\"Globalisation, free trade, investment, entrepreneurial zeal are all set to metamorphose Indian pharma companies that were once labelled as the copy cat drug makers into discovery-led firms.\"
These are tough days for world’s Big Pharma. Depleting pipelines, patent expirations, soaring R&D costs and risks etc. have all put the Big Pharma in rough weather. Against this backdrop, fast growing Asian economies - notably China and India, represent new horizons of opportunities. The silver lining to this gloomy scenario is the fast transforming Indian pharma industry.
Globalisation, free trade, investment, entrepreneurial zeal are all set to metamorphose Indian pharma companies that were once labelled as the copy cat drug makers into discovery-led firms. The business leaders of top companies have understood quite early that the only way to survive and thrive in the increasingly global business world is to excel in innovation-driven R&D.
In the year 2005, India became a TRIPS signatory. In a proactive move, by 2007 more than a dozen Indian companies have launched new drug discovery programmes, while some have reached the last phases of trials too.
Companies like Ranbaxy, Dr. Reddy’s Laboratories (DRL), Nicholas Piramal (NPIL), Glenmark and Wockhardt are currently spending 4-7% of their revenues on R&D. Though miniscule compared to that of world’s Big Pharma, according to ASSOCHAM, this figure is likely to go up to 8-9% by the year 2010.
The Indian pharmaceutical industry has a remarkable line-up of NCEs in different stages of clinical development. DRL has 9 NCEs in various stages of testing. Among these one of the molecules for diabetes is currently under the final stages i.e. in Phase III and two more molecules are in Phase II. NPIL has three of its molecules in Phase II clinical trials. Ranbaxy has one of the molecules for Malaria in Phase II. Its another NCE for urinary incontinence has successfully completed phase I single and multiple dose studies. Glenmark has 2 molecules in Phase II and one in Phase I of the total six molecules. Wockhardt has one NCE in Phase II and one in Phase I stages of development. Apart from these, companies like Torrent Pharma, Zydus Cadila, Orchid and Sun Pharma are also gradually exploring novel drug discovery.
While the goal is same, interestingly, each company has adopted its own approach to achieve the goal. While some have collaborated with foreign firms as co-developers, others are outlicensing the molecules after early stages of clinical development in order to reduce the risks associated with development. DRL has tied up with Rheosciences of Denmark and ClinTec International of UK as co-developers for two of its molecules. Glenmark focusses on promising lead candidates till early clinical development and then outlicenses them to international pharma companies. NPIL’s strategy is to research collaboratively with academic institutions and foster public-private partnerships. Ranbaxy has entered into an agreement with the Department of Science & Technology (DST), Government of India. According to the agreement, DST will provide financial support to Ranbaxy in the field of drug discovery through soft loans. Surely, it will be interesting to see how these strategies pan out for these firms.
Although these are exciting times, it must be noted that these are still early days for the industry. As the articles that form a part of the cover story, and interviews with a few industry leaders reveal, a whole lot of changes need to happen at both the industry as well as the government level to facilitate the growth of industry into this area - Intellectual Property Rights, infrastructure and government policies being a few of them.
Though the path to becoming discovery-led global companies is onerous, it holds the potential to bring about a lot of advantages, opportunities and recognition. During the product exclusivity period that a successful NCE is granted, companies can recover their investment many times over. The availability of a talented scientific pool, cost advantages and large patient population provide a unique competitive edge to India. The budding R&D talent and the developing regulatory environment provide the right impetus to the Indian companies. However, the industry should work closely with the academia and the government needs to provide appropriate support to encourage the growth of research talent.
Indian companies getting into discovery also means that the needs of the vast patient population of the region are taken care of. It's also an opportunity for the industry to develop medicines for the poor and developing nations. The stage seems all set for transforming the kittens into tigers of tomorrow.