India’s Ministry of Health and Family Welfare has introduced a minimum 12-month residual shelf-life requirement for most imported medicines, replacing the earlier rule that required drugs to have more than 60% of their labelled shelf life remaining at the time of import. The amendment to Rule 31 of the Drugs Rules, 1945, was notified through the Drugs (Thirteenth Amendment) Rules, 2026, and published in the Official Gazette on October 29.
The revised regulation is intended to simplify pharmaceutical imports, reduce avoidable medicine wastage and improve inventory management across the supply chain. However, biological drugs and radiopharmaceuticals will continue to follow the earlier requirement, under which at least 60% of their labelled shelf life must remain at the time of import. The change does not relax existing requirements relating to medicine quality, safety or efficacy.
Key Takeaways
- India has introduced a minimum 12-month residual shelf-life requirement for most imported drugs.
- The new rule replaces the earlier requirement of more than 60% of the labelled shelf life remaining.
- Biological drugs and radiopharmaceuticals retain the 60% requirement.
- The amendment changes Rule 31 of the Drugs Rules, 1945.
- The Drugs (Thirteenth Amendment) Rules, 2026, were published in the Gazette on October 29.
- The government expects the change to reduce medicine wastage and simplify import procedures.
- Existing quality, safety and efficacy requirements remain unchanged.
What Has the Government Changed?
The Ministry of Health and Family Welfare has amended Rule 31 of the Drugs Rules, 1945, which governs conditions relating to the import of medicines into India.
Under the previous requirement, imported medicines generally needed to have more than 60% of their labelled shelf life remaining when they entered the country.
The government has now replaced this percentage-based requirement with a fixed minimum of one year for most imported drugs.
This means that the licensing authority will not permit the import of a medicine if it has less than 12 months of residual shelf life on the date of import.
The amendment was notified as G.S.R. 951(E) under the Drugs (Thirteenth Amendment) Rules, 2026.
The final notification was dated October 16, 2026, and the rules came into force upon publication in the Official Gazette on October 29, 2026.
New Rule vs Previous Rule
| Regulatory requirement | Earlier rule | New rule |
|---|---|---|
| Most imported drugs | More than 60% of labelled shelf life remaining | At least 12 months remaining |
| Biological drugs | More than 60% | 60% of labelled shelf life |
| Radiopharmaceuticals | More than 60% | 60% of labelled shelf life |
| Regulatory provision | Rule 31, Drugs Rules, 1945 | Rule 31, as amended |
The difference is particularly relevant for medicines with longer overall shelf lives.
For example, consider a medicine with a labelled shelf life of 36 months.
Under the earlier requirement, more than 21.6 months of shelf life needed to remain at the time of import.
Under the new rule, the general requirement is 12 months.
This gives importers more flexibility in managing shipments, inventory and distribution schedules.
Why Has the Government Changed the Rule?
The main objective is to improve the efficiency of India’s pharmaceutical supply chain.
Imported medicines often pass through several stages before reaching patients. These include customs clearance, warehousing, distribution, transportation and delivery to pharmacies or hospitals.
A strict percentage-based requirement can create difficulties for importers, particularly when medicines have long overall shelf lives.
Products that are still safe and usable may become difficult to import simply because they do not meet the percentage-based calculation.
The government believes that a fixed 12-month requirement provides adequate time for medicines to move through the supply chain while reducing unnecessary restrictions.
1. Reduce medicine wastage
One of the expected benefits is a reduction in avoidable wastage.
Importers may face situations in which medicines are still within their approved expiry dates but cannot be imported because they do not have the required percentage of shelf life remaining.
The revised rule could reduce the number of such shipments that are rejected or discarded.
2. Improve pharmaceutical inventory management
A fixed requirement could make it easier for pharmaceutical companies to plan shipments and manage warehouse inventory.
Importers can work with a predictable 12-month threshold rather than calculating different percentage-based requirements for products with different shelf lives.
This could improve procurement planning and reduce supply-chain costs.
3. Simplify import compliance
The government also wants to improve ease of doing business in the pharmaceutical sector.
A fixed time requirement is easier for importers, customs authorities and licensing officials to understand and apply consistently.
Why Are Biological Drugs and Radiopharmaceuticals Exempt?
The government has retained the earlier 60% requirement for biological drugs and radiopharmaceuticals because of their specialised nature and public-health considerations.
Biological medicines are produced using biological sources or processes. These include certain vaccines, blood products, hormones and advanced therapies.
Radiopharmaceuticals contain radioactive substances and are used in medical imaging and treatment.
Their storage, stability and handling requirements can be different from those of conventional medicines.
For these categories, the government has decided to retain the requirement that at least 60% of the labelled shelf life may be allowed at the time of import.
This means the new 12-month threshold does not apply uniformly to every imported medicine.
Does the New Rule Change Medicine Quality and Safety Standards?
No. The amendment only changes the residual shelf-life requirement applicable at the time of import.
It does not remove or relax the existing regulatory requirements under the Drugs and Cosmetics Act, 1940, or the Drugs Rules, 1945.
Imported medicines must continue to comply with applicable standards relating to:
- Quality and manufacturing practices.
- Safety and efficacy.
- Regulatory approvals and import licences.
- Labelling and packaging requirements.
- Storage and transportation conditions.
- Other applicable testing and compliance requirements.
A medicine with 12 months of remaining shelf life is not automatically approved for import. It must still satisfy all other applicable regulatory conditions.
The change should therefore be understood as a supply-chain and import-compliance reform, not a relaxation of medicine safety standards.
How Could the Change Affect Pharmaceutical Companies?
The revised requirement could benefit companies that depend on imported medicines, active pharmaceutical ingredients and specialised formulations.
Importers may gain greater flexibility when planning shipments from overseas manufacturing facilities.
Companies dealing in medicines with longer labelled shelf lives could particularly benefit because the fixed 12-month threshold may be less restrictive than the previous percentage-based calculation.
Hospitals and pharmacies could also benefit indirectly if improved inventory management reduces avoidable supply disruptions and wastage.
However, the actual impact will depend on the types of medicines imported, their manufacturing schedules, distribution timelines and demand in India.
The amendment does not guarantee lower medicine prices. Any savings would depend on how much importers and distributors save and whether those savings are passed on through the supply chain.
The Bigger Picture
India is one of the world’s major pharmaceutical markets and a significant supplier of generic medicines. Its pharmaceutical industry depends on international trade for certain specialised formulations, ingredients and finished medicines.
Import regulations therefore play an important role in maintaining the availability of medicines while ensuring that products meet appropriate safety and quality standards.
The new residual shelf-life rule reflects an attempt to balance these objectives. By replacing a percentage-based requirement with a fixed 12-month threshold for most medicines, the government is seeking to reduce procedural difficulties without changing the underlying quality standards.
The impact will become clearer as pharmaceutical importers adjust their procurement and inventory practices under the revised regulation.
Looking Ahead
The revised rule is now in force following its publication in the Official Gazette. Pharmaceutical importers, distributors and regulatory teams will need to update their compliance procedures to reflect the new 12-month requirement and the separate treatment of biological drugs and radiopharmaceuticals.
The longer-term outcome will depend on whether the change reduces rejected shipments, improves medicine availability and lowers avoidable inventory costs. The government will continue to face the challenge of simplifying pharmaceutical trade while ensuring that medicines reaching Indian patients remain safe, effective and of acceptable quality.
Frequently Asked Questions
1. What is the new shelf-life rule for imported medicines in India?
Most imported medicines must have at least 12 months of residual shelf life remaining on the date of import into India.
2. When did the new rule come into effect?
The Drugs (Thirteenth Amendment) Rules, 2026, came into force upon publication in the Official Gazette on October 29, 2026.
3. What was the earlier requirement for imported drugs?
The earlier rule generally required imported medicines to have more than 60% of their labelled shelf life remaining at the time of import.
4. Are biological drugs covered by the new 12-month requirement?
No. Biological drugs retain the separate requirement allowing import with 60% of the labelled shelf life remaining.
5. Do radiopharmaceuticals also have an exemption?
Yes. Radiopharmaceuticals can continue to be imported under the 60% residual shelf-life provision.
6. Why has the government introduced the new rule?
The government wants to simplify import procedures, reduce avoidable medicine wastage, improve inventory management and strengthen pharmaceutical supply-chain efficiency.
7. Does the amendment relax medicine quality standards?
No. Existing quality, safety and efficacy requirements under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, remain applicable.
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