The Schedules in the Drugs and Cosmetics Act classify drugs based on various criteria, including their potential for abuse, control measures, and prescribing regulations.
Detailed Study of Important Schedules and Parts in The Drugs and Cosmetics Rules, 1945
Schedule G of (Study of Schedules)
Scope:
Lists drugs that must carry the legend: “Caution: It is dangerous to take this preparation except under medical supervision” on their label.
Examples:
Certain hormones, sulfonamides, and other drugs with significant adverse effects if used without medical guidance.
Importance:
Ensures the necessity for medical supervision and warns consumers about the risks of unsupervised use.
Schedule H
Scope:
Includes prescription drugs that can only be sold by retail on the prescription of a Registered Medical Practitioner (RMP).
Labeling Requirement:
Must display: “Schedule H drug – Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.”
Importance:
Controls misuse of potent medications and ensures dispensing only on valid prescriptions.
Schedule M
Scope:
Provides Good Manufacturing Practices (GMP) requirements for pharmaceuticals, including plant design, standards for premises, equipment, and operations.
Key Components:
Quality control systems.
Qualification and responsibilities of technical staff.
Hygiene requirements.
Self-inspection and quality audit protocols.
Importance:
Ensures consistent manufacturing standards for drugs to maintain safety, efficacy, and quality.
Schedule N
Scope:
Prescribes requirements for machinery, equipment, and premises for efficiently running a pharmacy.
Examples of Requirements:
Adequate space for storage and dispensing.
Proper facilities for cleanliness and order.
Importance:
Ensures pharmacies meet minimum standards to safely store and dispense drugs.
Schedule P
Scope:
Specifies the life period or shelf-life of drugs.
Key Details:
Defines the duration a drug remains fit for consumption under recommended storage conditions.
Importance:
Ensures consumers use drugs within safe time frames, reducing risks of degradation or reduced efficacy.
Schedule T
Scope:
Provides Good Manufacturing Practices for Ayurvedic, Siddha, and Unani medicines.
Focus:
Requirements for manufacturing premises and hygiene.
Quality control for traditional medicine preparation.
Importance:
Protects consumers by ensuring consistent quality in Indian traditional medicine systems.
Schedule U
Scope:
Specifies particulars to be shown in manufacturing records and records to be maintained by manufacturers of drugs.
Key Points:
Batch manufacturing records.
Analytical reports.
Distribution records.
Importance:
Facilitates traceability and quality checks, aiding in batch recalls or investigations of quality complaints.
Schedule V
Scope:
Covers standards for patent or proprietary medicines, including vitamin and mineral preparations.
Key Provisions:
Minimum requirements for vitamin and mineral content.
Labeling standards for patent or proprietary medicines.
Importance:
Ensures OTC products meet minimum standards of quality and labeling.
Schedule X
Scope:
Lists drugs requiring additional strict controls due to potential for abuse (e.g., psychotropic substances).
Requirements:
Strict control on manufacturing and distribution.
Special record-keeping for production, stocking, and sale.
Sold only against prescription (similar to Schedule H but more stringent).
Importance:
Prevents misuse or illegal trafficking of potent or habit-forming drugs.
Schedule Y
Scope:
Provides requirements and guidelines for clinical trials and new drug approvals in India.
Key Points:
Protocols for conducting clinical trials.
Ethical considerations, informed consent, and safety reporting.
Post-marketing surveillance requirements.
Importance:
Protects participants in clinical trials and ensures robust data for drug safety and efficacy.
Schedule F
Scope:
Sets standards for biological products such as vaccines, sera, immunologicals, and diagnostic agents.
Key Aspects:
Production standards and safety requirements.
Storage conditions and labeling specifics.
Quality testing and official release by recognized institutions (e.g., Central Drugs Laboratory).
Importance:
Ensures safety and potency of vaccines and biologicals, which have unique storage and handling requirements.
Part XII B
Context:
Related to requirements for import and registration of drugs for importers.
Focus:
Documents required for import registration.
Criteria for approval or rejection of imported drug licenses.
Importance:
Ensures imported drugs meet the same standards of quality, efficacy, and safety as domestic drugs.
DMR (OA)
DMR (OA):
Stands for Drug (Master Formula) Record (Oral Administration) or Drug Manufacturing Record (Oral Administration).
Purpose:
Document detailing formulation procedures, batch sizes, ingredients, and manufacturing steps for orally administered drugs.
Importance:
Maintains consistency in production and aids in tracing deviations from standard manufacturing practices.
Schedules Overview
Schedule | Description | Key Provisions/Examples |
G | Strict control drugs prone to abuse | Prescription required; e.g., morphine, codeine. |
H | Prescription drugs | Prescription mandatory; e.g., antibiotics. |
M | Manufacturing practices | GMP adherence, inspections. |
N | Narcotic and psychotropic substances | Special licenses; e.g., cocaine, LSD. |
P | Testing and standards | Quality verification for vitamins, OTC drugs. |
T | Medical devices regulation | Safety, labeling standards. |
U | Cosmetics regulation | Prohibits/restricts substances in cosmetics. |
V | OTC drugs | Direct sale allowed; e.g., paracetamol. |
X | High-abuse drugs | Strict control; e.g., heroin, fentanyl. |
Y | Clinical trials | Ethical guidelines, regulatory approvals. |
Part XII B | Import/export regulations | Licensing, inspections for transit safety. |
F | Essential drugs | Ensures availability; e.g., insulin, antibiotics. |
DMR (OA) | Advertisement regulations | Prohibits misleading claims in ads. |