ORSZCA congratulates Swiss Pharma Nigeria and PharmEvo (Pakistan) on achieving WHO prequalification (PQ) status for 20mg dispersible Zinc Sulphate tablets. Swiss Pharma Nigeria is the first African manufacturer to achieve PQ for Zinc tablets. While PharmEvo is the first manufacturer in the world achieve PQ status for a Zinc syrup.
What does prequalification mean?
Prequalification signals confidence in the quality of medicines manufactured and makes them eligible, in principle, for procurement by UN agencies and donor organisations.
How many prequalified products are there for the treatment of diarrhoea?
The short answer is not enough. There are no prequalified ORS products and only six Zinc products (seven if you include Zinc Syrup).
Zinc sulphate dispersible tablets 20mg
| WHO Ref No | Applicant | Country | Date of Prequalification | |
| 1 | DI002 | Nutriset | France | 04-Dec-12 |
| 2 | DI005 | Macleods Pharmaceuticals Ltd | India | 07-Dec-16 |
| 3 | DI011 | Ipca Laboratories Ltd | India | 15-May-20 |
| 4 | DI013 | The ACME Laboratories Ltd | Bangladesh | 02-Nov-21 |
| 5 | DI014 | Swiss Pharma Nigeria Ltd. | Nigeria | 02-May-23 |
| 6 | DI009 | PharmEvo (Pvt) Ltd. | Pakistan | 12-Jul-23 |
Zinc sulphate syrup 10mg/5mL
| WHO Ref No | Applicant | Country | Date of Prequalification | |
| 7 | DI010 | PharmEvo (Pvt) Ltd | Pakistan | 12-Jul-23 |
How do UN Agencies and donor organisations procure Co-packaged ORS and Zinc if there are no prequalified ORS products?
It would appear that they rely on certificates of Good Manufacturing Practice (GMP). However, quality is a concern. In UNICEF’s Oral Rehydration Salts and Zinc: Market and Supply Update of September 2022 they stated as a challenge:
Due to the limited number of quality suppliers of ORS and ORS and zinc co-packaged products, there are even fewer that can meet the quality standards required for international procurement. Some of the suppliers that UNICEF had awarded supply agreements to as an outcome of its last tender were cancelled as they were not able to maintain product quality standards throughout their LTA [Long Term Agreement] duration. As ORS is an over-the-counter medication and is marketed socially in many countries, supplying demand through UNICEF does not offer sufficient incentive to improve manufacturing and product quality to meet international procurement standards.