The drug developing dreams of Indian pharma companies will only realise with proper regulations and explicit patent norms set by the government, say experts from pharma industry. Despite the efforts of the Indian pharma industry to develop an indigenous molecule, the lack of adequate support from the government is becoming an impediment in smooth sail of research projects, they regret.

The comment was unanimously raised by various experts in the drug industry in an interesting debate on whether Indian pharma is on its way to becoming the next big drug developing nation, held as the part of the three day Pharmaceutical Outsourcing Congress India 2009 conducted by Ideas Exchange, a part of iX Events Pvt Ltd.

The Indian pharma industry will experience the boom which has happened in the Information Technology in the past decade and is capable to bring in new molecules to the market, said Dr Somesh Sharma, managing director, Piramal Life Sciences. The industry should also include the medical fraternity in pharma debates and the universities should increase their activities on innovation research. The government has also an important role to play in the drug development activities through adequate and industry friendly activities, he added.

"The current research activities are quite hopeful on developing a drug indigenously and to take it to the global pharma market. There will definitely be several failures and we have to overcome them to success. The investment, in this level, is not adequate and we have to increase the investments for R&D. And the industry needs a lot of support from the government to achieve this goal," said Dr Sharma.

Echoing the views of Dr Sharma, Nimish Vachharajani, vice president - Development, Advinus Therapeutics, added that entering into partnership with big pharma in R&D is a way to acquire adequate knowledge for drug development. However, the Indian industry has to move ahead from just copying the standard operating procedures to develop their own procedures which could be on par with the international standards. Though there will be failures in the beginning the industry should also have the ability to identify the winners in drug development activities, he added.

On the other side, the panel which moved against the motion, Dr Dhanjay Bakhle, head of clinical development, Reliance Lifesciences and Dr Shoibal Mukherjee, senior vice president - clinical development, GVK Biosciences, said that India need an introspection about its current status in the global drug development scenario. The current regulatory set ups and the patent regiment should be thoroughly scrutinised before going into higher dreams of indigenous drug development, said Dr Bakhle.

"The important point we have to discuss is whether India is going to remain as a beehive by providing services to the multi nationals. The question is whether we are going to produce new drugs or to provide service for the overseas research firms," he opined. Incremental innovations would be a stepping stone for the industry to grow towards developing new molecules and the government should consider revising the Section 3 (d) of the Indian Patents Act with regards to this, he added.

Commenting satirically on the current research scenario in India, Dr Shoibal Mukherjee, pointed out the pitfalls in the Indian regulatory system in restricting phase-I studies of molecules developed overseas and the procedural delays in getting approval for clinical trials and marketing drugs. He added that with the current situation, India is going to take lot more years to place itself in the innovator company's club. The restrictions on conducting drug studies in large animals are also a point to be noticed as a hindrance for the smooth drug developing process, he averred.

Chairing the session, Ranga Iyer, managing director, Wyeth Ltd, opined that the current ecosystem should be changed and the government should play an active role in promoting the research for drug development for the benefit of the country. The issues related to patentability of incremental innovation should be changed for Indian companies to become active partners for drug development in collaboration with overseas firms, he added.

The three day conference to explore the opportunities in outsourcing activities in pharmaceutical sector has in-depth analysis on the opportunities and roadblocks in clinical trials outsourcing, biotech drug development, effective methods to tap the manpower, role of intellectual property rights in Indian pharma and venture capital possibilities in drug research investments. An exclusive session with the newly appointed Indian officials of US Food and Drug Administration (FDA) and a business exchange meet for the participants to make new business contacts quickly were also organised in the Congress.