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Context

• The death of 66 children in the Gambia, linked to cough syrups manufactured by an Indian firm, has spurred the government to launch an urgent probe into the matter.
• Samples of the cough syrups, being blamed for the deaths, have been sent for testing.

Kids poisoned by cough syrup in Gambia

• The cough syrups contained unacceptable amounts of diethylene glycol and ethylene glycol, considered to be poisonous compounds.
• After this, the WHO raised an alert, linking the deaths in the Gambia to the four cough syrups, made by Haryana-based Maiden Pharmaceuticals.

While the probe is on, the incident has certainly put the spotlight once again on quality monitoring and due diligence by companies and the need for stricter regulations.

India’s drug export to Africa

• India is a significant player in the pharmaceutical market in Africa.
• A recent report revealed that 20% of India’s exports of pharmaceuticals of about $17 billion go to Africa.
• The Gambia received 3.6 lakh doses of the Indian vaccine in March 2021, showing the importance that India attaches to this nation.
• Africa is, therefore, a major partner in India’s pharmaceutical industry.

What is Diethylene Glycol (DEG)?

• WHO said that Diethylene Glycol (DEG) or ethylene glycol is toxic to humans when consumed and can prove fatal.
• It can cause kidney and neurological toxicity and has been associated with several cases of mass poisoning when consumed via drugs.
• The chemical tastes sweet and is water-insoluble.
• The toxic effects of the chemical include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury.

Are the syrups sold in India?

• A drug regulatory expert who was part of the investigation into the 2020 J&K deaths said India has phased out syrups in favour of suspensions.
• The chemical is used as a solvent for Active Pharma Ingredients (API).
• To save on costs, some companies use industrial propylene glycol that may contain diethylene glycol and ethylene glycol as contaminants.

India’s response to Gambia deaths

• It is certainly the responsibility of the importing country to test medicines before releasing them in their market.
• After being informed about the incident, India’s apex regulatory body, Central Drugs Standard Control Organisation (CDSCO) opened investigations and lifted control samples.

Issue: India’s credibility at stake

• India is one of the leading exporters of medicines.
• PM Modi recently stressed that Indian drugs had earned the world’s trust and that India could be called the ‘pharmacy to the world’.
• However, such negative reports on the quality and safety of our medicines will be a massive blow to the country’s image as a source of cheap generic drugs to the world.

Issues highlighted by the incident

• Smuggling of cheap drugs: Inquiry reveals that these were imported from an Indian manufacturer, not under public tender but privately.
• Ignorance by authorities: The drug which is banned for domestic consumption has got exported and led to fatalities. This is a huge blissful mistake by Indian Authorities.
• Lack of inspection: There are not enough drug inspectors in the country to conduct as many inspections as is ideally required in such as vast set-up.
• Inadequacies in quality-check: Despite huge production units, there are not an adequate number of laboratories to test the samples in time if all the samples that should be lifted for testing are picked up.
• Blot on credibility: The matter, if not properly handled, can damage the perception that Indian medicines are trustworthy for African countries and the global South.

Health cooperation between India and Africa

• 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 programs under the Indian Technical and Economic Cooperation (ITEC) program are part of inter-governmental action.
• There is a 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 followed WHO standards in the main and their budget-friendly medicines have been a boon to many African countries for their public health programs.

Possible factors behind this tragedy

• There are rackets 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.

Way forward

• The pharmaceutical trade is vital and must be protected from predatory practices and violations of regulatory norms.
• Regulatory mechanism on both sides should be strengthened.
• African importers should be given lists of recognised Indian manufacturers.
• Training should be provided to drug controllers to curtail the menace of counterfeit and poor-quality medicine entering Africa from India.

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