UPSC Drug Inspector case studies
UPSC Drug Inspector · Put your knowledge to work in context.
The UPSC Drug Inspector examination is a recruitment process conducted by the Union Public Service Commission to fill Drug Inspector posts in central government organisations such as the Central Drugs Standard Control Organisation. The role centres on enforcing the Drugs and Cosmetics Act and Rules: inspecting manufacturing and testing premises, reviewing records, drawing samples, and supporting licensing and enforcement decisions. The UPSC Drug Inspector case studies are 5 cases and about 4,814 words.
1A cefixime sample with a fake origin: substandard or spurious?
A Drug Inspector of the State Drugs Control Administration, during a routine inspection of a retail medical store, draws a sample of Cefixime 200 mg tablets (batch CFX-2417, manufacturing date 11/2024, expiry 10/2026) from a stock of 42 strip packs. The store holds a valid sale licence and produces a purchase invoice from a city wholesaler.
1,048 words, about 5 min2Three months of accelerated data and a requested 24-month shelf life
A manufacturer of Pantoprazole 40 mg enteric-coated tablets holds a Form 25 licence and currently declares a 12-month shelf life. It applies to the State Licensing Authority to extend the shelf life to 24 months, submitting data on three batches: 3 months at 40 ± 2 °C/75 ± 5% RH, and essentially no long-term data beyond the initial time point.
983 words, about 5 min3INR 8.2 after a course of fluconazole in a stable warfarin patient
A 62-year-old man with atrial fibrillation has been stable on warfarin 5 mg daily for three years, with INR values between 2.4 and 2.9. He develops oral candidiasis and a medical officer at a primary health centre prescribes oral fluconazole 150 mg once daily for 10 days; no INR monitoring is arranged.
907 words, about 5 min4Two positive sterility tests, a leaking HEPA filter and 5,200 vials already sold
An injectable unit manufactures Ceftriaxone sodium 1 g powder for injection, batch CRN-118, comprising 9,400 vials. Release testing by membrane filtration shows turbidity in 2 of 20 vials: one in fluid thioglycollate medium incubated at 35 °C on day 5, and one in soyabean casein digest medium at 22 °C on day 9.
914 words, about 5 min5Starch in the ashwagandha: an ayurvedic churna that is not what it claims
A Drugs Inspector (Ayurveda) draws a sample of 'Ashwagandha Churna' 100 g, batch ASH-09/24, from a unit holding a Form 25D manufacturing licence. The label declares 100% Withania somnifera root powder and a minimum total withanolide content.
962 words, about 5 min