Drugs and Cosmetics Act – Lesson 2 – Schedules A-F

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Drugs and Cosmetics Act – Lesson 2 – Schedules A – F

The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India.

Schedules of Drugs  and Cosmetics Act

Schedule A: Forms and applications

Schedule B: Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories

Schedule C: Biological and Special Products

Schedule C(1): Other Special Products

Schedule D: Class of Drugs: Extent and conditions of exemption

Schedule D(I): Information and undertaking required to be submitted by the manufacturer of his authorized agent
application form for a Registration Certificate. The format shall be properly filled in for each application in Form 40.

Schedule D(II): Information required to be submitted by the manufacturer or his authorized agent with the application for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly and the detailed information, secret in nature, may be furnished on a computer floppy.

Schedule E: Omitted

Schedule E(1): List of Poisonous Substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine

Schedule F: Part I to Part XII-A – Omitted

Part XII-B: Requirements for the functioning and operation of a Blood Bank and / or for preparation of Blood Comp
(I) Blood Banks / Blood Components
(II) Blood Donation Camps
(III) Processing of Blood Components from whole blood by a Blood Bank

Part XII-C:
(I)  Requirements for manufacture of Blood Products
(II)  Requirements for manufacture of Blood products from bulk finished products

Part XIII: General
Schedule F(I):
Part I: Vaccines
(A) Provisions applicable to the production of Bacterial Vaccines
(B) Provisions applicable to the production of Viral Vaccines
Part II: Antisera
Provisions applicable to the production of all sera from living animals

Part III: Diagnostic Antigens
Provisions applicable to the manufacture and standardization of Diagnostic Agents (Bacterial Origin)

Part IV: General

Schedule F(II): Standards for Surgical Dressings

Schedule F(III): Standards for umbilical Tapes Schedule FF: Standards for Ophthalmic Preparations

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