India's pharma regulatory failures point to a deeper structural flaw

The recent tragedy of the contaminated cough syrups, leading to heartbreaking and avoidable deaths of children both here and abroad is not an isolated incident. It is merely the latest, most horrific symptom in a continuing and distressingly predictable series of regulatory failures that plague India’s health sector. When one drills down, the pathology is not just in the failed product or the rogue manufacturer; it’s lodged deep in the very design of the regulatory machinery intended to protect the public.

 

The systemic rot is visible across the landscape. The cough syrup disaster, which indicts the Central Drugs Standard Control Organisation (CDSCO) and its state-level counterparts, finds an echo in other critical areas. We have seen similar, recurrent lapses in the regulation of food articles, where the Food Safety and Standards Authority of India (FSSAI) often seems overwhelmed. We have also seen this in the oversight of hospital and medical establishments, where quality-of-care issues remain largely unchecked.

 

These are not independent, random occurrences. They are all pointers to a larger, more fundamental issue. When we look at pharma, food, or clinical establishments, it is natural and logical for us to focus on the regulatory agency. But the sad truth is that the regulators in these three domains, and indeed most regulatory agencies of the Ministry of Health and Family Welfare (MoHFW), suffer from basic design flaws.

 

What do we mean by this?

 

To begin with, a lot of the health regulators are administrative units within the ministry and not standalone, arm’s-length agencies, unlike the Securities and Exchange Board of India or the Reserve Bank of India. Most of them are not empowered to write regulations without the approval of the ministry, cannot recruit expert personnel, do not have access to financial resources and depend on budgetary handouts from the ministry. In other words, they do not have the domain and resource autonomy essential for effective regulation.

 

Hence, we need to look deeper at the parent ministry, with a sprawling and often conflicted mandate, and a structure ill-equipped for the vital, specialised task of regulation.

 

Why is regulation so important in the context of health? All areas of health, namely medical care, hospitals, medicines, and para-medical assistance, among others, are textbook examples of information asymmetry. The consumer has no way of knowing whether she is getting what is required, or its quality or efficacy. Hence, the ministry dealing with health needs to have the capacity to think deeply about, understand, and design appropriate regulatory structures.

 

MoHFW is a behemoth, tasked with a dizzying array of responsibilities. A quick look shows that the ministry’s domain encompasses a very large number of statutory and non-statutory bodies. While an exact, universally agreed-upon single number of regulators in MoHFW is elusive due to the lack of an agreed-upon taxonomy of bodies, we are looking at scores of institutions.

 

For instance, it houses major regulatory agencies like the CDSCO, the National Medical Commission, the National Commission for Allied and Healthcare Professions, the Pharmacy Council of India, the Dental Council of India, and the FSSAI, et al.

 

In addition to these, the MoHFW oversees a vast number of “autonomous agencies”— a paradoxical term in the Indian context — which include premier research and education institutes like the All India Institutes of Medical Sciences, the Indian Council of Medical Research institutions, and the National Institute of Health and Family Welfare.

 

Further complicating matters, the ministry is the nodal agency for implementing a multitude of enormous, large-scale public health schemes — from the National Health Mission and Ayushman Bharat (PM-JAY) to major disease control programmes.

 

Herein lie the seeds of structural paralysis. The ministry simultaneously executes three distinct, often conflicting, roles:

 

• Regulation and standard-setting.
• Service delivery and direct running of institutions.
• Scheme implementation and financing.

 

This leads to a severe lack of focus. The essential organisational principles of efficiency, specialisation, and accountability are sacrificed at the altar of administrative convenience.

 

A regulatory function, by its very nature, demands intellectual and financial autonomy. Regulation requires empowered arm’s-length agencies that can deliver tough decisions, often against powerful vested interests, without the shadow of political or operational interference from the parent ministry. This autonomy must be backed by rigorous, predefined accountability mechanisms and transparency. Regulators are primarily thinkers, standard-setters, and enforcers — a cerebral function requiring domain expertise, legal clarity, and financial self-sufficiency. The parent ministry of the regulator has to have this regulatory DNA.

 

On the other hand, running institutions and schemes requires an entirely different administrative skill set: A much more hands-on, operational approach focused on logistics, procurement, personnel management, and meeting quantitative targets. An administrator tasked with ensuring ₹10,000 crore is spent efficiently on the NHM in a quarter can’t possibly give her full cognitive capacity to the esoteric legal fineprint required for effective drug inspection and prosecution.

 

The current structure, where the same administrative ecosystem oversees both the regulator and the regulated (or where the operational wing overshadows the enforcement wing), creates an institutional conflict of interest. It dilutes the regulator’s voice and limits its resources, staffing, and independence, turning it into a subordinate office rather than a powerful, independent sentinel of public health.

 

The recurring tragedies — from tainted drugs to substandard hospital care — are not merely a call for more inspectors or better vigilance at the field level, though those are urgently needed. They are a clarion call for a fundamental re-engineering of the parent ministry’s design.

 

We must move beyond focusing solely on agency failures and address the parent ministry’s structural issues. The government must seriously consider a clear organisational demarcation of MoHFW, somewhat similar to the Jaswant Singh inspired “Ministry of Finance for the 21st century”. Until we accept that the ministry cannot be the umpire, the player, and the stadium owner all at once, India’s public health will remain perennially vulnerable to the next cough syrup scandal.

 

The time for structural reform is long past due. The cost of continued administrative inertia is measured in lives.  

 

The author is an honorary senior fellow at the Isaac Centre for Public Policy, and a former civil servant