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Over 50 Drugs Fail Quality Test: Paracetamol, Pan D, and Other Common Medicines Raise Safety Concern

September 26, 2024
Over 50 Drugs Fail Quality Test: Paracetamol, Pan D, and Other Common Medicines Raise Safety Concern

The recent report from the Central Drugs Standard Control Organisation (CDSCO) has sent shockwaves through the pharmaceutical industry and medical community alike. With over 50 drugs, including popular medications such as paracetamol and Pan D, flagged as "Not of Standard Quality" (NSQ), the safety and efficacy of these widely used treatments have come into question. We are sharing this news report as found through reliable sources such as Hindustan Times and India Today, highlighting the recent safety concerns raised by the CDSCO regarding over 50 medications, including paracetamol and Pan D.

What is the CDSCO's 'Not of Standard Quality' Alert?

The Central Drugs Standard Control Organisation (CDSCO) is responsible for regulating and ensuring the quality of pharmaceuticals in India. Each month, they conduct random checks on medications available in the market to assess their compliance with safety standards. Drugs found to be substandard are categorized under the "Not of Standard Quality (NSQ)" alert. However, what does this mean for the typical customer?

Why Are These Quality Alerts Important?

NSQ alerts are crucial because they help identify potentially harmful drugs before they cause widespread damage. The list of flagged drugs serves as a warning to healthcare professionals, pharmacies, and patients to avoid certain batches or products. With over 53 medications on the latest list, concerns have been raised over the reliability of some of the country's most trusted pharmaceutical companies.

Paracetamol, Pan D, and Other Top-Selling Drugs on the List

Among the most widely used drugs that failed the CDSCO’s quality tests are paracetamol (a popular pain reliever), Pan D (used for acid reflux), and Glimepiride (a common anti-diabetic drug). Other medications flagged include Telmisartan (for high blood pressure), Shelcal (a calcium and vitamin D3 supplement), and Metronidazole (an antibiotic used to treat infections).

The Impact of Substandard Paracetamol on Public Health

Paracetamol, known for its efficacy in treating pain and fever, is one of the most commonly prescribed and over-the-counter drugs worldwide. However, the substandard quality of this medication could lead to inadequate treatment, potential overdoses, and liver damage if not taken cautiously.

According to the CDSCO report, paracetamol tablets manufactured by Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL) were among those flagged for failing to meet safety standards. This raises significant concerns, as millions rely on this drug for pain management.

Pan D Fails Quality Test: What This Means for Acid Reflux Patients

Pan D, a popular antacid used to treat acid reflux and indigestion, also failed the CDSCO’s stringent quality checks. Manufactured by Alkem Laboratories, this drug has been deemed "spurious" by a Kolkata-based laboratory. The failure of Pan D raises concerns for individuals who regularly use it for gastrointestinal issues, as substandard medication could exacerbate conditions rather than alleviate them.

Which Pharmaceutical Companies Are Involved?

Some of India's leading pharmaceutical companies are under scrutiny due to the NSQ alert. Among the most prominent names are Alkem Laboratories, Hetero Drugs, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, and Meg Lifesciences. These companies have manufactured many of the drugs flagged in the report, prompting investigations into their quality control processes.

Alkem Laboratories and the Issue with Clavam 625 - Clavam 625, an antibiotic produced by Alkem Laboratories, is one of the many drugs flagged in the CDSCO’s report. This drug, often prescribed for bacterial infections, was found to be spurious in quality checks. Given the widespread use of antibiotics like Clavam 625, the implications of such a failure are far-reaching, especially in terms of treatment efficacy and the potential rise in antibiotic resistance

Shelcal: Calcium Supplement Failure and Its Consequences - Shelcal, a widely used calcium and vitamin D3 supplement, also did not meet the required standards. Manufactured by Pure & Cure Healthcare and distributed by Torrent Pharmaceuticals, this product is relied upon by many for bone health, particularly among the elderly. Substandard supplements can lead to deficiencies and other health complications.

The Regulatory Response and Manufacturer Denials

In response to the NSQ alerts, several pharmaceutical companies have issued statements denying responsibility for the flagged products. Companies like Sun Pharma, Glenmark, and Macleods Pharmaceuticals have all claimed that the batches tested were not produced by them, suggesting that the drugs in question might be spurious.

Spurious or counterfeit drugs have become an increasing concern in the global pharmaceutical market. These drugs are either falsely labeled, substandard, or contain incorrect or harmful ingredients. The presence of spurious drugs can lead to ineffective treatments and even fatal outcomes. With many manufacturers denying the production of the flagged drugs, the CDSCO is now tasked with investigating whether counterfeit drugs have infiltrated the market.

The Broader Impact on Public Health

For patients, the implications of substandard drugs are significant. Medications that fail to meet quality standards can result in ineffective treatment, prolonged illness, and in severe cases, life-threatening reactions. For those relying on medications for chronic conditions like diabetes or high blood pressure, the use of substandard drugs can have long-term health consequences.

What Steps Should Patients Take?

Patients who are currently taking any of the drugs listed in the CDSCO’s report should consult with their healthcare providers immediately. Doctors and pharmacists can provide alternative medications or advise on whether patients need to switch to a different batch of the same medication.

What Is Being Done to Address the Issue?

  • CDSCO’s Role in Ensuring Drug Safety - The CDSCO conducts random quality checks on medications to ensure their safety and efficacy. Following the release of the NSQ alerts, the regulatory body has banned 156 fixed-dose drug combinations (FDCs) in the Indian market, citing "likely risks to humans." These FDCs include popular fever medications, painkillers, and allergy tablets like Cheston Cold and Foracet.
  • The Need for Stricter Quality Control Measures - The latest NSQ alert has highlighted the need for stricter quality control measures within India’s pharmaceutical industry. Manufacturers must adhere to higher standards of safety and efficacy to prevent further incidents of substandard drugs reaching the market.

References:

  1. Paracetamol, Pan D among 53 medicines to fail drug regulator's quality test
  2. Antacid Pan D, Paracetamol, Glimepiride among over 50 drugs that fail quality test
  3. Paracetamol among 53 drugs to fail quality test