WHO has labeled four cough syrups Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup of Maiden Pharmaceutical Ltd (Haryana, India) as substandard medicines.

WHO raises medical alert over 4 cough syrup inflicting 64 deaths in Gambia: India's reputation at stake — Image Source – Divya Bharat;

The declaration which was made on 5 Oct 2022 (following the deaths of 66 children who consumed these products in Gambia last month) downgrades the reputation of India, which is regarded as Global Pharmacy.

Further, the manufacturer Maiden Pharmaceuticals Limited, has not guaranteed the safety and quality of these products to the World Health Organization.

India: the global pharmacy

India has provided medical assistance to several nations in multiple instances, some of the major relief operations are:-

Operation Rainbow 2004:- Flood relief and medical supplies to Sri Lanka, during Tsunami.
Operation Maitri / Amity 2015:- Helped Nepal during the earthquake.
Flood relief operation in Pakistan:- assisted through UN in 2010 and willingness extended in

These efforts scaled up during COVID-19, wherein India provided essential drugs like Remdesivir, Hydroxychloroquine, and also COVID Vaccine doses to 100 plus nations under Mission Sagar.

This earnt massive gratitude for India, from Bhutan and Nepal in one of the UNGA meetings.

Apart from this, India is the fifth largest drug exporter to US after China, Mexico, Canada, and Japan. Mainly due to the inexpensive price scale of India.

Global Pharmacy getting sick

Indian Pharmaceutical companies have been receiving warning letters from US FDA, and recently in Feb 2022 Indiana Chem port, Gujarat was charged for dire quality products by the US FDA. (https://www.fiercepharma.com/manufacturing/fda-wallops-indiana-chem-port-warning-letter-blasting-api-quality-equipment)

The recently released US trade report cites that after China, India is the second largest source of counterfeit pharmaceuticals (followed by the Philippines, Vietnam, Indonesia, and Pakistan).

These citing are also validated by a joint study conducted by OECD and EUIPO.

Global medical warnings raised by WHO:-

Till today, the World Health Organization has raised more than 30 warnings concerning noxious drugs and faulty medical devices around the world. The warnings related to drugs and pharmaceuticals are:-

1. Substandard (contaminated) pediatric medicines in Africa (5 Oct 2022).
2. Fake DIPRIVAN (Propofol) in U.S.A (25 Aug 2022).
3. Fake DYSPORT (Clostridium botulinum type A toxin-haemagglutinin complex) in Europe and Eastern Mediterranean regions (19 Aug 2022).
4. Fake Intratect (Human normal immunoglobulin) in U.S.A, Eastern Mediterranean and South-East Asia regions (27 May 2022).
5. Fake DESREM (Remdesivir) in U.S.A and South-East Asia (9 Mar 2022).
6. Fake Soliris in U.S.A, Europe, and South East Asia (22 Dec 2021).
7. Fake Combiart identified in WHO region of Africa (21 Dec 2021).
8. Fake COVID-19 VACCINE AstraZeneca in Eastern Mediterranean (4 Nov 2021).
9. Fake COVID-19 Vaccine Pfizer-BioNTech in Eastern Mediterranean (4 Nov 2021).
10. Fake COVID-19 Vaccine COVISHIELD identified in Africa and South-East Asia (31 Aug 2021).
11. Fake Remdesivir in U.S.A (13 Aug 2021).
12. Fake CYTOTEC (misoprostol 200 mg) identified in WHO region of Africa (10 Aug 2021).
13. Fake COVID-19 Vaccine BNT162b2 in U.S (26 Mar 2021).
14. Fake VITAMIN A (retinol) identified in WHO region of Africa (10 Mar 2021).
15. Fake HARVONI (Ledipasvir/sofosbuvir) in U.S.A and Europe (8 Dec 2020).
16. Fake Fluzone® Quadrivalent Influenza Vaccine identified in USA. (30 Oct 2020).
17. Fake and contaminated Defibrotide identified in Western Pacific, Europe, and Eastern Mediterranean (7 May 2020).
18. Fake chloroquine in Africa (9 Apr 2020).
19. Fake HIV rapid diagnostic tests in U.S.A and Africa (27 Mar 2020).
20. Fake antimalarial drugs in West and Central Africa with outdated WHO Essential Drugs Programme logo (9 Mar 2020).
21. Fake meningitis vaccines circulating in Niger (28 Jan 2020).
22. Fake Rabies Vaccines and Anti-Rabies Serum circulating in the Philippines (20 Jan 2020).
23. Fake Rabies Vaccines in the Philippines (1 Feb 2019).
24. Fake ICLUSIG 15mg & 45mg in several nations (1 Feb 2019).
25. Fake oral cholera vaccines circulating in Bangladesh (21 Mar 2019).
26. Fake hydrochlorothiazide (containing glibenclamide) in Cameroon (17 Apr 2019).
27. Fake meglumine antimoniate ampoules in Iran and Pakistan (24 Apr 2019).
28. Fake Augmentin (Amoxicillin trihydrate – Potassium clavulanate) in Uganda and Kenya (20 Aug 2019).
29. Fake Quinine Bisulphate circulating in Uganda and fake Quinine Sulphate circulating in Central African Republic and Chad (16 Oct 2019).
30. Fake Amoxicillin + Clavulanic Acid products under the name “Augmentin and Amoxicillin Clavulanate Potassium” and “Bactoclav”, in Haiti (16 Oct 2019).

Global measures to monitor medical standards

WHO Surveillance and Monitoring System

WHO launched its Global Surveillance and Monitoring System in 2013, to train and motivate nations to report offences relating to substandard and falsified medical products and to resolve them methodologically.

This program mainly provides technical support, links incidents between countries, reports to WHO, gauges the damage caused and identifies vulnerabilities and trends.

Till today the organization has provided technical support in over 100 cases and has trained a global network of around 550 regulatory staff in 141 Member States in this domain, and also works with the top 18 international procurement agencies.

Citing

Since 2013, the organization has received 1500 reports of cases of substandard or fake products. And alleges that 1 in 10 cases are from low and middle-income nations.

Most of the reports (42%) come from Africa Region, (21%) America, and (21%) Europe.

UNDOC guidelines for combating falsified medical products

This gives a detailed procedure to combat fake drugs and medical products. It mainly implies that regulatory authorities are responsible for the regulation and control of medical products and they must contribute to promoting and protecting public health by ensuring:-

Medical products are of the required quality, safety, and efficacy;
Health professionals and consumers have the necessary information to enable them to use products rationally;
Medical products are appropriately manufactured, stored, distributed, and dispensed;
Illegal manufacturing and trade are detected and adequately sanctioned;
Promotion and advertising are fair, balanced, and aimed at rational use;
Access to medical products is not hindered by unjustified regulatory work.

The report illustrates the Swedish model to counter offences relating to drug malpractices.