India is far from debating issues like the pros and cons of taking oral contraceptives OTC or the US FDA’s refusal to approve the world’s first ‘female Viagra’, which claims to increase female libido. Both topics have become women’s rights issues, with women groups arguing that the regulator’s lack of faith in Flibanserin, Sprout Pharmaceuticals’ ‘little pink pill’, is an indication that the agency does not feel that women’s sexual health issues are as important as men’s. On the other side of the fence, critics, including some women health advocacy groups, say the agency’s caution, citing ‘not very robust effectiveness and … a safety profile (that) had not been really characterised very well at all’, befits a new drug application and even question the pharma industry’s drive to invent a pill for every ill.
India Pharma Inc’s engagement with women’s rights issues seem far down the priority list, when one considers the existential issues staring them in the face. At the recent Pharma Summit organised by ASSOCHAM, one got the sense that PM Modi’s urgency for change has filtered down to the ministries and there will be no further delay on the policies which are already under review. (See report: ‘Govt to release policy to improve bulk drug capacity: Subburaj’, on page 16).
The frustration and worry can be gauged by two comments. The first was the sign off quote in the keynote address presented by Nishant Berlia, Member, Management Board, Apeejay Stya Group and Svran Group. Referring to the former US President Ronald Reagan’s pithy views of the economy; ‘If it moves, tax it. If it keeps moving, regulate it. And if it stops moving, subsidise it,’ he seemed to be warning the government that if remedial measures were not implemented, we would soon have to adopt drastic measures.
Dr Surinder Kher, CEO, Acron Acunova’s comment was also in the same vein of dark humour, who asked if January 30, Mahatma Gandhi’s death anniversary, also become the death anniversary of clinical research in India. He was referring to the now infamous gazette notification released on January 30, 2013 mandating new compensation guidelines and other changes in clinical trial regulations.
Beyond the budget, will the policies be truly or merely play lip service to the consultative process? Will the cautious optimism and wait-and-watch stance finally break? The industry is on tenterhooks on many counts, and meeting these expectations will be a tall task. This is truly a make or break year for India Pharma Inc.