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Drugs, diagnostics and medical technology

Drug approval and trials, the pharmacopoeia, substandard medicines, generics, prices, devices and pharmacovigilance. It serves GS3 answers on science and technology in health.

Foundation note: Who regulates medicines in India, and the drug schedules

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Pharmacovigilance: The monitoring of a medicine after it reaches the market, gathering reports of adverse effects so that harm which shows only in wide use is caught and acted on.

Materiovigilance: The same watch kept on medical devices after they reach the market, for faults and for the harm they cause in use.

Child sex ratio: Girls per 1,000 boys in the 0 to 6 age group.

Schedule K: The schedule of the Drugs Rules, 1945 that exempts specified classes of drugs from certain provisions of the Drugs and Cosmetics Act, 1940.

Fixed dose combination: A medicine with two or more active drugs combined in a fixed ratio in a single dosage form.

Schedule H2: The schedule of the Drugs Rules, 1945 listing drugs that must carry a QR code or bar code for track and trace.

Track and trace: A mechanism that follows every unit of a product from factory to retail store.

Virtual autopsy: A non invasive or minimally invasive examination of a deceased person using CT and MRI without extensive dissection.

Orphan drug: A medicine for a rare disease, neglected because its market is small.