The Indian pharma industry has gained significant global presence in the last few years and has been competing with other major countries on equal terms. Its remarkable growth can be attributed to its ability to rapidly access and adopt new technologies and also to its success in evolving an effective mechanism to strengthen research and development.
The industry's advanced manufacturing facilities have earned laurels from global regulatory authorities. As a result, the world today turns to the Indian pharma industry not only for high-quality and low-cost generic drugs, but also for in-licensing and out -licensing of drugs. The robust Indian pharma industry today produces a range of formulations, has the expertise for active pharmaceutical ingredients (APIs) and sees significant opportunities for value-creation. Hence, the theme of the 63rd edition of IPC, ‘Pharma Vision 2020: India: The Pharma Power house’, encapsulates the present stature of the Indian pharma industry.
India, the pharma power house
India ranks third in terms of manufacturing pharma products by volume and 14th in value terms globally. The Indian industry produces around 20 to 24 per cent of the global generic drugs.
The significant changes in the global pharma market offer immense opportunity for Indian pharma industry. Patents around $13 billion in the U.S. revenue of blockbuster drugs expired in 2007 and patents worth $ 60 billion will expire by 2012. As a result, the newly available market will be filled by generics worth $73 billion , says SM Mudda, chairman, scientific services, Local Organizing Committee and Executive Director- Technical & Operations, Micro Labs Ltd, some
India is capable of capturing this opportunity and can become a global base for outsourcing of pharmaceuticals since it has advantages over other countries of the world. The estimated turnover of the Indian pharmaceutical industry is Rs. 84,000 crore or US$ 21 billion with an annual growth rate of 13 per cent, he added.
The country is a leading global provider already with an export turnover of over Rs. 40,000 crore or US$ 10 billion to 200 countries. There is a strong manufacturing infrastructure with approximately 161 USFDA, 90 MHRA and 1,000 WHO GMP approved world-class manufacturing facilities in India.
Almost 25 per cent of global Abbreviated New Drug Application (ANDA) filings are from India. There is also an abundance of scientific manpower. The country is an excellent centre for clinical trials in view of the diversity in population.
With a stable economy and 10 to 13 per cent growth rate of the industry compared to four to five per cent in the developed countries, India can become a pharma power house and can look forward to be a global destination for manufacturing, R&D and clinical studies of generic formulations as well as new molecules pharmaceuticals, said Mudda.
According to Suresh Khanna, Honorary Joint Secretary, Local Organizing Committee of 63rd IPC and chairman, Stabicon Lifesciences Pvt Ltd, with a number of drugs going off patent, India sees a big opportunity to encash this. Also competitive costs of manufacture of quality products and known efficiency in supply chain, places India in a very favourable situation. Even clinical research organizations (CROs) are expected to see increased business in the coming years.
Indian pharma sector has grown big in the area of generic products locally as well in the international level. To graduate to the next level, domestic companies need to invest in R&D to innovate medicines to meet unmet needs of patients said Dr Premnath Shenoy, Hon. Secretary, Karnataka Drugs & Pharmaceutical Manufacturers Association (KDPMA).
For this Government should come out with an industry friendly long- term policy for the sector which could include incentives for investment in R&D, liberalization of pricing of pharmaceuticals and so on, he added.
According to SG. Biligiri, President, Karnataka Drugs and Pharmaceuticals Manufacturers Association and Associate Secretary, 63rd IPC, for India to become a pharma power house, it will need to emphasize on biosimilar development and marketing since that is the future. The country will also need to look for collaborative R & D efforts and give a fillip to the open source drug discovery model.
The growing pharma sector & govt support
Though the government recognized the remarkable growth of this industry and are taking certain initiatives to support the modernization of the industry, regulatory mechanism, training and education, a lot more needs to be done to encourage the domestic industry in terms of making it competitive compared to Chinese API industry, said Mudda.
The regulatory standards have to be raised on par with the developed countries and all possible assistance has to be given to small-scale industry to encourage compliance with the Good Manufacturing Practices. Although some of the larger companies have taken some steps towards drug innovation, the industry as a whole has been following the business model of using their expertise in reverse-engineering new processes for manufacturing drugs at low costs until recently. The government needs to support the R&D initiative in a big way for encouraging development of new molecules and innovative delivery systems, averred Mudda.
The Pharmexcil , sponsored by the Ministry of Commerce is doing excellent work by organizing buyer- seller meets, participating in trade fairs, delegation visits to potential countries, imparting Intellectual Property Rights (IPRs) knowledge and even giving subsidies for product registration, overseas visits and for participation in industry fairs. The Government also supports the industry by providing necessary documentation for product registration and subsequent exports.
However, the government could consider giving incentives to make manufacturing activities efficient like formation of pharma specific clusters, thereby ensuring world class infrastructure particularly uninterrupted supply of power. It can also help by expediting the process of import and export and to set systems to speedily issue documents required for exports like Product Permissions, Certificate of Pharmaceutical Products CoPP/ Foreign Sales Corporation (FSC), no objection certificates (NOCs) for imports, opined Khanna.
According to Dr. Shenoy, if the government takes immediate steps in the above areas, the industry would be immensly benefited and would grow at a much higher pace.
“Despite the tax holidays and investor meets organized by the Union government, it needs to focus on setting up more infrastructure and create an eco-system as well as initiatives such as pharma parks,”
The industry's advanced manufacturing facilities have earned laurels from global regulatory authorities. As a result, the world today turns to the Indian pharma industry not only for high-quality and low-cost generic drugs, but also for in-licensing and out -licensing of drugs. The robust Indian pharma industry today produces a range of formulations, has the expertise for active pharmaceutical ingredients (APIs) and sees significant opportunities for value-creation. Hence, the theme of the 63rd edition of IPC, ‘Pharma Vision 2020: India: The Pharma Power house’, encapsulates the present stature of the Indian pharma industry.
India, the pharma power house
India ranks third in terms of manufacturing pharma products by volume and 14th in value terms globally. The Indian industry produces around 20 to 24 per cent of the global generic drugs.
The significant changes in the global pharma market offer immense opportunity for Indian pharma industry. Patents around $13 billion in the U.S. revenue of blockbuster drugs expired in 2007 and patents worth $ 60 billion will expire by 2012. As a result, the newly available market will be filled by generics worth $73 billion , says SM Mudda, chairman, scientific services, Local Organizing Committee and Executive Director- Technical & Operations, Micro Labs Ltd, some
India is capable of capturing this opportunity and can become a global base for outsourcing of pharmaceuticals since it has advantages over other countries of the world. The estimated turnover of the Indian pharmaceutical industry is Rs. 84,000 crore or US$ 21 billion with an annual growth rate of 13 per cent, he added.
The country is a leading global provider already with an export turnover of over Rs. 40,000 crore or US$ 10 billion to 200 countries. There is a strong manufacturing infrastructure with approximately 161 USFDA, 90 MHRA and 1,000 WHO GMP approved world-class manufacturing facilities in India.
Almost 25 per cent of global Abbreviated New Drug Application (ANDA) filings are from India. There is also an abundance of scientific manpower. The country is an excellent centre for clinical trials in view of the diversity in population.
With a stable economy and 10 to 13 per cent growth rate of the industry compared to four to five per cent in the developed countries, India can become a pharma power house and can look forward to be a global destination for manufacturing, R&D and clinical studies of generic formulations as well as new molecules pharmaceuticals, said Mudda.
According to Suresh Khanna, Honorary Joint Secretary, Local Organizing Committee of 63rd IPC and chairman, Stabicon Lifesciences Pvt Ltd, with a number of drugs going off patent, India sees a big opportunity to encash this. Also competitive costs of manufacture of quality products and known efficiency in supply chain, places India in a very favourable situation. Even clinical research organizations (CROs) are expected to see increased business in the coming years.
Indian pharma sector has grown big in the area of generic products locally as well in the international level. To graduate to the next level, domestic companies need to invest in R&D to innovate medicines to meet unmet needs of patients said Dr Premnath Shenoy, Hon. Secretary, Karnataka Drugs & Pharmaceutical Manufacturers Association (KDPMA).
For this Government should come out with an industry friendly long- term policy for the sector which could include incentives for investment in R&D, liberalization of pricing of pharmaceuticals and so on, he added.
According to SG. Biligiri, President, Karnataka Drugs and Pharmaceuticals Manufacturers Association and Associate Secretary, 63rd IPC, for India to become a pharma power house, it will need to emphasize on biosimilar development and marketing since that is the future. The country will also need to look for collaborative R & D efforts and give a fillip to the open source drug discovery model.
The growing pharma sector & govt support
Though the government recognized the remarkable growth of this industry and are taking certain initiatives to support the modernization of the industry, regulatory mechanism, training and education, a lot more needs to be done to encourage the domestic industry in terms of making it competitive compared to Chinese API industry, said Mudda.
The regulatory standards have to be raised on par with the developed countries and all possible assistance has to be given to small-scale industry to encourage compliance with the Good Manufacturing Practices. Although some of the larger companies have taken some steps towards drug innovation, the industry as a whole has been following the business model of using their expertise in reverse-engineering new processes for manufacturing drugs at low costs until recently. The government needs to support the R&D initiative in a big way for encouraging development of new molecules and innovative delivery systems, averred Mudda.
The Pharmexcil , sponsored by the Ministry of Commerce is doing excellent work by organizing buyer- seller meets, participating in trade fairs, delegation visits to potential countries, imparting Intellectual Property Rights (IPRs) knowledge and even giving subsidies for product registration, overseas visits and for participation in industry fairs. The Government also supports the industry by providing necessary documentation for product registration and subsequent exports.
However, the government could consider giving incentives to make manufacturing activities efficient like formation of pharma specific clusters, thereby ensuring world class infrastructure particularly uninterrupted supply of power. It can also help by expediting the process of import and export and to set systems to speedily issue documents required for exports like Product Permissions, Certificate of Pharmaceutical Products CoPP/ Foreign Sales Corporation (FSC), no objection certificates (NOCs) for imports, opined Khanna.
According to Dr. Shenoy, if the government takes immediate steps in the above areas, the industry would be immensly benefited and would grow at a much higher pace.
“Despite the tax holidays and investor meets organized by the Union government, it needs to focus on setting up more infrastructure and create an eco-system as well as initiatives such as pharma parks,”
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