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The year 2023 unfolded against a backdrop marred by the persistent emergence of substandard drugs, casting a shadow over India’s pharmaceutical landscape. However, amid these challenges, the Indian government stood as a bulwark of proactive measures, initiating a resolute campaign to fortify regulations and elevate drug standards, ensuring the nation’s pharmaceutical integrity.
The alarming issues related to poor-quality drugs initially grabbed headlines in October 2022 when Maiden Pharma’s cough syrups were implicated in the tragic deaths of 70 children in Gambia. This distressing revelation was swiftly followed by a parallel catastrophe involving Marion Biotech’s cough syrups, which resulted in 19 fatalities in Uzbekistan within a mere three months.
As the calendar turned to 2023, the specter of substandard drugs persisted, prompting global concern. The World Health Organisation (WHO) raised alarms over QP Pharma Chem’s contaminated cough syrups in the Marshal Islands and Micronesia. Furthermore, Nigeria’s regulatory authority, NAFDAC, flagged SyneCare, and the WHO issued a stark alert regarding a batch of cough syrup named COLD OUT, manufactured by FOURRTS Labs and identified in Iraq.
A recurring theme in these instances was the presence of perilous levels of toxic substances, specifically diethylene glycol and ethylene glycol. However, the issue extended beyond contamination by DEG & EG, with cases of substandard drugs, including eye drops, surfacing in Sri Lanka and the US.
Serious allegations were levied against companies like Indiana Ophthalmics and Global Pharma. Indiana Ophthalmics faced accusations that its steroid eye drop caused severe eye damage in Sri Lanka. Simultaneously, Global Pharma grappled with 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 tragic death.
Responding to these grave challenges, the Indian government launched an intensified effort to ensure better drug quality, aiming to safeguard the country’s esteemed status as the ‘pharmacy of the world.’ This multifaceted approach included comprehensive investigations, license suspensions for implicated companies, and the implementation of more rigorous and random quality checks for pharmaceutical manufacturers.
A sweeping crackdown exposed over 50 companies involved in the manufacturing of substandard cough syrups. In a decisive move, state and central drug regulators joined forces to inspect 76 pharmaceutical companies nationwide. The Drug Controller General, in collaboration with the government, took assertive action by revoking licenses of 18 companies accused of producing spurious drugs, sending a clear message of zero tolerance.
Recognizing the imperative to address drug quality for international exports, the government directed state drug regulators to scrutinize cough syrups intended for export. The Directorate General of Foreign Trade mandated the comprehensive testing of cough syrup samples and the production of a certificate of analysis before export, underscoring the commitment to ensuring the quality of pharmaceutical products leaving the country.
As India navigated the storm of substandard drugs in 2023, the government’s steadfast actions signaled a commitment to resilience and rectification. These measures not only aimed at safeguarding public health within the nation but also sought to restore global confidence in India’s pharmaceutical prowess. In the face of adversity, India’s pharmaceutical industry, fortified by regulatory vigilance, is poised to emerge stronger, ensuring that the pursuit of excellence continues to be the hallmark of its pharmaceutical endeavors.