The Gambian tragedy

THE death of 66 children in The Gambia, linked to cough syrups exported from India, is distressing as well as shocking. The matter, if not properly handled, can damage the perception that Indian medicines are trustworthy for African countries and the global South. According to news reports from two leading sources in The Gambia, The Standard and the Fortuna network, information regarding the linkage of the deaths to the cough syrups has come from a WHO announcement on October 5. This announcement links the deaths to acute kidney injury (AKI) and says that these were connected to the cough syrups imported from an Indian company.

Pharmaceutical trade is vital and must be protected from predatory practices and violations of regulatory norms.

Apparently, deaths among children were occurring over a few months. In August, these deaths were called a ‘mystery disease’ and then linked to paracetamol syrup by the Gambian Ministry of Health and the Medicines Control Agency (MCA), according to the Standard newspaper. Now that the WHO has issued a medical product alert for contaminated medicines, the link to the AKI and the 66 deaths seems more clearly established.

The Gambia withdrew these medicines and recalled them from households. Inquiry reveals that these were imported from an Indian manufacturer, not under public tender but privately. The importer is not Indian. These were sold through private clinics, hospitals and pharmaceutical shops in small towns. The main problem is the presence of diethylene glycol and ethylene glycol as contaminants. The MCA has asked healthcare workers not to prescribe these. It lacks a laboratory to test medicines for quality.

Two issues directly impinge on how this matter will be handled. First, the Indian company has clarified that it has not sold these products in India. Why did it export them to The Gambia? What is good for India must be applied to all countries with whom we trade. On the Gambian side, the media has asked how contaminated products entered the country, because all importers share the list of imported medicine with the MCA. Evidently, there are slippages on the regulatory mechanism, both in India and The Gambia.

This is regrettable. India is a significant player in the pharmaceutical market in Africa. A recent book, The Harambee Factor India: Africa Economic and Development Cooperation, revealed that 20% of India’s exports of pharmaceuticals of about $17 billion go to Africa. Africa is, therefore, a major partner in India’s pharmaceutical industry.

Pharmaceutical companies from India have invested in Ethiopia, Uganda, DR Congo, Zambia, South Africa, Ghana and other places, since markets are not unified and each product has to be separately registered in every country. The African Medicines Agency needs to establish regional testing and regulatory mechanisms in which India may help.

Health cooperation is an important part of the India-Africa engagement. The India-Africa Health Sciences platform, Pan-African e-Network project, e-Arogya Bharti, and training programmes under the Indian Technical and Economic Cooperation (ITEC) programme are part of inter-governmental action. There is growing pharmaceutical trade, medical tourism and hospital management between India and Africa. This is because of the confidence that India is a cost-effective but efficient partner in the health sector.

Indian companies have established a reputation as partners of choice — particularly of international healthcare NGOs and aid agencies — over the past decades. They have engaged local authorities and public tenders effectively and nurtured a confidence in their quality. They have followed WHO standards in the main and their budget-friendly medicines have been a boon to many African countries for their public health programmes.

With The Gambia, a small English-speaking country in West Africa, India had exports worth $155 million in 2021. Pharmaceutical exports were to the tune of $9.23 million or 6%. Pharmaceutical trade is an important aspect and needs to be protected from predatory practices and violations of regulatory norms. If not, India’s pharmaceutical interface with Africa could suffer a jolt. The WHO announcement would have rattled regulatory authorities in many African countries. Traders could have carried these medicines across borders and these would not show up in trade statistics.

India has assisted drug regulators in Africa under the ITEC programme and improved surveillance and regulation. However, these are effective only if the medicines come in through normal routes and do not evade the regulatory mechanisms in place. About two decades ago, there was a racket of counterfeit Indian medicines turning up in many African countries. Some of these were coming from unregistered producers in India, who would produce medicine depending on what cost was paid to them without concern for quality. In some cases, competitors from other countries were known to make counterfeit medicines with Indian markings and dump them in markets where Indian pharmaceuticals were well regarded. Consistent work by Pharmexcil, Indian Drug Manufacturers Association and Indian embassies in Africa helped to overcome these problems. Regulatory mechanism on both sides was strengthened. African importers were given lists of recognised manufacturers. The training provided to drug controllers also helped to curtail the menace of counterfeit and poor-quality medicine entering Africa from India.

However, from time to time, like in the present case, lapses occur. These can sully India’s image in an important sector of collaboration. The Gambia received 3.6 lakh doses of the Indian vaccine in March 2021, showing the importance that India attaches to this nation.

Both nations need to work together through their regulatory agencies to determine how the Indian manufacturer could export what he cannot sell in India and how The Gambia could have allowed it to enter. This is the least that can be done to prevent another tragedy.