Fixing individual accountability is central to ethical governance in public-health regulation. Illustrate with reference to pharmaceutical batch release.

Ethical governance requires that every decision affecting public safety can be traced to a person who answers for it. In drug regulation, the most consequential such decision is batch release, the final quality review before a batch reaches patients. MoHFW's draft amendment to the Drugs Rules, 1945 shows how naming one person turns a shared, diffuse duty into personal responsibility [1].

Why individual accountability matters ethically

• Shared responsibility weakens duty: licences now list "technical staff" for manufacturing and testing, but no one is named for the release decision [1].
• Duty of care: like an auditor signing accounts, a named signatory carries the patient's right to health under Article 21.
• Restoring trust: after the cough-syrup quality concerns, sales were restricted to licensed pharmacies through G.S.R. 927(E) [5].

How the draft fixes accountability

• Named authorised person: manufacturers must formally designate a qualified, experienced person, and licence applicants must name them [1].
• Audit trail: records for every batch and a prescribed Batch Release Certificate let a failed batch be traced to the person who signed it [1].
• Global benchmark: WHO GMP defines the authorized person as someone recognised by the national regulator, responsible for each batch and for recalls [2].

Manufacture → QC testing → Authorised person review → Certificate → Market
                                     ↑                                  │
                     trace & recall ←──────── batch fails (NSQ) ←───────┘

Accountability loop created by the draft

Making accountability real, not a formality

• Independence: WHO guidance says an authorised person who took part in producing or testing a batch cannot release it [3]. The draft only says "qualified".
• Regulator recognition: the regulator should recognise authorised persons, as WHO GMP envisages [2]. This would shield them from employer pressure.
• Enforcement capacity: CAG found 88% of drugs inspector posts vacant in Karnataka, and 59% of drugs used up before their test results arrived [4]. The Parliamentary Standing Committee asked for Drugs Controller vacancies to be filled on a fixed timeline [6].
• MSME support: smaller firms needed an extension to 31 December 2025 to meet the revised Schedule M [7], so the new rule should be phased in with support.

Batch release shows that accountability works when a decision carries a name, a record and a consequence. The final rule should add independence safeguards, regulator recognition and fully staffed inspectorates. That would align India with WHO GMP, protect the Article 21 right to health and advance SDG 3 (good health and well-being).