Who regulates medicines in India, and the drug schedules

Prelims and MainsCurrent affairs on this: Drugs, diagnostics and medical technology

Medicines are governed by the Drugs and Cosmetics Act, 1940 and its 1945 Rules, and four bodies divide the work. The Central Drugs Standard Control Organisation, under the Drugs Controller General of India in the Health Ministry, approves new drugs and clinical trials, licenses imports and sets quality rules; State licensing authorities license manufacture and sale within the State, so quality enforcement varies by State. The Indian Pharmacopoeia Commission writes the standards a drug must meet and runs the pharmacovigilance programme that collects adverse event reports. The National Pharmaceutical Pricing Authority, under the Department of Pharmaceuticals, fixes prices of essential medicines under the Drug Price Control Order using the National List of Essential Medicines (NLEM). The schedules to the Rules decide how a drug is sold: Schedule H needs a prescription, Schedule H1 needs a prescription and a register, Schedule X needs a prescription in duplicate and locked storage.

Who does what for a medicine in India

Body	Ministry	Law	Does	Example in the news
CDSCO (DCGI)	Health and Family Welfare	Drugs and Cosmetics Act, 1940; NDCT Rules 2019	approves new drugs and trials, licenses imports, sets quality norms	cough syrup export testing
State licensing authorities	State health departments	Drugs and Cosmetics Rules, 1945	license manufacture and sale, inspect units	substandard drug alerts
Indian Pharmacopoeia Commission	Health and Family Welfare	Drugs and Cosmetics Act	writes the Pharmacopoeia, runs pharmacovigilance (PvPI) and materiovigilance	reference substances
NPPA	Department of Pharmaceuticals, Chemicals and Fertilisers	DPCO 2013 under the Essential Commodities Act	fixes ceiling prices of NLEM medicines	price caps on stents and cancer drugs

Approval is central, manufacturing licences are State, standards and prices sit with two other bodies; most drug quality failures fall in the gap between the first two.Source: Drugs and Cosmetics Act and Rules; DPCO 2013

Schedules that matter for the exam: G (habit forming, caution label), H (prescription only), H1 (added in 2013: third and fourth generation antibiotics, anti tuberculosis drugs and some habit forming drugs; the chemist keeps a register for three years and the pack carries a red border warning), X (narcotic and psychotropic, double lock, duplicate prescription), M (good manufacturing practice, revised in 2023 to WHO standards after the cough syrup deaths abroad), Y (clinical trials), J (diseases no drug may claim to cure).
New drugs and trials run under the New Drugs and Clinical Trials Rules, 2019; medical devices under the Medical Devices Rules, 2017, which classify devices into four risk classes, A to D with D the highest: Class B covers low to moderate risk items such as blood pressure monitors, hypodermic needles and pulse oximeters, and Classes C and D cover cardiac stents and hip and knee implants; materiovigilance is the device counterpart of pharmacovigilance.
Pricing: the DPCO 2013 caps the price of each NLEM medicine at the average of brands with over one per cent market share; NLEM 2022 lists 384 medicines; scheduled drugs may rise only with the wholesale price index.
The recurring failures: substandard drugs from small units licensed by States, which the Centre cannot inspect without the State; diethylene glycol in cough syrups; antibiotics sold without prescription despite Schedule H1.
Reform on the table: a Drugs, Medical Devices and Cosmetics Bill to replace the 1940 Act was published in draft in 2022 and has not been enacted.

Mains: India makes a fifth of the world's generic medicines under a law written in 1940 that splits approval from manufacturing licences, so the quality failures that reach the news are failures of the split, not of the science.