The Hindu Business Line : Post-product patent, R&D is way forward for pharma cos

WITH the Government putting in place a product patent regime from January 1, 2005, domestic pharmaceutical companies are focusing their research and development (R&D) efforts on various therapeutic segments ranging from metabolic disorders, diabetes, pain management, anti-infectives and even cancer.

Speaking to Business Line, Mr Malvinder Mohan Singh, President, Pharmaceuticals, Ranbaxy Laboratories, said that his company's focus on R&D is evident from the fact about 150 new scientists have been added to their team, including 30 expatriates. The company is bracing for opportunities in the US and European markets when several drugs are expected to go off-patent in the next few years. "We will be focusing on development of new drug delivery system (NDDS) as well as new chemical entity (NCE)," he said.

An official of Wockhardt Ltd said, "We saw the writing on the wall much earlier and spent close to 7 per cent of our revenue on R&D." Added Mr J.P. Parswani, Vice-President, Marketing, Cadila Pharmaceuticals, "While we are focusing on both developing new molecules and new delivery systems, our aim is reduce patient suffering and bring the cost of drugs down."

An ICRA study also points to R&D being a key focus area. It says, "Quite a few Indian companies have increased their focus on discovery of NCE and have progressed to the stage of clinical research; this has been achieved at a fraction of the international costs."

For example, Ranbaxy Laboratories Ltd's molecule for pulmonary asthma is in the second phase of clinical trials and another molecule for malaria in the first phase. Dr Reddy's Laboratories Ltd has two anti-cancer drugs in Phase I and Phase II stages and a dyslipidemia drug in Phase I trial stage. The company has four other molecules in pre-clinical trial stages.

Cadila Pharmaceuticals has five molecules for metabolic disorders and pain management in pre-clinical trials, Wockhardt has an anti-infective which has completed Phase I trial in India while Lupin Ltd's anti-migraine is in Phase II trials, anti-psoriosis molecule is undergoing Phase I trials and anti-TB molecule is in the pre-clinical stage.

While stating that increased R&D throws up various opportunities, on a cautious note, the ICRA report has said, "The next stages, viz. Phase II and Phase III clinical trials involve major expenditure and may be beyond the financial capabilities of most Indian companies."

Indian companies have limited experience in conducting extensive clinical trials, which spans across the globe, and in interacting with international regulatory authorities during the process of approval of NCE.

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