Pregabalin is a controlled drug in the UK and US, and that status, not the pharmacology, shapes how M Care exports it from India.
Pregabalin has been a Schedule 3 controlled drug in the UK since 1 April 2019, and it has sat in Schedule V under the US Controlled Substances Act since 2005. That status is not a footnote. It determines whether a shipment needs an import permit or a controlled-drug licence held by the importer before it clears port, and the requirement is set by the destination country, not by India. M Care builds the export file around that reality rather than around a generic template.
Pregabalin exporter and bulk supplier from India.
Export documentation for pregabalin is built around the importer's own controlled-drug status rather than a standard generic-export file. Where the destination requires it, such as a UK Home Office controlled-drug import licence or a US DEA import permit, M Care coordinates the shipment to match the paperwork the importer already holds; M Care does not obtain permits on the importer's behalf. Standard export documents, invoice, packing list, certificate of analysis and certificate of origin, accompany every consignment, with product sourced from WHO-GMP certified Indian manufacturers. M Care's own catalogue for pregabalin currently runs to 42 lines (37 capsule lines and 5 tablet lines) across the 25 mg, 50 mg, 75 mg and 150 mg strengths. Pregabalin is not scheduled under India's NDPS Act, so export from India does not require a separate Indian narcotics export authorisation on that basis; this is distinct from India's domestic Schedule H1 dispensing classification for pregabalin, coming into force from mid-November 2026, which governs retail sale within India and does not itself change export-side documentation. Destination-side controls still apply and should be confirmed before the order is placed.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Gabapentinoid (structural analogue of GABA; binds the alpha-2-delta subunit of voltage-gated calcium channels), sourced and documented for export.
The single fact a buyer must confirm before ordering pregabalin is that it is a controlled substance in a growing list of destination markets, most consequentially Schedule 3 in the UK since 1 April 2019 and Schedule V federally in the US since 2005. That status, not the pharmacology, determines whether a shipment needs an import permit or a controlled-drug licence held by the importer before it clears port, and the requirement is set by the destination country rather than by India. Only once that is confirmed does the clinical profile matter: pregabalin is a gabapentinoid that binds the alpha-2-delta subunit of voltage-gated calcium channels, reducing excitatory neurotransmitter release, and it is prescribed for peripheral and central neuropathic pain, as adjunctive therapy for partial-onset seizures, and, depending on jurisdiction, for fibromyalgia or generalised anxiety disorder. It carries no international UN scheduling and is not listed under India's own Narcotic Drugs and Psychotropic Substances Act, so import licensing obligations sit with the buyer's own national regulator and vary by country rather than following one global rule.
Active ingredient
Pregabalin. Gabapentinoid (structural analogue of GABA; binds the alpha-2-delta subunit of voltage-gated calcium channels).
Forms and strengths
25 mg; 50 mg; 75 mg; 150 mg.
Indications
Pregabalin is an oral gabapentinoid used for peripheral and central neuropathic pain, as adjunctive therapy for partial-onset seizures, and, depending on jurisdiction, for fibromyalgia or generalised anxiety disorder. It is a controlled substance in several major markets, including the UK (Schedule 3) and the US (Schedule V). M Care supplies it as capsules and tablets across the 25 mg to 150 mg range.
Administration
Oral. Capsules and tablets.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
M Care supplies pregabalin capsules and tablets to hospital procurement teams, licensed pharmaceutical importers and tender desks across the UK and EU, Gulf and GCC states, Africa and Latin America, and Southeast Asia and the CIS. Because the molecule is a controlled drug in several of those jurisdictions, buyers are typically importers who already hold, or are in the process of securing, a controlled-drug or precursor import licence from their own national authority, rather than general wholesalers new to scheduled products. Tender desks sourcing for public hospital formularies and neurology or pain-management distributors make up the bulk of enquiries, alongside regulatory affairs teams handling the registration dossier ahead of a first shipment.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on pregabalin.
A dispensing or clinical pharmacist reviewing an incoming pregabalin consignment checks the certificate of analysis against pharmacopoeial limits for related substances and residual solvents, and confirms the capsule or tablet strength matches the registration dossier. M Care's own pregabalin catalogue covers 25 mg, 50 mg, 75 mg and 150 mg across capsules and tablets, while marketed pregabalin products globally can range up to 300 mg depending on jurisdiction, so the exact strength and form ordered should be checked against the buyer's approved labelling. Renal-clearance labelling should also be verified, since pregabalin is eliminated largely unchanged by the kidneys and dose adjustment for reduced creatinine clearance is a standard formulary note rather than an optional one. Storage and handling review should flag that pregabalin carries recognised abuse and dependence potential, particularly in combination with opioids or other CNS depressants, which is the underlying reason for its Schedule 3 (UK) and Schedule V (US) status. Formulary teams in jurisdictions where the molecule is controlled will also want confirmation that pack quantities and labelling match what their local scheduling requires before the batch is released to inventory.
The documentation pack a regulator actually asks for.
The documentation pack for pregabalin includes a certificate of analysis against the applicable pharmacopoeial monograph, stability data, and a free sale certificate, structured to CTD or eCTD module format for the importer's dossier. GMP certification is held by the manufacturer, not by M Care: M Care is CDSCO licensed and ISO 9001:2015 certified as a merchant-exporter, and does not itself hold or claim WHO-GMP or WHO-PQ status. The molecule-specific addition to this pack is controlled-drug paperwork keyed to the destination market: importers in the UK are expected to hold a Home Office controlled-drug import licence under the Misuse of Drugs Regulations 2001, and importers in the US are expected to hold the relevant DEA import authorisation under Schedule V of the Controlled Substances Act. Buyers in markets without national scheduling should still confirm their own import requirements, since pregabalin's control status is set country by country rather than by a single international convention. Separately, from mid-November 2026 (180 days after its May 2026 gazette notification), pregabalin will be classified under Schedule H1 of India's own Drugs Rules, 1945, a domestic retail-dispensing control requiring a doctor's prescription and pharmacy record-keeping for sale within India. This is a domestic sale-and-dispensing classification and does not itself alter export licensing or documentation requirements; buyers should confirm current export and import compliance requirements directly with their own regulatory counsel.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Schedule 3 controlled drug in the UK under the Misuse of Drugs Regulations 2001, effective 1 April 2019
Schedule V controlled substance under the US Controlled Substances Act since 2005
No international UN scheduling under the Single Convention on Narcotic Drugs or the Convention on Psychotropic Substances; control status is set nationally and varies by destination country
Not scheduled under India's Narcotic Drugs and Psychotropic Substances Act, 1985, so Indian export is not restricted on that basis; destination-country import licensing still applies
India: pregabalin added to Schedule H1 of the Drugs Rules, 1945 by gazette notification dated 20 May 2026 (Drugs (Second Amendment) Rules, 2026, G.S.R. 377(E)), effective 180 days later from mid-November 2026; this is a domestic retail-dispensing control (prescription-only sale, pharmacy record-keeping) and does not itself alter export licensing or documentation requirements
Carries recognised abuse and dependence potential, particularly in combination with opioids or other CNS depressants
Adjacent lines procurement desks order alongside pregabalin.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for pregabalin.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Pregabalin supply, the specific questions.
Is pregabalin a controlled substance, and does that stop M Care from exporting it?
No, it does not stop export. Pregabalin is a Schedule 3 controlled drug in the UK (since 1 April 2019) and Schedule V under the US Controlled Substances Act (since 2005). It is not scheduled under India's NDPS Act, so Indian export is not restricted on that basis, but the importer's own national controlled-drug licence and import permit still apply and must be arranged on the buyer's side.
What import documentation does a UK buyer need for pregabalin?
Pregabalin sits in Schedule 3 of the UK Misuse of Drugs Regulations 2001. UK importers are expected to hold the relevant Home Office controlled-drug import licence before the shipment arrives. M Care coordinates shipping documents to match the licence the importer already holds; it does not apply for the licence on the importer's behalf.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care is a merchant-exporter, not a manufacturer, so it does not hold WHO-GMP or WHO-PQ certification itself. M Care is ISO 9001:2015 certified and CDSCO licensed, and it sources pregabalin from WHO-GMP certified Indian manufacturers, with GMP certificates supplied as part of the documentation pack.
What strengths of pregabalin can M Care supply?
M Care's pregabalin catalogue currently runs to 42 lines: 37 capsule lines and 5 tablet lines, across the 25 mg, 50 mg, 75 mg and 150 mg strengths. M Care does not currently carry strengths above 150 mg. Confirm the specific strength and form available for your order against the current line list and the buyer's own registration dossier before ordering.
Is pregabalin under international UN scheduling?
As of August 2026, no. Pregabalin has no international scheduling under the UN Single Convention on Narcotic Drugs or the Convention on Psychotropic Substances. Its controlled status is set at the national level, currently including the UK and the US, so buyers must check their own country's classification rather than assume a single global rule applies.
What clinical indications does pregabalin cover?
Approved indications vary by regulator but commonly include peripheral and central neuropathic pain, adjunctive therapy for partial-onset seizures, and, depending on jurisdiction, fibromyalgia or generalised anxiety disorder. Buyers should confirm which indications are approved in their own market, since labelled indications differ between the US, EU and other regulators.
What documentation does M Care provide with a pregabalin shipment?
Standard export documents accompany every consignment: certificate of analysis, certificate of origin, invoice and packing list, plus a free sale certificate and manufacturer GMP certificate on request, structured to CTD or eCTD format. For controlled markets, shipping is timed to the importer's own permit or licence rather than dispatched ahead of it.
Why does pregabalin need different handling from an ordinary generic export?
Because it is a scheduled controlled drug in major destination markets, pregabalin shipments can require an import permit or controlled-drug licence held by the buyer before customs clearance, unlike most generics on M Care's catalogue. Skipping that check risks the shipment being held at port, so it is confirmed before dispatch rather than after.
Has India changed pregabalin's domestic regulatory status recently?
Yes. A gazette notification dated 20 May 2026 (Drugs (Second Amendment) Rules, 2026, G.S.R. 377(E)) adds pregabalin to Schedule H1 of India's Drugs Rules, 1945, coming into force 180 days later, from mid-November 2026. Schedule H1 is a domestic retail-dispensing control requiring a doctor's prescription and pharmacy record-keeping for sale within India. It does not itself change export licensing or documentation requirements; buyers should confirm current export and import compliance requirements with their own regulatory counsel.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.