Drugs and Cosmetics Act, 1940

Drugs and Cosmetics Act, 1940

Introduction

• The Drugs and Cosmetics Act, 1940 was enacted by the Government of India to regulate the import, manufacture, distribution, and sale of drugs and cosmetics.
• It ensures safety, efficacy, and quality of drugs and cosmetics available in India.
• The Act has undergone several amendments, especially after the Hathi Committee Report (1975), to strengthen drug regulation.
• Complemented by the Drugs and Cosmetics Rules, 1945, which provide detailed procedures for implementation.

Objectives of the Act

1. To regulate import, manufacture, distribution, and sale of drugs and cosmetics.
2. To ensure that drugs and cosmetics sold in India are safe, effective, and of standard quality.
3. To prevent the sale of substandard, adulterated, misbranded, and spurious drugs.
4. To lay down standards for clinical trials and use of investigational drugs.
5. To regulate the ayurvedic, siddha, and unani (ASU) drugs alongside allopathic medicines.
6. To control advertisement and false claims relating to drugs and cosmetics.
7. To protect the consumer’s right to safe healthcare products.

Definitions under the Act

1. Drug (Section 3(b)): Includes
• All medicines for internal or external use of human beings or animals.
• Substances intended to be used in diagnosis, treatment, mitigation, or prevention of disease.
• Substances other than food intended to affect the structure or function of the body.
• Devices intended for internal or external use in diagnosis, treatment, or prevention.
2. Cosmetic (Section 3(aaa)):
• Any article intended to be rubbed, poured, sprinkled, or sprayed on, or introduced into, the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.
3. Adulterated drug: A drug mixed with inferior substances, contaminated, or prepared in insanitary conditions.
4. Spurious drug: Drugs which are falsely labeled, imitations, or substitutes of another drug.
5. Misbranded drug: Drugs that are falsely labeled, misleading, colored, flavored, or lacking required warnings.

Salient Features

• Drug Technical Advisory Board (DTAB):
• Apex advisory body on technical matters relating to drugs regulation.
• Comprises experts from medical, pharmaceutical, and scientific fields.
• Drug Consultative Committee (DCC):
• Advises Central and State governments on matters of uniform enforcement of the Act.
• Central Drugs Laboratory (CDL):
• Acts as an appellate authority for drug testing and analysis.
• Licensing and Control:
• Mandatory licenses for manufacturing, import, and sale.
• Different schedules (A to Y) under Rules cover forms, records, labeling, clinical trials, etc.

Schedules under Drugs and Cosmetics Rules, 1945 (Important Ones)

• Schedule C & C1: Biological and special products (e.g., vaccines, sera, insulin).
• Schedule E1: List of poisonous substances (e.g., digitalis, ergot, aconite).
• Schedule F: Standards for biological products.
• Schedule G: Drugs to be used under medical supervision (antibiotics, hormones).
• Schedule H: Prescription drugs – sale only on prescription of a Registered Medical Practitioner (RMP).
• Schedule H1: Includes antibiotics, anti-TB drugs, psychotropic drugs – stricter control with prescription record maintenance.
• Schedule X: Narcotic and psychotropic substances – high abuse potential, special license needed.
• Schedule M: Good Manufacturing Practices (GMP) for pharmaceutical companies.
• Schedule Y: Requirements and guidelines for clinical trials, new drug approval.
• Schedule T: GMP requirements for Ayurvedic, Siddha, and Unani drugs.

Offences and Penalties

1. Manufacture/sale of adulterated/spurious drugs:
• Punishable with imprisonment (minimum 5 years, extendable to life) + fine (minimum ₹10 lakh or 3 times the drug’s value).
2. Misbranded drugs:
• Up to 1 year imprisonment + fine.
3. Manufacture without license:
• Up to 3 years imprisonment + fine.
4. Repeat offences:
• Higher penalties, cancellation of license, and disqualification from manufacturing or selling.

Application in Hospital and Healthcare Settings

• Hospitals must procure drugs only from licensed suppliers.
• Maintenance of pharmacy records as per Schedules.
• Use of prescription-only drugs (Schedule H, H1, X) under strict supervision.
• Storage of narcotic/psychotropic substances with special security and record-keeping.
• Hospitals participating in clinical trials must follow Schedule Y requirements (ethics committee approval, informed consent).
• Cosmetics used in hospitals (e.g., antiseptic creams, disinfectants) must conform to quality standards.

Relation to Other Laws

• Narcotic Drugs and Psychotropic Substances Act, 1985 – stricter control over addictive substances.
• Consumer Protection Act, 2019 – patients can sue hospitals/doctors for substandard or harmful drugs.
• Indian Penal Code (IPC) – Sections related to adulteration, negligence, and fraud apply.

Recent Developments

• Introduction of Online Pharmacy Regulations (draft 2018, ongoing debates).
• Strengthening of pharmacovigilance system for adverse drug reaction (ADR) monitoring.
• Digital tracking of Schedule H1 and Schedule X drugs to curb misuse.
• Alignment with global standards (WHO GMP, ICH-GCP for clinical trials).

Do’s and Don’ts for Healthcare Providers

Do’s

• Prescribe only licensed and approved drugs.
• Keep proper records for Schedule H1 & X drugs.
• Educate patients about dosage, risks, and side effects.
• Report adverse drug reactions to authorities.

Don’ts

• Do not prescribe or dispense drugs without valid license.
• Do not stock expired, spurious, or adulterated medicines.
• Do not advertise drugs claiming miraculous cures.
• Do not use unapproved or untested drugs in patients.

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