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The Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory authority, has flagged 112 drug samples as Not of Standard Quality (NSQ) in its monthly drug alert for September 2025, including one spurious sample from Chhattisgarh. These findings highlight ongoing concerns about medicine safety in India, underscoring the critical need for stringent regulatory oversight to protect public health.
Key Findings on Substandard and Spurious Drugs
In its latest routine surveillance, CDSCO reported 52 substandard drug samples were identified by Central Drugs Laboratories, while State Drugs Testing Laboratories found 60 samples failing quality standards. The NSQ classification means these drug batches did not meet one or more specified quality parameters, such as assay of active ingredients, dissolution, or uniformity of weight. However, this failure applies only to the particular tested batches and is not indicative of the overall quality of all products of the same drug on the market.
Of particular concern, one drug sample from Chhattisgarh was labeled spurious—manufactured by an unauthorized company using a brand name belonging to another entity. This matter is under investigation, with regulatory action underway under the Drugs and Cosmetics Act.
Compared to August 2025, when 94 substandard samples were reported, the number has increased, signaling persistent challenges in maintaining drug quality.Expert Perspectives on Drug Quality and Regulation
Experts emphasize the complexity of India’s drug regulatory environment as a significant factor contributing to the prevalence of substandard drugs. Dr. T. Prashant Reddy, coauthor of “The Truth Pill: The Myth of Drug Regulation in India,” warns that fragmented regulation—where states license manufacturers but the central government sets standards—leads to inconsistent enforcement. Furthermore, recent legislative changes, such as the Jan Vishwas Act (2023), have decriminalized some offenses related to drug quality, weakening accountability.
Dr. Reddy also highlights the lack of transparency around inspection outcomes and recalls and notes the influence of political and administrative interference in undermining effective oversight. These systemic issues create avenues for manufacturers, especially smaller pharmaceutical firms with limited resources, to produce drugs that fail to meet quality standards.
Pharmaceutical industry data show that many substandard drugs originate from MSME (micro, small, and medium enterprises) pharma firms, which often face financial constraints and lack adequate manufacturing infrastructure. These firms sometimes use subpar raw materials and have inconsistent supply chain management, further compromising drug quality.
Context on Public Health Implications
Substandard and spurious medicines pose significant risks to public health. Patients using such drugs may not receive adequate therapeutic benefits, potentially leading to treatment failure and worsening medical conditions. Additionally, the presence of harmful contaminants or incorrect active ingredient dosages can cause adverse reactions and toxicity.
The World Health Organization (WHO) categorizes substandard and falsified medical products as a global health threat. WHO alerts have documented contaminated oral liquid medicines in India and occasional deaths linked to toxic cough syrups, emphasizing the urgent need for vigilance in drug manufacturing and distribution.
Practical Implications for Consumers
Consumers are advised to take several precautions to ensure medication safety:
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Purchase medicines from reputable and licensed pharmacies.
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Check for packaging integrity, expiration dates, and batch numbers.
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Be cautious of unusually low prices or unfamiliar brands.
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Report any adverse drug effects or suspicion of counterfeit products to health authorities.
Healthcare professionals must remain vigilant for signs of substandard drugs during prescription and dispensing, reporting such instances promptly to regulatory bodies.
Limitations and Ongoing Challenges
While CDSCO’s monthly alerts play a vital role in identifying and removing unsafe medicines from circulation, limitations remain:
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NSQ results apply only to specific batches, meaning not all products of the same drug are necessarily affected.
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Detection depends on samples tested, which may not cover the entire market comprehensively.
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Enforcement actions can be delayed due to legal and investigative processes.
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Consumers and even pharmacists often have limited means to verify medicine quality independently.
Experts call for strengthening India’s regulatory framework with better resource allocation, unified licensing and inspection systems, increased transparency, and harsher penalties for violations to tackle these challenges effectively.timesnownews+1
Medical Disclaimer
This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare professionals before making any health-related decisions or changes to your treatment plan. The information presented here is based on current research and expert opinions, which may evolve as new evidence emerges.
References
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Central Drugs Standard Control Organisation (CDSCO). “Monthly Alert: Not of Standard Quality (NSQ) Drug Samples September 2025.” CDSCO Official Portal. October 2025.
