India's pharmaceutical industry must transition from its traditional strength in cost-effective generic medicines to focus on innovation, advanced manufacturing, quality and global regulatory standards to realise its growth potential, according to industry experts. With India targeting a pharmaceutical market of $130 billion by 2030, the next phase of growth will require greater investments in research and development, digital technologies and contract research and development manufacturing, as reported by Business Standard. The discussions were held at a recent industry event in Hyderabad ahead of the 19th edition of CPHI & PMEC India 2026, scheduled to be held in November across venues in Delhi-NCR.
India's pharmaceutical ambitions are facing a critical regulatory capacity constraint that threatens to limit the industry's transition to innovative medicines. Despite achieving extraordinary scale as the world's third-largest producer by volume and supplying around 20% of global generic medicines, India ranks only eleventh globally in pharmaceutical exports by value with a share of around 3%. The Central Drugs Standard Control Organisation (CDSCO) has not built regulatory capacity at the pace of India's pharmaceutical ambitions expansion. Only 201 drug inspectors were in position against a sanctioned strength of 504 as of December 2023, with India requiring around 210 inspectors merely for manufacturing oversight. The government's ₹10,000 crore Biopharma SHAKTI programme decision to create a dedicated scientific review cadre within CDSCO represents an important reform, though implementation with sufficient scale and specialisation is crucial.
Tata Consultancy Services (TCS) has launched TCS ADDAgentHub, a groundbreaking AI platform designed to revolutionize drug development processes, enhancing efficiency and safety in pharmaceutical operations. The platform enables pharma companies to embed AI agents into enterprise workflows and is stated to have improved efficiency by up to 40 per cent in clinical data management and other operational tasks. According to ETPharma, the platform demonstrates up to 30 per cent reduction in clinical study build effort through metadata-driven automation and up to 30 per cent cost savings in end-to-end safety case processing. As per TCS, the platform enables a shift from reactive to proactive, scalable, and audit-ready operations amidst an ever-changing regulatory environment.
Sarvesh Singh, CEO, Lifesciences and Pharma, Government of Telangana, emphasized the state's ambition to move up the value chain beyond manufacturing. "Telangana has already established itself as India's pharmaceutical manufacturing powerhouse and a global vaccine hub, but our ambition now goes beyond manufacturing. We want Telangana to emerge as the life sciences innovation capital of India," Singh stated. The state is focusing on biologics, biosimilars, cell and gene therapies and aims to attract $25 billion in investments and create more than five lakh jobs over the next five years through its Next-Gen Life Sciences Policy 2026-2030. Singh noted that the state is focusing on areas where biology, chemistry and technology converge to drive innovation.
M Roja Rani, Executive Director, Bulk Drug Manufacturers Association of India, highlighted the need to reduce dependence on imported key starting materials and intermediates. "The capability to manufacture is well established; the priority now is to strengthen competitiveness, reduce dependence on imported key starting materials and intermediates, and build greater depth across the domestic value chain," Rani explained. She noted that greater investment in research and development, new technologies and API capacity would be essential over the next three to five years, while initiatives such as the PLI scheme and bulk drug parks could further strengthen domestic manufacturing. The 19th edition of CPHI & PMEC India 2026 will be held at IICC, Yashobhoomi, Dwarka from November 23-25, while PMEC India will be held at IEML, Greater Noida from November 24-26.
Pushpa Vijayaraghavan, Director, Healthcare and Lifesciences Advisory, Sathguru Management Consultants, outlined the comprehensive transformation needed across multiple segments. "We have to preserve our generics base, move faster on API backward integration, build scale in biologics and biosimilars, and invest far more seriously in innovation," Vijayaraghavan explained. Chakravarthi AVPS, Chairman, Federation of Pharma Entrepreneurs, Telangana and Andhra Pradesh, emphasized that compliance is now the baseline for pharmaceutical companies, with innovation and technology becoming the key differentiators. "The next phase of growth must go beyond cost competitiveness. Compliance is now the baseline; the real competitive advantage will come from innovation, advanced and sustainable packaging, traceability, technology and globally benchmarked quality," he stated. For Viksit Bharat 2047, India must build precisely these industries — science-intensive, high-productivity, innovation-driven, export-oriented and capable of creating highly skilled employment.
