Drugs and Cosmetics Act
Contents
• Definitions

• Administration of the act and rules

• Provisions related to Import

• Provisions related to Manufacture

• Provisions related to Sale

• Labeling and Packaging

• Schedules to the act and rules
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Indented Learning Objectives

• At the end of this lecture, student will be able to

– Enlist the Schedules to the act and rules

– Discuss the Administration of the act and rules

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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
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Schedules to the rules
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.

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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
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Schedules to the rules
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

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Schedules to the rules

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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Administration of the act and rules

A) Advisory :
1)Drugs Technical Advisory Board-DTAB
2)Drugs Consultative Committee-D.C.C.
B) Analytical :
1)Central Drugs Laboratory – CDL
2)Drug Control Laboratory in states
3)Government Analysts
C) Executives :
1)Licensing authorities
2)Controlling authorities
3)Drug Inspectors
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Summary
• Schedules A, B C, C1, D, E, F, F1, F2, FF, G, H, K, M, M1, M2, N, O, P, Q, R, S, T, U, V, Y
Advisory :
1)Drugs Technical Advisory Board-DTAB
2)Drugs Consultative Committee-D.C.C.
B) Analytical :
1)Central Drugs Laboratory – CDL
2)Drug Control Laboratory in states
3)Government Analysts
C) Executives :
1)Licensing authorities
2)Controlling authorities
3)Drug Inspectors