Drugs & Cosmetic Act Schedule in Brief

Schedules to the rules


TYPE

CONTENT

“A”

Performa for forms( Application, issue, renewal,
etc.) manufacture for sale/distribution of Allopathic drugs, Loan Licence,
re-packing for sale, operate a Blood Bank , manufacture for sale or for
distribution of LVPs etc

“B”

Rates of fee for test or analysis by CDL or Govt.
analysts

“C”

List of Biological and special products (Injectables) applicable
to special provisions. Sera.

Solution of serum proteins intended for injection,
Vaccines for parenteral injections. Toxins, Antigen.

Antitoxins

“C1

List of Biological and special products (non-parenteral)
applicable to special provisions. Ergot preparations, Adrenaline, Fish
liver oil,  Vaccines etc

“D”

List of drugs that are exempted from provisions of import

“E1

List of poisonous substances under the Ayurvedic ,
Siddha and Unani systems 

“F”

Provisions 
applicable to blood bank

TYPE

CONTENT

“F1”

Special provision applicable to biological and special
products, eg. Bacterial and viral vaccines, sera from living animals,
bacterial origin diagnostic agents

“F2”

Standards for surgical dressings, Gauze or other dressings
used to cleanse a wound, Skin sealants or barriers, Solutions used to moisten
gauze

“F3”

Standards for sterilized umbilical tapes

“FF”

Standards for ophthalmic preparations

“G”

List of substances required to be used  under medical supervision and labelled
accordingly

“H”

List of substances (prescription) that should be sold by
retail only on prescriptions of R.M.P.

TYPE

CONTENT

“J”

List of diseases and ailments that drug should not claim
to cure. AIDS, Angina Pectoris, Appendicitis, Arteriosclerosis, Blindness,
Blood poisoning, Bronchial asthma, Cancer and benign tumour,
Cataract, Spondylitis, Stammering, Stones in gall-bladder, kidney, bladder,
Vericose vein

“K”

List of drugs that are exempted from certain provisions
regarding manufacture. Analgesic Balms, Antacid preparations, Gripe Water for
use of infants, Inhalers, containing drugs for treatment of cold and nasal
congestion, Syrups, lozenges, pills and tablets for cough,  Liniments for external use, Skin ointments
and ointments for burns,  Absorbent
cotton wool, bandages absorbent guaze and adhesive plaster.

“M”

Requirements of manufacturing premises, GMP  requirements  of factory premises, plants and equipments

“M1”

Requirements of factory premises for manufacture of
Homeopathic medicines

“M2”

Requirements of factory premises for manufacture  of cosmetics

“M3”

Requirements of factory premises for manufacture  of medical devices

“N”

List of equipment to run a Pharmacy

TYPE

CONTENT

“O”

Standards for disinfectant fluids

“P”

Life period(expiry) of drugs

“Q”

Coal tar colors permitted to be used in cosmetics. Guinea
GreenB, Tartrazine, Sunset yello FCF, Amaranth, Erythrosine etc

“R”

Standards for mechanical contraceptives

“R1”

Standards for medical devices

“S”

Standards for cosmetics

“T”

Requirements (GMP) of factory premises for Ayurvedic,
Siddha,  Unani drugs

TYPE

CONTENT

“U”

Manufacturing and analytical records of drugs

“U1”

Manufacturing and analytical records of cosmetics

“V”

Standards for patent or proprietary medicines

“W”

List of drugs marketed under generic names- Omitted

“X”

List of narcotic drugs and psychotropic substances

“Y”

Requirement and guidelines on clinical trials for import
and manufacture of new drugs

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