Usha Sharma seeks the views of industry stalwarts on the recent upheavals in the Indian pharma regulatory system and finds that they are not giving up but revving up for the future
– Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy Laboratories
– Dr Jayesh Lele, State Secretary, Indian Medical Association Maharashtra
– Abhay Kumar President, Indian Pharmacist Association
– Apurva Shah, Group Managing Director, Veeda Clinical Research
– Dr Gopakumar G Nair, Founder, Gopakumar Nair Associates
– Ranjit Shahani, President OPPI and Vice Chairman and Managing Director, Novartis India
– Archana Dubey Mitra, Vice President-International Marketing, Bal Pharma
| Conclusion
The regulatory reforms in the Indian pharma industry may upset pharma entrepreneurs in the short term but is likely to be beneficial in the long term. However, it seems that India is following the steps of western countries and accordingly bringing changes in the system. The US FDA is hiking fees for generic drug makers up to 48 per cent from October 2013 which would impact exports to the US. At the same time thanks to DPCO 2013 the prices of 348 medicines will be reduced which will impact the sales in the domestic market. Similarly, in India the patent office has drafted a gazette notification aiming to promote e-filing patent applications in India and proposed to hike patent fees. Post DPCO 2013, pharma companies and associations realised the danger of revenue loss and inorder to get alternate solutions both have come together and discussed the issue in depth. Despite the recent discussions and collaboration for a common goal, friction exists as was evident when the Department of Pharmaceutical (DoP) and NPPA requested the industry to share their products details and the pharma companies were not pleased by this demand and failed to respond favourably. Beside this there are many more drafts guidelines and notifications which are still lying in the Government offices and are likely to come into effect shortly. It is upto the pharma companies to foresee these changes and their repercussions so that they are ready to meet them head on and play their role in maintaining the truce between the government and the industry players. |