The year of substandard drugs | How 2023 saw India crackdown on poisonous pharmaceuticals

The year 2023 was markedby repeated instances substandard drugs coming to the surface, but it was also marked by the Indian government's proactive measures to tighten regulations and enhance drug standards.

The issues with poor-quality drugs first gained prominence in October 2022 when Maiden Pharma's cough syrups were linked to the deaths of 70 children in Gambia, followed by Marion Biotech's cough syrups causing 19 deaths in Uzbekistan within three months.

Throughout 2023, such issues persisted, even, in one, prompting the World Health Organisation (WHO) to raise concerns about QP Pharma Chem's contaminated cough syrups in the Marshal Islands and Micronesia. Additionally, Nigeria's regulatory authority NAFDAC flagged SyneCare, and the WHO issued an alert regarding a batch of cough syrup, COLD OUT, from FOURRTS Labs identified in Iraq.

A common denominator in these instances was the presence of dangerous levels of toxic substances, specifically diethylene glycol and ethylene glycol. However, the problem extended beyond contamination by DEG & EG, with cases of substandard drugs, including eye drops, surfacing in Sri Lanka and the US.

Serious allegations were made against companies like Indiana Ophthalmics and Global Pharma. Indiana Ophthalmics' steroid eye drop was accused of causing severe eye damage in Sri Lanka, and Global Pharma faced allegations of contamination in their eye drops and ointments for dry eyes in the US, linked to over 50 adverse events, including vision loss and one death.

In response to these challenges, the Indian government intensified efforts to ensure better drug quality and safeguard the country's reputation as the ‘pharmacy of the world’. Measures included investigations, licence suspensions for implicated companies, and more rigorous and random quality checks for pharmaceutical manufacturers.

A significant crackdown revealed over 50 companies manufacturing substandard cough syrups. In a substantial move, State and central drug regulators inspected 76 pharma companies nationwide, and the Drug Controller General, in collaboration with the government, revoked licences of 18 companies accused of producing spurious drugs.

Lastly, recognising the need to address drug quality for international exports, the government directed state drug regulators to analyse cough syrups intended for export. The Directorate General of Foreign Trade mandated the testing of cough syrup samples and the production of a certificate of analysis before export, aiming to assure the quality of pharmaceutical products leaving the country.