Invitation to manufacturers of family planning medicines in Nepal to submit an Expression of Interest (EOI) for Technical Assistance



Date of Publication: October 18, 2024

To support national and global efforts to increase access to and the affordability of quality assured family planning (FP) medicines, the Department of Drug Administration (DDA), with technical assistance from the Promoting the Quality of Medicines Plus (PQM+) program implemented by U.S Pharmacopeial Convention (USP) with funding from the U.S. Agency for International Development (USAID), invites Nepali pharmaceutical manufacturers of selected FP medicines to submit an Expression of Interest (EOI) for technical assistance after an evaluation of their manufacturing site to comply with good manufacturing practices (GMP) as per the World Health Organization (WHO) Prequalification (PQ) requirements.

1.     PROCEDURE FOR THIS INVITATION TO SUBMIT EOI 

The current invitation is published in accordance with the provision of Drug Act 2035 to prevent the misuse or abuse of drugs and allied pharmaceutical substances and false or misleading information relating to the efficacy and use of drugs and to control the production, sale, distribution, export, import, storage and consumption of those drugs which are not safe for public consumption, efficacious and of standard quality. 

The assessment of manufacturers under this invitation includes inspection of manufacturing site, review of product dossier including product data and information compared to the requirements set for internationally accepted standards such of the WHO good manufacturing practices (GMP) and National GMP requirements. In collaboration with the DDA, based on the assessment report and corrective and preventive action plan, PQM+ program will provide the needed technical assistance to address the areas of improvement within the mandate and period of performance of PQM+ program. 

Interested manufacturers in Nepal are therefore encouraged to submit their expression of interest for technical assistance to manufacture FP medicines specified below.

2.     PRODUCTS INCLUDED IN THIS INVITATION 

The purpose of this invitation is to invite manufacturers to participate in the technical assistance program to increase the supply of quality assured FP medicines to meet WHO-recommended quality standards. The medicinal products listed herein have been identified by WHO Department of Reproductive Health and Research, and the Reproductive Health Supplies Coalition as vital to effective prevention and treatment and are included in the national list of essential medicine of Nepal (6th revision).

Interested manufacturers are encouraged to submit documentation for recommended dosage forms and strengths of oral hormonal contraceptive medicines as follows: 

1. Ethinylestradiol + desogestrel, tablet 30 micrograms +150 micrograms
2. Ethinylestradiol + levonorgestrel, tablet 30 micrograms + 150 micrograms
3. Levonorgestrel, tablet 30 micrograms
4. Levonorgestrel, tablet 750 micrograms (pack of two); 1.5 mg (pack of one)
5. Norethisterone, tablet 350 micrograms
6. Norgestrel, tablet 75 micrograms
7. Desogestrel, tablet 75 micrograms 
8. Ulipristal acetate, tablet 30 mg

3.     QUALITY ASSESSMENT PROCEDURE FOLLOWING SUBMISSION OF AN EXPRESSION OF INTEREST BY MANUFACTURER 

The assessment in response to the EOI will be conducted to determine whether the manufacturers of FP products listed above meet the quality standards recommended by WHO and is manufactured in compliance with GMP norms. The procedure for evaluation will include:

• Evaluation of production and quality control status of the manufacturer based on production capacity, GMP standing, market information, and other criteria.
• Assessment of product data and information on safety, efficacy and quality submitted by the manufacturer including product manufacturing and testing data and results.
• Assessment of manufacturing site’s compliance/adherence to GMP, consistency in production and quality control of starting materials, packaging materials and finished product. 
• Random sampling and testing of products.

4.     TECHNICAL ASSISTANCE TO MANUFACTURERS OF SELECTED PHARMACEUTICAL PRODUCTS FOLLOWING SUBMISSION OF AN EXPRESSION OF INTEREST 

PQM+ will assess the manufacturing site and review the product data and information against the requirement for GMP compliance and WHO PQ for the product. In partnership with DDA, PQM+ will provide the needed technical assistance to the selected manufacturers to address the deficiencies identified from the assessment to ensure the products meet internationally accepted quality standards.

PQM+, in collaboration with DDA, reserves the right to prioritize the manufacturers to receive technical assistance based on the assessment and existing compliance level to ensure effective support to those selected pharmaceutical companies. 

5.     DEADLINE AND SUBMISSION PROCEDURE FOR EOI

A covering letter expressing the manufacturer’s interest in receiving technical assistance for manufacturing selected FP products should be submitted to PQM+ within on or before November 17, 2024 (5:00 PM) to PQM+ Nepal, House no 405, Prasuti Griha Marga, Ward no 11, Babarmahal, Kathmandu, Nepal or via e-mail at usp.nepal@usp.org.

A preliminary assessment questionnaire will be sent to interested manufacturer upon request. The filled questionnaire should be submitted along with the expression of Interest.