Formulating policies for success
At a recent industry seminar, there was general consensus that slipups by individual pharma companies were dragging down the entire industry. Dr Claus-Dieter Boedecker, who heads Merck (India) as well as Merck Millipore India agreed that India is not alone at the receiving end of heightened regulatory vigil over non-compliance, but this year has seen an unusually high number of such ‘unpleasant surprises.’
Being tarred with the same brush is today a real concern but has not reduced global interest in India’s market. Global PE firm KKR is reported to be close to buying a minority stake in Hyderabad-based Gland Pharma while US generics major Mylan, as well as two Indian companies, are said to be interested in buying out Chennai-based Bafna Pharmaceuticals. Both Gland Pharma and Bafna Pharma have focused on niche high value products and that’s been their path for success.
Casting the US FDA or other regulators, overseas of domestics, as the big bad wolf is not the solution. Raising the bar and implementing stricter policies to ensure good manufacturing practices quality is the way forward. But many argue that we already stand the risk of strangulation by regulation. How do we find the middle path, formulating policies for success, which will address both access and affordability as well as insure growth of a sector? As a part of its IPC Special, Express Pharma invited industry experts to share their thoughts. So while journalist-activist Bharathi Ghanashyam, co-founder of the blogsite/group, Journalists Against TB talks about the reforms needed in our TB control policy (page 49), legal eagle Kirit Javali highlights the need for policies to ensure affordability and availability of drugs (pg 50). With regards to clinical trials management, Dr Sauren Das comments that regulations must be implementable and practical (pg 51) and NGO head Harsha K Rajasimha (pg 52) urges the Government to provide direction and support to take on the urgent unmet needs of the 70+ million rare disease patients.
With this year’s 65th edition of the Indian Pharmaceutical Congress being hosted by the Indian Pharmacy Graduates Association, we focused on the theme: ‘Curriculum for change’ (pages 20-25) and got stalwarts like Dr B Suresh (pg 27), Dr Mahesh Burande (pg 28), Atul Kr Nasa, Vijay Bhalla (both on pg 32), Dr Roop Krishen Khar (pg 33), and SL Nasa (pg 34) to share their suggestions.
We round off this issue with Hay Group’s Global Managing Director – Life Sciences, Ian Wilcox, making the case that life sciences companies will ultimately rely on the strength of human capital initiatives to support the goal of showing value. A sound business strategy will underperform unless the human capital and cultural component of change is a top priority.
Viveka Roychowdhury
Editor
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