Stringent regulations and ever increasing approval timelines are hampering the India pharma story, though recent recommendations on the compensation guidelines show that the regulators are trying to accommodate at least some of industry’s concerns. Similarly, the Foreign Investment Promotion Board (FIPB) has cleared foreign direct investment (FDI) in seven brownfield proposals. But will this convince industry players that things will improve enough?
In India’s latest tryst with compensation guidelines for clinical trial-related injury and death, the Drug Technical Advisory Board (DTAB) has made various suggestions/clarifications at a meeting in May. They reveal some surprising recommendations. (See story: DTAB recommends changes to compensation g’lines for clinical trials; http://bit.ly/1afGBTa).
Patient groups may not approve some of the Board’s recommendations. One example is the DTAB’s view that compensation need not be paid if the trial participant dies or is injured due to the failure of the investigational product since ‘the trial is conducted with the objective of assessing the therapeutic effect of the drug along with safety.’
Similarly, the DTAB has recommended that the trial participant should be provided free medical management only in case the injury is related to the trial, otherwise this could be seen as ‘inducement’. The term ‘related to the trial’ is nebulous and gives rise to dispute: an accident is obviously not ‘trial-related’ but a slip or a fall could be related to the trial medication though proving it could be difficult.
Industry has in general welcomed the fact that the minutes of the DTAB meeting show that the authorities are at least discussing the topic but seems cautious of hoping for too much, too soon. Ever since the guidelines were released on January 30, industry associations and individual pharma companies have tried to reason with the regulator that certain clauses needed clarifications. There were dire predictions that GSR53(E), the offending gazette notification, would be the death knell of clinical research in India and in time, would set back the country’s pharma industry as well.
In fact, the exodus of Indian pharma companies and talent to greener pastures has already started, claims a survey conducted between March-June this year by The Associated Chambers of Commerce and Industry of India (ASSOCHAM). The survey, based on interviews with around 250 top industry hands, from five top pharma hubs of the country (Andhra Pradesh, Gujarat, Karnataka, Maharashtra and Tamil Nadu) blamed prolonged approval timelines and restrictive regulations as reasons to shift operations to more accommodating countries in South Asia. Countries like Cambodia, Korea, Philippines, Singapore, Thailand, Vietnam and others, are reportedly ‘wooing India’s R&D industry’ with ‘sops and transparent regulations’ says the ASSOCHAM survey. Getting permissions/approvals for trials or marketing drugs takes more than 12-15 months in India while the US FDA, EU and Singapore issue such approvals within a month’s time, points out the survey.
Sri Lanka, the topic of our cover story in this issue, is another country set to benefit from the decreasing incentive for pharma companies in India. With tax sops in SEZs set to expire, Indian pharma companies are looking at the island nation as the next frontier. But, with other Asian nations like Singapore and China moving in quickly, pharma companies from India will have to be much more aggressive and exploit ancient cultural ties with the island nation. Similarly, regulators in India will need to move much faster to bring back the ‘feel good’ factor. Wooing back Indian pharma will prove much harder once they taste success overseas.
Viveka Roychowdhury
Editor
