3. First Schedule
List of approved Ayurvedic, Siddha and Unani books.
second Schedule
Standards to be complied with by imported drugs and by drugs manufactured
for sale, sold, stocked or exhibited in India.
5. Schedule A
Applications for licences for import, manufacturing and sale of Drugs and
Cosmetics, the forms in which the licences are granted and renewed and other
forms.
Schedule B
Fees for analysis of Drug and Cosmetics that have to be paid to the Central
Drug Laboratories or other Government Laboratories.
6. Schedule C
List of Biological and Immunological Products, Antibiotics and Ophthalmic
lotions and Ointments and all products for parenteral use (Injections).
Schedule C(I)
List of drugs from biological origin namely Alkaloids, Hormones, Vitamins and
Antibiotics for oral use.
7. Schedule D
Exemptions that have been granted to drugs and importers of drugs from
complying with the requirements of import of drugs and also conditions for
such exemptions.
Schedule E
List of poisons for which labelling and other requirements were to be complied
with. This schedule has been deleted.
SCHEDULE E (I)
List of poisonous substances under the Ayurvedic, Siddha and Unani Systems
of Medicines.
8. Schedule F
Special provisions to be complied with, for the manufacture, testing and labelling of biological products for human
use like Sera and Vaccines. These provisions have now been deleted.
The requirements for running Blood Banks and other requirements are now included.
Schedule F (I)
Special provisions to be complied with for the manufacture, testing and labelling of Veterinary Biological Products.
SCHEDULE F (II)
Standards for Surgical Dressings.
SCHEDULE F (III)
Standards for Umbilical tapes.
SCHEDULE FF
Additional Standards for Ophthalmic preparations.
9. Schedule G
List of drugs which should be used be patient under medical supervision and
which shall be labelled with words:
“Caution – It is dangerous to take this preparation except under medical
supervision.”
Schedule H
List of drugs which are to be sold by retail against the prescription of
Registered Medical Practitioner and which shall be labelled with words:
“Schedule H Drug – Warning: to be sold by retail on the prescriptions of a
Registered Medical Practitioner only.”
10. Schedule I
List of poisons of particulars about the proportion of poison in certain cases.
Schedule I was linked with Schedule E.
When Schedule E was deleted in 1982, Schedule I was also deleted.
Schedule J
Names of diseases and ailments (by whatever name described) which a drug
may not purpose to prevent or cure by means of claims made on the label of the
container of the drug.
11. Schedule K
Names of drugs or classes of drugs which are exempted from complying with
the provision for manufacture, sale and standards of drugs and the conditions
for such exemption.
Schedule L
List of drugs which are required to be sold by retail against the prescription of
a Registered Medical Practitioner.
Subsequently, the drugs listed in Schedule L were transferred to Schedule H.
Schedule L was deleted in 1982.
12. Schedule M
Good Manufacturing Practices (GMP) and the requirements of premises, plant and equipments of manufacture of drugs.
Part I – Good Manufacturing Practises for premises and materials.
Part I-A – Specific requirements for manufacture of sterile products, parenteral preparation and sterile ophthalmic
preparations.
Part I-B – Specific requirements for manufacturing of oral solid dosage forms (Tablets and Capsules).
Part I-C – Specific requirements for manufacture of oral liquids (Syrups, elixirs, emulsions and suspensions).
Part I-D – Specific requirements for manufacture of topical products i.e. external preparations (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.
13. Schedule M (I)
Requirements for factory premises of Homeopathic Medicines.
Schedule M(II)
Requirements for factory premises of Cosmetics.
Schedule M(II)
Requirements for factory premises for manufacture of Medical Devices.
14. Schedule N
List of minimum equipments, requirements of premises for the effective running
of a pharmacy.
Schedule O
Standards for Disinfectant fluids.
15. Schedule P
Life Period and Conditions of Storage of Drugs.
Schedule P (I)
Pack sizes of Drugs.
Schedule Q
List of Coal Tar colours permitted to be used in Cosmetics.
16. Schedule R
Standards and labelling requirements of Condoms, Copper T and
Contraceptive Tube Rings.
Schedule R (I)
Standards to be complied with by medical devices.
Schedule S
Standards for cosmetics.
17. Schedule T
Requirements of factory premises and hygienic conditions to be complied with
by the manufacturer of Ayurvedic, Siddha and Unani drugs.
Schedule U
Particulars to be shown in the manufacturing records, record of raw materials
and in the analytical records of drugs.
Schedule U (I) – Particulars to be shown in the manufacturing records.
Schedule U (II) – Records of Raw Materials.
Schedule U (III) – Particulars to be recorded in the analytical records.
18. Schedule V
Standards for patent and proprietary medicines and the maximum and
minimum quantities of vitamins that are permitted to be added in such
preparations for oral use.
Schedule W
Names of drugs which shall be marketed under generic names only.
19. Schedule X
Names of psychotropic drugs for which special control measures have been
laid down.
Schedule Y
Requirements and guidelines on clinical trials for import and manufacture of
new drugs.
21. Drug and cosmetic Act Drug and Cosmetic RUle
Schedule I and II Schedule A-Z
Chapters – 5 (IVA – ASU) Parts – 19
Section – 39 (33 – ASU) Rules – 169 (151 – 169 ASU)
22. DrugS and cosmeticS Act
Chapter I Introductory (Section 1-4).
Chapter II DTAB, CDL, Drugs Consultative Committee (Section 5-7A).
Chapter III Importance of Drugs and Cosmetics Act (Section 8-15).
Chapter IV Manufacturing, Sale and Distribution of Drugs and Cosmetics (Section 16-33A).
Chapter IVA Provisions related to ASU (Section 33B-33O).
Chapter V Miscellaneous (Section 33P-38).
23. Chapter Iva – provisions related to ASU
Section 33B Application of IVA
Section 33C DTAB for ASU (13 members)
Section 33D Drug Consultative Committee for SU
Section 33E Misbranded drugs
Section 33EE Adulterated drugs
24. Section 33EEA Spurious drugs
Section 33EEB Regulations for Manufacturing and Sale of ASU drugs
Section 33EEC Prohibition of Manufacturing and Sale of ASU drugs
Section 33EED Power of Central Government to prohibit manufacturing of ASU medicines
Section 33F Government Analysts
Section 33G Power of Inspectors
Section 33H Provisions related to Section 22(Power of Inspectors), 23(Procedure of Inspection),
24(Person bound to disclose place were Drugs and Cosmetics are manufactured and
kept, 25(Report of Government Analysts)
25. Section 33I Penalty of Manufacturing, Sale etc. of ASU drugs
Section 33J Penalty of Subsequent offences
Section 33K Confiscation
Section 33L Application of Provisions of Government department
Section 33M Cognizance of offences
Section 33N Power of Central Government to make rules
Section 33O Power to amend 1st Schedule
26. Drugs and cosmetics RUles related to ASU
Rule 151 Manufacturing on more than one premises
Rule 154 Form of licence to manufacture ASU drugs
Rule 154-A Form of Loan Licence
Rule 155 Certificate of Renewal of licence
Rule 155-A Certificate of Renewal of loan licence
Rule 155-B Certificate of award of GMP
27. Rule 159 Cancellation and Suspension of Licence
Rule 161 Labelling, Packing and Limit of Alcohol
Kapur Asava, Ahiphenasava, Margamadasava – 15 ml
Mritsanjivani Sura – 16 % v/v, 30 ml
Mahadrakshava – 16 % v/v, 120 ml
Rule 161-B Self life
Rule 168 Standards to be complied with manufacture, sale and distribution of ASU drugs
Rule 169 Permitted excipients
Antioxidant – 6
Preservative – 14
Colouring – 63
Additives – 87
Flavouring – 127
