India’s contract drug manufacturers urge government support to reduce regulatory hurdles and expedite clearance for raw materials as global pharmaceutical firms seek to diversify away from China. The CRDMO sector is projected to grow significantly, but inefficiencies in India’s approval processes create competitive disadvantages. Industry leaders advocate for a CRDMO park to streamline operations and enhance the sector’s capabilities.

India’s contract drug manufacturers have called upon the government to eliminate regulatory barriers and expedite the approval process for essential raw material imports. This request arises as various global pharmaceutical companies seek to lessen their dependence on China. According to a Boston Consulting Group report, the Contract Research Development and Manufacturing Organisation (CRDMO) sector in India holds significant growth potential, aiming to expand from $3 billion to between $22 billion and $25 billion by 2035, while the global market value stands at approximately $140 billion to $145 billion.

At a recent event, Krishna Kanumuri, CEO and Managing Director at Sai Life Sciences, emphasized the industry’s potential, stating, “The government has to understand that this industry has potential, if not scale, right now.” The Indian CRDMO sector is well-positioned to benefit from the ongoing strategic shift by global firms to diversify their supply chains post-pandemic, particularly in light of U.S. legislation prohibiting federal contracts with specific Chinese biotech firms based on national security concerns.

Nonetheless, the current regulatory framework in India has been criticized for lagging behind market needs. As pointed out by Vikash Aggarwala from the Boston Consulting Group, approval processes and regulatory requirements can delay project initiation for Indian firms, taking between 8 to 15 days, compared to just three days for their Chinese counterparts. Industry representatives are advocating for more business-friendly policies that recognize India’s heavy reliance on China for drug-related raw materials.

Nandini Piramal, Chairperson of Piramal Pharma, identified various operational challenges, including the absence of customs warehouses in strategic locations and high logistics costs, along with limited cold storage facilities and bottlenecks in the clearance of raw material imports. She asserted, “All of those, I think, add more friction to the ease of doing business.” Furthermore, the lack of a centralized digital system for approvals can exacerbate project delays.

Peter Bains, the CEO-designate of Syngene, echoed these sentiments, stating that the inefficiencies create disadvantages for India in competing with other jurisdictions. While the Indian government has committed over $2.86 billion to the biotech sector, industry figures are advocating for enhanced measures.

Manni Kantipudi, CEO of Aragen Life Sciences, suggested the establishment of a dedicated CRDMO park that would streamline the approval process and simplify export and import procedures. This initiative, he argues, could foster a more conducive environment for the growth of the contract drug manufacturing sector in India.

In summary, India’s contract drug manufacturers are seeking government intervention to streamline regulatory processes and enhance import clearance for vital raw materials. With significant potential for growth, industry leaders are calling for policy reforms to improve the ease of doing business and reduce reliance on China. The establishment of a CRDMO park could be a strategic step toward achieving these goals.

Original Source: www.business-standard.com

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