Despite the uncertain global economic climate, the growth momentum for generic Drug spending will continue says Catherine Tang, Biomedical Industry Practice Leader for the Spire Research and Consulting. Its share of total drug spending is set to increase. Demand growth, primarily from emerging markets, is being accelerated by healthcare reforms in the major developed markets of USA and Europe; as well as impending patent cliffs, where some USD 75 billion worth of drugs go off patent between 2012 and 2015. This presents new potential for manufacturers of API and drug intermediates (active pharmaceutical ingredients and excipient components used in generic formulations) in India. 

India is well-poised in the Global Api Industry, but headwinds from higher export barriers and increased pharma co-vigilance are major threats that will inevitably raise production costs and erode margins. To retain its pole position in the competitive generic market and claim blue sky space, API manufacturers need to relook business processes to operate more efficiently. And to keep Indian drugs on the world-stage amidst rising defaults on quality, India-based API manufacturers should invest in branding to make made-in-India drugs more acceptable globally.

What would make India the No1 producer of APIs?

Assurance of quality has to be the uppermost priority, given the new requirements from Europe. Indian drug manufacturers will need a quality assurance and branding strategy to complement its current low-cost value proposition. 

In light of increased FDA inspections, companies might adopt technology to automate process data collection such that the complex manufacturing processes can be better managed. Investing in information management systems will help optimize workflow, derive better quality metrics and ensure adequacy of audit trails.