For R&D growth in India, industry-university gap need to be bridged and government must initiate policies to help contain risk in R&D in the pharma and biotechnology sectors so that new molecules can be brought to the market, opined Dr Anand Kumar, deputy managing director (DMD) of Indian Immunologicals Limited (IIL).

The widening gap between the industry and university is the main reason for the Indian pharma sector lagging behind in R&D and new product development. According to Anand Kumar, despite India having well qualified, knowledgeable and skilled pharmaceutical workforce and investing Rs. 100s of crores for R&D, things will not change unless the this gap between the industry and academia is bridged.

Apart from improving the pharmacy education, Indian policy makers should also focus on improving industry-university relations to develop R&D sector in the country. “Unlike in the western countries, there is a huge gap between industry and academia here in India. Moreover cultural bindings and lack of free flow of ideas right from childhood to organisation level is the major hindrance for innovation. Policy makers and the government needs to devise systems that encourage free flow of ideas and develop risk management systems to implement these ideas. Only then India can improve its R&D in pharma that will help invent new molecules and develop innovative drugs and vaccines for various diseases,” opined Kumar.

While interacting with Pharmabiz, about increasing US FDA warning letters to Indian pharma companies, Dr. Anand Kumar pointed out that, Indian pharma industry, though is robust and has adopted highest quality standards complying with global regulators, it still needs to improve in lot of areas. “Particularly we need to develop a system and inculcate a culture of objective data recording among employees and operators inside the industry. This will help the organisation to improve their processes and correct the errors from time to time and thus avoid falsification and data integrity problems,” said Kumar.

“No doubt, Indian pharma industry is giving tough time to the US and EU companies as we are competing neck to neck with them and supplying high quality and affordable generic medicines to their markets. But at the same time we need to improve our systems and not give the slightest chance for them to point a figure at us,” opined Kumar.

With patent regime going off, there are lot of Indian companies filing ANDAs and DMFs at US FDA for product approvals and manufacturing of branded generics. But as the situations have changed, Indian companies need to check and cross check their data to avoid any complications during inspections.