The Drugs and Cosmetics Rules, 1945, framed under the Act, are divided into various Schedules that specify requirements related to drugs and cosmetics.
Some important Schedules include:
Schedule C and C (1) of Legal Definitions of Schedules
Pertains to biological and special products like sera, vaccines, insulin, and other biological products. They have stricter storage and licensing requirements.
Schedule G
Lists drugs that must be taken under medical supervision and carry the statutory warning: “Caution: It is dangerous to take this preparation except under medical supervision.”
Schedule H
Specifies prescription drugs that cannot be sold without a valid prescription of a qualified doctor.
Schedule H1
Introduced to curb misuse of certain antibiotics, psychotropic substances, and other medicines.
It mandates even more stringent record-keeping than Schedule H.
Schedule X
Pertains to certain habit-forming drugs such as barbiturates. Requires special prescription and record-keeping procedures.
Schedule M
Provides Good Manufacturing Practices (GMP) requirements for factory premises, plant, and equipment for manufacture of drugs.
Schedule M-II
Similar to Schedule M but specifically for cosmetics, detailing GMP requirements for cosmetics manufacturing.
Schedule Y
Provides requirements and guidelines for clinical trials of new drugs, including data submission, ethical considerations, and approval processes.
Schedule T
Lays down GMP for Ayurvedic, Siddha, and Unani medicines.
Schedule | Focus | Details |
C & C(1) | Biological products | Sera, vaccines, insulin, etc., with stricter storage and licensing requirements. |
G | Medical supervision drugs | Must carry a warning: “Dangerous without medical supervision.” |
H | Prescription drugs | Cannot be sold without a valid prescription. |
H1 | Antibiotics and psychotropic substances | Requires stricter record-keeping than Schedule H. |
X | Habit-forming drugs | Includes barbiturates; special prescription and record-keeping needed. |
M | GMP for drugs | Requirements for manufacturing premises, equipment, and practices. |
M-II | GMP for cosmetics | Similar to Schedule M but for cosmetics manufacturing. |
Y | Clinical trials | Guidelines for trials, data submission, ethics, and approvals. |
T | Traditional medicines (GMP) | GMP requirements for Ayurvedic, Siddha, and Unani medicines. |
Each Schedule details specific standards, labeling requirements, packaging norms, testing methods, and other compliance factors that manufacturers, importers, and sellers must follow.