India’s pharma future relies on regulatory strengthIndia’s pharma future relies on regulatory strength

The Indian pharmaceutical industry, historically known for its dominance in the production of small molecules, is poised to establish itself as a major supplier in large molecule and biologics space. Coinciding with the country’s centenary of independence, the Government of India aspires to reach a $500 billion valuation for the pharmaceutical industry by 2047. Although currently valued at $65 billion, the sector is projected to reach $120 billion to $130 billion by 2030.

As India strives to establish itself in biologics, the importance of regulatory compliance and a deeply ingrained quality culture has become more critical than ever. While the sector has made significant strides in meeting global demand – supplying nearly 40% of global generics and 60% of vaccines – sustainable growth hinges on addressing persistent challenges in regulatory compliance.

Over the years, many Indian pharmaceutical companies including contract development and manufacturing organization (CDMO) Aurobindo and Dr Reddy's Laboratories have faced scrutiny from the US Food and Drug Administration (FDA) for lapses in quality control, data integrity, and operational practices.

At CPHI India, industry leaders emphasized that fostering a culture of compliance must reach beyond meeting regulatory requirements and become a daily practice.

“You cannot prepare for any inspection,” said Subhrangshu Chaudhury, vice president at Centaur Pharmaceuticals. “If you are open for business every day, you have to be ready for inspection every day.”

“Compliance is not about preparation; it should be in our culture. When manufacturing drug products, it should be ingrained that no previous residue is present when producing a new product. If we take care of our culture, compliance automatically follows.”

Leadership was highlighted as the key driver for this cultural shift. Matruprasad Priyadarshi, senior director at United States Pharmacopeia (USP)-India said, “Unless the quality culture is inbuilt in the organization, bringing change, innovation, and embracing new technologies will remain difficult.” He further argued that a compliance-oriented mindset must be championed by leadership and permeate at all levels of an organization to ensure sustainable growth.

Meenakshi Jain, head of regulatory generics development at Sandoz, emphasized the role of a positive workplace environment in fostering compliance. “Creating a psychologically safe environment is actually the foundation,” she said.

Stronger global cooperation 

The panelists mutually agreed that regulatory collaboration accelerates compliance and streamlines drug approvals in India. They called for the Central Drugs Standard Control Organization (CDSCO), India’s regulatory authority, to deepen its alignment with international bodies such as the FDA, UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and European Medicines Agency (EMA).

“CDSCO organized the first-ever global regulatory conference here in India, where more than 120 countries’ regulators assembled,” said Matruprasad, citing the World Health Organization (WHO) as a partner. “All the major topics in small molecules, biologics, advanced therapies were discussed and deliberated, and best practices from different regulators were shared in an open, transparent manner, so that each regulator can learn from each other.”

He further highlighted ongoing collaborative efforts, including joint working committees with the US FDA, initiatives like WHO-GMP inspections, and mutual recognition of inspection reports.

“CDSCO undergoes assessment every seven years, ensuring its practices align with global benchmarks,” he added. “These steps demonstrate CDSCO's growing stature as a globally recognized regulatory authority.”