Indian Pharmaceutical Industry - A Global Industry
The Indian Pharmaceutical Industry has witnessed a robust growth over the past few years moving on from a turnover of approx. US $ 1 billion in 1990 to over US $30 billion in 2015 of which the export turnover is approximately US $ 15 billion. The country now ranks 3rd world wide by volume of production and 14th by value, thereby accounting for around 10% of world’s production by volume and 1.5% by value. Globally, it ranks 4th in terms of generic production and 17th in terms of export value of bulk actives and dosage forms. Indian exports are destined to more than 200 countries around the globe including highly regulated markets of US, West Europe, Japan and Australia. It has shown tremendous progress in terms of infrastructure development, technology base creation and a wide range of products. It has established its essence and determination to flourish in the changing environment. The industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing technologies. Formulations in various dosage forms are being produced in GMP compliant facilities. Strong scientific and technical manpower and pioneering work done in process development have made this possible.
Recognizing the potential for growth, the Government of India took up the initiative of developing the Indian Pharmaceuticals sector by creating a separate Department in July 2008. The Department is entrusted with the responsibility of policy, pIanning, development and regulation of Pharmaceutical Industries. An assessment of the Indian Pharmaceutical Industry's strength reveals the following key features:
- Strong export market- India exported drugs worth US$ 15 billion to more than 200 countries including highly regulated markets in the US, Europe, Japan and Australia. Large Indian pharma companies have emerged as among the most competitive in the evolving generic space in North America and have created an unmatched platform in this space. Indian companies are also making their presence felt in the emerging markets around the world, particularly with a strong portfolio in anti-infective and antiretroviral.
- Large domestic pharma companies have continued to grow, assuming leadership position in many therapies and segments in the Indian market as well as creating a strong international exports back-bone.
- Competitive market with the emergence of a number of second-tier Indian companies with new and innovative business modules.
- Indian players have also developed expertise in significant biologics capabilities.
- Biologic portfolios while still nascent in India are being built with an eye on the future.
- Multinational companies have continued to invest significantly in India and are making their presence felt across most segments of the Indian pharma market. Companies have also begun to invest in increasing their presence in tier II cities and rural areas and making medical care more accessible to a large section of the Indian population.
- Low cost of production.
- Low R&D costs.
- Innovative Scientific manpower.
- Excellent and world-class national laboratories specializing in process development and development of cost-effective technologies.
- Increasing balance of trade in Pharma sector.
- An efficient and cost effective source for procuring generic drugs, especially the drugs going off patent in the next few years.
- An excellent center for clinical trials in view of the diversity in population.
Experience & Expertise
India is the only country with largest number of US-FDA compliant plants (more than 262 including APIs) outside of USA. We have nearly 1400 WHO-GMP approved Pharma Plants, 253 European Directorate of Quality Medicines (EDQM) approved plants with modern state of the art Technology. No other country can boast of such an infrastructure.
Thus Indian pharma companies have a wide variety of experience in manufacturing as per global standards. Through intensive competition in the Indian market, Indian companies are experienced in the manufacturing of a variety of formulations that makes them efficient and competitive in their operations.
The Indian pharma market is mature with decades of experience in generics manufacturing, catering to the needs of the general population. These companies have the experience and know-how to produce quality drugs in an efficient, high-quality and cost-effective manner without compromising on any aspect. There are many companies manufacturing drugs for oncology, AIDS and other complex therapies.
Low cost of manufacture
India is capable of manufacturing low-cost generic alternatives due to a number of economic factors favoring the industry. Some of these include the competitive land rates, the cheap labor available, low resource costs like water, electricity etc., lower cost of production machinery. Importantly, the various drugs like, Intermediates, APIs and Formulation companies are seamlessly integrated while following international regulations of safety.
Research & Development
The Government has taken several policy initiatives for strengthening Research & Development in Pharmaceuticals sector such as fiscal incentives to R&D units sector and streamlining of procedures concerning development of new drug molecules, clinical research and new drug delivery systems leading to new R&D set-ups with excellent infrastructure in the field of original drug discovery.
India has a large branded generics market which enables most companies to launch their version of a generic drug in the market place. Research and Development is an important aspect for development of generics that match the quality and cost targets.
India is now increasingly recognized as a strategic partner in the drug discovery value chain. Further, there are Indian companies which are investing in their R&D centers and are offering early stage discovery services as well as promising molecules. A large scientific pool in India is dedicated to Research and Development of patent non-infringing methodologies for drugs.
Highly educated, specialized scientists
India's rich human capital is the strongest asset for the Indian Pharmaceuticals Industry which is a knowledge-led industry. Various studies show that the scientific talent pool of Indians is the second largest English-speaking group worldwide, after the US. This enables easier access to qualifications that handle the basic work in a plant or an R&D set-up in India. National Institute of Pharmaceutical Education and Research (NIPER) at Mohali is a premier institute in the field of Pharmaceuticals. The institute is a member of Association of Commonwealth Universities. NIPER Mohali is offering Masters level programs and PhD programs in 15 streams. The laboratories here are fully equipped with modern facilities and the available facilities are of international level and standards. Further, six new National Institutes of Pharmaceutical Education and Research (NIPER) were opened in 2007. Recently, three new NIPERs have been proposed in the states of Maharashtra, Rajasthan and Chattisgarh.
Experience in International Servicing
Many of the Indian pharmaceutical companies are experienced in servicing top multinational companies for their highly regulated markets, meeting their stringent quality expectations. The same experience enables Indian organizations to cater to the needs of the regulatory authorities of most nations across the world. Further, technical consultancy capability of NIPERs is contributing to the growth of the industry.
Indian clinical trials industry has developed a complete gamut of clinical research services capabilities of global standards. From medical writing to site management, data management, regulatory submissions to patient recruitment the expertise meets the highest standards of stringent regulatory conditions internationally.
There is an effective control system to monitor the quality of pharmaceuticals at all the levels in India. There are various agencies/ bodies under Ministry of Health & Family Welfare and Department of Pharmaceuticals. They are responsible for standard of drugs, market authorizations, import licenses, cGMP, monitoring of quality of drugs & cosmetics manufactured, pre & post licensing inspection, and price control etc. The recent initiatives through new legislations and optimized processes are targeted towards regulating the industry better and effectively.
Drugs have to comply with stringent quality provisions under the Drugs and Cosmetic Act of India. Any drug including API confirms to the specifications of the prescribed pharmacopeias or those claimed on the label ensuring that all the products manufactured in India are of highest quality. All the pharmaceutical products are inspected at the customs port of the country by competent authorities before they are shipped out.
Creating conducive Environment for Promotion of Pharma Industry