Unit 1: Drugs and Cosmetics Act, 1940 & Rules, 1945

Definition

The Drugs and Cosmetics Act, 1940, along with its Rules of 1945, is the cornerstone of pharmaceutical regulation in India. It establishes legal definitions, standards for drug quality, and regulatory mechanisms to ensure the safety, efficacy, and ethical manufacture and distribution of drugs and cosmetics.

1.1 Definitions (Section 3)

• “Drug”: Includes all substances intended for diagnosis, treatment, mitigation, or prevention of disease in humans or animals; covers bulk drugs, formulations, biologicals (vaccines, sera), and devices notified as drugs.

• “Cosmetic”: Any article intended to be rubbed, poured, sprinkled, or sprayed on, or applied to, the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.

• “Manufacturer”: Any person or company engaged in the production, propagation, cultivation, or preparation of drugs or cosmetics.

• Key Terms: “Sale,” “Distribute,” “Import,” and “Label” are all explicitly defined to prevent ambiguity in enforcement.

1.2 Schedules (Rule 67 onwards)

• Purpose: Classify drugs by risk, prescribing restrictions, or labelling requirements.

• Notable Schedules under the Act (expanded in Unit 2):

  • Schedule G: Insulin and oral hypoglycemics—label warning “to be sold by retail on the prescription of a Registered Medical Practitioner only.”

  • Schedule H: Prescription drugs—mandatory “Rx” symbol and legend restricting sale to prescription.

  • Schedule X: Drugs requiring stringent control (e.g., narcotics, psychotropics)—records of purchase and sale must be maintained for two years.

• Labelling & Packaging: Schedule M prescribes Good Manufacturing Practice requirements for facilities; Schedule D & D1 govern blood products and sera.

1.3 Import & Manufacture Licences (Sections 7–24)

• Licence to Manufacture for Sale:

  • Application: Submit Form 20 (homeopathic) or Form 24 (allopathic), with prescribed fees, to the State Licensing Authority.

  • Conditions: Premises, equipment, personnel, and quality control lab must comply with Schedule M standards.

  • Validity & Renewal: Typically valid for five years; renewal requires submission of renewal application before expiry.

• Import Licence:

  • Granting Authority: Central Licensing Authority (DCGI).

  • Requirements: Form 10, free sale certificate from exporting country, product dossier demonstrating safety, efficacy, and quality.

1.4 Offences & Penalties (Sections 27–32)

• Manufacture/Sale of Adulterated or Spurious Drugs:

  • Penalties: Imprisonment up to seven years and fines up to ₹10 lakh, escalating for repeat offenses.

• Violation of Licence Conditions:

  • Consequences: Suspension or cancellation of licence; possible prosecution for continued breach.

• Misbranding & False Labelling:

  • Definition: Claims about therapeutic efficacy not supported by data or failure to include mandatory legends.

  • Penalties: Imprisonment up to one year and fines.

• Import of Unapproved Substances:

  • Penalties: Seizure of consignment; prosecution under both the Act and Customs Act.

Key Takeaways for Exams

1. Articulate the statutory definitions of “drug” and “cosmetic” and their regulatory implications.

2. Summarize the purpose of major schedules under the Act and how they control risk and prescribing.

3. Describe the licensing process for manufacturing and importing drugs, emphasizing application forms, conditions, and authorities.

4. List principal offences (adulteration, spurious drugs, misbranding) and associated penalties to underscore the Act’s deterrent effect.

5. Explain how the Act’s framework—definitions, schedules, licensing, and penalties—works cohesively to safeguard public health.

Unit 2: Detailed Study of Schedules, Sale of Drugs, Labelling & Packing, Administration

Definition

This unit delves into the specific Schedules under the Drugs and Cosmetics Rules that categorize drugs by risk and manufacturing standards, and explains the statutory requirements for sale, labeling, packaging, and administrative responsibilities essential for regulatory compliance.

2.1 Detailed Study of Key Schedules

2.2 Sale of Drugs

2.2.1 Retail Sale Licenses

• Forms & Authorities:

  • Form 20B: Allopathic drugs; Form 21B: Non‑allopathic; issued by State Drug Controller.

• Conditions:

  • Qualified personnel (registered pharmacist) must be in charge.

  • Premises must meet storage, refrigeration (where applicable), and hygiene standards.

2.2.2 Schedule‑Based Restrictions

• Schedule H & X: Sale only against a valid prescription; records maintained in a bound register with prescriber’s name, patient name, drug name, and quantity dispensed.

• Schedule G: Insulins dispensed under prescription only; similar record‑keeping as Schedule H.

2.3 Labelling & Packing

2.3.1 Mandatory Label Elements

• Name of drug (generic and brand), strength, dosage form, batch number, manufacturing and expiry dates, net contents, manufacturing license number, and manufacturer’s name and address.

• Schedule‑specific Legends:

  • Schedule H/X: “To be sold by retail on the prescription of a Registered Medical Practitioner only.”

  • Schedule G: “Warning—It is dangerous to take this preparation except under medical supervision.”

2.3.2 Packaging Standards

• Primary Packaging: Material compatibility (e.g., amber glass for light‑sensitive drugs), child‑resistant closures for Schedule H and X.

• Secondary Packaging: Outer cartons must carry complete label information and batch details.

• Tamper‑Evidence: Seals, shrink bands, or blister packs to indicate possible breach.

2.4 Administration & Oversight

2.4.1 Regulatory Authorities

• Central Drugs Standard Control Organization (CDSCO): Central Licensing Authority for imports, clinical trials, and Schedule Y approvals.

• State Drug Controllers: Issue manufacturing and retail sale licenses; conduct factory and pharmacy inspections.

2.4.2 Inspections & Enforcement

• Routine Inspections: Verify compliance with Schedules M, F, and manufacturing license conditions.

• Sampling & Testing: Collect samples from market and manufacturing sites for pharmacopoeial testing.

• Penalties: Non‑compliance can lead to suspension/cancellation of licenses, seizures, and prosecutions under Sections 27–32 of the Act.

Key Takeaways for Exams

1. Differentiate the major Schedules by their focus (e.g., prescription control, GMP, clinical trials, blood products).

2. Explain the licensing and record‑keeping requirements for retail sale under Schedule H and X.

3. List all mandatory label elements and schedule‑specific legends required on drug containers.

4. Describe the roles of CDSCO and State Drug Controllers in licensing, inspection, and enforcement.

5. Apply knowledge of Schedules and labelling rules to ensure legal compliance and patient safety.

Unit 3: Major Pharmacy‐Related Legislations

Definition

This unit reviews key Acts beyond the Drugs and Cosmetics Act that shape pharmaceutical practice, from licensing of pharmacists to control of medicinal preparations and regulation of narcotics, ensuring ethical standards, public safety, and professional accountability.

3.1 Pharmacy Act, 1948

• Objective: Regulate the profession of pharmacy by setting standards for education, registration, and practice of pharmacists.

• Key Provisions:

  • Pharmacy Council of India (PCI): Statutory body to prescribe qualifications for pharmacists, conduct inspections of institutions, and maintain the Central Register of Pharmacists.

  • State Pharmacy Councils: Register pharmacists locally, enforce professional conduct, and handle disciplinary matters.

  • Educational Standards: Specifies minimum requirements for Diploma in Pharmacy (D. Pharm) and Bachelor of Pharmacy (B. Pharm) curricula.

  • “Pharmacist” Definition: Individual registered under the Act entitled to prepare, compound, and dispense drugs.

3.2 Medicinal & Toilet Preparations (Excise Duties) Act, 1955

• Objective: Exempt specified medicinal and toilet preparations from central excise duty to make essential drugs affordable.

• Key Features:

  • List of Exempted Items: Penicillins, streptomycin, vitamins, certain analgesics, soaps, shampoos, and toothpastes containing specified active ingredients.

  • Conditions of Exemption: Manufacturers must maintain detailed records and restrict sale of exempted goods to medicinal use, not for cosmetic or industrial purposes.

3.3 Narcotic Drugs and Psychotropic Substances Act, 1985 & Rules

• Objective: Implement India’s obligations under international drug control treaties by regulating cultivation, manufacture, possession, sale, and distribution of narcotics and psychotropics.

• Key Provisions:

  • Schedules of Controlled Substances:

    • Schedule I & II (NDPS Act): Heroin, opium, cocaine – highest control; use limited to medical/ scientific purposes with special permits.

    • Schedules of Psychotropic Substances (Rules): Amphetamines, benzodiazepines – regulated manufacture and distribution.

  • Licensing Requirements: Separate licenses for cultivation, production, transport, and dispensing; stringent record‐keeping and reporting.

  • Penalties: Ranging from fines to rigorous imprisonment, scaled by quantity trafficked and intent.

  • Authorities: Narcotics Commissioner at central and state levels to oversee implementation and enforcement.

Key Takeaways for Exams

1. Pharmacy Act: Understand the roles of PCI and State Councils, and the requirements for pharmacist registration and education.

2. Medicinal & Toilet Preparations Act: Know which products are exempt from excise duties and the conditions manufacturers must meet.

3. NDPS Act: Distinguish between narcotic and psychotropic schedules, licensing processes, and the severe penalties for violation.

4. Professional Impact: Recognize how these Acts collectively ensure qualified personnel, affordable medicines, and tight control over high‐risk substances.

Unit 4: Drugs and Magic Remedies (Objectionable Advertisements) Act, Prevention of Cruelty to Animals Act 1960, DPCO 2013 & NLEM

4.1 Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

Definition

This Act prohibits advertisements of “magic” remedies claiming to cure specified diseases and regulates legitimate medicinal advertising to protect consumers from misleading claims.

Key Provisions

• Prohibited Advertisements: Any claim that a drug can diagnose, cure, mitigate, or prevent conditions such as diabetes, cancer, tuberculosis, obesity, mental illness, or sexual impotence.

• Permitted Information: Factual details—generic drug name, dosage form, formulation strength, price, and true class of the drug (e.g., “antacid”).

• Penalties: First offense—fine up to ₹5,000; subsequent offenses—up to ₹10,000 or imprisonment up to six months.

4.2 Prevention of Cruelty to Animals Act, 1960

Definition

This Act and its Rules govern the ethical treatment of animals, including their use in scientific research and teaching, ensuring humane care and minimizing suffering.

Key Provisions

• Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA): Central authority to approve and monitor institutions’ animal facilities and experimental protocols.

• Institutional Animal Ethics Committee (IAEC): Local body reviewing each protocol to ensure adherence to the “3Rs”—Replacement, Reduction, and Refinement.

• Licensing: Mandatory for breeders, experimenters, and institutions; strict record‑keeping of species, numbers, and experimental procedures.

• Penalties: Violations attract fines up to ₹10,000 and/or imprisonment up to three years.

4.3 Drug Price Control Order (DPCO), 2013

Definition

DPCO 2013, issued under the Essential Commodities Act, empowers the government to regulate the prices of essential and life‑saving drugs to ensure affordability.

Key Features

• National List of Essential Medicines (NLEM): Prices of formulations containing drugs on the NLEM are capped; manufacturers must sell at or below the “ceiling price” calculated from average market prices.

• Price Revision: Ceiling prices are reviewed every five years or as needed based on market dynamics and inflation indices.

• Compulsory Licensing: Under DPCO, companies producing patented drugs can be compelled to license to other manufacturers to ensure supply at reasonable prices.

• Enforcement: State Drug Controllers monitor compliance; penalties include fines and withdrawal of manufacturing licenses for over‑pricing.

4.4 National List of Essential Medicines (NLEM)

Definition

NLEM is a periodically updated list of medicines considered to satisfy the priority healthcare needs of the population, guiding procurement, supply, and price regulation.

Key Criteria for Inclusion

• Public Health Relevance: High disease burden, clinical efficacy, safety profile.

• Evidence‑Based Selection: WHO‑aligned therapeutic value; cost‑effectiveness.

• Affordability & Accessibility: Essential for primary healthcare delivery; available in suitable dosage forms.

Applications

• Procurement & Supply: Central and State governments ensure these medicines are stocked in public health facilities.

• Insurance & Reimbursement: Insurers and government schemes prioritize NLEM drugs for coverage.

• Price Control: Drugs in NLEM automatically fall under DPCO price regulation.

Key Takeaways for Exams

1. Objectionable Advertisements Act: Recognize prohibited claims and the narrow scope of permissible drug advertising.

2. Prevention of Cruelty to Animals Act: Understand the roles of CPCSEA and IAEC in ethical animal research and the “3Rs” principle.

3. DPCO 2013: Explain how NLEM inclusion triggers price capping and the mechanisms for calculating and enforcing ceiling prices.

4. NLEM Utility: Appreciate how the list shapes drug procurement, reimbursement policies, and ensures equitable access to essential medicines.

Unit 5: Other Legislations & Committees

Definition

This unit reviews additional legal frameworks, advisory bodies, and ethical guidelines that influence pharmaceutical practice, public health policy, and research integrity in India.

5.1 Key Committees & Inquiries

5.1.1 Hathi Committee (1975)

• Mandate: Review pesticide residues in food and industrial chemicals, recommending permissible limits and monitoring protocols.

• Impact: Established tolerance levels for chemical residues, influencing safety standards for raw materials and excipients in pharmaceuticals.

5.1.2 Mudaliar Committee (1962)

• Mandate: Examine public health infrastructure and medical education post‑independence.

• Recommendations: Strengthened regulatory oversight of drug quality, promoted expansion of pharmacy and medical colleges, and laid groundwork for revising the Drugs and Cosmetics Act.

5.1.3 Drug Enquiry Committee (1948)

• Mandate: Investigate the state of indigenous drug production and recommend policies to encourage domestic pharmaceutical industry.

• Outcomes: Led to import controls, incentives for local manufacturing, and the development of public sector drug undertakings.

5.2 Ethical & Access‑Related Legislation

5.2.1 Code of Pharmaceutical Ethics (DCA Guidelines)

• Purpose: Provide principles for ethical promotion, dispensing, and patient counseling by pharmacists and industry.

• Key Tenets:

  • No inducements to prescribers or patients.

  • Accuracy and balance in drug promotional materials.

  • Confidentiality and informed consent in patient interactions.

5.2.2 Medical Termination of Pregnancy (MTP) Act, 1971

• Objective: Legalize abortion under specified conditions to safeguard women’s health.

• Conditions: Permits termination up to 20 weeks with the opinion of qualified medical practitioners; earlier gestation limits for single vs. two‑doctor approvals.

• Relevance: Pharmacists and manufacturers must ensure availability of approved abortifacient drugs (e.g., mifepristone, misoprostol) under regulated conditions.

5.2.3 Right to Information (RTI) Act, 2005

• Objective: Promote transparency by empowering citizens to request information from public authorities, including regulatory agencies (CDSCO, State Drug Controllers).

• Implications: Stakeholders can obtain data on licensing, inspection reports, clinical trial approvals, and drug safety notifications.

5.3 Intellectual Property Rights (IPR) in Pharmaceuticals

5.3.1 Patent Act, 1970 (Amended 2005)

• Scope: Patent protection for novel pharmaceuticals reduced to 20 years; allows process patents prior to 2005 and product patents thereafter.

• Flexibilities: Compulsory licensing provisions enable generic production of life‑saving drugs under public health grounds.

5.3.2 Trademark & Copyright

• Trademarks: Protect brand names and logos of pharmaceutical companies.

• Copyright: Applies to written materials (package inserts, promotional literature) and digital content.

5.3.3 Data Exclusivity & Regulatory Data Protection

• Concept: Confidential clinical trial data submitted for drug approval is protected from unfair commercial use for a limited period.

• Status: India does not currently provide formal data exclusivity, relying instead on patent protection.

Key Takeaways for Exams

1. Committees: Summarize the mandates and impacts of the Hathi, Mudaliar, and Drug Enquiry Committees on pharmaceutical regulation and public health.

2. Ethics & Access Laws: Explain how the Code of Pharmaceutical Ethics, MTP Act, and RTI Act shape professional conduct, drug availability, and transparency.

3. IPR Framework: Distinguish between process vs. product patents, understand compulsory licensing, and recognize the roles of trademarks and data protection.

4. Integration: Appreciate how these supplementary legislations and committees complement core drug laws to ensure ethical, accessible, and innovative pharmaceutical practice.