Drug Registration Guidance Document (DRGD) Third Edition, Fourth Revision January 2023
Appendix 18: List of Permitted, Prohibited and Restricted Substances
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APPENDIX 18 LIST OF PERMITTED, PROHIBITED AND RESTRICTED SUBSTANCES
Contents: 1. List of Prohibited and Restricted Active Ingredients and Combination
1.1 List of Prohibited Active Ingredients and Combinations
a) Specific Active Ingredients b) Combinations 1.2 List of Restricted Active Ingredients and Combinations
a) Specific Active Ingredients b) Combinations
2. List of Prohibited and Restricted Excipients
2.1 List of Prohibited Excipients
2.2 List of Restricted Excipients
3. List of Permitted and Restricted Colouring Agents
3.1 List of Permitted Colouring Agents
3.2 List of Restricted Colouring Agents
IMPORTANT NOTE:
The following lists are by no means exhaustive.
Drug Registration Guidance Document (DRGD) Third Edition, Fourth Revision January 2023
Appendix 18: List of Permitted, Prohibited and Restricted Substances
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1. LIST OF PROHIBITED AND RESTRICTED ACTIVE INGREDIENTS AND COMBINATION
1.1 List of Prohibited Active Ingredients and Combinations
a)
Prohibited Active Ingredients NO. PROHIBITED ACTIVE INGREDIENTS
1.
1,3-dimethylamylamine (DMAA)
2.
Aristolochic Acid
3.
Aminopyrine/ Amidopyrine
4.
Astemizole
5.
Bacillus Coagulans
6.
Berberine
7.
Butobarbitone
8.
Chlormezanone
9.
Cisapride
10.
Conjugated Linoleic Acid
11.
Crinis Carbonisatus
12.
Danthron
13.
Dipyrone
14.
Enterococcus Faecalis
15.
Enterococcus Faecium
16.
Ethenzamide
17.
Euflavine
18.
Furazolidone
19.
Fenfluramine/ Dexfenfluramine
20.
Gadodiamide
21.
Gentian Violet
Drug Registration Guidance Document (DRGD) Third Edition, Fourth Revision January 2023
Appendix 18: List of Permitted, Prohibited and Restricted Substances
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NO. PROHIBITED ACTIVE INGREDIENTS
22.
Gamma-Butyrolactone (GBL)
23.
Gamma-Aminobutyric Acid (GABA)
24.
Gamma-Hydroxybutyric Acid (GHB)
25.
Haloquinol
26.
Hexachlorophene
27.
Mercurochrome
28.
Nimesulide
29.
Novobiocin
30.
Oxyphenisatin Acetate/ Acetophenolisatin
31.
Oxyphenbutazone
32.
Pergolide
33.
Phenacetin
34.
Phenazone/ Antipyrine
-
Propylphenazone
-
Isopropylphenazone
35.
Phenylbutazone
36.
Phenylpropanolamine
37.
Piperazine
38.
Prenylamine
39.
Quinalbarbitone
40.
Salicylamide
41.
Sibutramine
42.
Stanozolol
43.
Sulphaguanide
44.
Thioridazine
45.
Tegaserod
Drug Registration Guidance Document (DRGD) Third Edition, Fourth Revision January 2023
Appendix 18: List of Permitted, Prohibited and Restricted Substances
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NO. PROHIBITED ACTIVE INGREDIENTS
46.
Terfenadine
b)
Prohibited Combinations NO. PROHIBITED COMBINATIONS
1.
Ampicillin + Cloxacillin
2.
Antibiotics + Papain/ Prolase
3.
Antacid + Charcoal
4.
Combinations With Any Barbiturates
5.
Combinations of Two or More Analgesic with the Same Mode of Action
6.
Combinations Of Vitamin (S) With Other Drugs: a.
Vitamin (S) + Appetite Suppressant b.
Vitamin (S) + Corticosteroid
NOTE:
Combination of calcipotriol (Vitamin D3 analogue) + corticosteroid for topical treatment of psoriasis may be allowed, subject to provision of data to support efficacy and safety c.
Vitamin (S) + Analgesic d.
Vitamin (S) + Laxative e.
Vitamin (S) + Slimming Agents
7.
Cough, Cold and Allergy Products Containing: a.
Four or More Pharmacological Groups in One Product. b.
Two or More Drugs from the Same Pharmacological Group c.
Antypyretic - Analgesic + Expectorant d.
Anticholinergic + Bronchodilator e.
Codeine + Ephedrine/ Pseudoephedrine f.
Methapyrilene g.
Paracetamol + Mucolytic/ Expectorant
8.
Combinations Containing Antacid and Surface Local Anaesthetic Agent
9.
Combinations Containing Dextropropoxyphene