Indian pharma industry: Urgent need for action in the manufacturing sector

Dr Ajay Babu Pazhayattil, President of cGMPWorld, offers invaluable insights from FDA Form 483 observations issued to Indian pharma facilities, shedding light on the industry's critical challenges today. His analysis provides immediate and practical plans to minimise regulatory compliance risks. These measures will help reinforce the Indian industry's commitment to supplying the much-needed lifesaving drug products for the regulated US market

This article will explore how the year ahead may shape Indian pharmaceutical manufacturers based on the emerging trends from US FDA inspections. The analysis is based on the publicly available Form 483 inspection findings, inspection details, and inspection citation details for 20241. Indian pharma professionals pride themselves on being part of the largest medicine-producing country, the pharmacy of the world. Leaders of the Indian industry must acknowledge that this point of pride will not turn into the legacy they envision if significant changes are not enacted, and history continues to repeat itself. Express Pharma's2 call for action earlier in the year based on regulatory inspection trends in India has highlighted the sluggish nature of acting based on emerging trends. With the new regime in the US, an import tariff on pharma products is not just a possibility but an imminent threat. The regulator continues to focus on ensuring site compliance with incremental audits. Price erosion in generics still exists, and any supply challenges will result in lost business. All of these factors call for careful attention towards compliance risk reduction strategies.