The Central Drugs Standard Control Organization (CDSCO), the country's top drug regulator, has issued a new drug safety notice after discovering that 42 medication batches failed to pass a random drug sample test in September, while one medicinal sample was found to be misbranded.

'Not of Standard' medicines

These are some of the most commonly prescribed medicines that Indian doctors should take serious note of. These medication samples have been labelled as 'Not of Standard' because they don't meet FDA standards.

1. Domperidone and Pantoprazole are included in PENTALOC-D, a medication that combines the two. GERD (Gastroesophageal Reöux Disease) is treated with this medication combination.
2. In addition to Dexamethasone Sodium Phosphate Injection I.P, Paracetamol Tablets IP 650 mg, Rabeprazole Injection IP 20 mg, Gentamicin Injection IP – 2ml, and more.
3. In addition, COVID-19 medication Favipiravir tablets 400 mg (FAVIMAX-400) is also on the 'Not of Standard' list.

The Central Drugs Standard Control Organization (CDSCO) is India's version of the Food and Drug Administration (FDA). Medical equipment and medications are regulated by the CDSCO in India. Clinical trials are also overseen by the CDSCO as is the provision of expert advice on health problems and enforcement of the Indian Drug and Cosmetics Act.

The Drug Controller General of India (DCGI) is a CDSCO agency of the Indian Ministry of Health and Family Welfare responsible for medical device and drug regulation. It is the department's responsibility to carry out inspections audits post-market monitoring and recalls.

List of drugs declared as Not of Standard quality/spurious/adulterated/misbranded, for the month of September- 2021.

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Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.