India’s contract drug manufacturers are urging the government to streamline regulatory processes and grant faster clearances for vital raw material imports. As global pharmaceutical firms seek to diversify their supply chains and reduce dependence on China, industry leaders argue that policy support is critical for India’s Contract Research Development and Manufacturing Organisation (CRDMO) sector to capitalize on this opportunity.
Potential for Growth and Policy Hurdles
According to a report by Boston Consulting Group (BCG), India’s CRDMO sector has the potential to expand sevenfold, reaching a valuation of $22 billion-$25 billion by 2035, up from its current size. In contrast, the global CRDMO market is valued at $140 billion-$145 billion. However, industry experts stress that India’s regulatory framework must evolve to match this growth potential.
“The government has to understand that this industry has potential, if not scale, right now,” said Krishna Kanumuri, CEO and Managing Director at Sai Life Sciences, during an industry event this week.
One of the major concerns is delays in raw material import approvals, which significantly slow down project initiation. According to Vikash Aggarwala, MD and Partner at BCG’s healthcare practice, Indian firms often require 8 to 15 days to begin projects due to regulatory requirements, whereas Chinese firms can achieve this in just three days.
Industry Demands for Business-Friendly Policies
India’s contract drug manufacturers have benefited from global efforts to reduce reliance on China, especially after the pandemic and new U.S. legislation restricting federal contracts with certain Chinese biotech firms. However, regulatory bottlenecks continue to hinder growth.
Piramal Pharma Chairperson Nandini Piramal highlighted several logistical and infrastructural challenges, including the lack of customs warehouses at key locations, shortages of cold storage facilities, and delays in raw material clearances. “All of these add more friction to the ease of doing business,” Piramal stated.
Another major challenge is the absence of a centralized, digital single-window clearance system, leading to delayed approvals. Syngene CEO-designate Peter Bains noted that these inefficiencies create a competitive disadvantage for India compared to other global manufacturing hubs.
Call for Specialized CRDMO Parks
Industry leaders are advocating for dedicated CRDMO parks to facilitate seamless operations. Manni Kantipudi, CEO of Aragen Life Sciences, suggested that such parks could eliminate the need for repeated regulatory approvals, ensure faster export-import processes, and enhance India’s competitiveness in the global market.
With over $2.86 billion already invested in India’s biotech industry, companies are pushing for further government initiatives to position the country as a global leader in contract drug manufacturing.
The health and finance ministries have yet to respond to the industry’s demands for policy reforms. However, as the global pharmaceutical landscape shifts, the ability of Indian regulators to address these challenges will play a crucial role in determining the country’s standing in the CRDMO market.
