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.
It contains 168 rules
from 1 to 168 and 25 Schedules from Schedule A to Schedule Y.
Different type of
forms are also given for different type of approvals from drug authorities.
Following are the
schedules:
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 with the application form for a
Registration Certificate. The format shall be 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) 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
Schedule FF: Standards for Ophthalmic Preparations
Schedule G:
Schedule H: Prescription Drugs
Schedule G:
Schedule H: Prescription Drugs
Schedule
I: Omitted
Schedule
J: Disease and ailment (by whatever name
described ) which a drug not purport to prevent or cure.
Schedule
K: Class of drug: Extent and conditions of
exemption
Schedule
L1: Good Laboratory Practice
Schedule
M: Good manufacturing practices and requirements
of premises, plant and equipment for
Pharmaceutical product.
Part
I: Good manufacturing practices for premises and
materials.
Part I-A: Specific requirements for manufacture of sterile products, parenteral preparation (small volume injectables and large volume parenterals ) and sterile ophthalmic preparation
Part
I-B: Specific
requirement for manufacturing of oral solid dosage forms (Tablet and Capsules).
Part
I-C: Specific
requirement for manufacture of oral liquids (Syrups, elixirs, emulsions
and suspensions).
Part
I-D: Specific
requirements for manufacture of topical products i.e. external preparation
(creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and
identical products)
Part
I-E: Specific
requirements for manufacture of metered-dose-inhalers (MDI)
Part
I-F: Specific
requirements of premises, plant and materials for manufacture of active
pharmaceutical ingredients ( Bulk Drugs ).
Part
II: Requirements
of plant and equipment.
Schedule
M-I: 1.
Requirements of factory premises for manufacture of homoeopathic preparations.
2. Requirements of
plants and equipments.
Schedule
M-II: Requirements
of factory premises for manufacture of cosmetic.
Schedule
M-III: Requirements
of factory premises for manufacture of medical devices.
Part
I-B: Specific requirement for manufacturing of oral solid dosage forms (Tablet and
Capsules).
Part
I-C: Specific requirement for manufacture of oral
liquids ( Syrup, elixirs, emulsions and suspensions).
Part
I-D: Specific requirements for manufacture of
topical products i.e. external preparation ( creams, ointments, pastes,
emulsions, lotions, solutions, dusting powders and identical products )
Part
I-E: Specific requirements for manufacture of
metered-dose-inhalers (MDI)
Part
I-F: Specific requirements of premises, plant and
materials for manufacture of active pharmaceutical ingredients ( Bulk Drugs ).
Part
II: Requirements of plant and equipment.
Schedule
N: List of Minimum Equipment for the Efficient
Running of a Pharmacy
Schedule
O: Standard for Disinfectant Fluids
Schedule
P: Life Period of Drugs
Schedule
P1: Pack Sizes of Drugs
Schedule
Q: List of Dyes, colours and Pigments permitted
to be used in Cosmetics and Soaps as given under IS : 4707 (Part I)-1988 as
amended by the Bureau of Indian Standards
Schedule
R: Standards for condoms made of rubber latex
intended for single use and other mechanical contraceptives
Schedule
S: Standard for cosmetics.
Schedule
T: Good manufacturing practices for Ayurvedic,
Siddha and all Unani medicines.
Schedule
U: I – Particulars to be shown in the
manufacturing records.
II – Records of
Raw Materials.
III – Particulars to be recorded in the
analytical records.
Schedule
U(I): I – Particulars to be shown in manufacturing
records.
II – Records
of Raw Material.
Schedule
V: Standards for patent or proprietary medicines.
Schedule
W: Omitted
Schedule
X
Schedule
Y: Requirements and guidelines for permission to
import and/or manufacture of New Drug for sale or to undertake clinical Trials.
