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Drug Policies in India

  1. Key Laws and Acts
    • Drugs and Cosmetics Act, 1940: Regulates drug manufacture, import, sale, and distribution to ensure safety, efficacy, and quality.
    • Pharmacy Act, 1948: Regulates the education and practice of pharmacists through the Pharmacy Council of India (PCI).
    • Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954: Prohibits false advertisements of drugs that claim to cure serious diseases like cancer, diabetes, etc.
    • Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985: Regulates the production, sale, possession, and trafficking of narcotic and psychotropic drugs.
    • Drug Price Control Order (DPCO), 2013: Controls the price of essential drugs listed in the National List of Essential Medicines (NLEM).
  1. Regulatory Bodies
    • Central Drugs Standard Control Organization (CDSCO): National drug regulator that approves new drugs and clinical trials.
    • National Pharmaceutical Pricing Authority (NPPA): Controls and regulates the prices of essential drugs.
    • Pharmacy Council of India (PCI): Regulates pharmacy education and ensures that only registered pharmacists can practice.
    • Narcotics Control Bureau (NCB): Enforces the NDPS Act and prevents drug trafficking and abuse.
  1. Drug Classification
    • Schedule H: Prescription drugs (require a doctor’s prescription).
    • Schedule H1: Strictly controlled drugs, requires prescription and sale record (antibiotics, habit-forming drugs).
    • Schedule X: Highly regulated drugs with abuse potential (like narcotics).
    • OTC (Over-the-Counter) Drugs: Can be sold without a prescription (like paracetamol, pain balms).
  1. Drug Pricing Policy
    • Essential drugs in the NLEM are price-controlled under the Drug Price Control Order (DPCO).
    • The NPPA fixes the maximum retail price (MRP) of essential drugs to make them affordable.
    • Companies cannot sell essential drugs above the government-determined ceiling price.
  1. Sale and Distribution of Drugs
    • Retail and wholesale pharmacies require licenses under the Drugs and Cosmetics Act, 1940.
    • E-pharmacies are subject to regulatory uncertainty but must comply with drug laws.
    • Prescription-only drugs (Schedule H, H1, and X) cannot be sold without a valid doctor’s prescription.
  1. Drug Abuse and Control
    • NDPS Act, 1985 controls narcotics and psychotropic substances.
    • Severe penalties for illegal trafficking, possession, and misuse of drugs.
    • Rehabilitation centers support the treatment and rehabilitation of drug addicts.
  1. Challenges in Drug Policy
    • Counterfeit Drugs: Ensuring the authenticity of medicines in the market.
    • E-Pharmacies: Regulatory uncertainty for online drug sales.
    • Substance Abuse: Tackling drug addiction and controlling the misuse of psychotropic drugs.
    • Drug Resistance: Overuse of antibiotics leading to antimicrobial resistance (AMR).
  1. Future Trends
    • Regulation of e-pharmacies to ensure safe online sales.
    • Price control on more patented drugs to make critical treatments (like cancer drugs) affordable.
    • Digital health initiatives to track drug prescriptions and prevent misuse.
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