Importing Medicines into South Asia (SAARC): A Country-by-Country Guide (2026)

Last updated: 27 September 2026. Part of our region-by-region import guide series. Covers all eight SAARC countries.

South Asia is home to the world's biggest generic producer and some of its most import-dependent markets, side by side. India, Bangladesh and Pakistan make most of their own generics, so imports there are mostly new medicines, biologicals, APIs and products local industry can't make. Nepal, Bhutan, the Maldives, Sri Lanka and Afghanistan rely much more on imports, and several now fast-track products approved by trusted regulators. Everywhere, you'll need a local importer, price approval and a close eye on foreign exchange. And with Bangladesh's patent waiver due to end and India pushing API self-reliance, licensing and partnerships are growing fast.

This guide walks through every market in plain language:

• The big three producers: India, Pakistan and Bangladesh.
• The import-reliant markets: Sri Lanka, Nepal, Bhutan, the Maldives and Afghanistan.

It's written for manufacturers exporting to South Asia from China, Korea, Europe, the US and India itself, and for the regional distributors and importers who work with them.

How the region works

The same three doors exist here as everywhere else: register and sell commercially, supply public tenders, or use a special import route for an unregistered medicine a patient needs. What's different is who you're competing with:

• Strong local industry. Local manufacturers supply around 98% of Bangladesh's demand, about half of Nepal's, and most of India's and Pakistan's. Imports win where local plants can't compete: new medicines, biologicals, oncology, rare diseases and specialised APIs.
• A local importer is always required. Every country needs a licensed local importer, agent or representative to hold or manage the registration.
• Prices are controlled almost everywhere. India, Pakistan, Bangladesh, Sri Lanka, Nepal, Bhutan and the Maldives all cap prices on some or all medicines, and several benchmark against Indian prices.
• Reliance is spreading. The Maldives, Bhutan and Sri Lanka now have reliance routes for products approved by trusted regulators, and India waives local trials for some products approved in the US, UK, EU, Japan, Australia or Canada.
• Foreign exchange and politics move fast. Sri Lanka's 2022 crisis, Bangladesh's dollar shortage, Pakistan's import controls, the India–Pakistan trade suspension and Afghanistan's ban on Pakistani medicines have all changed supply in the past few years.

The markets at a glance

India

India is best known as an exporter, but it's also a large import market for new medicines, biologicals, rare-disease treatments and APIs.

• Two licences to import: the foreign manufacturer and each product need a Registration Certificate from CDSCO (applied for on Form 40), and the importer then needs an import licence (Form 10). Both are filed on the SUGAM portal.
• Who applies: an Indian authorised agent or subsidiary with a wholesale or manufacturing licence, or the foreign manufacturer itself if it holds an Indian wholesale licence.
• Timelines and fees: the Registration Certificate can take up to nine months from a complete application, and the import licence about 45 days. CDSCO's published guidance has put fees at around US$10,000 per manufacturing site and US$5,000 per product, but check the current schedule. CDSCO can inspect the foreign plant.
• New medicines: under the 2019 New Drugs and Clinical Trials Rules, import permission for a new drug is decided in 90 working days. Since August 2024, the local clinical trial can be waived for some categories approved in the US, UK, EU, Japan, Australia or Canada: orphan drugs, gene and cell therapies, pandemic drugs, special defence needs and significant therapeutic advances. Industry reported in 2025 that the waiver was still hard to use in practice.
• APIs: since January 2023, every API made in or imported into India must carry a QR code on every packaging level.
• Pricing: ceiling prices set by the NPPA apply to scheduled formulations on the national essential medicines list, including imported ones. They were revised for 906 formulations in April 2025. New drugs patented in India and orphan drugs have exemptions.
• Tenders: the Central Medical Services Society (CMSS) and state corporations buy for public health programmes. CMSS asks for WHO-GMP or WHO prequalification, a CPP and stability data. Since 2020, bidders from countries sharing a land border with India, including China, must register with a government committee before bidding.
• Without registration: government hospitals and medical institutions can import unapproved new drugs for life-threatening or serious conditions on Form CT-24/CT-25, up to 100 doses per patient. The 2025 and 2026 budgets also removed customs duty on dozens of cancer, rare-disease and lifesaving medicines, and on drugs supplied through patient assistance programmes.

Pakistan

• Who imports: the importer must hold a drug sale licence, and imported products are registered with DRAP on Form 5F in CTD format.
• Fast track: some CTD modules are optional for products approved by the reference regulators adopted by DRAP's Registration Board. Consultants list the FDA, EMA, MHRA, Health Canada, TGA, PMDA, Swissmedic and WHO prequalification.
• Fees: since August 2025, registering an imported product costs PKR 313,500.
• Pricing: in February 2024 the government deregulated prices for medicines outside the national essential medicines list. Essential medicines are still price-controlled.
• Without registration: hospitals and institutions can import unregistered drugs with DRAP pre-approval and a customs NOC, on a no-profit basis. Patients can apply online for personal imports with a prescription.
• Tenders: public buying is moving onto the EPADS e-procurement system, which is now mandatory.
• Watch out for: Pakistan imports around 95% of its APIs. After the April 2025 trade suspension with India, which had supplied a large share of raw materials, DRAP turned to China, Russia and Europe. Foreign-exchange controls in 2022 also show how quickly payment can become the bottleneck.

Bangladesh

• Who imports: a local nominated representative applies to the Directorate General of Drug Administration (DGDA).
• Registration: according to the government trade portal, an imported product needs a CPP or free sale certificate from one of seven reference countries: Australia, France, Germany, Switzerland, Japan, the UK or the USA, attested by a Bangladesh embassy. Registration typically takes four to six months and is renewed every five years, but a large backlog built up in 2024–25.
• Import quantities: DGDA approves quantities for each import and has often approved less than requested. With local industry supplying about 98% of demand, imports mainly fill gaps: biologicals, oncology and specialised products.
• Pricing: WHO lists 117 price-controlled medicines. News reports in January 2026 said the government plans to fix prices for about 295 essential medicines and set up a pricing authority.
• Tenders: EDCL, the state manufacturer, supplies most medicines to public facilities.
• The big change: Bangladesh is scheduled to graduate from Least Developed Country status on 24 November 2026, which ends its waiver on pharmaceutical patents. It has asked for a three-year deferral, which the UN General Assembly is due to consider in October. If graduation goes ahead, local makers can no longer freely copy patented medicines, and licensing becomes much more important.

Sri Lanka

• Who imports: a local authorised agent registers products with the National Medicines Regulatory Authority (NMRA). NMRA assesses foreign sites from the dossier and GMP certificate, and has published a guideline on reliance practices.
• Pricing: every registered product is price-controlled. Under a guideline effective July 2025, the maximum retail price is the CIF price plus taxes plus a single supply-chain markup of 45–75%, falling as the price rises. NMRA checks your declared CIF price against prices in India, Bangladesh and Sri Lankan tenders.
• Tenders: the State Pharmaceuticals Corporation (SPC) buys and imports for the public sector, and the Medical Supplies Division (MSD) plans, stores and distributes. After the 2022 crisis, a large share of the procurement budget came from donors, and tenders can take about nine months from planning to delivery.
• Local manufacturers: a buy-back agreement guarantees SPC purchases from local makers at cost plus 20%, and it was extended in 2024. Local industry holds about 20% of the market.
• Without registration: NMRA runs a waiver of registration (WOR) route for imports of unregistered products, with a revised guideline issued for comment in 2024.

Nepal

• Who imports: a Nepali importer registers the foreign company, then each product, with the Department of Drug Administration (DDA), then gets an import recommendation.
• GMP: according to DDA guidance summarised by India's export council, plants in countries without a stringent regulator get an on-site inspection before registration. That covers most Indian and Chinese plants.
• Pricing: DDA publishes maximum retail prices, which news reports say are pegged to India's NPPA ceilings. Importers undertake that their price is no higher than in the exporting country.
• Market: local manufacturers supply about half the market and are pushing for import curbs. Public tenders for free medicines have been criticised for buying at a fraction of retail price.

Bhutan

• Who imports: a local dealer or the manufacturer first needs a technical authorisation from the Bhutan Food and Drug Authority (BFDA), then registers each product. Registration takes two to three months and lasts three years.
• Reliance: a 2025 draft guideline allows abridged registration for products approved by a WHO-listed authority, a WHO maturity level 3 or 4 regulator, a PIC/S member or a SEARN member, or prequalified by WHO.
• Tenders: the Department of Medical Products buys centrally through annual tenders, and over 2,000 medicines have a retail price cap.

The Maldives

• Who imports: a Maldivian local representative with a medicine import licence. There's no local manufacturing.
• Fast track: the Maldives Food and Drug Authority's 2025 guideline has a reliance route for products approved by stringent regulators, WHO-listed authorities or maturity level 3+ regulators, or prequalified by WHO. It takes 20 calendar days, against 150 working days for a full review.
• Tenders: the State Trading Organisation has handled central buying, and a new State Pharma company takes over pharmaceutical management from July 2026. The national insurer, Aasandha, covers over 3,000 medicines.
• Watch out for: dollar shortages and payment arrears have caused medicine shortages. Agree payment terms carefully.

Afghanistan

• Regulator: the Afghanistan Food and Drug Authority is developing a new national medicines authority. Over 95% of medicines are imported, and much of the market has been smuggled.
• The big shift: the Taliban administration announced a ban on medicines from Pakistan in November 2025, and customs clearance stopped in February 2026. Prices rose sharply, and the administration is turning to India as its main supplier.
• Tenders: much public supply comes through UN agencies and donors. UNICEF, for example, tenders for essential medicines on the UN's procurement portal.
• Watch out for: banking restrictions make payments difficult, and aid cuts are closing health services.

Localisation isn't only a barrier: bulk, API, tech transfer and partnerships

South Asia has some of the world's most capable generic manufacturers, and governments here want even more self-reliance. For exporters, that closes some doors and opens others. In our experience of business development in the region, three shifts stand out:

• India wants its own APIs. For 97 APIs, China supplied 70% or more of India's imports in recent years. Production-linked incentive (PLI) schemes and three bulk drug parks are building local capacity, with 38 of 48 approved bulk drug projects commissioned by December 2025. That creates demand for technology, key starting materials, equipment and partners. See our guide to CEP vs DMF vs ASMF.
• Bangladesh's patent waiver is ending. If LDC graduation goes ahead, Bangladeshi companies will need licences for patented medicines they used to copy freely. That's a licensing opportunity for originators and biosimilar developers.
• Import-reliant markets want local plants. Sri Lanka's buy-back agreement guarantees purchases from local makers, and in June 2026 India's Zydus Lifesciences broke ground on a 50:50 joint venture with Sunshine Healthcare Lanka. Nepal's local industry is pushing for import limits too.

The deals that work here include:

• In-licensing into India. Indian companies license new medicines and biologicals from abroad and register and sell them locally. China's Junshi, for example, licensed its PD-1 antibody toripalimab to Dr. Reddy's for India and other markets.
• Ready-to-fill bulk and tech transfer for local plants in Sri Lanka, Nepal and Bangladesh that want to add products quickly.
• API and intermediate partnerships for India's and Pakistan's push to make more of their own APIs.
• Licensing and royalties in Bangladesh as patent protection returns. Our guide to out-licensing a dossier explains how these deals are priced.

If you're a regional company looking for a licence, bulk supply or technology partner, post an RFQ and choose dossier licensing as the registration need.

What this means for exporters from India, China, Korea, Europe and the US

For every exporter

• Compete where local industry can't. New medicines, biologicals, oncology, rare diseases, complex injectables and specialised APIs are where imports win.
• Price for the benchmark. Sri Lanka, Nepal and others compare your price with India's, so a low Indian price can cap what you earn elsewhere in the region.
• Use the reliance routes. The Maldives decides in 20 days and Bhutan has an abridged route for products approved by trusted regulators.
• Plan the payment route. Sri Lanka, the Maldives, Pakistan, Bangladesh and Afghanistan have all had dollar shortages or banking limits.

Exporting from India

• Your neighbours know your products. Nepal and Bhutan buy heavily from India, and Afghanistan is turning to India after banning Pakistani medicines.
• But Indian approval alone won't get you far in Bangladesh. Its reference-country list covers Australia, France, Germany, Switzerland, Japan, the UK and the USA, so an Indian-only product needs one of those approvals.
• Pakistan is on hold. Trade was suspended in April 2025, so check the current rules before quoting.
• Expect inspections in Nepal. Plants outside stringent-regulator countries get an on-site inspection before registration.

Exporting from China

• APIs are the big market. India and Pakistan both rely heavily on Chinese APIs, even as they build their own. Pakistan and China signed ten API agreements in May 2026.
• Watch India's procurement rules. Bidders from countries sharing a land border with India must register with a government committee before bidding in public tenders.
• Licensing into India works. Junshi's licence of toripalimab to Dr. Reddy's for India and other markets is one example.

Exporting from Korea

• Your MFDS approval helps in the smaller markets. Korea's MFDS is a WHO-listed authority, which counts for the Maldives' 20-day route and Bhutan's reliance guideline.
• Biosimilars and licensing are the opening. Indian companies already license biologicals from abroad, and Bangladeshi companies will need licences if the patent waiver ends.

Exporting from Europe

• EU approval opens several doors. It counts for India's local-trial waiver, Bangladesh's reference-country list (France, Germany, Switzerland and the UK are on it), Pakistan's reference regulators and the Maldives' and Bhutan's reliance routes.
• Tech transfer and licensing are growing. Governments across the region want local manufacturing, and European partners bring technology and approvals that local companies need.

Exporting from the US

• FDA approval is the strongest ticket here too. It counts for India's local-trial waiver, Bangladesh's reference list and nearly every reliance route in the region.
• India has made room for new medicines. Patented new drugs have a price-control exemption, and the 2025 and 2026 budgets cut customs duty on many cancer and rare-disease medicines and on patient assistance programmes.

Quick answers

How do I register an imported medicine in India?

Your Indian agent or subsidiary applies to CDSCO for a Registration Certificate for your plant and product, then an import licence, through the SUGAM portal. New drugs also need import permission under the 2019 New Drugs and Clinical Trials Rules.

Can I import generics into Bangladesh?

Only in limited ways. Local industry supplies about 98% of demand, DGDA approves import quantities, and an imported product needs a CPP or free sale certificate from one of seven reference countries.

Which South Asian markets fast-track products approved abroad?

The Maldives (20 days), Bhutan (abridged route), Sri Lanka (reliance guideline), Pakistan (lighter dossier for reference-regulator approvals) and India (local-trial waiver for some new medicines approved in the US, UK, EU, Japan, Australia or Canada).

What happens when Bangladesh graduates from LDC status?

Its waiver on pharmaceutical patents ends, so local companies can no longer freely make patented medicines. Graduation is scheduled for 24 November 2026, but a three-year deferral is under consideration at the UN.

Can unregistered medicines be imported for patients?

Yes, in most countries. India allows government hospitals to import unapproved new drugs for serious conditions, Pakistan allows hospital and personal imports with DRAP approval, and Sri Lanka has a waiver of registration route.

Ready to source for your market?

• Importers, distributors and tender bidders in South Asia: post your sourcing RFQ. Our RFQ guide shows what to include.
• Hospitals and patients needing an unregistered medicine: submit an RFP for named-patient import.
• Manufacturers looking to supply the region, whether finished products, bulk, APIs or tech transfer and licensing: list your company and products so buyers and agents can find you.

This guide summarises public regulations and official sources as of September 2026. Rules, prices and trade conditions change often in this region. Confirm current requirements with the regulator or a local regulatory partner before acting.

Sources

• Import and registration (CDSCO)
• Guidance document on import and registration (CDSCO)
• CDSCO FAQs on import and registration (CliniExperts, November 2019)
• FAQs on the New Drugs and Clinical Trials Rules (CDSCO)
• DCGI order on local clinical trial waivers (NIH ClinRegs, 2024)
• India waives local trial requirements (RAPS, 2024)
• No local clinical trial waiver despite rule change (ThePrint, March 2025)
• QR codes mandatory on APIs manufactured and imported (The Health Master, January 2022)
• NPPA revises ceiling prices for over 900 formulations (Business Standard, March 2025)
• DPCO price-control exemptions for newly patented drugs (SpicyIP, July 2020)
• Procurement (Central Medical Services Society)
• Restrictions on procurement from countries sharing a land border (Argus Partners, 2020)
• Union Budget 2025–26 highlights (PIB, February 2025)
• Customs duty exempted on 17 cancer medicines in Budget 2026–27 (All India Radio, February 2026)
• API imports and PLI for bulk drugs (PIB, March 2026)
• PLI schemes and bulk drug parks (PIB, December 2025)
• Junshi and Dr. Reddy's partnership (PharmaBoardroom, 2023)
• Application types for drug registration (DRAP)
• Revised DRAP regulatory fees (DRAP, August 2025)
• Import and export guidelines (DRAP, April 2022)
• Pakistan regulatory profile (GlobalReg)
• Deregulation of medicine prices outside the NEML (Profit, February 2024)
• EPADS procurement reforms (Associated Press of Pakistan, January 2026)
• Emergency plan after suspension of trade with India (Geo News, April 2025)
• Pakistan's pharmaceutical dependence and CPEC (The Friday Times, July 2026)
• Registration of imported medicines (Bangladesh Trade Portal)
• Bangladesh healthcare and pharmaceuticals (US International Trade Administration, March 2026)
• 1,000 drug registrations stuck (The Business Standard, August 2025)
• Import quantity approvals in Bangladesh (UK Government trade barriers)
• Pharma and API sector (Invest Bangladesh)
• How the UN will decide on Bangladesh's LDC graduation (The Business Standard, September 2026)
• The end of the exemption (The Daily Star, August 2025)
• Government to fix prices of 295 essential drugs (The Business Standard, January 2026)
• Bangladesh medical products profile (WHO, 2025)
• Medicine availability in public facilities (The Daily Star, July 2026)
• Guidelines (NMRA Sri Lanka)
• Price controls (NMRA Sri Lanka)
• Sri Lanka medical products profile (WHO, 2025)
• Pharmaceutical supply chain assessment: Sri Lanka (ADB, March 2025)
• Industry calls to extend the buy-back agreement (SLPMA, 2025)
• Guidelines for waivers of registration (NMRA Sri Lanka, 2024)
• Zydus joint venture in Sri Lanka (DSIJ, 2026)
• Addressing drug shortages in Sri Lanka (LankaWeb, September 2026)
• Nepal medical products profile (WHO, 2025)
• Nepal country report (Pharmexcil)
• Maximum retail prices of medicines (DDA Nepal)
• Nepal medicine price revision (Khabarhub, 2026)
• Trust deficit over free medicines (The Kathmandu Post, May 2026)
• Medical products FAQs (Bhutan Food and Drug Authority)
• Guidelines for good reliance practices (BFDA, 2025)
• Bhutan medical products profile (WHO, 2025)
• Product registration guideline v6 (Maldives Food and Drug Authority, April 2025)
• Maldives medical products profile (WHO, 2025)
• What's behind the medicine shortage (Maldives Independent, February 2025)
• State Pharma to take over pharmaceutical management (MBT, May 2026)
• Healthcare and medical treatment in Afghanistan (UK Government, October 2025)
• Ban on medicine imports from Pakistan (KabulNow, November 2025)
• Price surge after suspension of Pakistani imports (8am Media, February 2026)
• Afghanistan turns to India for medicines (Afghanistan International, November 2025)
• UNICEF tender for essential medicines in Afghanistan (UNGM, January 2025)