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India set to become leading API manufacturer

16 November 2013
Express Pharma Magazine India

India set to become leading API manufacturer

The Active Pharmaceutical Ingredient (API) industry is growing due to increasing demand from emerging markets. Though India is currently a global API manufacturer of some importance, issues concerning quality, proper infrastructure and differential laws within the country have held back its potential. Will India overcome these concerns and maintain its competitiveness in global markets? Catherine Tang, Business Development Director, Biomedical of Spire Research and Consulting, shared her thoughts in Express Pharma Magazine India.

India is poised to become a hub for API production, as the total expenditure on drugs worldwide is set to increase. Besides, healthcare reforms and impending patent cliffs in the developed markets of Europe and the US are presenting new opportunities for API manufacturers. However, India is threatened by export barriers and rising inspection checks, which could raise manufacturing costs and crimp profit margins.

Tang remarked that there should be emphasis on quality assurance, and a branding strategy should be adopted to overcome the limitations of the current low-cost value proposition. With an increase in Food and Drug Administration (FDA) inspections of overseas production sites, Indian API producers should invest in information management systems that will optimize workflow, provide improved quality metrics and ensure adequacy of audit trails.

At the same time, the infrastructure for inbound logistics should be improved to maintain competitiveness. Manufacturers should be less dependent on import of materials from other countries, and the government should be more supportive by extending tax support for process automation.

Meanwhile, India also needs to resolve issues with its legal framework. Pharma laws and regulations need to become better aligned with global best practices so as to benefit manufacturers. This will eventually boost global customers’ confidence in the “Made-in-India” label.

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