Ethiopian Food and Drug Authority (EFDA)

Guideline for Registration of Low-Risk Medicines

First Edition
June 2020
Addis Ababa, Ethiopia

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Contents
1. Background ............................................................................................................................... 3
2. Definitions ................................................................................................................................. 5
3. Scope ......................................................................................................................................... 5
4. Objective ................................................................................................................................... 5
5. Criteria for risk categorization of medicines ............................................................................. 5
6. Low risk products categories..................................................................................................... 7
7. Required documents .................................................................................................................. 7
7.1. Administrative documents .................................................................................................. 7
7.2. Technical Document ......................................................................................................... 11
8. Application and Assessment procedure .................................................................................. 12
8.1. Application procedure ....................................................................................................... 12
8.2. Switching high risk to low risk or vice versa. ................................................................... 12
8.3. The review procedure ....................................................................................................... 12
9. Post approval control Activities .............................................................................................. 13
10. Post approval Changes and Re-registration applications ........................................................ 14
10.1. Variation ........................................................................................................................ 14
10.2. Re- registration............................................................................................................... 14

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Abbreviations

API Active Pharmaceutical ingredient

cGMP Current Good Manufacturing Practice
CPP Certificate of Pharmaceutical Products
CTD Common Technical Document
EFDA Ethiopian Food and Drug Authority
eRIS Electronic Regulatory Information System
FPP Finished Pharmaceutical Products
MA Marketing Authorization
NMRs National Medicine Regulators
OTC Over-the Counter
PIL Patient Information Leaflet
PoM Prescription only Medicine
SmPC Summary of Product Characteristics
SRA Stringent Regulatory Authority

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1. Background

The Ethiopian Food and Drug Authority (EFDA) is mandated by the Proclamation No.
1112/2019 to ensure safety, efficacy and quality as well as rational use of medicines. Article 19
sub-article 1 of the proclamation decrees that “the rigor of regulatory assessment of medicines
shall be commensurate with the products type, nature and potential risk to human health”.
Accordingly, the evaluation process to ensure safety, efficacy and quality of low risk medicines
needs minimum exertion for effective utilization of limited resource and to ease the accessibility
of the products for consumers. Products that are relatively safe and of proven efficacy; such as
some over the counter (OTC) medicines, products fulfilling criteria for risk categorization of
medicines set in this guideline are pharmaceutical products that fall in the jurisdiction that
permits abbreviated assessment as they are generally considered as low risk products.

Risk-based dossier assessment approach is one of the strategic directions of the regulatory
authority to expedite marketing authorization process and its implementation requires
classification of products in to low and high-risk category so as to proportionate risks during
dossier assessment. For low risk medicines, the evaluation process will be limited to a ‘partial
review of the product dossier; concentrating on the assessment of administrative requirements,
product information, specifications, stability and shelf life, and others as applicable. However,
full and rigorous dossier assessment might be conducted for a product designated as low risk if
there is satisfactory reason for in-depth evaluation.

This guideline is prepared based on the provisions in the Proclamation No. 1112/2019 and other
NMRs experiences regarding regulation of low risk medicines and consists of criteria for low
risk designation and requirements to process marketing authorization of medicines.

Therefore, the intentions of this guideline is to set criteria and provide guidance for applicants on
how to apply for marketing authorization (MA) of such products through low risk approval
pathway.

All users of this guideline are kindly requested to forward their valuable comments and
suggestions to the Food and Drug Authority of Ethiopia, P.O.Box. 5681, Tel. 251-11 552 41 22,
or email: contactefda@efda.gov.et, Addis Ababa, Ethiopia.

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2. Definitions

For the purpose of this guideline the following definitions are applicable.

Authority means Ethiopian Food and Drug Authority

Low-risk Medicine means medicinal products that contain known chemical entity with
established safety profile over years both in local and global markets, indicated for well-
documented conditions, provided by conventional dosage forms such as oral solids, liquids, and
topical preparations. This includes OTC medicines and other products designated as low risk
products by the Authority.

Lower-risk medicine applications means an application for marketing authorization of

medicines eligible for approval by low risk application track based on the EFDA`s low risk
designation criteria as outlined in this guideline.

OTC Product means a product designated and listed as OTC medicines by the Authority.
Partial or abbreviated review means a dossier assessment process that is carried out for
evaluating low risk products by focusing on selected section of product dossier.

3. Scope

This guideline is applicable to dossier assessment and market authorization of all medicines
designated and listed as low risk medicines by the authority.
4. Objective

The objective of this guideline is to set requirements for registration of low risk medicines and
enhance the availability of these products in the market.

5. Criteria for risk categorization of medicines

In this guideline, medicines are classified as low risk based on the criteria listed below;
1. Medicine inherent characteristics (e.g. bioavailability, solubility, polymorphism etc)
– Medicines with API that have low bioavailability & solubility and that exists in
different polymorphs can be an example of high-risk product.
2. Dosage form and route of administration

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 – Dosage forms such as injectable, manufactured by lyophilization, and product
which administered by IV, IV infusion and some inhalation products are generally
considered as high risk.
3. Therapeutic index of medicines
– Products with narrow therapeutic index are considered as high-risk product.
4. Safety of medicine (active ingredient) under consideration
– There must be enough supporting scientific evidence that the medicine have a
wide margin of safety
– Its mode of action and pharmacokinetics; such as its absorption, metabolism and
excretion are not affected by other commonly used drugs or display marked
fluctuations between individuals because of concomitant diseases, interactions
with food, or genetic or environmental factors (working conditions, climate, and
so forth)
5. Complexity in medicine manufacturing and the impact of poor quality in manufacture
6. The risk associated with the claims including labelled use
– Labelling and package inserts and other information forming the basis for
advertising and promotion shall fulfil EFDA’s labelling requirements for
medicinal products
7. The nature of the condition being treated or prevented
– Medicines used in life threatening conditions are example of high-risk product.
8. The nature and number of the population using the product
– Medicines that have low and well-documented risks in specific patient groups, for
example in elderly people, during pregnancy and lactation, and in patients with
impaired liver or kidney function can generally be considered as a low risk
product
9. Potential for drug resistance
– Products that do not have potential impact on the development of anti-microbial
resistance in the general population are considered as low risk products
10. The potential for misuse, abuse, and with a potential for causing dependence
– Narcotic and psychotropic medicine are considered as high-risk product

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 11. Use of medicines as Prescription vs Over-the-counter (OTC)
– Medicines reasonably regarded as appropriate for self-diagnosis, self-medication
and self-monitoring are generally considered as low risk products
6. Low risk products categories

Based on the criteria set above; the general category of products listed below are eligible for low
risk products for market authorization.
a. Keratolytic
b. Anti-dandruff;
c. Topical antibacterial
d. pholcodine linctus or a codeine-containing combination analgesic
e. Medicated plasters/ patch/ pad
f. Non-steroidal and antihistaminic having wide therapeutic index
g. Multivitamin and minerals
h. Anthelmintic having local action
i. Dermatological products having local action
j. Locally-acting lozenges/ pastilles;
k. Topical analgesic/ counter-irritants;
l. Anti-acne
m. Oral mucosal analgesic
The lists of specific products indicated in annex I of this guideline are recognized as low risk
products. However, the list will be regularly updated for products that fit in to the above general
category of medicines based on the Authority`s inclusion criteria.

7. Required documents

7.1. Administrative documents

For low risk medicinal products with API(s) that are not new to the Ethiopian market, all
administrative documents need to be completed, signed and submitted by the applicant. The date
of application should correspond to the date of submission of the registration dossier to the
Authority. A list of major administrative documents required for low risk products market
authorization applications are described below:

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a) Application form

An application for new marketing authorization of low risk products should be submitted on-line
through the (https://www.eris.efda.gov.et/) under low risk medicine application pathway. The
application form is provided in Annex I of Guideline for registration of medicines 4th edition, 2020 to
facilitate the online submission.

b) Application letter

A dated and signed letter for submission of the dossier by mentioning the product included in the
dossier from the manufacturer and/or local agent responsible for registration.

c) Agency agreement
1. An agency agreement should be submitted in line with the requirements indicated under
the Module 1 (Administrative and product information section) of the Medicine
registration guideline, 4th Edition, 2020.

2. The agreement should state that if any fraud or unsuspected and unacceptable adverse
event occurs to the consumer under normal utilization, all the party’s (local agents,
manufacturer, and/or license holder) mentioned in the agreement will be responsible for
the product recall and for substantiating any related consequences and liable for legal
action as per article 38 (1&4) of proclamation No 1112/2019 or other relevant laws of
the country

d) Certificate of good manufacturing Practices

A copy of valid Good Manufacturing Practice (GMP) and Manufacturing License Certificate of
FPP manufacturer should be provided. Inspection of the manufacturing site (by the Authority)
may not be pre-request for submission of application for registration of medicine. However, the
manufacturing site should be inspected before issuance of the marketing authorization of the
medicine under consideration. Thus, the copy of GMP certificate or GMP waiver letter issued by
the Authority shall be requested prior to issuance of marketing authorization.

e) Certificate of pharmaceutical product

A valid Certificate of pharmaceutical product or marketing authorization certificate should be
provided. Certificate of pharmaceutical product as a requirement for registration could be optional

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provided that valid cGMP Certificate and Market Authorization Certificate issued by NMRA in the
country of manufacture are submitted. The format of the CPP is provided in Annex II of Guideline
for registration of medicine 4th edition, 2020. The CPP should be valid at a time of submission and
should be in line with the explanatory notes of the CPP and summary of product characteristics.

f) Marketing Authorization status in other countries

The list of the countries in which the product under consideration is approved (registered),
pending application, withdrawn (the reason thereof) should be summarized (in tabular form) and
provided.

The countries in which the final product under consideration has already been marketed should
be listed and the approval paperwork for granted marketing authorization as a low risk or
equivalent category (such as OTC) of product should be provided.

For a low risk drug products registered by SRA, the information submitted should be true and
have confirmations for composition (formulation), strength, manufacturing, specifications,
packaging, manufacturing site and Product information sameness with the product on the market
in the SRA country or country of manufacturing at all times.

g) Product information

Product information including the package insert, labelling, and summary of product
characteristics (SmPC) should be provided in accordance with the requirements of EFDA`s
directive for labelling. All product information label statements are required to be in English or
Amharic. The information provided should not vary significantly from the claims made for the
same product in any other jurisdiction. Any information appearing in the product information
[labels, patient information leaflet (PIL), and SmPC] should be based on scientific justification.

Labelling (immediate and outer label)

Labels should be only original labels or computer-ready colour-printed labels and in the case
where the text of the labels is printed directly on plastic bottles through a silk screen process,
photocopies of these labels will be accepted for approval. The titles for batch number,
manufacturing, and expiry dates should be part of the printing (type written materials, stickers,

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etc., are not acceptable). If the labelling technology of the manufacturer is such that this
information is to be printed on the label during production, a written commitment to show all the
required information on the label of the finished product must be submitted. The contents of the
label should at least contain:
a) The name of the product‒ brand and generic/International Non-proprietary Name (INN)
b) Pharmaceutical form and route of administration
c) Qualitative and quantitative composition of active ingredient(s), preservative(s), and
antioxidant(s)
d) The volume of the contents, and/or the number of doses, or quantity in container
e) Directions to consult the package insert or the carton label for complete directions for use
f) Handling and storage conditions
g) Batch number
h) Manufacturing date
i) Expiry date
j) Name and site address of manufacturer
k) Country of origin

Patient Information Leaflet (PIL) or Package Insert

The general content of the PIL should be prepared in line with SmPC of Medicines. The PIL
should not be described or presented in a manner that is false, misleading, or deceptive or is
likely to create an erroneous impression regarding its use in any respect, either pictorially or in
words. The leaflet should provide clear information on the following:
a) Restriction on the maximum single dose or maximum daily dose, but without
compromising on the dose that retains the necessary efficacy
b) Indication on whether the product is intended for children or adults; and specific dosage
strengths suitable for pediatric use. Adult dosage consideration to be given to the need for
several strengths
c) Display recommendation about duration of treatment to prevent unnecessary prolonged use
d) Simple consumer information that is not open to misinterpretation
e) The use(s) for which the product is intended

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f) Furthermore, as per Food and medicine administration proclamation No 1112/2019, the
information on leaflet of medicine that is included in the national essential medicine list of
Ethiopia or widely circulated in Ethiopian market is required to be at least in English and
Amharic.

h) Payment of service fees

Each application should be accompanied by a relevant service fee for registration as per the
regulation 370/2015. For details, the applicants are advised to contact the Authority for the
amount and modalities of payment.

7.2. Technical Document

a) An application dossier should be submitted in CTD format and should contain the
required information, including technical data that support the safety, quality and
efficacy of the product. The following technical documents shall be submitted for
review:
– Specifications of the API (s) and FPP
– Methods of analysis of API(s) and FPP
– Stability of FPP
– certificate of analysis, and
– compatibilities in relation to the following:
a) Active pharmaceutical ingredient
b) Excipients
c) Container & closure.

b) Applications for marketing authorization of low risk products that has already been
approved by SRAs, the applicant should provide evidences of approval by the SRAs and
documents listed under section 7.2 (a) of this guideline.

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8. Application and Assessment procedure

8.1. Application procedure

During application submission for MA of low risk products, the applicant shall give due
diligence considerations to verify its suitability for marketing authorization via such approval
pathway. At least the following aspects should be considered to decide whether a product is
suitable and rational for approval by low risk MA pathway:
a) Products included in the detailed list of low risk medicines (Annex 1) which will be
reviewed and updated periodically (annually).
b) Products which are not in the list of low risk categories but claimed to be low risk by the
applicant will be subjected for decision by the EFDA technical committee for such product
designation as per criteria in section 5 of this guideline.
c) Products switched from high risk to low risk (Example PoM to OTC) as per the principles
provided in section 8.2 of this guideline.
d) Applications for low risk medicine must be submitted electronically (via eRIS system). The
application dossier must be in Common Technical Document (CTD) format.
8.2. Switching high risk to low risk or vice versa.

Medicines under consideration having many years of marketing authorization approval as high-
risk product and long-term use and established low risk profile, may be switched to low risk
medicines category after inclusion in the low risk products based on available scientific
evidence. On the other hand for medicines market authorization status shift from low risk to high
risk, the authority will demand all requirements indicated in medicine registration guideline 4th
edition for market authorization approval based on full assessment.
8.3. The review procedure
As the low risk medicine applications needs abbreviated review process, shorter target times
apply to these types of applications. The Authority may make requests for further information
from the applicant if there are issues arising at any stage of the evaluation process and granting
the marketing authorization will be based on the outcome of the abbreviated review outcome.

Verifying eligibility of the medicine under consideration

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Before the assessment the application needs to be verified against the list of low risk medicine,
as indicated in general category of medicines listed under section 6 (including Annex 1) of this
guideline. It should also be validated to determine whether it is eligible for such approval
pathway, complete and meets the requirements for an effective application.

Return to the applicant

The applicant will be advised to shift the application path way if the application is found
ineligible for this approval pathway or found to be incomplete to initiate review. However,
submitting fabricated data will end up in rejecting the application or all applications from the
same the same manufacturer based on the severity of consequences of the fabricated data.

Review of documents
Although the applicants are required to submit complete dossier as per the Common Technical
Document (CTD) format, the evaluation should mainly focus on the administrative section
(Module 1) and technical documents indicated on 7.2 (a) of this guideline.

9. Post approval control Activities

It is well known that there is no medicinal product that is 100 percent safe. As a result, lessening
the requirements for marketing authorization of low risk products and simplifying the depth of
evaluation of these products needs to be accompanied by strengthened follow up on post
approval regulatory activities so as to minimize the unpredicted risks. Hence, EFDA will give
due emphasis on the following post approval regulatory activities.
a) Taking robust, appropriate and timely regulatory actions as per the proclamation No
1112/2019 and other relevant laws based on cGMP, Port clearance or ware houses and retail
outlets inspection findings, QC test reports, and/or ADE reports.
b) Revising low risk products list on predetermined regular basis
c) Establish and implement flexible system for switching high risk to low risk and vice versa

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10. Post approval Changes and Re-registration Applications

10.1. Variation

For post approval variations, the applicants are advised to refer to and provide all relevant
documents required by the guideline for submission of post approval variation medicine
application. Whenever a product has been withdrawn from the market and/or its marketing
authorization has been rejected, deferred, or withdrawn from market for any reason (such as
deficiencies in GMP, product quality defect or ADE reports) in other countries, the local agent or
the manufacturer should notify EFDA as per the article 67(17) of proclamation No 1112/2019.
10.2. Re- registration

Applications for re-registration of these category of medicines shall follow requirements

specified in Appendix 4 (Requirements for Re-registration) of the Authority`s guideline for
registration of medicines, 4th Edition, 2020.

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Annex 1: Medicinal products listed as Low-Risk

S/No. Name Strength Dosage Form

1. Antacid

1 Aluminum Hydroxide 320 mg/5 ml Mixture/Gel

360 mg/5 ml Suspension
500 mg Tablet (Chewable)

2 Aluminum Hydroxide + 220 mg + 195 mg/5ml Suspension

Magnesium Hydroxide 400 mg + 400 mg Tablet (Chewable)

3 Aluminum Hydroxide + 310 mg + 620 mg/5ml Suspension

Magnesium Trisilicate 120 mg + 250 mg ; Tablet (Chewable)
250 mg + 500 mg

4 Aluminium Hydroxide+ 225mg+200mg+25mg/5ml Suspension

Magnesium Hydroxide+ 400 mg+400 mg+40 mg Tablet
Simethicone

5 Calcium carbonate 500 mg Tablet(Chewable)

6 Magnesium Hydroxide 375 mg/5 ml, 7.75 % Mixture

300 mg; 311 mg Tablet (Chewable)

7 Magnesium Trisilicate 500 mg Tablet (Chewable)

2. Antispasmodics / Spasmolytic Analgesics

1 Hyoscine (Scopolamine) 5mg/5ml Drops, Syrup,

Butylbromide 10mg Tablet
7.5mg, 10mg Suppository

2 Dimenhydrinate 50mg Tablet

3 Hyoscine hydrobromide 150 microgram, 300 microgram Tablet

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S/No. Name Strength Dosage Form

3. Cathartics and Laxatives

1 Bisacody 5mg, 10mg Suppository

5mg, 10mg Tablet

2 Castor oil 30ml, 60ml syrup

3 Glycerin 1g, 1.36g, 2g, 2.76g Suppository

4 Magnesium Sulphate Oral powder

4. Medicines Used for Diarrhea

1 Oral Rehydration Salt (ORS) Powder

2 Zinc tablet 10mg, 20mg tablet

5. Antiflatulents

1 Activated Charcoal 125mg, 250mg Tablet

2 Simethicone 60mg, 80mg, 95mg Tablet (chewable)

95 mg, 125 mg Capsule
40 mg ; 150 mg ; 250 mg ; 62.5 drop
mg/5 mL

6. Antihaemorrhoidal Agents

1 Bismuth Subgallate Compound 2.25% +0.875%+ 1.875% Ointment

(Bismuth Subgallate +Bismuth +10.75%
Oxide + Peru Balsam+ Zinc Oxide) 59mg +24mg +49mg+296mg Suppository

2 Lidocaine HCl + Tribenoside (2.12gm+5gm)/100gm Cream

7. Antitussives/Expectorants/Mucolytics

1 Bromhexine Hydrochloride 4mg/5ml Elixir

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S/No. Name Strength Dosage Form

2 Chlorpheniramine maleate + (2mg + 100mg)/5ml Linctus

Ammonium chloride

3 Chlorpheniramine maleate + 4mg + 60mg + 500mg Tablet

pseudoephedrine + paracetamol 2mg + 30mg + 500mg

4 Dexchlorpheniramine+ 2mg +100mg + 20mg/5ml Syrup

Guaifenesin+ Pseudoephedrine

5 Dextromethorphan Hydrobromide 15mg/ml Drops

5mg,7.5mg,15mg/5ml Syrup
15mg Tablet

6 Dextromethorphan Hydrobromide + 0.3gm+7.6gm/100ml Syrup

Guaicol Sulphonate

7 Diphenhydramine+ 12.5mg +60mg + 130mg/5ml Syrup

Sodium Citrate+
Ammonium Chloride

8 Guaifenesin 100mg, 200mg Tablet

200mg Capsule
100mg/5ml Syrup

8. Antiasthmatics

1 Ephedrine + Theophylline 6mg + 30mg/5ml Elixir

2.24% + 0.30% Syrup
11mg + 120mg Tablet

2 Salbutamol (Albuterol) 0.1mg/dose Oral Inhalation

(aerosol)
2mg/5ml Syrup

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S/No. Name Strength Dosage Form

2mg, 4mg, 4mg(s/r) Tablet

3 Theophylline+ Guaifenesin 150mg + 90mg; 300mg + Capsule

180mg

150mg + 90mg/15ml Elixir

150mg + 90mg Tablet

9. Analgesics / Antipyretics

1 Acetylsalicylic Acid 300mg,324mg(microfined) Tablet

100mg,500mg (enteric coated)

2 Diclofenac Sodium 25mg, 50 mg,100mg Tablet

100mg Suppository
50mg Powder

3 Diclofenac Potassium 50mg Tablet

4 Diclofenac diethylamine 1.16% Gel

5 Ibuprofen 200mg, 400mg (enteric coated) Capsule

Tablet
100mg/5ml
Syrup

6 Paracetamol 100mg/ml Drops

125mg, 250mg Suppository
120mg/5ml, 250mg/5ml Syrup
100mg, 500mg Tablet

7 Paracetamol + Caffeine 500mg + 65mg Tablet

10. Antimigraine Headache Medicine

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S/No. Name Strength Dosage Form

1 Acetylsalicylic Acid + 250mg + 250mg + 65mg Tablet

Paracetamol+ Caffeine

2 Ibuprofen 300mg, 200mg, 400mg Capsule

(enteric coated) Tablet
100mg/5ml Syrup

3 Paracetamol + Caffeine 500mg + 65mg Tablet

11. Antirheumatics

1 Acetylsalicylic Acid 100mg, 300mg,324mg Tablet

(microfined)
500mg (enteric coated)

2 Acetylsalicylic Acid+ Paracetamol 250mg + 250mg + 65mg Tablet

+ Caffeine

3 Diclofenac Sodium 25mg, 50 mg,75mg,100mg Tablet

100mg Suppository
50mg Powder
1% Gel

4 Diclofenac Potassium 50mg Tablet

5 Indomethacin 25mg, 50 mg, 75mg Capsule

25mg(enteric coated) Tablet
100mg Suppository

6 Ibuprofen 300mg Capsule

200mg, 400mg (enteric coated) Tablet
100mg/5ml
Syrup

7 Methyl salicylate Ointment

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S/No. Name Strength Dosage Form

12. Anthelmintic

1 Albendazole 100mg/5ml Oral Suspension

200mg, Tablet
400mg Tablet

2 Levamisole 40mg Tablet

3 Mebendazole 100mg/5ml Oral Suspension

100mg, Tablet
500 mg Tablet

4 Niclosamide 500mg Tablet (chewable)

5 Praziquantel 600mg Tablet

6 Piperazine 500mg, 622.5mg, 706mg, Elixir

750mg,937.5mg, 1g /5ml
(Citrate)
300mg (Adipate) Tablet

7 Pyrantel Pamoate 250mg base/5ml Oral Suspension

125mg base Tablet

13. Vitamins and Minerals

1 Ascorbic Acid (Vitamin C ) 100mg, 500mg, 1g Tablet

2 Folic acid 5mg Tablet

3 Multivitamin Preparations Drops

Syrup
Tablet

4 Multivitamin with Minerals and/or Drops

Extracts Syrup
Tablet

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S/No. Name Strength Dosage Form

5 Vitamin B Complex Preparations Tablet

100mg + 200mg + 1000 g
(B1+B6+B12)

14. Ear, Nose and Throat Preparations

1 Amyl-Meta-Cresol + 0.6mg + 1.2mg Lozenges

Dichlorobenzyl Alcohol

2 Chlorhexidine Gluconate 0.12% Oral Solution

3 Dequalinium Chloride 0.25mg Lozenges

4 Hexetidine 0.1% Solution

5 Hexidine 0.1gm/100ml, 0.2% Oral Solution

6 Menthol + Eucalyptus Oil + Light 2% +10% 7% Inhalation

Magnesium Carbonate

7 Saline Solution 0.09% Solution

15. Antihistamines And Antiallergics

1 Cetirizine 5 mg, 10 mg Tablet

1mg/1ml Syrup

2 Chlorpheniramine Maleate 2mg/5ml Syrup

2mg, 4mg, 6mg Tablet

3 DexchlorpheniramineMaleate 2mg, 4mg, 6mg Tablet

2mg/5ml Syrup

4 DiphenhydramineHydrochloride 12.5mg/5mL Elixir

25mg, 50mg Capsule

5 Loratadine 5mg/5mL Syrup

10mg Tablet

6 Loratadine + pseudoephedrine 5mg + 120mg Tablets

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S/No. Name Strength Dosage Form

7 Pheniramine Aminosalicylate 50mg, 75mg Tablet

16. Anti-infectives, Topical

1 Benzoic Acid+ Salicylic Acid 6% +3%, Ointment

12% +6%

2 Benzyl Benzoate (BBL) 25% Lotion

3 Gentian Violet (GV) 0.5%, 1% Solution

4 Nitrofuranzone 30gm, 45mg Ointment

5 Sulphur 5%, 10% Ointment

6 Zinc Undecenoate + Undecenoin 20% +5% Ointment

Acid 20% +2% Powder
20% +2% Powder (aerosol)

17. Keratolytics /Caustics Agents

1 Benzoyl peroxide 2.5%, 5%, 10% Gel

2.5%, 5%, 10% Solution

2 Camphor Cream,
Lotion,
Solution

3 Salicylic Acid 2%, 5%, 10% Ointment

4 Salicylic Acid + Lactic Acid + 2gm+0.5gm+0.2gm/10gm Tincture

Polidocanol

18. Topical Agent For Psoriasis and Eczema

1 Ichthammol 10%, 20% Ointment

2 Zinc oxide 15% Ointment

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S/No. Name Strength Dosage Form

19. Antiprurities

1 Calamine 5% Lotion

2 Calamine+ Zinc Oxide 4%+3% Cream

15%+5% Lotion

20. Dermatologicals, Others

1 Methylsalicylate Ointment

2 Talc Dusting Powder Powder

21. Miscellaneous

1 Formaldehyde 3%, 8% (w/w or v/v) Solution

2 Halazone 4mg Tablet

3 Sodium Dichloroisocyanurate 67mg, 75mg Tablet

4 Sorbitol The initial dose for use as a Oral Solution 70%

laxative in adults is 30-150 mL
of an oral 70% solution

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