Recruitment of a Local Legal Consultant only for Nepalese Citizens
Recruitment of a local legal consultant only for Nepalese citizens
The Drugs Act, 1978, as amended from time to time, provides the framework to support the quality, safety, and efficacy of pharmaceutical products and services. A sustainable, well-functioning regulatory system will ensure an independent and competent oversight of medical products. The Drugs Act defines the institutions that are involved as part of the regulatory system, and to some extent, their composition, authority, functions, responsibilities, and enforcement powers. There is a single drug law in Nepal supported by regulations, rules, and codes. The purpose of the law is to provide a scope and definition of the regulated products and services and it provides a clear mandates, functions, roles, responsibilities, and enforcement power to avoid overlap or underlap of the power and authorities.
The Government of Nepal established the Department of Drug Administration (DDA) in 1979 as per the provision of section 5 of the Act. The DDA has been made responsible to carry out all the functions related tothe control of drugs under the Act and the rules framed thereunder.
In 2021 the maturity level of the DDA was assessed using the World Health Organization (WHO) Global Benchmarking tool and many recommendations were provided to increase the regulatory maturity level and to bring the legislative framework and DDA practices in line with WHO best practices. The role and responsibilities of the DDA need to be increased and the Drug Act and regulations need revision to also regulate food supplement (commonly called as nutraceuticals), medical devices, cosmetics and health technological products, and pharmacovigilance. MTaPS Nepal supported DDA to update the Drug Act and the Drug and Health Products Act was drafted to replace the current act. There are various regulations and guidelines to be updated under the new draft act, mainly registration regulation, inspection and investigation regulation, standard regulation, consultative council and advisory committee regulation. New regulations need to be drafted to address the pharmacovigilance, post-marketing surveillance and cosmetics. Apart from these, there is need of formulating several guidelines under the rules.
The purpose of this legal service is to update or replace the current regulations in line with the provisions under the draft act to address all the requirements of WHO bench marking for best practices at the national medicine regulatory authority. In collaboration with the MOHP, DDA and MTaPS, the legal services will assist in the formulation of new or revise regulations to bring DDA in line with WHO best practices.
The legal consultant will review the existing regulations in collaboration with the Ministry of Health and Population (MOHP) and DDA, prepare the drafts, discuss with the related stakeholders and incorporate their relevant feedback.
Number of consultants: one
Consultant qualification requirements:
- Bachelor’s degree in law.
- Minimum of 10 years of working experience in legal affairs, preferably related to the health field.
- Proven experience in the drafting of laws and legal documents, preferably regulatory laws or regulations
- Previous experience working with the MOHP, Nepal Law Commission and /or Ministry of Law, Justice and Parliamentary Affairs
- Demonstrated skills in stakeholder engagement and communication, especially with government representatives.
- Prior experience working with international organizations or USAID-funded projects preferred.
- Ability to work independently and efficiently and organize the work with minimum supervision.
- Advanced skills in Microsoft and Google suites of products.
- Ability to organize and facilitate working group and large consultative meetings.
- Ability to prepare and review reports, technical and policy documents and presentations
- Excellent written and verbal communication skills in Nepali and English
Description of Services to be provided:
The legal consultant will support MTaPS and in collaboration with the MOHP, Ministry of Law, Justice and Parliamentary Affairs, DDA and key stakeholders will:
- Review the existing regulations under the current drug act to identify the gaps.
- Draft the regulations to address the requirements for implementation of the draft drug and health product acton: a) registration regulation for medicines and nutraceuticals, b). regulation for health products including cosmetics, c)inspection and investigation regulation for medicines and health products, and)standard regulation for medicine and health products
- Facilitate consultative meetings with stakeholders to present and review the draft regulations
- Address the feedback received on the draft regulations during consultative meetings with stakeholders
- Finalize the draft regulations in collaboration with MTaPS for submission to the MOHP
- Identify the guidelines or codes with major components to be included in the regulation to meet the WHO best practices
|Deliverables or Milestones||Expected Date of Delivery or Completion||Estimated Hours of LOE Required|
|1. Draft/update registration regulation for medicine and nutraceuticals in Nepali (as per the provisions in the draft act)|
|2. Draft registration regulation for health products including cosmetics in Nepali (as per the provisions in the draft act)|
|3. Draft inspection and investigation regulation for medicines and health products in Nepali(as per the provisions in the draft act)|
|4. Draft standard regulation for medicine and health products in Nepali(as per the provisions in the draft act)|
|5. List of identified guidelines and codes with major aspects to be addressed to satisfy the need from the drug and health product act and regulations|
|Estimated Total LOE:||Days 80 days|
To apply, please go through the link below;