India’s Contract Drug Makers Urge Government to Ease Regulations for Faster Growth
India’s contract drug manufacturing sector is calling for regulatory reforms and expedited clearances for raw material imports to strengthen its position in the global pharmaceutical supply chain. The Contract Research Development and Manufacturing Organisation (CRDMO) industry, which could grow seven-fold to $22-25 billion by 2035, faces delays due to prolonged approval times, logistical challenges, and the absence of a centralized clearance system, according to a Boston Consulting Group report. Industry leaders argue that easing these hurdles is crucial as global pharmaceutical firms seek alternatives to China.
Despite benefiting from supply chain diversification post-pandemic and U.S. restrictions on Chinese biotech firms, Indian manufacturers struggle with approval delays of up to 15 days, compared to just three days in China. Executives from leading firms like Sai Life Sciences and Piramal Pharma have urged the government to address issues such as insufficient customs warehouses, cold storage facilities, and complex regulatory procedures. Syngene’s CEO-designate Peter Bains emphasized that these challenges put India at a competitive disadvantage against other jurisdictions.
To unlock the sector’s full potential, industry experts are advocating for a dedicated CRDMO park with streamlined policies, reduced bureaucratic approvals, and improved import-export capabilities. Manni Kantipudi, CEO of Aragen Life Sciences, proposed creating an environment where companies can operate with minimal regulatory delays. While India has invested over $2.86 billion in its biotech industry, executives believe that additional policy support is essential to drive growth and solidify India’s role as a global pharmaceutical hub.
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