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.
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.
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.
First Published: Dec 8, 2023 2:40 PM IST