HOMAP

Health & OTC Manufacturing Associates Pakistan

Mailing Address: House No. 1-D, Block C, Haq Bahoo Street, Judicial Colony, Canal Bank Road, Lahore
homap.association@gmail.com +92-321-6400352 [Convenor Adhoc Committee]

The
CEO
Drug Regulatory Authority of Pakistan
Islamabad

Respected Sir,

ISSUANCE OF PENDING FORM-7 OF Coal Tar

PERTAINING TO COMMON MOLECULES
DEALT BY H & OTC AND PE&R DIVISIONS

We are manufacturers of quality H & OTC products with approvals under Form-7, for local and international
markets.

Quite a number of applications of our associates are pending for approvals in H & OTC Division for the molecules
present in common molecule list. One of them is Coal Tar.

The H & OTC Division had already issued Form-7 of Coal Tar to a number of H & OTC Manufacturers. All the
manufacturers holding Form-6 have a fundamental right to be treated as par without any differentiation for
issuance of Form-7. It is worth mentioning here that this molecule is also used by manufacturers of
nutraceuticals / herbals in Europe, Australia, USA, Japan, China, India etc. These molecules are dietary
supplements used in H & OTC and consumer products.

We earnestly request you to kindly issue instructions to H & OTC Division for approval of pending Form-7 for
Coal Tar molecule present in the common molecules list.

Thanking you,

Yours sincerely,

Ehsan-ul-Haq
Convenor Adhoc Committee HOMAP
 Generic Name
of
Coal Tar

Generic Name of Coal Tar is Coal Tar.

Coal Tar
(BP Reference in Dietary Supplement Chapter)

MONOGRAGH-COAL TAR (BP)

Action and use

Used in treatment of psoriasis.

Preparations

Coal Tar Solution

Strong Coal Tar Solution

Zinc and Coal Tar Paste

DEFINITION

Coal Tar is a product obtained from bituminous coal by destructive distillation at about 1000°.

CHARACTERISTICS
 A nearly black, viscous liquid. On exposure to air, the viscosity gradually increases. It burns in air with a
luminous, sooty flame. It has a weight per mL of about 1.15 g.

Slightly soluble in water; partly soluble in ethanol , in ether and in volatile oils.

IDENTIFICATION

 A. A saturated solution is alkaline to litmus solution.

 B. Carefully add 0.5 g to 10 mL of petroleum spirit (boiling range, 40° to 60°) and allow to stand for 30 minutes.
When examined in daylight, the supernatant liquid has a blue fluorescence which becomes more intense when
viewed under ultraviolet light (365 nm).

TESTS

Ash

Not more than 2.0%, Appendix XI J.

International References
Of
COAL TAR
As OTC Product

Reference 1:

Product Name
DHS Tar Shampoo, 8 Fluid Ounce
by DHS California

Product Class
OTC TOPICAL PREPARATIO
 Category: HUMAN OTC LABEL
 DEA Schedule: None
 Marketing Status: OTC monograph final
Ingredients
Ingredients: 2.9% Coal Tar Extract (0.5% Coal Tar)
USES
Anti Dandruf Preparation

Manufacturers:

DHS Tar Shampoo, 8 Fluid Ounce

by DHS California

Reference 2:
Product Name:

Scytera

Product Class
OTC Topical Preparaion
Manufactured By

DPT Laboratories, Ltd 318 McCullough Ave, San Antonio, TX 78215, United States.