With the new pharmaceutical policy and the Centre's stress on ‘make in India’ initiative, the country is likely to witness a large-scale growth of the bulk drugs industry soon.
The Indian pharmaceutical industry has achieved an eminent global position in pharma sector and has been witnessing phenomenal growth in the recent years. India is fast emerging as a world leader in generic pharmaceuticals production, supplying 20 per cent of the global market for generic medicines. The industry accounts for eight per cent of global production, and is exporting to over 200 countries. India is a major vaccine producer and has 18 major vaccine manufacturing facilities.
As these vaccines are used in the national and international market, this makes India a major vaccine supplier across the globe.
Indian pharmaceutical industry has been playing a pivotal role in supply of affordable and quality pharmaceuticals to the developed and developing countries. It is third largest in terms of volume and 13 largest in terms of value. The industry is estimated to grow at 20 per cent compound annual growth rate (CAGR) over the next five years. India is among the top 20 pharmaceutical exporting countries and the exports have grown significantly at a CAGR of around 19 per cent in the 11th plan period. The industry has seen tremendous progress in terms of infrastructure development, technology base and the wide range of products manufactured.
According to V K Subburaj, secretary, pharmaceuticals, Ministry of Chemicals and Fertilizers, government of India, with the launch of new pharma policy in the country, the central government wants to encourage innovation and growth in the pharmaceutical industry. “To make India self sufficient in the bulk drug sector and avoid excess dependence on China for APIs, we are planning to launch six pharma clusters across the country and want more firms to take up bulk drug manufacturing. We have also allowed 100 per cent foreign direct investment in pharma sector and have brought in drastic changes in laws regulating the medical devices industry. All our efforts are aimed at making India self sufficient and increase its export capacity to a bigger scale,” said the secretary.
For the overall growth of pharmaceutical manufacturing in the country, the central government is not only bringing in a new FDI policy or medical devices policy, but is also enhancing the pharmaceutical educational system in the country. As a part of this, the central government has already announced establishment of a number of NIPERs (National Institute of Pharmaceutical Education and Research) across the country. As the country has already a large number of pharmaceutical colleges running under private sector, NIPERs are expected to boost the core research in the pharmaceutical arena.
As India has already been recognized in quality generic manufacturing, the policy makers in the country are now planning to meet the pharma needs of the world as exports had already reached all corners of the world. “The pharma sector is a proud and successful industry in India today, exporting medicines to 220 countries in the world. Over 60 per cent of the vaccines are produced in India. There was nothing prior to Independence, but in a span of over 65 years we have achieved many successes in pharma and has become a global supplier today, said Subbaraj.
With the new policy initiatives by various state and central government, the pharmaceutical manufacturing sector in the country is expected to grow five times from the present Rs 2-lakh-crore level in the next 10 years.
India leads in disease burden in the world, including heart diseases, tuberculosis, cancer, blindness and mental illnesses and that itself is a huge opportunity for the domestic pharmaceutical sector to innovate and grow. To achieve innovation and new trends in R&D, there is a need to ramp up the capacities of NIPERs besides upgrading them in terms of quality. Except the Mohali institute, the remaining centres are stagnating even though these institutes were originally conceived on a par with the IITs, opined educational experts while explaining the need for quality education and innovation in R&D for the growth of pharma manufacturing in the country.
Experts revealed that though India has a large number of educated professionals in many fields, they are not sufficient to meet the requirements particularly of the pharma industry which is in need of need of thousands of quality graduates. Institutes like NIPER could produce only 600 graduates each year.
Except NIPER at Mohali, not many institutes in India have developed new drug molecules. According to Ariz Ahammed, joint secretary pharmaceuticals, about 136 molecules were launched last year of which only 38 are available in India. “As access to new drugs is very limited, we need to explore the field of innovation,” says Ariz.
Moreover, even globally, the drug research is shifting from chemistry to biology. According to experts in 2015, about 40 per cent of the approvals are expected for the biological medicines in the US. For the growth of the manufacturing as well as the research and development sectors, there is a greater need for the industry and academia link up. Towards this end, Niper-Hyderabad is likely to enter into a MoU with Dr Reddy's Laboratories soon.
2015- The year of API
As part of its initiative to bring in new policy changes in the pharmaceutical segment, the Union Minister of Chemicals & Fertilizers had indicated earlier that the pharma sector in India will become self-sufficient in the bulk drugs. To build confidence among the industry, the central government had declared “2015 – Year of Active Pharmaceutical Ingredients” way back in February.
To spruce up bulk drugs manufacturing in the country, the government had set up Katoch Committee to look into various issues concerning the bulk drugs production. Its recommendations have been received and will be implemented soon after once it is approved by the Cabinet.
In fact the bulk drugs industry constitutes the backbone of the pharmaceutical industry and the sector needs to be incentivized so as to take on the challenge from cheap imports. Without compromising on the quality, environmental requirements or regulatory necessities, the central government is coming forward to address all other issues concerning the industry. The central government wants the industry to avoid over-dependence on imports from one country for bulk drugs as it is detrimental to the country’s interest and hence a paradigm shift is necessary.
Stressing on Make in India, the government wants the pharma manufacturers to excel not just in formulations but also become world leader in the bulk drugs sector. As feared earlier, recently, China, which is regarded as a single source of low cost APIs, has increased the prices of API. Having understood the seriousness of the situation, the government of India wants to avoid future price and supply risks and ensure assured and sustained availability of these basic inputs to formulation sector. The latest incident is a clear pointer to the need for promoting API manufacturing in India.
This is also consistent with the avowed objective of the government regarding ‘Make in India’. In recognition of the situation, Department of Pharmaceuticals has declared the Year 2015 as the Year of API.
It is high time that government took immediate take measures to facilitate the growth of the pharma sector and also interact with the industry on a regular basis to improve government to business (G2B) interactions and promote better and more co-ordinated efforts to achieve the objective of ‘Make in India’, especially for the API sector.