Differentiate between the regulatory approach of the NDPS Act, 1985 and the Drugs Rules, 1945 in controlling substance misuse in India.

Q. Differentiate between the regulatory approach of the NDPS Act, 1985 and the Drugs Rules, 1945 in controlling substance misuse in India. (15 marks, 250 words)

India controls substance misuse through two distinct legal channels: the NDPS Act, 1985, a penal statute for narcotics and psychotropics, and the Drugs Rules, 1945 (under the Drugs and Cosmetics Act, 1940), which regulates legitimate medicines. Their divergence lies in what they target and how they enforce.

Nature and objective - NDPS Act: prohibitive, criminalising cultivation, manufacture, possession, sale and trafficking of narcotics and psychotropics, fulfilling India's UN convention obligations. - Drugs Rules, 1945: regulatory, ensuring safe access to therapeutic drugs while curbing over-the-counter misuse through scheduling [1].

Substances covered - NDPS: coca, opium, cannabis and listed psychotropic substances — inherently high-abuse agents. - Drugs Rules: legitimate medicines like antibiotics and Pregabalin, recently shifted to Schedule H1 for its sedative, euphoric misuse among youth [1].

Enforcement mechanism - NDPS: stringent — presumption of guilt, restrictive bail, and imprisonment; enforced by the Narcotics Control Bureau. - Drugs Rules: administrative control — sale only on a Registered Medical Practitioner's prescription, a separate retailer register kept three years, and mandatory warning labels [2].

Penal approach - NDPS: harsh, quantity-graded imprisonment. - Drugs Rules: milder penalties under the 1940 Act, favouring compliance over criminalisation [1].

Thus the two are complementary, not competing — NDPS shields society from narcotics, while the Drugs Rules balance patient access against prescription-drug abuse. Extending Schedule H1 to emerging misuse-prone drugs, backed by robust state drug-control capacity, offers a graduated public-health response aligned with SDG-3.

(~250 words)

Sources: 1. Union Health Ministry Brings Pregabalin Under Schedule H1 (PIB, 2026) — Pregabalin's Schedule H1 reclassification, misuse among youth, and the regulatory (vs penal) nature of the Drugs Rules. 2. Rules for Selling of Drugs Under Schedule H1 (PIB) — RMP prescription requirement, separate register, and three-year record retention.