Pharmacy laws in Nepal: the acts, rules and codes a pharmacy works under

Which laws apply to a pharmacy in Nepal?

Mainly these nine, in force on 5 October 2026; DDA, under the Ministry of Health and Food Safety, enforces the first four:

• Drugs Act, 2035
• Drugs Registration Rules, 2038
• Drug Standard Regulation, 2043
• Drug Sale and Distribution Code, 2080
• Nepal Pharmacy Council Act, 2057 and Regulation, 2059
• Public Health Service Act, 2075
• National Penal (Code) Act, 2074
• Value Added Tax Act, 2052 and VAT Rules, 2053; Income Tax Act, 2058
• Local Government Operation Act, 2074

DDA's Act, Rules and Codes page also lists the Drug Investigation and Inspection Rules, 2040 and the Narcotic Drugs Control Act, 2033, not covered here.

What does the Drug Act 2035 say about pharmacies?

The Drugs Act, 2035 (often written 'Drug Act 2035') is still the main law, amended up to 2082. Key sections:

• Sections 10 and 10क: register your name and shop with DDA, pay the fee and get a certificate; sell only DDA-registered medicines.
• Section 11, amended from 14 Shrawan 2082 (30 July 2025): the certificate lasts three years; renew before expiry, or within 30 days at double the fee, or it is cancelled automatically. A DDA notice of 20 Kartik 2082 still spoke of yearly renewal, so confirm with DDA.
• Sections 17 and 18: prescription-only medicines need a doctor's prescription and a pharmacist, pharmacy assistant or व्यवसायी (recognised drug seller) selling or present; breaking this is 'misuse'.
• Sections 20 and 21: DDA and provincial inspectors may inspect and seal stock; DDA can suspend a certificate for up to six months (appeal to the health ministry's Secretary within 35 days).
• Section 25: the government can ban a medicine by notice in the Nepal Gazette.

The English translation online stops at the 2057 amendment, so read the consolidated Nepali text instead; the renewal guide has the steps.

What do the Drug Registration Rules 2038 require?

Under Rule 6 of the Drugs Registration Rules, 2038, you apply on the Schedule-8 form, printed from DDA's online system DAMS (compulsory since 1 Bhadra 2072). After a 'necessary inquiry' and the Schedule-14 fee, DDA issues the Schedule-9 certificate, the फार्मेसी (औषधि पसल) दर्ता प्रमाणपत्र, marked retail or wholesale. Rule 11 binds certificate holders to DDA's codes, including Code 2080.

How are medicines classified in Nepal (Drug Standard Regulation groups a, b and c)?

The Drug Standard Regulation, 2043 (Law Commission English title: 'Drugs Category Rules, 2043') sorts medicines into groups क, ख and ग.

The printed group is a first check, not a guarantee: a 2017 audit of Nepali-made products judged it inappropriate on about one pack in ten. DDA sets each product's group at registration; the 1986 Schedule 4 lists are outdated, and we found no current official non-prescription (OTC) list.

The Public Health Service Act, 2075

Its section 29(8) bars a drug seller from selling any medicine without a doctor's recommendation, which conflicts with the group ग rule, so do not treat sale without a prescription as an unconditional right.

Can a pharmacy sell antibiotics without a prescription?

As a class, no: antibiotics are group ख, though the 1986 lists put a few antimicrobials, such as metronidazole, in group ग. DDA requires a red line (रातो धर्का) on antibiotic labels to mark them prescription-only (notice of 2081/11/19), and its notice of 2081/11/26 restricts Reserve-group antibiotics to hospital pharmacies.

What does DDA's Drug Sale and Distribution Code 2080 require?

The Drug Sale and Distribution Code, 2080, posted by DDA on 4 Magh 2082 (18 January 2026), repealed the 2071 Code. It requires:

• Staff: at least one full-time pharmacist or pharmacy assistant registered with the Nepal Pharmacy Council, or a व्यवसायी recognised by the Drug Advisory Committee (clause 6).
• Premises: clean, rodent-proof and protected from sun, damp and heat; expired and returned stock apart; narcotic, psychotropic and poisonous medicines locked; a fridge or cold room with a temperature indicator; a counselling place; a Nepali and English signboard with the DDA number; no minimum floor area or distance rule (clauses 3 and 4).
• Dispensing: prescription-only medicines only on an authorised doctor's prescription, stamped 'Dispensed by' with your name, council or व्यवसायी number and signature (clause 8).
• Bills: one for every sale, with the pharmacy's PAN, phone and DDA registration number, each item's batch, expiry date and price, and the seller's name and signature (clause 8(9)).
• Records: bills, records of damaged, expired or returned stock, narcotic and temperature records, certificates and DDA notices, kept at least three years; stock issued FEFO or FIFO (clauses 13 and 14).
• Buying: under DDA's directive of 18 Asar 2083 (2 July 2026), only from wholesalers the manufacturer or importer has authorised, keeping their name and registration number; packs marked 'संस्थागत आपूर्ति मात्र' (institutional supply only) are not for retail.

A separate Good Pharmacy Practice (कुशल फार्मेसी अभ्यास) certificate lasts three years. DDA's notice of 20 Chaitra 2082 (3 April 2026) says a new pharmacy may apply for registration only after preparing to meet all the Code's Good Pharmacy Practice standards in full.

What do the Nepal Pharmacy Council Act 2057 and Regulation 2059 require?

Under section 11 of the Nepal Pharmacy Council Act, 2057, nobody may practise pharmacy without registering with the Nepal Pharmacy Council (NPC); a pharmacist holds at least a bachelor's degree, a pharmacy assistant a certificate-level qualification. The NPC registers those who pass its licensing exam, for Rs 2,000 (pharmacist) or Rs 1,000 (pharmacy assistant) per its 2082 and 2083 notices. The Regulation, 2059 requires telling the NPC Registrar in writing within a month of leaving the profession or moving.

What rules apply to narcotic and psychotropic medicines?

Narcotic and poisonous medicines are group क. Each sale is recorded in the prescribed format with the prescription attached (Drugs Act s.33(2)); the prescription is stamped 'प्रयोग भएको (प्रेस्क्रिप्शन फिल्ड)' (Prescription Filled), and the record shows the buyer's name and address and the quantity. Code 2080 requires narcotic, psychotropic and poisonous medicines to be kept locked and their sale records kept at least three years.

DDA publishes the list of narcotic and psychotropic drugs and their record format online.

What are the penalties under Nepal's pharmacy laws?

Maximums run from one year or Rs 5,000 to life imprisonment (Drugs Act as amended to 2082, Pharmacy Council Act to 2075, Penal Code to 2080); courts set the actual penalty.

Section 34(2) fines can reach the amount in dispute or Rs 1 lakh, whichever is higher, but not a disproportionate sum (section 35(1)); victims must be compensated (section 34(4)).

Which tax laws apply to a pharmacy?

Medicines are VAT-exempt by HS code under Group 5 of Schedule 1 (as replaced by Finance Act 2083) of the VAT Act, 2052, as are listed items such as gauze, condoms, test kits and wheelchairs; unlisted goods such as cosmetics, and possibly some ayurvedic tonics and balms, carry 13% VAT (FY 2083/84) when a VAT-registered pharmacy sells them. VAT registration depends on taxable turnover (Rs 50 lakh over 12 months for goods, no change announced for FY 2083/84; ask your Inland Revenue Office whether medicine sales count), and only a VAT-registered shop may add VAT. The Income Tax Act, 2058 requires a PAN.

Our guide to VAT on medicines in Nepal has the detail.

Is there a pharmacy operation directive (फार्मेसी संचालन निर्देशिका)?

For a retail shop the national standards are in Code 2080, and registration stays with DDA; many 'pharmacy operation directives' online are hospital-pharmacy or municipal documents. But the Local Government Operation Act, 2074, section 11(2)(झ)(९), lists the operation, permission, monitoring and regulation of medicine shops among municipal functions, and section 58 allows a business tax. DDA's 2083 citizen charter also asks for your local level's recommendation for a new registration and each renewal, so ask your municipality what it requires.

Please note: This guide is general information for pharmacies in Nepal, written from the laws and official notices listed under Sources as they stood on the review date. It is not legal or tax advice. Rules, fees and forms change, so confirm with the office concerned or a qualified adviser before you act.