The Central Drugs Standards Control Organisation (CDSCO) has raised safety concerns after declaring over 50 widely used drugs, including paracetamol, Pan D, and calcium supplements, as ‘not of standard quality’ (NSQ). The findings were part of CDSCO’s August 2024 report, which generated alarm over the quality of essential medications used by millions in India.
Key Medications Fail Quality Checks
Among the medications flagged in the NSQ Alert category are some of the most commonly used drugs in India. These include paracetamol tablets (IP 500 mg), a popular pain reliever, and Pan D, an anti-acid used to treat conditions like acid reflux. Calcium and vitamin D supplements, which are vital for bone health, have also been found to fall short of quality standards, including the popular Shelcal brand.
Several other medications failed the quality checks, including:
- Vitamin C and D3 supplements
- Vitamin B complex tablets
- Glimepiride, a commonly prescribed anti-diabetic drug
- Telmisartan, a medication used to treat high blood pressure
- Metronidazole, an antibiotic used for stomach infections
These drugs were produced by various pharmaceutical companies, including major players like Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Pure & Cure Healthcare, and Meg Lifesciences.
Spurious Drugs and Manufacturer Responses
A Kolkata-based drug-testing laboratory played a pivotal role in identifying several antibiotics as spurious, including Clavam 625 and Pan D. Medications meant for children, such as Cepodem XP 50 Dry Suspension, were also flagged as failing the quality test.
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In a response to the findings, manufacturers of certain drugs, including Pulmosil, denied involvement in producing the faulty batches. According to the company, “The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious; however, the same is subjected to the outcome of the investigation.”
Broader Implications and the Recent Ban on Fixed-Dose Combinations
This revelation comes just months after the CDSCO imposed a nationwide ban on over 156 fixed-dose drug combinations, citing a “likely risk to humans.” The widespread failures in drug quality control underscore growing concerns about the safety and regulation of medications in India.
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The drugs flagged in the latest NSQ Alert were identified through random sampling carried out by state drug officers. Such quality control checks are crucial in ensuring the safety of drugs circulating in the Indian market. However, the increasing number of drugs failing these tests suggests that more stringent regulatory measures are needed to protect consumers.
A Growing Public Health Concern
The declaration of over 50 drugs as ‘not of standard quality’ raises significant public health concerns, especially given the critical role many of these medications play in managing chronic conditions like diabetes and hypertension, as well as common health issues like pain and acid reflux.
Consumers are urged to exercise caution and consult healthcare professionals before continuing to use any of the drugs mentioned in the CDSCO’s report. Meanwhile, the central regulator continues its investigation into spurious drugs, as well as efforts to improve the overall quality and safety of medicines available in India.
