Spurious or NSQ: How India’s drug industry is evading regulatory action?
While spurious drugs and not-of-standard quality are distinct by definition, medical experts agree that both zero-ingredient and substandard medicines are equally harmful in terms of treatment.
In a damage control effort following the latest product inspection report by India’s drug regulator, the pharmaceutical industry has issued statements that further confuse patients.
While individual drug manufacturers whose brands appeared in the August drug alert attribute the situation to the presence of spurious drugs in the market, an industry lobby contends that the real issue is the misrepresentation of the term "not-of-standard quality (NSQ)" as synonymous with "spurious" drugs. They assert that no spurious products should be linked to the industry and that the concerns over NSQ are being exaggerated.
While spurious drugs and NSQs are distinct by definition, medical experts agree that both zero-ingredient and substandard medicines are equally harmful in terms of treatment.
The Central Drugs Standard Control Organisation (CDSCO) published its August inspection report last week, naming several commonly used drug brands found to be of either NSQ or spurious quality. The alert identified leading brands such as Clavam 625 (antibiotic), Pan-D (antacid), Pulmosil Injection (hypertension), Pantocid (antacid), Telma H (blood pressure), Deflazacort (muscular dystrophy), and Paracetamol IP (anti-pyretic) among others.
The Indian Pharmaceutical Alliance (IPA) expressed deep concern over what it described as a gross misrepresentation and distortion of facts by certain media outlets regarding the CDSCO's drug alert. The IPA stated that misleading coverage irresponsibly conflates “not of standard quality” with “spurious,” unfairly implicating legitimate manufacturers in the production of counterfeit drugs.
One of the companies named in the CDSCO alert, Alkem Laboratories, denied the claims regarding its brands' quality. Alkem stated that the samples listed in the CDSCO report are spurious and not manufactured by them. The company emphasized the existence of counterfeit drugs as a significant concern, yet it appears the IPA's primary focus is not on the potential health risks posed by NSQ medicines.
The IPA highlighted that manufacturing spurious drugs is a serious criminal offense that endangers public health. The association pointed out that linking legitimate manufacturers with spurious products can severely damage reputations and have financial repercussions, ultimately tarnishing India’s standing as a reliable supplier of medicines globally. “It is critical that a clear distinction between NSQ and spurious drugs is made,” the IPA stated.
The IPA will continue to collaborate with the government to strengthen systems and implement stringent measures against spurious drugs. This issue is vital for both India’s global reputation and public health protection.
Alkem Laboratories also refuted the CDSCO claims regarding its products Pan-D (sales of Rs 2,803 million in the first half of 2024) and Clavam 625 (sales of Rs 2,657 million in the first half of 2024), stating that the batches in question are not-of-standard quality. The company emphasised its commitment to quality and patient safety, asserting that all its products adhere to current good manufacturing practices (cGMP).
"In its investigation, Alkem compared the CDSCO’s samples with its actual product batches and found significant differences in physical appearance, color, and labeling. The company has submitted a response to the CDSCO, including an assessment report confirming that the samples collected are indeed spurious and not manufactured by Alkem," the company claimed.
CDSCO inspectors regularly collect samples from medicines sold in the domestic market, issuing alerts on its website after testing them in competent laboratories. While the regulator’s findings are factual, it is crucial for both the industry and the regulator to address these issues effectively to protect public health.
