Reforming India’s Drug Laws: Why Expertise Still Sits Outside the Room

                          - Ganadhish Kamat

India’s Drug Law Reform: Still Stuck in 1940

India’s Drugs and Cosmetics Act was written for a country that no longer exists. In 1940, India had no meaningful pharmaceutical industry and depended heavily on imports—hence an entire chapter in the law devoted to imported drugs. Eighty-five years later, India is the “pharmacy of the world,” yet continues to be governed by a legal framework designed for colonial-era realities.

Yes, amendments have been made. But amendments are not transformation. The skeleton of the law remains unchanged—and increasingly unfit for purpose.

To its credit, the Ministry of Health and Family Welfare (MoHFW) recognized this in 2016 and sought industry inputs to overhaul the system. Indian pharmaceutical professionals routinely engage with global regulators like the US Food and Drug Administration and the European Medicines Agency and understand modern regulatory science far better than most legacy frameworks reflect. So, many professionals including myself submitted inputs. Yet, when the draft New Drugs, Medical Devices, and Cosmetics Bill emerged in 2022, it was a disappointment. It largely reproduced the old law with cosmetic changes and a new chapter on medical devices. This was not reform—it was replication. Incidentally this attempt of revising the law was made just after the DEG contaminated cough syrups manufactured in India, lead to death of 100s of children in Gambia and Uzbekistan. 

And then, in 2025, just after another incident of DEG contaminated cough syrup resulting in death of 20 children in MP, came reports of yet another revised bill. Prepared, submitted, but never tabled in Parliament. Reform in India, it seems, is perpetually “almost there.”

Why does this keep happening?

One uncomfortable answer is this: India's regulatory agencies don't have required talent & exposure on one hand while the regulatory reform process remains insular, underpowered, and disconnected from real-world practice.

In mature regulatory ecosystems, regulators don’t draft laws in isolation. Agencies like the US Food and Drug Administration and the European Medicines Agency work closely with professional bodies such as the International Society for Pharmaceutical Engineering and the Parenteral Drug Association. Draft guidances are debated in technical forums, refined through industry working groups, and stress-tested before implementation. The result: regulations that are not only scientifically sound but also practical and enforceable.

India, by contrast, has no such culture of structured regulatory dialogue.

Associations like the Indian Pharmaceutical Alliance and the Indian Drug Manufacturers' Association—along with ISPE and PDA chapters—largely confine themselves to seminars, conferences, general discussions and sometimes lobbying for favourable government policies. These are valuable, but they do not substitute for sustained policy engagement. There are few formal mechanisms where regulators and industry experts co-create regulations through iterative, technical consultation.

The cost of this disconnect is not theoretical—it is visible in policy outcomes.

• Medical Devices Regulation Confusion: India took years to bring medical devices under a regulatory framework, culminating in the 2020 notification expanding the definition of “drug.” Yet, implementation has been marked by ambiguity, frequent clarifications, and industry uncertainty—symptoms of inadequate pre-consultation despite the availability of global models.

• Schedule M (GMP) Upgrades: The push to align India’s GMP standards with global expectations has been long overdue. However, the recent revisions have triggered concerns among MSME manufacturers about feasibility, timelines, and interpretation—issues that could have been anticipated and mitigated through structured engagement with bodies like ISPE and PDA.

• Clinical Trial Regulations (2013–2019): India’s abrupt tightening of clinical trial rules following public interest litigations led to a near-collapse of the trial ecosystem. Subsequent relaxations had to be introduced to revive the sector. This regulatory whiplash reflected reactive policymaking rather than calibrated, consultative reform.

These are not failures of intent—they are failures of process. When laws are drafted without deep, continuous engagement with practitioners, they oscillate between overcorrection and underperformance.

The irony is stark. India has one of the largest pools of pharmaceutical talent in the world—professionals who design plants, run global quality systems, and interact daily with regulators across continents. Yet, this expertise remains largely untapped in shaping India’s own regulatory architecture.

If India is serious about becoming a global leader in pharmaceuticals—not just in volume but in innovation and quality—it must fundamentally rethink how it makes its laws. Reform cannot be an occasional, top-down exercise. It must be a continuous, collaborative process.

The Ministry of Health and Family Welfare must institutionalize structured engagement platforms with industry and professional bodies. Associations like Indian Pharmaceutical Alliance and Indian Drug Manufacturers' Association must evolve from event organizers into policy stakeholders. And global organizations like International Society for Pharmaceutical Engineering and Parenteral Drug Association must be actively integrated into India’s regulatory discourse—not treated as peripheral knowledge partners.

Until then, India risks continuing a cycle of draft, delay, dilute—and repeat.

A 21st-century pharmaceutical powerhouse cannot be governed by a 1940 mindset. And reform that excludes expertise is not reform—it is paperwork.