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Mumbai, Aug. 23: Glenmark Pharmaceuticals’ admission last week of one of its drug failing clinical trials shows much hard work needs to be done before domestic firms can possess the skills in developing original drugs.
Companies such as Dr Reddy’s Laboratories (DRL), Ranbaxy, Glenmark, Piramal Life Sciences, Sun Pharmaceutical Advanced Research Company and Lupin are engaged in the research and development (R&D) of new chemical entities (NCE), and their drugs are undergoing clinical trials.
In all, Indian companies are researching over 50 new drugs.
However, none has been successful, in contrast to their achievements in introducing generic versions of drugs discovered by international firms.
Last week, Glenmark said its oglemilast, a drug against chronic obstructive pulmonary disease, has failed clinical trials, resulting in a huge slide in stocks.
In 1997, Hyderabad-based DRL had licensed an anti-diabetic molecule called balaglitazone to Denmark’s Novo Nordisk. However, in 2004, Novo Nordisk terminated the clinical development because the results did not meet the desired targets.
Rheoscience, also from Denmark, then took over the development of the drug. Balaglitazone is now in Phase-III clinical trial. DRL officials had earlier indicated that the drug could be launched next year, though observers were being cautious.
According to industry experts, the efforts of the companies should be seen in the context of the process being a high-risk one, where there are few successes and many failures.
Usually, it takes around a decade to launch a new drug.
Lack of proper skills also puts Indian companies at a disadvantage.
Sujay Shetty, associate director (pharmaceuticals and lifesciences) at consulting firm PricewaterhouseCoopers, said domestic companies had good expertise in generic drugs, but the skill required for innovation was different and scarce in India.
“There is a fairly limited skill sets available here in terms of taking a molecule right through its life cycle,’’ Shetty told The Telegraph.
Shetty is confident that a new drug by an Indian company could emerge in the next two to three years.
Recently, Piramal Life Sciences, the research arm of the Ajay Piramal group, announced that its first drug from a portfolio of around 12 molecules could be unveiled as early as 2011.
It thus remains to be seen if Piramal Life Sciences is indeed successful in attaining this forecast or another domestic company overtakes it in being the first Indian company to hit the market with an original and not a copycat drug.
“There are a bunch of Indian companies who are doing good work in drug discovery,’’ he said.