In September 2022, the deaths of 66 Gambian children were linked to the ingestion of cough syrups contaminated with diethylene glycol (DEG) manufactured by an Indian company, Maiden Pharmaceuticals. This is not the first time that such contamination has been linked to pharmaceutical supplies from India, where contaminated and subpar medications continue to be a major issue.

Earlier in 2019, in the northern state of Himachal Pradesh, 13 children were reported dead after being administered a cough syrup adulterated with DEG. Similarly, the deaths of another 12 children in Jammu in 2019 were also allegedly tied to the ingestion of cough syrup tainted with DEG.

Although the sale of subpar medications is a major crime in India, most manufacturers either face penalties or a year in prison as a minimum sentence. However, most of the time, the authorities just temporarily suspend their license for a few days. For instance, Digital Vision has had 19 violations of quality standards since 2009, yet regulators have taken no significant action against it.

The COVID pandemic was another time when multiple cases of the manufacture or sale of substandard drugs were reported. The Authentication Solution Providers’ Association (ASPA), an organization working against counterfeiting activities, stated that over the last two years, fake COVID-19 medicines were found in most Indian states, especially at a time when there was a severe shortage of COVID-19 products. According to the agency, India lacks suitable regulations for the pharma industry and has no well-defined regulatory and legal structures.

For a long period, problems with poor-quality medicines have flown under the radar, but the recent alarm sounded by the WHO on the four types of substandard cough syrups made by Maiden Pharmaceutical has raised attention to the issues at play.

Reacting to the issue at hand, the Ministry of Health and Family Welfare explained that the Indian government and the Haryana government imposed a ban on Maiden Pharmaceuticals. Additionally, External Affairs Minister, Dr. S. Jaishankar, told his counterpart in Gambia that the matter was being seriously investigated by appropriate authorities. However, India′s mainstream medical community has been slow to react, despite the accumulating claims and evidence.

India is the world’s largest manufacturer of generic drugs. However, several experts have estimated that 12% to 25% of the active pharmaceutical ingredients and finished medical products supplied by India are contaminated, substandard, or counterfeit.