What stays on the top of pharma shelf—ease of doing business or patient safety?

Three individuals allegedly bought expired medicines at scrap prices, relabelled them with professionally printed stickers, repackaged them, and pumped them back into the pharmaceutical supply chain. This incident is a stark reminder that expired medicines are not merely a regulatory concern—they are a patient safety hazard. Yet, barely a week later, the Ministry of Health and Family Welfare (MoHFW) proposed making it easier to import medicines much closer to their expiry dates.

The timing could not have posed a more uncomfortable question: can a pharmaceutical supply chain already struggling to keep expired medicines off pharmacy shelves safely accommodate medicines entering the country with substantially less shelf life remaining?

Parsing the proposal

On 22 June 2026, the MoHFW published draft amendments to Rule 31 of the Drugs Rules, 1945,(1) replacing the existing requirement that imported drugs retain at least 60 per cent of their total shelf life with a flat requirement of 12 months’ residual shelf life. Under the current regime, a medicine with a total shelf life of 36 months can be imported only if approximately 21.6 months remain before expiry. The government argues that the proposed change would reduce wastage, improve the availability of medicines, simplify customs compliance, and promote ease of doing business by aligning India more closely with international supply chains.(2)

Those objectives are legitimate. But they rest on an assumption that India’s pharmaceutical supply chain functions efficiently enough for medicines with shorter remaining shelf lives to safely reach patients. That assumption merits closer examination.

One size does not fit all

The draft notification identifies reduced wastage and improved availability as its objectives but does not quantify the extent to which the existing 60 per cent rule has constrained imports or affected medicine availability.

The amendment exempts biological products and radiopharmaceuticals, and rightly so. Biologicals are temperature-sensitive and have variable shelf lives, while radiopharmaceuticals are susceptible to radioactive decay and may have shelf lives ranging from only a few hours to a few days.

Notably, many medicines with similarly short or unstable shelf lives are conspicuously absent from the list of exceptions. These include allergen extracts used for diagnostic testing and immunotherapy, which may have total shelf lives of only 9–18 months;(3) certain enzyme preparations with comparatively short stability periods;(4) and other biologically derived products that may lose potency much earlier than conventional medicines.

The proposed change also overlooks the slow turnover of inventory movement in India. Transportation of imported medicines from foreign manufacturers typically takes 3–15 days by air and up to 2–4 weeks by sea. Customs clearance and regulatory verification by drug control authorities may take another week. Thereafter, medicines are stored in warehouses and distributed through wholesalers over a period of six to eight weeks before finally reaching hospitals or retail pharmacies, where dispensing depends on patient demand. A medicine imported with only twelve months of residual shelf life may therefore reach a patient with less than eight months remaining before expiry. In slower-moving supply chains, particularly in smaller towns, rural markets, or low-demand therapeutic categories, medicines may reach consumers when they are already close to expiry—or even after becoming expired.

Perils of post-dated pills

Twenty-six years ago, the People’s Union for Civil Liberties filed a complaint against the Gobind Ballabh Pant Hospital, alleging that doctors administered expired medicines to patients, resulting in 26 deaths.(5) An expert committee subsequently found serious lapses on the part of the hospital administration.

This is not merely a story of the past. In June this year, an 11-year-old girl in Talabaruda village in Odisha’s Banspal block allegedly died after consuming an expired medicine obtained from an Auxiliary Nurse Midwifery Centre to treat fever. In another reported case from February 2026, a six-month-old infant died in Hyderabad suspectedly after consuming an expired medicine.

These incidents reflect a broader reality. Medicine users are often not vigilant about checking expiry dates. An empirical study conducted in rural Tamil Nadu found that approximately 30–60 per cent of consumers did not check the expiry dates of medicines before use.(6)

Time to regulate based on realities

Expired medicines may not merely result in reduced therapeutic efficacy. Many undergo significant degradation and changes in chemical composition over time. In time-sensitive conditions or among vulnerable patients, diminished efficacy alone can have serious clinical consequences. In other critical therapies, the use of expired medicines may also result in serious adverse health outcomes.

Ease of doing business is an important regulatory objective. But medicines are not ordinary consumer goods. Patients consume them with the expectation that they will be safe, effective and capable of treating illness. They must therefore retain their therapeutic quality throughout the supply chain.

India cannot afford to facilitate the circulation of near-expiry medicines when supply chains remain lengthy, consumer awareness of expiry dates is limited, and unscrupulous actors continue to exploit expired medicines for profit.

A more balanced regulatory approach would classify medicines according to their stability profiles, therapeutic risks and supply-chain realities rather than replacing one uniform rule with another.

While regulators deliberate on the proposed amendments and stakeholders submit their comments, the central question remains: what deserves pride of place on India’s pharmaceutical policy shelf—ease of doing business or patient safety?

Endnotes

1. Ministry of Health and Family Welfare, Government of India. Draft Notification: Amendment to Rule 31 of the Drugs Rules, 1945. Gazette of India (Extraordinary), 22 June 2026. Available at: https://egazette.gov.in/WriteReadData/2026/273833.pdf.

2. Press Information Bureau, Government of India. “Draft Amendment to Rule 31 of the Drugs Rules, 1945.” Ministry of Health and Family Welfare. Available at: https://www.pib.gov.in/PressReleasePage.aspx?PRID=2278097®=48&lang=1.

3. Cox LS, et al. “Allergen Immunotherapy: A Practice Parameter Third Update.” Journal of Allergy and Clinical Immunology, 2011. Available at: https://www.jacionline.org/article/S0091-6749(10)01566-6/fulltext.

4. Feller G. “Stability and Stabilization of Enzymes.” Advances in Enzymology and Related Areas of Molecular Biology, Vol. 67, 1993. Available at: https://www.sciencedirect.com/science/article/pii/000326709385082U.

5. Ferner RE. “Expired Medicines.” BMJ. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC1118495/.

6. Suresh K., et al. “Consumer Awareness Regarding Expiry Dates of Medicines: A Rural Tamil Nadu Study.” Journal of Family Medicine and Primary Care. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11512748/.

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