Legal Definitions of Schedules (Under the Act and Rules)

• Legal Definitions of Schedules under the Drugs and Cosmetics Rules, 1945, framed under the Act and Rules, are divided into various Schedules that specify requirements related to drugs and cosmetics.
• Some important Schedules include:

1. Schedule C and C(1)

   • Pertains to biological and special products like sera, vaccines, insulin, and other biological products. They have stricter storage and licensing requirements.

2. 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.”

3. Schedule H

   • Specifies prescription drugs that cannot be sold without a valid prescription of a qualified doctor.

4. Schedule H1

   • Introduced to curb misuse of certain antibiotics, psychotropic substances, and other medicines.
   • It mandates even more stringent record-keeping than Schedule H.

5. Schedule X

   • Pertains to certain habit-forming drugs such as barbiturates. Requires special prescription and record-keeping procedures.

6. Schedule M

   • Provides Good Manufacturing Practices (GMP) requirements for factory premises, plant, and equipment for manufacture of drugs.

7. Schedule M-II

   • Similar to Schedule M but specifically for cosmetics, detailing GMP requirements for cosmetics manufacturing.

8. Schedule Y

   • Provides requirements and guidelines for clinical trials of new drugs, including data submission, ethical considerations, and approval processes.

9. Schedule T

   • Lays down GMP 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.

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