Indian export rules buyers should know: CDSCO NOCs and shelf life

Most buyers never see the Indian side of an export, but it shapes what can be shipped, which documents travel with it, how fresh the stock is and how long the order takes. Indian rules changed several times between 2024 and 2026, especially for medicines that are not approved for the Indian market, which are often the ones named-patient and orphan buyers need.

This guide summarises the rules a hospital, licensed importer, CRO or NGO should know. It is a plain overview, not legal advice, and it flags where sources conflict or where practice differs between ports.

Who regulates a medicine export from India

Several authorities touch each export. Knowing who does what helps a buyer understand why a document is requested.

Export NOCs for unapproved, new and banned drugs

A CDSCO Office Order dated 30 April 2024 withdrew the power of state licensing authorities to issue NOCs for making unapproved, banned or new drugs solely for export, with effect from 15 May 2024. As the Nhava Sheva customs notice restates, the manufacturer must now obtain the NOC from the CDSCO zonal office through the SUGAM portal before the state grants the manufacturing licence, and may make the product only after that.

How the 2025 system works

CDSCO's guidance document, applied from May 2025 and described by commentators as Export NOC 2.0, sets out a two-step process.

1. Registration. A manufacturer holding a licence in Form 25, 28 or 28D files a one-time Integrated Registration Form with the zonal office. The NOC is issued within 7 working days of application and is valid for 1 year or until the sanctioned quantity is used up, whichever is earlier.
2. Release at the port. For each consignment, the manufacturer submits reconciliation details online, with the certificate of analysis, the purchase order, export invoice and shipping bill details, the label and the state export licence, which the port office verifies.

The older quantity-specific and purchase-order-specific NOC continues only for controlled (NDPS) drugs and banned drugs.

What the regulator asks about the destination

The guidance asks for the approval status of the product in the importing country. Where that is not available, the alternatives depend on the product. For a formulation unapproved in India, approval in a listed stringent regulatory country (the United States, EU member states, Canada, Japan, Australia or Switzerland) or in the importing country may be submitted. For unapproved fixed-dose combinations, NDPS drugs and banned drugs, approval from the importing country's regulator is mandatory.

For buyers this means a named-patient or special access approval from the destination may be requested early, sometimes before the product is made. The manufacturer also undertakes that a falsified document leads to cancellation of the NOC and a one-year bar on new applications, which trade press reported when the guidance was revised in 2025.

The 60 percent residual shelf-life rule

The guidance includes a shelf-life condition that is often misunderstood. If a formulation made under an export NOC is not exported, for example because an order was cancelled, the unexported quantity can be used for a later export order only while it keeps 60 percent of its residual shelf life. Below that threshold it must be destroyed in the presence of the state licensing authority. For active pharmaceutical ingredients the threshold is 3 months of residual shelf life.

This is a rule about reusing the manufacturer's stock. It is not a minimum shelf life that every exported medicine must have on arrival. Destination countries set their own arrival rules, such as two thirds in Qatar or 60 percent in Ghana, which the shelf-life guide compares. In practice, the Indian rule means short-dated NOC stock of an unapproved product cannot simply be offered to the next buyer.

Port clearance and the 31 December 2026 date

Public Notice 88/2026 of the Jawaharlal Nehru Custom House at Nhava Sheva, issued in July 2026, set out port procedures for drug exports.

• Manufacturers exporting approved drugs upload the documents prescribed by DGFT through the e-Sanchit system at export.
• Exporters other than the manufacturer must produce all relevant documents to the CDSCO port office and obtain its NOC. Customs ordinarily relies on that check and does not ask for the same documents again.
• Unapproved, new or banned drugs need the CDSCO NOC obtained before the manufacturing licence, and the shipping bill details, such as description, brand, specification, quantity, weight and origin, must match the NOC.
• Interim relaxation. Clearance can be allowed where the CDSCO NOC was obtained after manufacture, provided the exporter holds a valid state NOC, product permission and manufacturing licence. The notice set this relaxation to end on 30 September 2026, and Public Notice 121/2026 extended it to 31 December 2026. After that date, clearance is strictly subject to the 30 April 2024 Office Order.

The notices bind one customs house. Other ports may apply the same rules with different procedures or dates, so buyers should ask the exporter to confirm the current position with its customs broker. The update on the extension has the details.

Controlled drugs: NDPS export authorisations

Narcotic drugs and psychotropic substances need an export authorisation from the Narcotics Commissioner for each consignment. The Central Bureau of Narcotics requires the original import certificate issued by the government of the importing country with the application. The shipment must go in one consignment within the authorisation's validity, and no amendment or extension of the authorisation is allowed. A decision period of up to about 21 working days for a complete application is reported in secondary summaries.

The destination import certificate is therefore the first step, and buyers should start it before anything else. Precursor chemicals follow a separate NOC system.

Other rules that shape an export

• Exporter licences. A supplier needs an IEC, GST registration and, in practice, a state wholesale drug licence in Form 20B or 21B under the Drugs and Cosmetics Rules. The supplier verification guide shows how to check them.
• Payment deadlines. Under the FEMA export regulations as amended in September 2026, export proceeds for goods must be realised within nine months of shipment, or twelve months if invoiced or settled in rupees. Earlier versions and summaries give different periods, so confirm with the bank. The payment guide explains the effect on terms.
• Product documents. Certificates of a pharmaceutical product and WHO-GMP certificates are obtained by the manufacturer, as the COPP guide explains.

A checklist for buyers

1. Ask whether the product is approved in India, a new drug, unapproved, banned or controlled, since that decides which approvals apply.
2. Share the destination import approval or registration status as early as possible.
3. Fix the consignee and purchase order before the exporter applies for any NOC, because changes can require an amended NOC.
4. State the minimum remaining shelf life required on arrival.
5. For controlled drugs, obtain the destination import certificate first.
6. Build the Indian steps into the plan with the lead time estimator and the document checklist tool.