Counterfeit Drugs in the market: What you should know?

The Central Drugs Standard Control Organisation (CDSCO) has recently identified over 50 drugs as "Not of Standard Quality" (NSQ), raising concerns about the safety and authenticity of medicines in India. 

This development has led to confusion surrounding the terms “counterfeit” and “spurious,” leaving consumers uncertain about how to verify the quality of their medications. Healthcare professionals and pharmaceutical stakeholders emphasise the need for clearer distinctions to prevent misinformation.

“NSQ drugs differ from counterfeit or spurious ones,” explained Rajiv Singhal, General Secretary of the All India Organisation of Chemists and Druggists (AIOCD). “While NSQ drugs come from legitimate manufacturers but fail to meet regulatory standards, counterfeit drugs are deliberately fraudulent, and spurious drugs may contain harmful ingredients.”
 
Consumer Vigilance Crucial in Ensuring Medication Quality
 
Consumers have a crucial role in ensuring the medicines they purchase are genuine. Alok Malik, President and Head of India Formulations at Glenmark Pharmaceuticals Limited, advised, “Buy medicines only from trusted retailers and avoid unregulated online platforms to reduce the risk of counterfeit drugs.” He stressed the importance of obtaining a bill when purchasing medications. “A bill serves as proof of purchase and provides a record in case of a recall or adverse effects.”
 
Malik further noted that genuine medicines should display visible batch numbers and expiry dates, confirming regulatory compliance. He encouraged consumers to check for high-quality packaging, clear fonts, correct spellings, and intact seals. “Be cautious of heavily discounted medicines, as counterfeit drugs are often sold at lower prices,” he warned. If consumers suspect their medicines are counterfeit or of poor quality, they are encouraged to report the issue. Regulatory bodies like the CDSCO have portals for complaints, which help authorities address these concerns. Singhal noted, “Consumer reports play an important role in tackling issues with medicine quality.”
 
Singhal also stated that the association is prepared to handle the recall of medicines if any companies or consumers identify them as counterfeit or spurious. "We advise purchasing medicines from offline pharmacies as they have proper licenses to sell drugs," he added, highlighting the importance of verified sources for ensuring the authenticity of drugs.
 
Regulatory Measures Target Counterfeit and Substandard Medicines
 
According to union health ministry data, in the year 2022-23, the Indian government reported that 3,053 drugs were identified as substandard and 424 drugs were classified as spurious or adulterated. In response, the CDSCO and State Drugs Controllers initiated risk-based inspections of more than 400 drug manufacturing facilities.
 
These inspections are based on various risk factors, such as the number of drugs previously declared Not of Standard Quality, complaints received, and the critical nature of the products involved. Over 300 actions have been taken against manufacturers, including show-cause notices and the suspension or cancellation of licences. The government has also implemented measures to counter the prevalence of spurious and substandard drugs. The Drugs and Cosmetics Act has been amended to impose stricter penalties for the manufacture of such drugs, making certain offences cognisable and non-bailable. Special courts have been established in various states and Union Territories for the trial of cases related to drug quality offences.
 
Recent amendments require drug manufacturers to submit bioequivalence study results and evidence of stability and safety before being granted licences. In December 2023, amendments were made to the Drugs Rules to revise Good Manufacturing Practices, reinforcing the need for rigorous standards in pharmaceutical production. The CDSCO continues to coordinate with State Drug Control Organisations and holds consultations to ensure uniformity in the administration of the Drugs and Cosmetics Act.
 
The Indian government has times and again issued advisories aimed at combating the circulation of counterfeit and spurious medicines. The CDSCO regularly publishes "Drug Alerts" identifying specific medicines that fail to meet quality standards. These reports help inform the public and the pharmaceutical industry. The issue of counterfeit and substandard drugs poses ongoing challenges for the healthcare sector in India. In response, pharmaceutical companies and regulators are collaborating to implement safeguards ensuring the authenticity of medicines in the market. As of August 2023, the Drugs Controller General of India (DCGI) mandated the use of barcodes or QR codes on the packaging of the top 300 medicine brands, allowing consumers to verify key details such as the manufacturer, batch number, and expiry date. This regulation aims to combat counterfeit drugs and enhance patient safety.
 
Pharmaceutical Sector Steps Up Against Counterfeit Threats
 
Pharmaceutical companies actively monitor the market and report any substandard or counterfeit drugs to regulatory authorities. Meanwhile, state FDA field officers regularly collect random drug samples from the market for testing. This multi-tiered approach aims to curb the circulation of counterfeit medicines that can harm public health. Recent reports highlighted confusion following a list of NSQ drugs, as certain companies clarified that flagged batches were not produced by them. “It is critical that a clear distinction between NSQ and spurious drugs is made,” emphasised Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance. “Manufacturing spurious drugs is a serious criminal offence that threatens public health, and linking spurious products with legitimate manufacturers has severe reputational and financial impacts.”
 
To assist consumers in verifying the authenticity of their medicines, many pharmaceutical brands, including Glenmark, now include unique product identifiers and QR codes on their packaging. “Scanning the QR code with your smartphone provides instant verification of authenticity,” Malik explained, urging consumers to report any suspicious products to retailers and authorities. A spokesperson for Sun Pharma stated, “We investigated and found that Pulmosil, Pantocid, and Ursocol batches tested by the regulatory authority are not manufactured by us.” The spokesperson assured that the company is implementing measures to ensure patient safety, including QR codes for easy verification of authenticity.
 
Alkem Laboratories Ltd also denied claims that its products Pan-D and Clavam 625 were NSQ. After investigating, Alkem found that samples collected by the CDSCO were spurious and not manufactured by them. The company has incorporated unique features and QR codes in the packaging of both products to distinguish genuine items from counterfeit ones. “The alarming rise in counterfeit medicines highlights our commitment to ensuring patient safety,” Malik said. “Every product that leaves our facilities undergoes rigorous testing to comply with safety standards.”