Pharmaceutical Company Doing Business Guide In Nepal

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�  Nepal has become a WTO member on April 23, 2004. World market of pharmaceutical products is now open to Nepalese industries and simultaneously Nepalese market is open to industries worldwide.

�  There are 44 pharmaceutical industries in operation at present in Nepal as per department of Drug association (DDA)

�  All the pharmaceutical units are in private sector and registered as private limited company

�  All pharmaceutical industries produce pharmaceutical products in tablet and capsule forms while a limited number of units produce products in liquid, ointment, dry syrup, powder forms.

�  Majority of the industries are producing same group of products, but some have started producing cardiovascular, psychotropic and anti-diabetic products too

�  Most of these companies as urged by DDA, have already acquired WHO-GMP (GOOD MANUFACTURING PRACTISE) Certificate and are also ISO 9001:2000,14000 certified companies

Introduction

Opportunities �  A number of attractive investment opportunities can be found in

medicine and health care supply manufacturing. �  Nepal’s population of approximately 28 million is a sizeable market.

To date, approx. 50% or more of this market has been met by way of imports.

�  There is scope not only for the production of the branded medicines but also for bulk drugs which provide the raw materials for medicines.

�  Pharmaceutical industry has experienced significant growth in recent years, there is scope for large scale pharmaceutical manufacturers which can introduce new technologies and take the pharmaceutical industry to a higher level.

�  The Government favorable policies, the existence of the domestic market and export potential, favorable WTO/TRIPS policy, restriction on imports without WHO/GMP Certification, and the rise in health care awareness among the people provide some added incentives for the investors to consider Nepal’s pharmaceuticals industry.

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Regulatory Framework �  Drug Act 1978 (2035) �  Regulation on Constitution of Drug Consultative Council and Drug

Advisory Committee1979 �  Drug Registration Regulation 1981, �  Drug Investigation and Inspection Regulation 1983, �  Codes on Drug Manufacturing, 1984, �  Drug Standard Regulation, 1985. �  Code on sale-distribution of drugs, 2015 �  Drug Registration Regulation (1981) 2038. �  Narcotic Drugs (Control) Act, 2033 (1976) �  Drugs Category Rules, 2043(1986)

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Laws and Regulations Other Relevant Laws A)  Land Acquisition Act 2034 B)  Industrial Enterprises Act 2016 C)  Investment Board Nepal Act D)  Income Tax Act and Rules E)  Value Added Tax and Rules F)  Labor Act 2074 and Labor rules 2075 G)  Bonus Act 2030

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Incentives Value Added Tax Following items are exempt from VAT � Raw materials purchased or imported by the drug

industries to the extent approved by the Department of Drug Management.

Custom Duty Concessions Custom duty full exemption � All equipment/machineries and parts thereof imported

by the medicine manufacturing industries. �  Import of raw materials, packing materials, chemicals,

etc. made by medicine industries on recommendation of Department of Medicine.

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Address- Patandhoka, Post Box No. 252, Lalitpur -3,Nepal Contact Number- +977 1 5521605 Email- FDI@bakertilly.com.np Website- http://www.bakertilly.com.np