Drug Regulator Flags 49 Drugs for Substandard Quality, 1 Declared Spurious

Recently, the Central Drugs Standard Control Organization (CDSCO) issued an alert after finding that 49 drugs, including popular ones like Aspirin and Vitamin D3, have failed quality tests. The drugs were tested for dissolution and assay content, and most of the flagged drugs fell short in meeting the required standards. Out of the 1,273 drugs tested, 1,225 were declared to be of standard quality, while 48 were labeled as 'substandard,' and one drug was deemed 'spurious.'

Some of the manufacturers whose drugs were flagged include Maxheal Pharmaceuticals, Zee Laboratories, Hindustan Antibiotics Ltd., Cadila Pharmaceuticals, and Alkem Health Science (a unit of Alkem Laboratories Limited). One of the drugs declared spurious is Heparin injection, which is used to treat blood clots.

Among the flagged drugs are medications used to prevent and treat harmful blood clots, asthma, blood pressure, swelling caused by heart disease, cough, and peptic ulcers. Additionally, two nutritional supplements used to prevent hair loss and support the formation of red blood cells were also highlighted in the alert.

Notably, 12 of the 48 drugs linked to substandard quality are associated with pharmaceutical units in Himachal Pradesh. The drug regulator has taken action against some manufacturers, including ordering partial stop manufacturing for Zee Laboratories and Wings Pharma.

This news comes amidst growing concerns over drug quality in India, as the Minister of State, Ministry of Health and Family Welfare, revealed that a significant number of drug samples were found not of standard quality or spurious during the last reporting period.