The ‘Make in India’ initiative of the Government of India is to focus on 25 sectors of the economy for job creation and skill enhancement.
Some of these sectors are automobiles , chemicals, I.T, pharma, biotechnology, textiles, ports, aviation, leather, tourism, railways, renewable energy, mining, etc.,
The Indian Pharmaceutical Industry
The pharma industry in India is the third largest in terms of volume and thirteenth largest in terms of value and dominated by branded generics which constitute nearly 70% to 80% of the market. India has achieved an eminent global position in the pharma sector by virtue of its huge pool of scientists. The industry is estimated to grow at 20% compounded annual growth rate over the next five years.
Apart from the problem of competing with countries like China, Korea and Malaysia, the other challenges faced by the Indian Pharma industry are:-
According to WHO estimates, 30% of Branded drugs sold in the developing is counterfeit. The Government of India has taken steps to counter this by upgrading the State Drug Testing laboratories with modern technology and the latest testing equipments, enforcing serialization, non clone able packaging and 2D bar coding and increasing the number of new drug manufacturer inspectors.
Clinical Trial quality
In effective regulation of clinical trials leading to unethical practices in conducting clinical trials. The Government of India, after the Supreme Court directions had constituted the Dr. Ranjit Roy Chaudhury expert committee and its recommendations are in the process of being implemented.
Patent Issues and Drug pricing policies in the market
The promotion of generic products and the Drug Pricing policies of the Health Ministry to prevent prices of life saving drugs from becoming unaffordable to the common man have caused a number of issues to Multinational companies who are questioning the commercial viability of India as a profitable destination for clinical trial
Government’s initiative to promote the Indian Pharma Industry
- Indian and global companies have expressed intent for 175 investments worth Rs. 1000 cr. in Gujarat
- Telengana Government has proposed to set up India’s largest integrated pharmaceutical city spread over 1100 acres near Hyderabad in a bid to attract investments of Rs. 30, 000 cr.
The Road Ahead
Indian pharma Industry is expected to grow to US$ 85 billion by 2020. The Government is taking several cost effective measures in order to bring down Health care expenses by speedy introduction of generic drugs, thrust on rural health programs, life saving drugs and preventive vaccines and health insurance for all.
However, all the above initiatives are only proposed by the Government and may take years to be implemented. The ground reality is that the pharma industry has not seen any concrete steps taken by the Government to put the pharma industry back on track and the road to recovery.
Meanwhile, many multinational companies unhappy with the Government’s Drug pricing policies and promotion of generic drugs have left India for countries like Korea, Malaysia and some African countries having easier regulatory policies and speedier sanctions. Even Indian companies like Biocon and others have shifted their clinical trials to Malaysia and Korea due to the new regulatory norms and inordinate delay in according sanctions.
In conclusion, for the Indian Pharmaceutical Industry, ‘Make in India’ is just a slogan and the multinational companies leaving India is a clear signal that they are not investing in India until the Government comes up with easier and clearer regulatory policies and faster sanctions.
Indian Biotech Industry
The past one decade has seen the Indian biotech industry growing from strength to strength. Being one of the top ten destinations in the world, Indian biotech sector has expertise and is leading in vaccines and agri-biotech. Some of the companies specialize in bio-pharmaceuticals and are leading in the world.
However, the major areas in biotech sector, viz., Biosimilars, Vaccines and Stem cells require smooth regulatory framework and guidelines that would help in trials and development.
Some of the Highlights:
Market size -2% of the global biotech industry
Ranked 12th in the World and 3rd in Asia Pacific
Comprises of about 400 companies and worth US$ 4 billion
Average growth rate of 20% and poised to reach US$ 7 Billion by 2015
Major Initiatives by Govt. of India
- CSIR – Institute of Himalayan Bioresource Technology has signed MOU to transfer of technology in cosmetic, food, and pharma industries for end applications.
- DBT has allocated Rs 4.6 crores to University of Agricultural Sciences to support a national multi-institutional project titled ‘A value chain on jackfruits and its products
- Under the 12th five year plan to set up Biotechnology Regulatory Authority of India (BRAI) and a central agency for regulatory testing and certifications.
With an annual investment of US$ 4.019 million to US$ 5.024 million, in the next five years the biotech industry can grow to US$ 100 million by 2025 with a 25% return on investment and a growth rate of 30% year on year. With the support and initiatives of the Govt of India the industry can attain global leadership in providing affordable health care and innovative medicines and quality food for all.
In response to Prime Minister Narendra Modi’s plan of making it easier to do business in India, the Health Ministry proposed pre submission meetings between the Drug Regulators and the Drug manufacturing companies before formal applications for clinical trials. This move is expected to increase transparency, predictability and accountability.