Adieu annus horribilis 2013
Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon
The year 2013 was probably one of the worst years for the Indian economy, with inflation running unbridled and economic growth grinding down to a level below five per cent.
Unfortunately, the pharmaceutical sector also witnessed an unprecedented slowdown growing at barely 5.2 per cent in 2013 against an average growth of 12 per cent the previous year. The negative impact was further compounded with adverse policy decisions w.r.t pricing, FDI, clinical trials and compulsory licensing in India. An overactive US FDA issuing notices to some of the leading Indian pharma companies tarnishing the image of the sector. Collectively all this made 2013 an ‘Annus Horribilis’ for the Indian pharma sector.
The silver lining
However, on the brighter side, India took the lead of developing and adopting biosimilar guidelines which enabled the approval of world’s first biosimilar of Herceptin for breast cancer, developed in India by Biocon and Mylan. The introduction of biosimilar Trastuzumab in India in 2014 will offer an affordable option for millions of cancer patients in India and in the other world markets subsequently.
2014: A promising year of positive change
2014, as the year of general elections, is expected to lead to a stable majority government at the Centre. Hopefully, that will be a starting point for some of the challenges to be addressed through bold policy reforms.
We hope that the new government will be able to manoeuvre the winds of change and create real jobs, provide good infrastructure for industrial growth, ensure safety and security for women and promote better governance. We will need innovative solutions to address these numerous challenges and emerge as a robust economy. Healthcare for all is a critical need which can only be addressed through access to affordable medicines. The government needs to enable affordable innovation by defining a smarter regulatory pathway that cuts the cost of drug development. Regulatory reforms that address issues related to Intellectual Property and clinical development coupled with use of technology for procurement will enable better access to drugs.
The Indian pharma sector also needs to take corrective action to address non-compliance issues to regain the reputation of a provider of good quality affordable generics for the patients and healthcare systems across the globe. India has successfully leveraged its strengths of ‘low cost manufacturing’ and ‘quality of talent pool’ to gain global recognition, however, it now needs to ensure that it has rigorous processes for self -audit to ensure zero tolerance to non-compliance.
For Biocon, 2014 holds good promise as we bring the world’s first biosimilar Trastuzumab to cancer patients in India, our novel biologic Alzumab makes a positive impact on the lives of several patients, our Malaysia plant nears completion and all our business verticals continue to report a robust growth.
Year 2014 can be a year of positive change if every Indian citizen commits itself to engage with the political process, plays the role of an active citizen and demands good governance. Citizen participation is critical for creating an economically strong India that can gain global recognition.