Medicine Registration Guidance Nepal

Medicine Registration Guidance, Issued under Drug Registration Regulation 2038 Published by Government of Nepal Ministry of Health Department of Drug Administration(DDA) Nepal

Medicines registration is the process by which a national regulatory authority approves the use of a medicine in a country, having considered evidence of the Medicine’s safety, quality and efficacy. It is thus primarily concerned with protecting public health. Product assessment and registration are carried out by the drug regulatory authority to ensure that the pharmaceutical products meet appropriate standards of safety, efficacy and quality.

There are different divisions under Department of Drug Administration (DDA) namely Registration, Management and Inspection division. Under each division there are different sections. These sections are responsible to carry out the regular regulatory and administrative function under DDA.

The development of the guideline was felt need towards better management of regulatory system. The present registration guidance document encompasses the drug registration requirements and processes applicable to all kinds of medicines manufacturing and marketing authorization, importation recommendation and different permission, pharmacy registration.

The guidance document is also expected to promote accountability and transparency of the regulatory processes and facilitate communication between the regulatory authority, the pharmaceutical industries, importers, media, health care stakeholders, and the public.

Compliance to this guideline will facilitate the speedy processing and evaluation of the applications and subsequent registration of the medical products and help to promote good regulatory practice leading to better governance of the sector.

Chapter I: Medicine manufacturing industry establishment procedure
Chapter II: Import registration
Chapter III: Pharmacy registration
Chapter IV: Ayurvedic including Herbal Medicine Registration

Background

Medicine Registration Guidance
Tools to deliver services and regulatory compliance are required to make working procedure more transparent and efficient. Various guidance and procedures including Standards for Pharmaceutical Regulation and Care, 2000 were already developed but there is needed to collate them for easy and handy referencing. A consolidated and up-to-date guidance on manufacture, sale-distribution and import of medicines should be in place as reference document for use by all concerned parties. The regulatory process is under automation. Once completed this guidance document shall take a form of quality manual of the Department of Drug Administration (DDA) and promote good regulatory practice in the country. Appropriate and effective conduct of regulatory process is an essential prerequisite for introducing medicinal product to the market and keeping it there in compliance with legal, scientific, ethical and administrative standards, norms and other requirements.

The medicine registration guidance document is developed to complement the working procedure ( Karyabiddhi ) of the Department of Drug Administration, 2065.

Regulatory Framework:

Preamble of the Drug Act 1978 (2035) includes;
In order to prohibit the misuse or abuse of drugs and allied pharmaceutical materials as well as the false or misleading information relating to efficacy and use of drugs and control the production, marketing, distribution, export-import, storage and utilization of those drugs which are not safe for use by people, efficacious and of standard quality, the Drug Act 1978 ( 2035 ) is enacted and implemented throughout the country.

For the purpose of the Drug Act 1978 (2035) the ‘drug’ has been defined as “any substance to be used for the diagnosis, cure, mitigation, treatment or prevention of a disease in a human being, animal or bird or to be used to destruct vermin or insects which cause diseases in the human being, animal or bird or any substance used to affect the structure or any physiologic function of the body of a human being, animal or bird or allied ingredients or components to be used for the preparation of such substance.”

To implement and fulfill the objectives of the National Drug Policy 1995 ( 2051 ) and the Drug Act 1978 activities related to drug production, import, export, storage, supply, sales, distribution, quality assessment, regulatory control, rational use and information flow are carried out as per the law.

To enforce and implement regulatory measures Drug Advisory Committee and Drug Consultative Council are provisioned with duties and responsibilities. Some important regulations and organizational set up are in place for the effective implementation. The main regulations include:

Regulation on Constitution of Drug Consultative Council and Drug Advisory Committee 1979
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

All these regulatory instruments become effective only when they are efficiently enforced, evaluated and updated.

All these regulatory instruments become effective only when they are efficiently enforced, evaluated and updated. An efficient organization and procedural guidance are needed for ensuring effectiveness of regulations. The principle organization, the Department of Drug Administration ( DDA) is in existence as per the clause 5 of the Act. National Medicine Laboratory ( NML ) is set up as a principal organization for testing quality standards of drug in the country. These organizations are entrusted with the responsibility of continually evolving a regulatory system which can effectively ensure that regulatory compliance is upheld and there is efficiency, effectiveness, transparency, clarity and equity in the functioning of the organization complying fully with the legislative and regulatory framework, and that the stakeholders would be in a position to bring about mutual benefit for all the customer and the patients.

Manufacture, sale-distribution, export and import of drugs are regulated as per the section 7, 8, 8a, 9, 10, 10a, and 11 of the Act. The subsequent sections of this guidance may be referred as requirements for obtaining recommendation letters or registration certificate or product license or marketing authorization whichever seems relevant for the applicant in pursuant to section 28 of the Drug Act 2035.

Currently DDA performs its function from the Department in Kathmandu and three of its branch offices one each in Biratnagar, Birgunj and Nepalgunj.

New organization and management, expansion of regulatory scope to regulate health technological products, sampling and testing of products from user’s point and e-regulation are some of the recent initiatives undertaken by the Department.