Antibiotic Stewardship: A Complete Overview for Healthcare Professionals

Antibiotic stewardship refers to coordinated interventions designed to improve and measure the appropriate use of antibiotics by promoting the selection of the optimal antibiotic regimen including dosing, duration, and route of administration. The primary goals are to optimize clinical outcomes, minimize toxicity and adverse events, limit the development of resistance, and reduce unnecessary costs. Why Is Antibiotic Stewardship Important? Core

By Pharmacology Mentor

Tuberculosis and Its Treatment

Introduction Tuberculosis (TB) remains a major global health threat, caused by Mycobacterium tuberculosis (M.tb), a slow-growing, aerobic, acid-fast bacillus with a unique, lipid-rich cell wall conferring virulence and intrinsic drug resistance. Diagnosis relies on acid-fast stains, culture, PCR, and clinical criteria. TB is primarily pulmonary but can affect any organ. Increased risk is seen in immunosuppressed individuals, with airborne human-to-human transmission. Microbiology

By Pharmacology Mentor

Pharmacokinetics – What the body does to Drug?

Pharmacokinetics, derived from the Greek words 'pharmakon' meaning drug, and 'kinesis' meaning movement, is the science that elucidates what the body does to a drug following administration. Pharmacokinetics is the study of how drugs move through the body. It includes processes like absorption, distribution, metabolism, and excretion (ADME), which determine how much of the drug is present at its action

By Pharmacology Mentor
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Pharmacology of Anticholinergics: Atropine

Introduction Atropine—the prototypical naturally occurring belladonna alkaloid—has been used in medicine for well

By Pharmacology Mentor

Metronidazole: an antibiotic and antiprotozoal medication

Introduction Metronidazole is a widely used antimicrobial agent recognized for its efficacy against

By Pharmacology Mentor

Pharmacology of Vecuronium

Vecuronium is a non-depolarizing neuromuscular blocking agent utilized for muscle relaxation during

By Pharmacology Mentor

Pharmacology of Albendazole

Introduction Albendazole is a broad-spectrum anthelmintic widely used in both human and

By Pharmacology Mentor

Understanding Pharmacology: From Basic Principles to Nature of Drugs

Introduction Pharmacology is a multidisciplinary field that explores the interactions between chemicals

By Pharmacology Mentor

Antiretroviral Drugs

Introduction Antiretroviral drugs have revolutionized the treatment of HIV, turning what was

By Dr. Ambadasu Bharatha

Bronchial Asthma and its Treatment

Asthma Bronchial asthma is a condition characterized by bronchial hyperreactivity and inflammation.

By Pharmacology Mentor

Antiepileptic Drugs

Introduction Epilepsy is a chronic neurological disorder defined by recurrent, unprovoked seizures

By Pharmacology Mentor
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Over-the-Counter (OTC) Drugs in India: A Comprehensive Overview

Main Takeaway: India lacks a unified regulatory framework for OTC drugs, creating a complex landscape where medications not listed as prescription-only are sold over-the-counter. With 62.3% of urban populations practicing self-medication and an estimated market value of ₹188.6 billion, the CDSCO's upcoming 2025 OTC Drug Regulation represents a significant step toward establishing proper oversight and consumer safety. 1. Current Regulatory Status in India Absence of Unified OTC Framework Unlike Western countries, India currently lacks specific unifying regulations for OTC drugs. The term "OTC" has no legal recognition in Indian law. Instead, the regulatory approach follows a negative definition: drugs are considered OTC unless specifically listed as prescription-only medicines. Existing Drug Classification System Under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945, medications are categorized into different schedules: ScheduleDescriptionRequirementsSchedule HPrescription drugs"To be sold by retail only on prescription of a registered medical practitioner"Schedule H1Restricted prescription drugsStricter prescription requirementsSchedule XNarcotics and controlled substancesPrescription mandatorySchedule GCaution drugs (antihistamines)"Caution: it is dangerous to take this preparation except under medical supervision"Schedule KHousehold remediesCan be sold in villages with population below 1,000 Central Drugs Standard Control Organization (CDSCO) The Central Drugs Standard Control Organization (CDSCO), headed by the Drug Controller General of India (DCGI), serves as India's primary drug regulatory authority. CDSCO is responsible for: 2. The Upcoming 2025 OTC Drug Regulation Key Regulatory Changes The Over-the-Counter Drug Regulation India 2025 introduces several landmark changes: Schedule O Classification: Official categorization of OTC drugs into a new Schedule O Mandatory Labeling Requirements: Clear dosage instructions, warnings, and QR codes for consumer verification Advertising Restrictions: Ban on TV/radio advertisements for certain categories like antibiotics Online Sale Regulation: Only licensed platforms can sell OTC drugs with proper segregation from prescription medicines Approved OTC Medications Under 2025 Framework Drug CategoryApproved OTC MedicinesPain ReliefParacetamol, IbuprofenCold & FluCetirizine, ChlorpheniramineAntacids & DigestiveRanitidine, Antacid Gel, DigeneSkin CareCalamine lotion, Antifungal creamsVitamins & SupplementsVitamin C, B-complex, Iron tabletsOral RehydrationORS sachets, Electrolyte powders Important Exclusions: Antibiotics, steroids, and habit-forming drugs remain strictly excluded from OTC classification. 3. Popular OTC Brands and Market Leaders Major Indian OTC Brands Pain Relief Medications: Digestive Health: Cold and Respiratory: Market Size and Growth The Indian OTC market is valued at approximately ₹188.6 billion (US$ 2.7 billion) with a 9% CAGR, expected to reach ₹441.1 billion (US$ 6.5 billion). Major market players include: 4. Self-Medication Practices in India Usage Statistics Self-medication prevalence varies significantly across India: Common Reasons for Self-Medication Urban Population Motivations: Most Commonly Self-Treated Conditions: Medication Preferences Most Used OTC Medications: 5. Distribution Channels and Accessibility Traditional Pharmacy Chains Leading Retail Pharmacy Networks: Online Pharmacy Growth The e-pharmacy sector has experienced rapid expansion since 2016, with platforms offering:pmc.ncbi.nlm.nih 6. Traditional Medicine Integration AYUSH System Integration India's unique healthcare landscape includes traditional medicine systems regulated under the Ministry of AYUSH 7. Regulatory Challenges and Future Outlook Current Issues Regulatory Gaps: Safety Concerns: Progressive Regulatory Measures Recent Developments: Behind-the-Counter Medicines The DCC is introducing a "Behind the Counter" category for medicines that don't require prescriptions but must be sold "only under the supervision of a qualified pharmacist". 8. Impact on Healthcare Accessibility Benefits of OTC Availability Risks and Mitigation Strategies Public Health Risks: Proposed Solutions: The evolution of India's OTC drug landscape reflects the country's efforts to balance healthcare accessibility with patient safety. The 2025 regulatory framework represents a crucial step toward establishing international standards while addressing India's unique healthcare challenges and diverse population needs.

By Pharmacology Mentor

Pharmacology of Paracetamol/Acetaminophen

Introduction Paracetamol—known as acetaminophen in some regions—is one of the most widely used analgesics and antipyretics. Celebrated for its efficacy and relatively favorable safety profile compared to nonsteroidal anti-inflammatory drugs (NSAIDs) and

By Pharmacology Mentor