Between January and September 2026, the Directorate General of Foreign Trade (DGFT) has quietly rewritten several import policy conditions that directly touch pharmaceutical raw material sourcing, SEZ-based device and food manufacturing, and key pharma intermediates. Unlike headline-grabbing FTP overhauls, these changes arrived as targeted ITC (HS) notifications — easy to miss, but carrying real consequences for landed costs, customs clearance, and export obligations. Here is what has actually changed, and what your compliance calendar needs to reflect.
Minimum Import Price Now Applies to Key Antibiotic APIs
Notification No. 56/2025-26 dated 29 January 2026
The Directorate General of Foreign Trade issued Notification No. 56/2025-26 dated 29 January 2026 amending India’s import policy for certain key antibiotic raw materials, placing price-based import restrictions on Penicillin, 6-APA and Amoxycillin falling under Chapter 29 of the ITC (HS) classification. Rather than banning imports outright, DGFT amended the import policy for Penicillins and its salts, Amoxicillin and its salts, and 6-APA under ITC (HS) Codes 29411010, 29411030, and 29411050 of Chapter 29, keeping the import policy “Free” but introducing new minimum import price (MIP)–based restrictions.
The specific thresholds matter for procurement planning: imports of Penicillin G-potassium with CIF value below ₹2,216 per kg, Amoxicillin Trihydrate below ₹2,733 per kg, and 6-APA below ₹3,405 per kg are now classified as “Restricted.” These restrictions apply for one year from the date of publication of the notification. Any consignment priced below these benchmarks now requires an import licence rather than free clearance — a step that can add weeks to a shipment timeline if not planned for in advance.
There is meaningful relief for export-oriented operations: the MIP conditions do not apply to imports by 100% Export Oriented Units, units in Special Economic Zones, or imports under the Advance Authorisation Scheme, provided the imported inputs are not sold into the Domestic Tariff Area. For bulk drug manufacturers and formulators who source Pen-G-based intermediates for domestic sale, however, the MIP is a real cost floor that must now be built into supplier contracts and customs declarations for the remainder of the one-year window.
SEZ and EOU Importers Get Broader QCO/BIS Relief — With a Catch
Notification No. 20/2026-27 dated 2 June 2026
This is arguably the most consequential change for pharma, device, and food companies operating through Special Economic Zones. The DGFT, through Notification No. 20/2026-27 dated 2 June 2026, amended Para 2.03A(iii) of the Foreign Trade Policy (FTP) 2023 to clarify the applicability of Quality Control Orders (QCOs) and Bureau of Indian Standards (BIS) requirements on imports made by Special Economic Zone Units and Developers.
Previously, the exemption from mandatory QCOs was limited to imports of inputs required for export production, subject to restrictions on Domestic Tariff Area clearance and available only for physical exports. The revised text goes considerably further: it significantly expands the exemption by allowing SEZ Units and Developers to import all permissible goods, including raw materials, components, consumables, spares, and capital goods, required for authorized SEZ operations without QCO compliance at the import stage.
The important qualifier — and the one businesses most often overlook — is that this is not a blanket waiver. Any transfer, removal, or clearance of such goods, or products manufactured from them, into the DTA must comply with applicable QCOs, BIS certification, and other regulatory requirements. In practical terms: a device or food manufacturer inside an SEZ can now bring in components and consumables — even those otherwise subject to a mandatory BIS QCO — without holding a BIS licence at the port of entry, but the moment finished goods or unused inputs move into the domestic market, full BIS/QCO compliance kicks back in. Also notable, the exemption from QCOs under the BIS Act, 2016 is now available to both SEZ Units and SEZ Developers, not just SEZ units as earlier, closing a gap that had left developers in an ambiguous compliance position.
For companies running contract manufacturing or bonded-warehouse-style operations for medical devices or packaged food inside SEZs, this changes import documentation strategy — but DTA sale planning must now build in lead time for BIS certification before goods cross the customs boundary into domestic trade.
Pharma Intermediate Restrictions: The ATS-8 Deadline Just Landed
A separate but connected thread involves Chapter 29 pharmaceutical intermediates. Following an October 2025 DGFT amendment to import policy conditions for pharmaceutical chemicals under Chapter 29 of ITC (HS) 2022 Schedule-I, a specific restriction applies to ATS-8 (4R-Cis-1,1-Dimethylethyl-6-cyanomethyl-2,2-dimethyl-1,3-dioxane-4-acetate) — the restriction on this key statin intermediate is applicable till 30th September 2026, with import restricted if the CIF value is below USD 111 per kg. With that window closing this month, importers of statin intermediates should confirm with DGFT whether the condition has been extended, lapsed, or replaced before placing new purchase orders — a lapse without renewal automatically reverts the item to unrestricted “Free” status, while an extension keeps the price floor in place.
Food Sector: Halal Certification Process Streamlined
On the food and meat export side, DGFT’s Notification No. 59/2025-26 introduced a streamlined Halal certification process for meat and meat products — a change aimed at reducing documentation friction for exporters to Gulf and Southeast Asian markets that mandate Halal compliance as an import precondition. Meat and poultry exporters should review updated certifying-agency lists and application formats before their next shipment cycle, since certificates issued under the old process may face scrutiny at the destination port.
What Pharma, Device & Food Importers Should Do Now
- Audit antibiotic API contracts: Verify CIF pricing on Penicillin, 6-APA, and Amoxycillin shipments against the ₹2,216/₹2,733/₹3,405 per kg thresholds before the one-year MIP window lapses in January 2027.
- Reassess SEZ import documentation: If you operate a device, pharma, or food unit inside an SEZ, map which imported components previously required BIS/QCO paperwork at entry and confirm eligibility under the revised Para 2.03A(iii).
- Plan DTA clearance separately: Build BIS certification lead time into any plan to sell SEZ-manufactured goods domestically — the import-stage exemption does not carry through to domestic sale.
- Track the ATS-8 and Chapter 29/38 conditions: Confirm current status of pharmaceutical intermediate restrictions before the 30 September 2026 deadline passes.
- Update Halal certification workflows: Meat and meat product exporters should confirm their certifying agency is recognised under the streamlined process.
- Watch export obligation timelines under Advance Authorisation: The obligation clock starts from first import under the authorisation, not licence issuance — a distinction that has cost exporters significant duty benefits when missed.
These notifications individually look narrow, but together they signal DGFT’s continuing shift toward price-floor-based import controls for strategic pharma inputs, tighter alignment between SEZ trade facilitation and domestic quality standards, and incremental digitisation of trade documentation. Businesses that treat each ITC (HS) notification as a compliance checkpoint — rather than background noise — will avoid the customs holds and duty forfeitures that are increasingly common outcomes of missed deadlines.
ACPL’s regulatory experts can help you navigate DGFT foreign trade policy updates for pharma, devices, and food imports. Contact us at info@acplgroupindia.co.in or call +91-9266665201 for a consultation.