In recent months, the Central Drugs Standard Control Organisation (CDSCO) of India has reported a significant increase in the number of drugs classified as Not of Standard Quality (NSQ). The surge highlights critical challenges in drug quality assurance, regulatory oversight, and public health consequences.
Recent Findings
According to the CDSCO, the number of flagged NSQ drugs rose dramatically from 34 in October 2024 to 145 in January 2025. This increase coincides with a broader participation of state laboratories in drug testing, which has been credited for the spike in reported NSQ cases. The marked jump in cases, categorized by the CDSCO, includes various formulations from common analgesics like paracetamol to heart medications and vitamin supplements.
During the January review, central regulators identified 52 NSQ samples while the remaining 93 were flagged by state laboratories. Notable products among the NSQ drugs included Monopropylene Glycol and Ticagrelor Tablets, among others, with most of the flagged drugs reportedly manufactured in the 2023–2024 period and set to expire by 2026.
Factors Contributing to the Surge
One primary explanation for the rise in NSQ reports is the increased engagement of state laboratories in assessing drug quality. The Health Ministry emphasized that heightened reporting from state entities is crucial for developing a comprehensive database on drug safety. By enhancing transparency and accountability in drug manufacturing, these efforts are expected to yield better quality control and improve the overall pharmaceutical landscape in India.
Moreover, as the global marketplace increasingly scrutinizes product quality and compliance, a robust regulatory framework becomes essential. Drug quality failures could lead to severe health risks, including ineffective treatment and adverse health outcomes for patients.
Public Health Implications
The implications of rising NSQ drugs are profound, especially in a country like India, which is known as the “pharmacy of the world.” India accounts for a considerable percentage of global pharmaceutical exports, providing a substantial share of generic medications to countries around the world. If drug quality issues persist, it could jeopardize India’s reputation and adversely impact global supply chains.
Moreover, patients could be at risk if substandard medications are circulated. Poor-quality drugs may result in inadequate therapeutic responses, contributing to antibiotic resistance and increasing the potential for adverse drug reactions—notably in vulnerable populations such as children, the elderly, and those with chronic illnesses.
Regulatory Response and Future Directions
In response to these challenges, the CDSCO is reportedly taking measures to enhance oversight and streamline drug approval processes. Plans for a digital drug regulatory system to consolidate vital information regarding drug manufacturers and supply chains are being developed.
Additionally, there is a focus on improving the accountability mechanisms within drug manufacturing. By emphasizing regulatory compliance and quality assurance, Indian authorities aim to reinforce trust in the pharmaceutical sector both domestically and internationally.
-Raja Aditya
