CDRA Raises Alarm Over Substandard Drugs, Highlighting Shelcal 500 and Pan D

The Central Drug Regulatory Authority (CDRA) has issued a critical warning regarding the quality of several pharmaceutical products circulating in India, with particular emphasis on the popular calcium supplement Shelcal 500, the combination medication Pan D, and Vitamin D3 tablets from Life Max Cancer Laboratories. These products, along with others, have been flagged for failing to meet the required safety and quality standards.

After an extensive review of approximately 3,000 drug samples, the CDRA found 49 products categorized as “Not of Standard Quality” (NSQ), representing about 1.5% of the total tested samples. Among the problematic drugs were commonly used medications such as paracetamol, oxytocin, and fluconazole, which have raised significant concerns for public health and safety.

Identifying Substandard Medications

The inspection uncovered multiple drugs that did not meet the necessary quality standards, including:

• Tamsulosin and Dutasteride Tablets (Urimax D)
• Calcium and Vitamin D3 Tablets I.P. (Shelcal 500)
• Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Capsules I.P. (Pan D)
• Nandrolone Decanoate Injection IP 25mg/ml (Deca Durabolin 25 Inj.)

Key NSQ Drugs Discovered

Additionally, the report revealed that 49 drugs from established companies such as Alkem Health Science, Aristo Pharmaceuticals, and Hindustan Antibiotics failed to meet the required quality standards. Notable products among these NSQ drugs included:

• Neurotem-NT
• Cefuroxime Axetil Tablets IP 500 mg
• Loperamide Hydrochloride Tablets IP
• Floxages-OZ (Ofloxacin and Ornidazole Tablets IP)
• Moxica-250 (Amoxicillin Dispersible Tablets IP 250 mg)
• Fluorometholone Eye Drops IP
• Telmisartan Tablets IP 40 mg
• Pantoprazole Injection BP 40 mg

In addition, quality concerns were raised with paracetamol tablets manufactured by Karnataka Antibiotics & Pharmaceuticals Ltd.

Urgency for Enhanced Consumer Safety

The CDRA’s findings have sparked significant concern among healthcare professionals and the general public. Pharmacies and medical facilities are being strongly urged to verify their drug inventories to ensure that the flagged medications are not distributed. These revelations have also prompted questions about the quality of medicines sold through online pharmacies, as the rise of telemedicine and online prescriptions increases the risk of counterfeit drugs entering the market.

To tackle these challenges, authorities are working to implement stricter regulations for online pharmacies and digital prescriptions. This move is essential in safeguarding consumer health in the age of e-pharmacies, where the lack of physical inspection makes it easier for counterfeit or substandard drugs to circulate.

Pharmaceutical Industry’s Response

The pharmaceutical industry has mostly distanced itself from responsibility for the substandard products flagged by the CDRA. Alkem Laboratories, for example, clarified that the flagged drugs were counterfeit and not produced by their company, stating, “We are fully cooperating with authorities to address the counterfeit drug issue.”

Industry representatives have called for greater collaboration with regulatory bodies to enhance testing processes and improve the accuracy of drug quality assessments. There is also growing support for leveraging third-party testing laboratories, accredited by international standards, to ensure more transparency. Furthermore, many manufacturers are advocating for the use of advanced technologies like Artificial Intelligence (AI) and the Internet of Things (IoT) to monitor production in real-time, providing continuous quality assurance.

Potential Risks of Substandard Medicines

Substandard medicines pose a serious threat beyond individual health. They undermine public trust in the healthcare system, lead to financial strain on families, and have the potential to contribute to larger public health crises, such as the development of drug-resistant diseases like tuberculosis and malaria.

A recent study by the National Institute of Public Health highlighted that substandard antibiotics were responsible for 30% of treatment failures in India, worsening the burden on the healthcare system and undermining the effectiveness of treatment protocols.

CDRA’s Proactive Steps

To address these issues, the CDRA has introduced several proactive measures. One key area of focus is monitoring the importation of raw materials used in drug manufacturing, as impurities in these ingredients are a leading cause of substandard drugs. The CDRA has also implemented stricter compliance requirements for active pharmaceutical ingredients (APIs), demanding greater transparency about the origin and quality of raw materials used by manufacturers.

To strengthen enforcement, the CDRA has rolled out a digital reporting system, enabling manufacturers to submit real-time production data. This will allow regulatory bodies to better track and monitor drug production, improving compliance and reducing the chances of substandard drugs entering the market.

Technology in the Fight Against Counterfeit Drugs

The CDRA is also leveraging cutting-edge technology to combat the issue of counterfeit drugs. In collaboration with tech firms, the regulatory body is exploring the use of blockchain technology and AI to track and verify pharmaceutical shipments. Blockchain offers a secure, transparent way to trace drugs through the entire supply chain, from manufacturing to delivery, ensuring authenticity at every stage.

AI is being used to analyze data from drug testing laboratories, helping to identify patterns and predict which products are more likely to be substandard. This technology enables regulators to act proactively, focusing on high-risk products before they are distributed widely.

Role of Healthcare Professionals

Healthcare professionals, including doctors, pharmacists, and hospital administrators, play a crucial role in identifying and addressing the issue of substandard drugs. To equip them with the knowledge and tools needed, regular training programs are being encouraged, particularly for pharmacists who are at the front lines of drug distribution. These training sessions focus on helping healthcare professionals spot counterfeit drugs and verify their authenticity.

In addition, a national helpline is being considered to allow healthcare workers to report suspected substandard drugs swiftly, ensuring a more coordinated response to future incidents.

Empowering Consumers for Safer Health Choices

As part of efforts to protect consumers, authorities are planning the launch of a mobile app that will enable users to scan QR codes or barcodes on drug packaging to confirm their authenticity. This app will provide instant access to critical information about a drug’s manufacturing details, batch numbers, and quality certifications.

Additionally, public health campaigns aimed at educating consumers about how to differentiate between legitimate and substandard drugs are being rolled out, with a special focus on rural areas where information is often harder to access.