Culling the most recurrent predictions featured in our cover story (Jan 1-15 2015, pages 18-26), it’s clear that regulations and by extension, regulators, will set the pace of growth (or degrowth) in 2015 as well. Industry association chiefs like OPPI’s Ranjana Smetacek, IDMA’s SV Veeramani and ABLE’s Dr PM Murali remain cautiously bullish on the sector, provided progress is made on their laundry list of suggestions to the government, which are sure feature in their budget wish list.
The government has shown it is willing to listen to industry demands; the latest example being the medical devices sector. On Christmas Eve, the medical devices segment was carved out into a separate sub category, with amended FDI rules that allowed 100 per cent FDI. 2015 could see a spurt in investments in local med device manufacturing and hopefully lower prices of medical devices like heart stents as well as diagnostic kits, most of which are imported today.
Will 2015 will be a better year to conduct clinical research in India? Industry sources point out that in the two years since the Swasthya Adhikar Manch’s PIL, they have not had a chance to plead their case. They are hoping that since the next Supreme Court hearing on January 13 is on a non-miscellaneous day, they will finally have an opportunity to have their say.
Dr Viraj Suvarna of Boehringer Ingelheim hopes that the Solicitor General of India will give a fitting riposte to the petitioners and the Chief Justice will be satisfied. His hope that the stranglehold on clinical trials will be lifted is echoed by LexCounsel, the legal firm representing the Indian Society for Clinical Research (ISCR) in the case, who reason that once the PIL is resolved, there will be some stability in the clinical research scenario in the country which will in turn allow regulators to address other areas of oversight in the modified regulations.
Christmas Eve had another ‘gift’ for the pharma sector: the Department of Industrial Policy and Promotion (DIPP) released the first draft of the National IPR Policy. It will no doubt be analysed and compared to IPR policy recommendations submitted to the DIPP on October 21 by a three-member IPR think tank selected by the DIPP.
The DIPP seemingly bypassed these recommendations, putting together a second IPR think tank. While the first think tank comprised three academicians, questions have been raised about the conflict of interest some members of the second think tank have, as they represent pharma companies on IPR matters.
Legal eagle Dr Gopakumar Nair feels that the Indian pharma industry has been under a siege on various fronts in 2014 and with more changes on the anvil, like the proposal to bring all pharma related regulatory and administrative activities under one roof, there is no doubt that the churn will continue into 2015.
To end on a more optimistic note, hope still springs eternal. It seems our analysts expect adversity to ignite survival instincts. Agile pharma players have revamped their strategy tool kit for 2015. For example, Glenmark’s Glenn Saldanha predicts that companies with a differentiated product portfolio and strong emphasis on brand building will outperform industry growth rates. In terms of which markets will be future growth drivers, he flags off LatAm and certain emerging markets in Asia and Africa.
Both Saldanha and Venus Remedies’ Dr Manu Chaudhary are gung ho about the opportunities but underline the role of the government to create a supportive infrastructure, encourage R&D and fast track clinical trial and marketing approvals. Chaudhary also underlines the need for clarity on regulations related to herbal medicines.
If 2014 was about surviving, 2015 will be about thriving. Tai Pi Advisors’ Anil Khanna predicts that as price controls put pressure on profits, companies will explore new distribution and marketing models, with some companies even supplying direct to patients. Such models are already underway globally (AstraZeneca’s Arimidex Direct and Pfizer’s Lipitor for You programmes); it remains to be seen if these will fall foul of the pharma marketing practices code which as per government decree, will kick into effect from January 1.
Stock analysts like Sarabjit Kour Nangra of Angel Broking predict that most pharma stocks will out perform the Sensex and as markets like Russia become unstable, developed markets will stabilise and strengthen.
May the year 2015 bring collaboration rather than confrontation; stability, not strife.
Viveka Roychowdhury
Editor
viveka.r@expressindia.com