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Schedules of Drugs & Cosmetics Act from A to Y with their short description used in Indian
pharmaceutical manufacturing.
Ankur Choudhary | Regulatory | Print | Question ForumBe the first to comment!
Indian pharmaceutical GMP guidelines are given in Drugs & Cosmetics Act 1940. Rules are
given for pharmaceuticals and schedules are there to comply those rules.
MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) updates this time
to time. Pharmaceutical industries in India those are manufacturing the drug products
for domestic market have to follow the Drugs & Cosmetics Act.
properly filled in for each application in Form 40. The detailed information, secret in nature, may
be furnished on a computer floppy.
Schedule D(II): Information required to be submitted by the manufacturer or his authorized
agent with the application form for the registration of a bulk drug/formulation/special product for
its import into India. The format shall be properly filled in 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 Components
(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 II: 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