Amendment to Drugs Rules, 1945 (Health, Diseases and Biotechnology)
Amendment to Drugs Rules, 1945 (Health, Diseases and Biotechnology)
Why In News:
The Centre amended the Drugs Rules, 1945 to remove an exemption that had previously allowed the sale of certain cough syrups without prescription in small villages and areas with limited pharmacy access. This effectively makes all cough syrups prescription-only.
Legal Framework: Drug Regulation in India
Drugs and Cosmetics Act, 1940: Primary legislation governing manufacture, distribution, sale, and import of drugs and cosmetics in India.
Drugs Rules, 1945: Delegated legislation (rules) under the 1940 Act, including drug schedules that classify medicines by prescription requirements.
Schedule H drugs: Can only be sold on the written prescription of a Registered Medical Practitioner (RMP). Most antibiotics, psychotropics, and habit-forming drugs fall under this schedule.
Schedule H1: A stricter sub-category covering antibiotics and habit-forming drugs; pharmacists must maintain a separate register.
Schedule X: Drugs with high abuse and addiction potential (e.g., specific narcotics and sedatives).
Regulatory body: Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare.
Why This Amendment Matters
The earlier exemption allowed sale of certain cough syrups and antihistamines in remote villages without prescription, citing poor healthcare access. Critics argued this enabled misuse of codeine-based cough syrups, which have opioid properties.
India is the world's third-largest pharmaceutical producer by volume and largest generic drug exporter. Regulatory credibility is essential for sustaining India's $30 billion pharma export industry.
Key Facts for Prelims
CDSCO: Central Drugs Standard Control Organisation; headed by the Drugs Controller General of India (DCGI); national regulator for drugs, medical devices, and clinical trials.
Pharmacovigilance Programme of India (PvPI): Monitors Adverse Drug Reactions (ADRs) through a national network; helps identify unsafe drug combinations and regulates recalls.
State Drug Controllers: Each state has a separate State Drug Control Organisation; drug regulation in India is a concurrent function between CDSCO and state regulators.