sukeshemana Introduction: CDSCO Drug Alert 2024
In a significant development that has raised public health concerns, over 50 commonly used drugs in India have failed quality checks, according to the Central Drugs Standards Control Organisation (CDSCO). This revelation has left many patients and healthcare providers worried about the efficacy of essential medicines such as Paracetamol, Pan-D, and Amoxicillin, among others. These drugs, widely used to treat various ailments, were found to be of “Not of Standard Quality” (NSQ), prompting immediate calls for stricter regulation and better manufacturing practices.
A National Concern over Drug Quality in India
India, known as the pharmacy of the world, is one of the largest producers of generic drugs. However, a new concern has arisen in the pharmaceutical industry regarding the quality of drugs available in the Indian market. The CDSCO’s latest report from August 2024 has flagged 53 drugs, which include critical medications like Paracetamol (IP 500 mg), Pan-D, and Amoxicillin, for failing quality tests. This raises a pressing question: how safe are the medicines being consumed by millions in India? The issue isn’t just limited to generic drugs but extends to well-known branded medications as well. In this article, we will break down the details, timeline, and expert opinions on this pressing issue that is now making headlines.
A Detailed Overview of the Drugs Failing CDSCO Quality Tests
In August 2024, the CDSCO issued its monthly drug alert report, listing 53 allopathic drugs that failed to meet quality standards. This included widely-used drugs like Paracetamol, a staple in almost every household for fever and pain relief, and Pan-D, a commonly prescribed antacid. Along with these, antibiotics such as Amoxicillin and medications like Glimepiride (used for diabetes management) and Telmisartan (used to treat high blood pressure) were also found to be substandard.
The drugs, flagged under the “Not of Standard Quality (NSQ)” category, are typically tested on various parameters including the amount of active ingredient, dissolution, and bioavailability. The failure of these tests means that the drugs either don’t contain the specified amount of active ingredient or fail in other critical tests, potentially making them less effective or even harmful in some cases.
Several prominent pharmaceutical companies were linked to these findings, including Alkem Laboratories, Hetero Drugs, Karnataka Antibiotics & Pharmaceuticals Ltd, Hindustan Antibiotics Limited, and Pure & Cure Healthcare.
List of Prominent Drugs that Failed the Quality Test
Among the list of 53 drugs, some notable ones include:
- Paracetamol (IP 500 mg tablets): One of the most commonly used medications for pain and fever relief.
- Shelcal (Vitamin C and D3 tablets): A calcium and vitamin D supplement widely prescribed for bone health.
- Vitamin B complex and C soft gels: Popular supplements for improving overall health.
- Pan-D (antiacid): Used to relieve symptoms of acidity and gastroesophageal reflux disease (GERD).
- Glimepiride (anti-diabetic drug): An important medication for managing blood sugar levels in patients with Type 2 diabetes.
- Telmisartan (for high blood pressure): A drug that helps manage hypertension.
Additional drugs like Metronidazole, prescribed for stomach infections, and Cepodem XP 50 Dry Suspension, used for treating bacterial infections in children, were also found to be substandard.
Full Timeline: From Testing to Alerts
The timeline for this quality test and the subsequent alerts can be traced back to early August 2024 when the CDSCO began its random monthly sampling. Samples of these drugs were collected from various regions in India and were sent to state drug testing laboratories. After weeks of testing, the results were compiled, and by September 20, 2024, three separate alerts were issued.
The first alert listed 48 drugs, some of which were repeated multiple times due to the presence of different samples from the same batch. The second alert flagged 11 drugs, which included two ayurvedic or herbal medicines. A third list contained five additional drugs, three of which were from Sun Pharma, one from Glenmark, and one from Macleods.
Notably, some companies such as Sun Pharma, Glenmark, and Macleods denied producing the flagged drugs, calling them spurious. Investigations are still ongoing regarding these claims.
The Role of CDSCO and Drug Monitoring in India
The CDSCO is responsible for ensuring the safety, efficacy, and quality of drugs marketed in India. It conducts random quality checks through its state drug officers, who collect drug samples from across the country for testing. These tests are carried out based on parameters set by the Indian Pharmacopoeia.
According to an official from the Central Drugs Standards Control Organisation, these NSQ findings are usually minor and not life-threatening, although the substandard nature of the drugs raises significant concerns. “Such lists are released every month to show that the Drugs Controller General of India (DCGI) is continuously monitoring drug quality and taking action against manufacturers selling substandard products,” a senior official from CDSCO told ANI.
In addition to its regular monitoring, the CDSCO has been taking strong action against manufacturers of spurious or adulterated drugs. In the month of August 2024, the organization banned over 156 fixed-dose drug combinations, citing potential risks to human health.
Experts Opinions on Drug Quality and Safety in India
Several experts have weighed in on the CDSCO’s recent findings. Dr. Sanjeev Jain, a leading pharmacologist, expressed his concerns: “The presence of substandard drugs in the market is not just a regulatory failure but poses a direct risk to patient safety. Patients relying on these medications may not receive the therapeutic effects they need, leading to further complications.”
Meanwhile, Dr. Kavita Rao, a public health expert, highlighted the need for better vigilance at the manufacturing level. She stated, “While the CDSCO’s actions are commendable, it is essential to have stricter oversight at the production stage itself. Regular audits and increased transparency from pharmaceutical companies are critical to ensure that only drugs of the highest quality reach consumers.”
Pharmaceutical consultant Dr. Amit Patel commented on the spurious drugs issue, stating, “The fact that companies like Sun Pharma are claiming that the flagged drugs are spurious brings to light another issue in the supply chain. There needs to be stricter tracking of drugs from manufacturing to distribution to prevent such cases.”
Impact on Consumers and Healthcare Providers
The revelation that such widely-used drugs have failed quality tests has caused concern among patients and healthcare providers. For patients, it raises the question of whether the medications they are consuming are truly effective. For healthcare providers, it calls for more cautious prescribing and a potential shift to alternative medications that have passed quality tests.
Many doctors are now advising patients to check for updates on drug safety and to consult their healthcare provider if they are currently taking any of the drugs mentioned in the CDSCO’s report.
Conclusion: Moving Forward with Stricter Drug Regulations
The recent findings by the Central Drugs Standards Control Organisation (CDSCO) have brought to light serious issues in the quality of some of India’s most commonly used drugs. As more attention is drawn to these failures, it is clear that stricter regulations and more stringent quality checks are needed to ensure the safety and efficacy of medications available in the Indian market.
Moving forward, pharmaceutical companies, regulatory authorities, and healthcare providers must work together to restore public trust in the system. This includes enforcing stricter quality control measures, ensuring transparency in drug manufacturing, and holding manufacturers accountable for the drugs they produce. For patients, this development serves as a reminder to stay informed and to always consult their healthcare provider regarding the safety of their medications.
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FAQs and Their Answers
- What does “Not of Standard Quality (NSQ)” mean in CDSCO drug testing?
- NSQ refers to drugs that fail to meet the regulatory standards for quality, which include the correct composition of ingredients, potency, and effectiveness. Such drugs may not perform as intended or could be harmful.
- How often does CDSCO conduct drug quality tests?
- CDSCO conducts monthly tests on a random sample of drugs available in the market. The results are then published in their drug alert reports, identifying drugs that fail to meet quality standards.
- What should patients do if they are using a drug that has failed a CDSCO quality test?
- Patients using any drug listed in the CDSCO’s alert should consult their healthcare provider immediately. Physicians may prescribe alternatives or advise further steps based on the individual’s condition.
- How does CDSCO determine which drugs to test?
- CDSCO performs random sampling from various pharmacies and hospitals across India. The samples are tested in government laboratories to assess their quality and adherence to the Indian Pharmacopoeia.
- Are the substandard drugs dangerous for health?
- While substandard drugs may not always be immediately life-threatening, they can be ineffective and might cause complications by not providing the required therapeutic benefits, leading to longer recovery times or worsened conditions.