Research and development in Indian industry has witnessed a significant shift in last decade. Today, the strategic focuses of these major Indian pharmaceutical companies is to shift from " business driven research" to "research driven business" and have a firm foothold in international markets with an emphasis on advanced markets. Basically economic reforms and acceptance of WTO norms on intellectual property were the key drivers to catapult/ administer this change in Indian industry.
The previous Indian Patents Act (1970) recognized patents on pharmaceutical 'processes', but not on `products', allowing domestic pharmaceutical companies to produce cheap copies of patented drugs made by foreign companies using alternative production methods.
With the enforcement of product patent regime in India, there are other opportunities that will be open for the Indian industry to grow and make an impact in the global arena. First, the market for off-patented generic drugs prior to 1995 is open to be exploited. Second, Indian companies will look for stable export markets.
In India, research and development in the area of drugs and pharmaceuticals is carried out in about 143 in-house research and development units in industry recognized by the Department of Scientific and Industrial research, six laboratories of the Indian Council of Medicines research and nearly 50 universities.
India enjoys a competitive advantage in the global economy by virtue of its vast English speaking manpower coupled with rich-biodiversity. And given its proven strengths in process re-engineering skills besides low cost research and development and manufacturing, India offers strategic opportunities and can emerge as a potential location for pharmaceutical R&D. Given all these factors, the key forward looking companies like Ranbaxy, Dr.Reddy's Laboratories, Wockhardt, Nicholas Piramal, Torrent, Cipla, Lupin etc made substantial investments to upgrade research and development infrastructure in an effort to ascend the research value chain and sustain global challenges/competitiveness and avail the opportunities.
Ranbaxy invests around 6 per cent of its global sales into research and development and are accelerating into new drug delivery systems. Therapeutic focus at research and development is on urology, respiratory, anti-infective, anti-inflammatory and metabolic disorders segments.
Dr.Reddy's Laboratories' formulation research and development activities comprises of both branded and generic formulations. Generic business operations started in 2001 and focuses on North American and European Union markets.
Aurobindo Pharma Ltd, originally a pharma major in bulk drugs started development of generic formulations in 2002 and focuses on US, Europe and Brazilian markets.
Sun Pharma started its research and development centre in Mumbai in 1997 to develop innovative dosage forms and generics for the developed markets in US and Europe. The company has received 15 Abbreviated New Drug Application (ANDA) approvals till April 2005.
Wockhardt has filed 15 ANDAs with the USFDA, with a target opportunity of US $ 4 billion. The company has received approval for 6 ANDAs so far.
Nicholas Piramal is currently working on over 60 projects encompassing conventional and novel drug delivery systems (eg: oral disintegrating systems, controlled release) for domestic and international markets.
Cipla has developed more than 140 products on an exclusive basis for its US partners viz, Ivax, Watson, Eon labs, Norton Grore and Pentech. With a much lower research and development budget, Cipla's model continues to build up an attractive generic pipeline.
Lupin's research and development activities focus on the following areas: generics, new chemical entities, novel drug delivery systems (NDDS). NDDS activities include oral controlled release systems (OCRS) and advanced drug delivery systems.
Zydus Cadila's formulation research and development activities focus on novel drug delivery research (development of novel platform technology for slow/ extended release of drug from matrix) and development of novel formulations for filing ANDA.
Also, the availability of low development cost and expertise in India has led to the emergence of many contract research and development organizations (CRO). Many multinational companies have started to utilize these CROs for development of formulations for domestic and international markets. Recently multinational companies like Ratiopharm, Apotex and Ivax have started research and development centres in India, thanks to the availability of low development cost and expertise.
Thus, over the years, we would find a domestic market dominated by multinationals and Indian companies, but also Indian companies tap off-patented generic export markets.
(The author is senior general manager - R & D (Regulated Markets) Micro Labs Ltd., Bangalore.)