The technology absorption, adaptation and innovation is a continuous process in the pharmaceutical segment to ensure the competitive advantage in the market. Recognizing the vital role played by R&D in the overall operations and the future progress, the Indian pharmaceutical companies have started making huge investment in R&D during last couple of years. The R&D activities continued with focus on developing innovative, environment friendly and cost-effective technologies for high value APIs and it is playing crucial role in establishing its brand image for partnership with other world leaders.
The industry has further accelerated the progress on developing new chemical entities as well as development of safe, effective, patentable and science based herbal drugs. With the help of excellent talent pool, cost-effective manufacturing base and easy availability of cheap raw materials, the Indian pharma industry is set to tap new opportunities in the field of contract manufacturing, contract research, clinical trials and biotechnology.
To overcome the problems of new patent regime, the Indian pharma sector geared its resources towards R&D. Several companies are spending more than 10 per cent of their revenues on R&D. The investment in R&D is always for long term and it takes longer time to generate profits. These investments are putting initial burden on working, but it is creating strong base for Indian companies.
The generics industry has witnessed growth in recent years, and is expected to grow significantly in the near-to-medium term. Patents on a number of significant pharmaceutical products are expected to expire in the next 5-7 years. In addition, government, insurers and healthcare organizations in developed countries are increasing promoting generics to reduce public expenditure on healthcare. Several MNCs are sourcing drugs from lower cost producers like India and China. In this context, the investment in R&D will give upper hand to Indian companies in the long term.
Ranbaxy Laboratories, among the top 10 global generic players with growing presence in 23 of the top 25 pharma markets and the largest ANDA filers with US FDA, has realigned and strengthened its business units, and is actively pursuing various options to augment its global operations. The R&D expenditure for the year ended December 2005 increased by 47 per cent to Rs 486.36 crore from Rs 331.39 crore in the previous year.
The company introduced 49 new products and line extensions in India through its Pharma Research capabilities. The company filed 36 ANDAs with the US FDA, including 10 under the US President's Emergency plan for AIDS Relief (PEPFAR) program. It received approvals for 19 ANDAs, including 3 under PEPFAR program. Its cumulative ANDA applications reached at 183, with 114 approvals obtained and 69 pending approvals with US FDA. The company filed 131 DMFs during 2005.
Ranbaxy made 52 national filings for 46 product in 7 European Union Reference Member States and 51 Mutual Recognition Procedure applications for 6 products in 24 EU concerned member states. The company filed 110 products in emerging markets, comprising the Brazil, Russia, India, China, South Africa (BRICS) countries. Its pharmaceutical research team filed 35 patents in India.
The company is also developing safe and effective herbal dugs that comply to international quality standards. It launched 2 products in the international market LEAV (a natural sweetener) in Malaysia and Revital Appetit (appetite enhancer for kids) in Romania. It also filed two products in Russia, Ukraine and Malaysia and it has several niche products under the over-the-counter category.
Cipla, a Rs 3000 crore Mumbai based pharma company, stepped up its R&D expenditure to Rs 155 crore during 2005-06 from Rs 98 crore in the previous year, a growth of more than 58 per cent. The company is focusing on result-driven research work to develop and enhance know-how for new drug delivery systems and manufacturing processes both for APIs and drug formulations. Cipla entered strategic alliance with Avestha Genegraine Technologies Pvt Ltd for the development of biotherapeutic.
The company's manufacturing facilities are approved by several regulatory bodies like US FDA, MHRA (UK), PIC (Germany), MCC (South Africa), TGA (Australia), Department of Health (Canada), ANVISA (Brazil), SIDC ( Slovak Republic), the Danish Medical Agency and the WHO. Its Kurkumbh plant has been certified for compliance with ISO 14001 and OHSAS 18001 standards.
The company has entered into partnerships for 123 products with a number of partners in the USA alone. It filed over 170 registrations in Europe, principally for marketing its drug formulations in the continent. In addition, Cipla has approvals for over 4000 drug formulations in the emerging markets, including South & Central America, the Middle East and Africa.
Dr Reddy's Laboratories (DRL) entered tie-up with Rheoscience A/S to co-partner the development of balaglitazone (DRF 2593) a partial PPR-gamma agonist for the treatment of Type 2 diabetes. This product is likely to move to Phase III clinical trials. Further, its five key NCEs advanced to clinical development and few are in pre-clinical stage.
The company strengthen its generics and API pipeline. It filed 12 ANDAs during 2005-06, taking the total number of ANDAs filings to 70. Out of this, 49 ANDAs are pending with US FDA for approvals. The company filed 30 DMFs during 2005-06 and its total number of DMFs reached at 151 - 81 filed in the US, 28 in Canada and 42 in Europe.
DRL has been aggressively investing in expanding its pipeline of APIs and finished dosages. It is actively pursuing collaborative mechanisms in its discovery R&D. However, its R&D expenditure during the year ended March 2005-06 declined by 14.7 per cent to Rs 253.94 crore from Rs 297.79 crore in the previous year. The decrease in absolute value of R&D expenses was largely on account of lower costs in the Drug discovery and in Generics business segments.
Lupin Research Park at Pune, sprawling across 19 acres with a built up area of 1.50 lakh sq.fts., housing 320 scientists, is the hub of all research initiatives undertaken by the company. It has attained capabilities to develop quality API's at productivity levels rivaling the best, value added finished products in the generic space based on platform technologies. Its R&D activity is vertically integrated, starting from process development of the API till the submission of dossiers for finished dosages.
Lupin's R&D activities are moving in great earnest and right direction. It is playing a pivotal role in selecting and developing molecules that are being commercialized successfully. The achievement of this activity could be gauged from the volume and diversity of its filings. During the year 2005-06, the company filed 18 ANDAs in US, 9 MAAs in UK6 MAAs in Australia, 3 MAAs in New Zealand, 2 MAAs in France, 3 MAAs in Croatia and 343 dossiers for the rest of the world. It has also filed 64 patents during the year.
The company's R&D expenditure reached at Rs 108 crore during the year ended March 2006 and worked out to 6.7 per cent of its total turnover. Successful transfers of technology to manufacturing plant and approval from regulatory bodies have resulted in commercialisation of several products particularly for the regulated markets. Several products are under various stages of regulatory approval process.
Glenmark commenced expansion of a new block at its Ankleshwar facility and the activity is expected to be completed shortly. Further expansion has been made in manufacturing infrastructure to cater to the increased demand. Construction of its US FDA-approvable plant at Aurangabad should commence from October 2006. The total R&D spending touched to Rs 46.69 crore during 2005-06 as against Rs 48.68 crore. The company is planning to file 10-12 ANDAs in the current year.
The company filed 2 DMFs in the first quarter of 2006-07 and expects to file 15 DMFs during the year. Work on oglemilast, GRC 8200 and GRC 10389 is progressing as per plan. Both oglemilast and GRC 8200 are progressing well in Phase II clinical trials. Glenmark also revealed three additional molecules targeting pain and inflammation in its pipeline; these leads are expected to enter clinical trials in FY 2007. GRC 10389, that was announced earlier will also commence Phase I trials in this financial year. Several products are in various stages of development.
Wockhardt continues to focus on R&D and the creation of successful IPRs. Through R&D and discovery of new drugs, the company also has the potential power to address unmet medical needs and improve the lives and health of millions of people across the globe. The pursuit of world-class quality has led to Wockhardt's manufacturing facilities receiving the approval of regulatory bodies such as the US FDA, MHRA, and WHO. The Wockhardt Biotech Park in India, received WHO certification during 2005 for both Wepox(r-erythropoietin) and Wosulin (r-insulin).
The company's R&D expenditure for the year 2005 increased to Rs 81.08 crore from Rs 71.49 crore in the previous year. This worked out 8.42 per cent of its total turnover. Wockhardt's focus on biotehnology started adding to its revenue. It has developed comprehensive capabilities in all facets of recombinant biotechnology including gene cloning, development of production strains, development of expression systems in yeast, mammalian and bacterial cells. The company launched three new products in India for managing diabetics, cancer/kidney failure and preventing hepatitis-B infection. These are now being introduced in other markets too around the world. The biotechnology products have received 25 approvals from 18 countries, and more are in the pipeline. Its biopharmaceutical portfolio grew by 54 per cent during the year 2005.
Nicholas Piramal, among the top ten Indian companies, is currently strengthen its R&D activity by appointing 350 scientists for long-term exploratory and applied research programs in chemistry, biology and natural product chemistry dedicated to discovery and development of new drugs for the global market. The company increased the number of drug candidates in its preclinical and clinical development pipeline. Its lead candidate, P-276-00 for cancer is undergoing phase I clinical trials in Canada and also received DCGI approval for start Phase I trials in India. Its five pre-clinical candidates - four new chemical entities and one mono-herbal preparation have exhibited good progress during FY2006. The company's R&D expenditure declined to Rs 91.15 crore from Rs 108.44 crore in the previous year.
Biocon is committed to realizing the potential of biotherapeutics and it is rapidly transforming into an innovation-led organisation. The company made the single largest capital investment of Rs 650 crore in Biocon Park. This integrated biopharmaceutical hub meets international regulatory standards and represents a signi-ficant advancement in sophistication and automation. Its pipeline of discovery-led research products is both extensive and exciting. Its R&D expenditure increased to Rs 40.07 crore during the year ended March 2006 from Rs 24.09 crore in the previous year.