MSMEs in pharma must invest in technology to maintain quality standards: Pharmexcil DG, ET HealthWorld

By Prathiba Raju and Abhijeet Singh

Hyderabad: Highlighting a critical gap between small and large business setups in India’s pharmaceutical landscape, Raja Bhanu, Director General, Pharmaceuticals Export Promotion Council of India (Pharmexcil), stressed the importance of technology investment for Micro, Small & Medium Enterprises (MSMEs) to maintain quality standards and strengthen India’s global pharmaceutical dominance.

Delivering the keynote address on “Navigating the Future of Pharmaceutical Exports” at the second edition of ET Pharma Next Gen LabCon event themed ‘Future-Ready Labs: Analog to Digital,’ Bhanu covered key aspects of pharma trade and offered several suggestions for individual growth and industry promotion.

Pharmexcil’s head emphasised that to maintain India’s dominance in the pharma sector, MSMEs must invest in technology for early detection and mitigation of errors to ensure globally acceptable quality. Advancements like automation, data analytics, and AI are essential for this goal.

The top official highlighted the ambitious goal of reaching $120 billion by 2030, stating that India must expand beyond small molecules into areas like biosimilars, complex generics, and gene therapies.

“Our products have balanced quality and affordability, which must continue through investments in R&D. The world demands products at Indian prices but with the quality of Stringent Regulatory Authority (SRA) countries, and the Indian pharmaceutical industry can meet this demand,” he added.

Addressing the long-standing criticism of Indian drug safety, Bhanu stressed that quality control is the backbone of the industry. “Quality aspects must be addressed immediately. Delaying them lowers the credibility of both the individual player and the entire sector, leading to national loss.”

Bhanu urged equipment manufacturers to integrate AI and ML not only into advanced equipment but also simpler ones to identify issues promptly. He called for domestic production of such equipment, integrating IT, BT (Biotechnology), and PT (Pharmaceutical Technology) with the right software.

Sharing insights on importers’ perceptions and global pharmaceutical trade norms, Bhanu pointed out the importance of attributable data and contemporaneous recording for ensuring product transparency and compliance with global standards.

“One of the key issues in our labs is that product rejections are often attributed to human error. Manufacturers need to analyze and control these errors scientifically,” he stated.

Concluding his address, Bhanu emphasised that detection at every level determines the credibility of both the manufacturer and the product. “The more we are tried and tested, the more we will be trusted.”