDA , European Medical Agency. It is also greatly influenced by trends in national and international market. The Indian pharmaceutical industry is poised for growth from US$30 billion to US$70 billion at an annual growth rate ~15 per cent.
However at least it can reach US$55 billion from US$ 30 billion in 2016 by 2020. The trajectories of phenomenal growth for this forecast are identified as market size expansion [domestic and global], competitive edge in pricing, availability of native human resource, tax reforms [ GST bill ] ,growth in health insurance sector, increased income , increased govt spending in public health care and investment by private and government in infrastructure.
There are some factors which can act as barriers to this growth rate such as strict implementation of price control in India, penalties and ban of Indian manufacturers by regulatory agencies due to violations and misappropriations of industrial practices, global hostile socio political developments and unprecedented natural calamities in the world.
India earns 70 per cent of its revenues by generics in regulated markets. This has become possible due to competitive pricing, development of indigenous CRO who are able to develop bioavailability and bioequivalence data of off patented brand in the global market. There are many Indian multinational pharmaceutical manufacturers who are approved by international regulatory agencies in India. For example , US FDA opened the India Office in New Delhi in 2008, to ensure that food and medical products exported from India to the US are safe, are of good quality, and are effective.
With right kind of domestic policies and subsidies by state and central governments, the indigenous manufactures have become international players and are right now have a global market share of 20 per cent in volume to become the largest provider of quality generics medicines. Indian manufactured over the counter [OTC] and patented drugs have market presence of 21 per cent and nine per cent respectively in USA.The success of Indian pharma sector are mainly attributed to its inherent strength of low manufacturing costs and availability of cheap well trained manufacturing human resources.For example, India’s cost of production is significantly lower than that of the US and almost half of that of Europe. The pharma industry of India has grown internationally into a multinational brand catering the requirements of rich and poor nations .
The Addendum 2015 of the Indian Pharmacopoeia (IP) 2014, published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health & Family Welfare, is expected to play a significant role in enhancing the quality of medicines that would in turn promote public health and accelerate the growth and development of pharmaceutical sector.
NPPA was established in 2008 in the Department of Pharmaceuticals of Ministry of Fertilizers and Chemicals , Government of India with a mission statement of ¨ Affordable Medicines for All”.The Establishment of NPPA had its own history. The Government of India passed its first legislation Drug Policy 1986,followed by modification in Drug policy 1986. The government of India passed Drug [Price Control] Order 1995, when it was found that the pharmaceutical industry was selling drugs at highly unreasonable and it started affecting affordability and subsequent compliance.
Not all drugs were brought into the ambit of price control. The drugs which are mostly essential drugs and drugs used in the primary health care. Government retained the option of amending the list depending on the situation in the health sector. The Drug Price Control Order was evolved into Pharmaceutical Policy 2002, National Pricing Policy 2012 and National Drug Price Control Order 2013. These legislations had an impact on industrial practitioners, who have learnt the skills of manufacturing cost -effective medicines. This has helped the pharmaceutical industry to have a competitive edge over peers of international competitors.
Indian pharmaceutical industry is always eager to update its technology by adopting the new inventions from around the world and also actively engage in developing its own indigenous products based technologies. India is known for its initiatives in the manufacture of biotherapeutics. The biotechnology enabled drug manufacturing companies are contributing novel biotherapeutics like vaccines, hormones,and monoclonal antibodies. The world is looking for Indian leadership in the areas of cost effective biogenerics .
The investments and encouragement to develop cost effective medicines to indigenous manufacturer by Department of Biotechnology, Government of India has created an environment of entrepreneurship among young scientists.
The application of nanotechnology in medicines and diagnostics by many startups is really commendable. A Haryana based Premas biotech firm in collaboration with Israel and China is in making a breakthrough in oral insulin. It is ahead of its competitors Biocon and Nova Nordisk. The government of India is encouraging industry and academics partnerships by funding BIRAC grants.The table 2 contains the Indian origin biotechnological companies involved in developing and manufacturing biotechnology based products.
The Indian health care delivery is poised for growth from several sectors like economic, social, disease burden, technological and demand for quality services with affordable cost. These drivers of health care delivery are also driving the growth of pharmaceuticals industry in India. For example, medical tourism is attracting patients from all over the world who visit India for cost -effective treatments with quality treatments which are cheaper to the extent of 40-80 per cent compared to the cost of treatments in their countries. This is evident by growth of corporate hospital brands in Hyderabad, Bangalore and Chennai.
Improved economy of individuals and access health care knowledge, is acting as a stimulus for demand for quality of health care services. On the other hand, The Government of India has a electoral commitment to deliver social justice as for the accessibility, affordability and availability of cost -effective medicines to public all across the country. The government's efforts to improve health education opportunities by opening several hospitals par with All India Medical Sciences throughout the country, investment in infrastructure by encouraging academicians with pharmaceutical Industry through various Birac schemes, initiating Jan Aushadhi schemes, enacting Pharm D regulations and Pharmacy Practice Regulations 2015 are some of the evidences.
The shortage of quality health care providers is a daunting problem of every society across the world. In India also the health care providers are trained in private institutions who are regulated by government nodal agencies like UGC, AICTE, Ayush, MCI, NCI and PCI. These agencies are regulating the education standards of doctors, nurses and pharmacists.
The leadership of Indian pharma industry in the global landscape is very much impressive and progressive. About 70 per cent of the generic medicines sold in regulated markets are made in India.
On the other hand,India is rightly described as hub of poor man's pharmacy. India is known for formulations of pharmaceuticals. India has responded to world health crises by supplying good quality of medicines to poor countries across the globe. For example when the African continent was reeling with AIDS epidemics. Indian Pharma Industry CIPLA took a daring leadership by supplying US$5510,000 worth of medicine to US$55500 and saved numerous lives in Africa. The indian scientists are quite competent to develop new drugs not only for India but for the whole world.
The domestic clinical services in India shall be soon upgraded to international standards. The Indian health consumer are becoming more and more alert about prescription drug abuse. The availability of clinical pharmacist with Pharm D qualifications is going to play a pivotal role in making all the changes. The corporate hospitals are appointing the Pharm D to bring quality use of medicines and also check the cost of treatments by making Pharm D incharge of pharmacy. The opportunities of pharmacy practice is possible, which promotes preventive healthcare in the society.
All these evidences are indicating a bright future for Indian pharmaceutical sector which poised to serve not only India but the whole world by providing quality medicines and pharmaceutical services in a cost -effective manner.
(The author is Director, SCS College Of Pharmacy, Harapanahalli)