The Ministry of Everything

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

- AARTHIKAM CHINTANAM K P KRISHNAN

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?