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API manufacturers need to relook business processes to operate more efficiently

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Catherine Tang

Despite the uncertain global economic climate, the growth momentum for generic drug spending will continue. 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 the US and Europe; as well as impending patent cliffs, where some $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 pharmaco-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 re-look the 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.

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 to optimise workflow, derive better quality metrics and ensure adequacy of audit trails.

The current physical infrastructure for inbound logistics has a direct impact on competitiveness. In this regard, India is out-competed by other global drug production hubs like Singapore, Ireland and Puerto Rico. The government has a role to play here in nurturing the industrial infrastructure for API production, taking a leaf from what Singapore has done with its Tuas biomedical park. API manufacturers should also consider backward integration to reduce reliance on the import of raw materials from China and other countries. Product registration fees and other forms of levies applicable to Indian API exporters warrant concrete mitigation strategies in order for India to remain competitive on the world stage.

As the third largest exporter of generic drugs, Indian drug makers and pharmalabs continue to receive strategic support from the government and industry councils. But new challenges on the blue-sky horizon call for the financial assistance provided by the government to expand so as to support upstream investment in process automation especially information management systems.

Lastly, Indian exporters should reach out to emerging markets with messages not only on cost-effective medicines but also value co-creating initiatives that encourage collaborative strategies with destination countries and companies.The growth of Indian companies in the pharma industry is handicapped by differential laws and regulation within India itself. The industry would benefit from a consolidation of the API manufacturers so that benefits of scale can be reaped. Lastly, more efforts are needed to raise the global customer confidence level associated with made-in-India drugs.

Catherine Tang, Director Biomedical, Spire Research and Consulting

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