49 medicines, including paracetamol, available in market, found to be substandard

As many as 49 medicines regularly prescribed by doctors for various conditions, including metformin for diabetes, pantoprazole for acidity, and paracetamol for fever, have been found to be substandard, while four have been classified as spurious in a monthly sampling by the apex drug regulator.

The Central Drugs Standard Control Organisation (CDSCO) has recently released alarming findings from its monthly survey, revealing that 49 medicines have been classified as substandard, with an additional four identified as spurious. This extensive survey, which included random sampling from the market, highlights serious concerns regarding the quality of medications available to the public.

In September, a total of 67 drugs were flagged as 'not of standard quality' (NSQ). The CDSCO’s laboratories discovered 49 of these drugs to be NSQ, while state laboratories identified 18. During the month, the CDSCO collected approximately 3,000 samples for testing, with the results of these investigations made public on October 25. Each month, the CDSCO releases findings from its random sampling conducted in the preceding month, which aims to maintain safety and efficacy in the pharmaceutical sector.

The list of NSQ drugs includes widely used medications such as metformin for diabetes, pantoprazole for acidity, and paracetamol for fever. The monthly reports not only serve to inform the public but also to hold pharmaceutical companies accountable for maintaining quality standards. According to the Drugs and Cosmetics Act, 1940, drugs can be categorized into three main groups: contaminated or adulterated drugs, spurious drugs, and substandard drugs.

Contaminated drugs pose significant health risks as they contain harmful adulterants, while spurious drugs are counterfeit products that bear the label of a legitimate company but are not actually manufactured by that company. Substandard drugs, however, contain active ingredients that do not meet the required potency, which can compromise their effectiveness in treating health conditions. This categorization is critical as it outlines the nature of the risk posed by different types of poor-quality drugs.

An analysis of the September findings revealed that six companies appeared in both August and September lists, indicating a troubling pattern of repeated offences. These companies include Hindustan Antibiotics, Life Max Cancer Laboratories, Alkem Health Sciences, Digital Vision, Nestor Pharmaceuticals, and Kerala Medical Services Corporation. Additionally, four other firms—Zee Laboratories, ANG Lifesciences India, Himalaya Meditek, and Protech Telelinks—had their names listed only in September but had multiple products deemed substandard.

The investigation conducted by the CDSCO and state regulators uncovered that a significant portion of the NSQ drugs are prevalent in various therapeutic categories. These include anti-hypertensive drugs like telmisartan, antibiotics such as metronidazole and gentamycin, calcium and vitamin supplements, antacids, antidiabetics, cough syrups, and pain-relief medications like diclofenac and nimesulide. Many of these drugs failed key quality assurance tests, including assay tests to measure active ingredient content, dissolution tests to assess how well the drugs dissolve in the body, and endotoxin tests to ensure sterility.

The implications of these findings are substantial, particularly for patient safety. The CDSCO clarifies that if a drug's name appears in the list, it does not imply that all versions of that drug from every manufacturer are substandard. The issue pertains specifically to the manufacturers linked to the NSQ drugs identified in the investigation. Companies listed have been served notices and urged to withdraw their NSQ drugs from circulation; however, there remains uncertainty regarding whether these withdrawals were effectively implemented.

Guidelines set by the Drugs Consultative Committee (DCC) stipulate that in cases where drugs are grossly substandard, further action may be warranted, including legal proceedings if evidence of criminal intent or gross negligence is established. Yet, there is a lack of transparency regarding the enforcement of these measures and whether any manufacturers have faced significant repercussions for their failures to comply with quality standards.

Despite the severity of these findings, health officials stress that the monthly alerts should not incite panic. Patients are advised to refrain from using only those medicines from specific batches highlighted by the CDSCO. The organization continues to monitor drug quality and issues notifications to manufacturers to ensure necessary actions are taken to uphold safety and efficacy.