India proposes 12-month shelf-life rule for imported drugs, easing 60% norm
Synopsis
India's health ministry wants to scrap the variable 60%-of-shelf-life rule for imported drugs and replace it with a straightforward 12-month minimum — a quiet but consequential regulatory shift that could cut medicine wastage, lower supply chain costs, and widen access to essential imports. Biologicals and radiopharmaceuticals are carved out and keep the stricter norm.
Key Takeaways
The Ministry of Health and Family Welfare has proposed replacing the 60 per cent residual shelf-life requirement for imported drugs with a flat 12-month minimum at the time of import.
The draft proposes amendments to Rule 31 of the Drugs Rules, 1945 and is open for stakeholder comments.
Biological products and radiopharmaceuticals are exempt — the existing 60 per cent norm will continue to apply to them.
The change is intended to reduce medicine wastage, lower inventory costs, and improve supply chain efficiency for pharmaceutical importers.
Quality, safety, and efficacy standards under the Drugs and Cosmetics Act, 1940 remain unaffected by the proposed amendment.
The Ministry of Health and Family Welfare (MoHFW) on Friday, 26 June issued a draft notification proposing to replace the existing residual shelf-life requirement for imported drugs — currently pegged at more than 60 per cent of total shelf life remaining — with a flat minimum of 12 months at the time of import. The move, aimed at improving pharmaceutical supply chain efficiency and easing the regulatory burden on importers, is open for stakeholder comments.
What the Proposed Amendment Says
The draft proposes amendments to Rule 31 of the Drugs Rules, 1945, shifting from a percentage-based threshold to a fixed 12-month floor. Under the current norm, a drug with a total shelf life of 24 months, for instance, must have at least 14.4 months remaining on arrival — a calculation that varies by product and has reportedly complicated inventory planning for importers.
The revised rule would standardise this requirement across most imported medicines, giving distributors and healthcare supply chains a predictable and uniform benchmark.
Exemptions for Biologicals and Radiopharmaceuticals
The government has proposed to retain the existing 60 per cent norm for biological products and radiopharmaceuticals, citing their specialised nature and heightened public health significance. These categories — which include vaccines, monoclonal antibodies, and short-lived radioactive diagnostic agents — will continue to operate under the stricter percentage-based requirement.
Why the Change Is Being Considered
According to the ministry, the percentage-based norm has contributed to avoidable medicine wastage, higher inventory costs, and supply chain inefficiencies. A fixed 12-month minimum, the ministry argues, still ensures patients receive medicines with adequate usable shelf life while giving importers and distributors sufficient time for distribution and consumption before expiry.
Notably, the amendment is expected to strengthen the availability of essential medicines across the country — a persistent policy concern, particularly for specialty and rare-disease drugs that are sourced predominantly from overseas.
Scope and Regulatory Guardrails
The MoHFW has clarified that the proposed change is limited strictly to the residual shelf-life condition at the time of import. It does not alter any other regulatory provisions governing the quality, safety, or efficacy of medicines under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. All existing quality and safety standards remain fully in force.
What Happens Next
Stakeholders — including pharmaceutical importers, industry associations, healthcare providers, and patient groups — have been invited to submit comments and suggestions on the draft notification. If finalised, the amendment would mark a meaningful shift in how India regulates imported medicine shelf life, aligning the country's norms more closely with ease-of-doing-business goals in the pharmaceutical sector.
Point of View
But the real question is whether 12 months is the right floor. For slow-moving specialty imports — particularly rare-disease drugs with limited distribution networks — a 12-month window may still leave room for wastage. The carve-out for biologicals and radiopharmaceuticals is prudent, but the ministry has not explained why the same logic does not apply to other time-sensitive categories. Stakeholder consultation will be the test: if industry uses it to lobby for a lower floor rather than to flag patient-safety concerns, the reform could quietly undermine the very access goals it claims to advance.
NationPress
26 Jun 2026
Frequently Asked Questions
What is the proposed change to India's imported drug shelf-life rule?
The Ministry of Health and Family Welfare has proposed replacing the existing requirement — that imported drugs must have more than 60 per cent of their total shelf life remaining at the time of import — with a fixed minimum of 12 months. The draft amendment to Rule 31 of the Drugs Rules, 1945 is currently open for stakeholder comments.
Why is the government proposing this amendment?
The ministry says the percentage-based norm has led to avoidable medicine wastage, higher inventory costs, and supply chain inefficiencies. A fixed 12-month floor is intended to standardise requirements, reduce wastage, and improve the availability of essential imported medicines across India.
Which drugs are exempt from the new 12-month rule?
Biological products and radiopharmaceuticals are exempt. The government has proposed retaining the existing 60 per cent residual shelf-life requirement for these categories, given their specialised nature and public health significance.
Will the amendment affect medicine quality or safety standards?
No. The MoHFW has clarified that the proposed change applies only to the residual shelf-life condition at the time of import. All quality, safety, and efficacy standards under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, remain fully in force.
How can stakeholders respond to the draft notification?
The Ministry of Health and Family Welfare has invited comments and suggestions from all stakeholders — including pharmaceutical importers, industry bodies, and healthcare providers — on the draft notification proposing the amendment to Rule 31 of the Drugs Rules, 1945.
