In disturbing news for public health in India, the Central Drugs Standard Control Organization (CDSCO) tested all drug samples from 112 (112) NSQ drug samples (Not of Standard Quality), resulting from the joint work done during September.
The worrying breakup occurred since 49 of these samples failed quality tests, mostly sited in the state of Himachal Pradesh, which is a major hub for pharmaceutical manufacturing. This is in keeping with the misfortune suffered by the country over the past from events where poor quality medication was blamed.
This brings the country to an alarming national level in drug regulatory mechanism failures and quality control standards. Several therapeutic classes were highlighted among the samples declared NSQ, including those more essential medicines, i.e. antibiotics and formulations for long-term or chronic conditions, such as hypertension, the sheer number of failures from one state points toward endemic compliance issues within its manufacturing ecosystem, which now threatens patient safety at the national level.
Regulatory Oversight and Drug Quality
The Central Drugs Standard Control Organization’s monthly post-market surveillance revealed that the 112 failed samples were flagged in central and state laboratories; the overwhelming majority of failures were designated ‘Not of Standard Quality,’ pointing to failures in meeting any one of the multiple quality parameters mandated by the Indian Pharmacopoeia.
These include such critical quality attributes as Assay failure-the active-ingredient content of the drug is outside limits allowed, plus dissolution rates and sterility and injections. Any of these deficiencies can impair effectiveness, and in some cases, they threaten health directly.
The report also pointed to one ‘spurious’ cough syrup from Chhatt isgarh, which signifies a parallel threat of counterfeit medicines in the supply chain.
Himachal’s Manufacturing Hotspot
The fact that 49 samples have failed the test in Himachal Pradesh sheds light on the pharmaceutical industry of the state. Himachal Pradesh is an essential hub of manufacture in the Indian pharmaceutical market, having a very high number of units manufacturing units in areas like Baddi. High incidences of quality failure in this region signify that the problem is systemic and not restricted to isolated batch failures.
Experts point toward the possibility of a lack of consistency in the enforcement of Good Manufacturing Practices (GMP) and a stretch to the capacity of the regulatory body for thorough and unannounced inspections.
In this case, urgent remedial action and an extensive audit are called upon to restore public faith and also safeguard those patients who rely on the integrity of medicines from this important pharmaceutical belt
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A recent media graduate, Bhumi Vashisht is currently making a significant contribution as a committed content writer. She brings new ideas to the media sector and is an expert at creating strategic content and captivating tales, having working in the field from past four months.
