To,

The Deputy Drugs Controller,

Health and OTC products,

Drug Regulatory Authority of Pakistan,

Islamabad.

Subject: Product Enlistment of FAST ACTION ENHANCEMENT TILLA

Respected Sir,

We M/s TASEER HERBAL PHARMA, A-780A, Mohan Pura, Rawalpindi-Pakistanare herewith, submitting the product dossier of our locally manufactured natural product “FAST ACTION ENHANCEMENT TILLA” on the prescribed form. All the necessary documents with original Challan fee receipt are attached here with this application for your perusal. Your kind concern is requested in this regard.

Thanking in anticipation,

Truly yours,

Hakeem & Dr.

TARIQ MEHMOOD TASEER

Chairman

FORM-4

[(See rule 3(3)]

APPLICATION FORENLISMENT OF LOCALLY MANUFACTUREDINDIGENOUS UNANI MEDICINE, HER BAL MEDICINAL PRODUCTS(PHYTOMEDICINE) HOMOPATHIC, MEDICINEOR HEALTHPRODUCTSFORTHERAPEUTIC OR DISEASE REDUCTION CLAIMS

(Attached readable soft copy with application)

I, Hakeem & Dr. TARIQ MEHMOOD TASEERowner of M/s TASEER HERBAL PHARMAhereby apply for enlistment of following product manufactured by my firm/company (has already applied as manufactured) located at the premises as under:TASEER HERBAL PHARMA, A-780A, Mohan Pura, Rawalpindi-Pakistan

  1. Product Profile

S.No / Brand Name of Product: FAST ACTION ENHANCEMENT TILLA
List of Ingredients with Strength / Common Name of Ingredients / Recommended Uses / Pack Size / Maximum Retail Price
1. / Syzygiumaromaticum
Myristicaceae
MyristicafragransHoutt
Cocciniagrandis
Celastruspaniculatus
Lion Fat
Black Beer Fat
sanda lizard
Eagle Kidney Fat
Arsenic
Cheuntakalan
Iodiodmurcery
Iodine
Belladonna
Astarknia
Zafran
Kasturi
almas / 2mg
2mg
2mg
2mg
2mg
5mg
2mg
2mg
5mg
3mg
10nos
.2mg
.6mg
.2mg
.1mg
.1mg
.1mg
.1mg / Clove Oil
Mace
nutmeg
Araniacoceinia
Staff tree
Lion Fat
Black Beer Fat
sanda lizard
Eagle Kidney Fat
Arsenic
Ant
Iodiodmurcery
iodine
Belladonna
Astarknia
Saffron
Musk deer
Gold foil / Erectile Dysfunction, Premature Ejaculation, Bended, Weak and Small Organ. / 50gm / Rs.1600/-

2. Master Formula. (Annexure A)

3. Manufacturing process and in process controls (Annexure B)

4. Testing specification for Raw Material and finished products. (Annexure C)

5. Shelf life and storage. (Shell life shall base on stability data). In case data not available then letter of

commitment for submission of data be submitted. (Annexure D)

6. Recommended Conditions for use. Evidence for therapeutic or disease reduction claims as per standards

of evidence (Annexure E)

7.Packaging and labeling.(Annexure F)

8.Maximum Retail price. (Annexure G)

9. Fee deposit receipt.(Fee deposited Challan copy attached)

10.I undertake and certify that the contents stated above are correct true to the

best of my knowledge (Attached undertaking on the notarized stamp paper).

Name of the owner

Hakeem & Dr. TARIQ MEHMOOD TASEER

Signature ………………….

Seal of the firm/ company

Dated…………………..

(Annexure A)

Master Formula

Active ingredients:

Each 1 g contains:

Syzygiumaromaticum
Myristicaceae
MyristicafragransHoutt
Cocciniagrandis
Celastruspaniculatus
Lion Fat
Black Beer Fat
sanda lizard
Eagle Kidney Fat
Arsenic
Cheuntakalan
Iodiodmurcery
Iodine
Belladonna
Astarknia
Zafran
Kasturi
almas / 2mg
2mg
2mg
2mg
2mg
5mg
2mg
2mg
5mg
3mg
10nos
.2mg
.6mg
.2mg
.1mg
.1mg
.1mg
.1mg

Excipients:

nil

(Annexure B)

Manufacturing process

Manufacturing process is consisted of following:

a)Purify all the ingredients completely and wash with distilled water.

b)Boil on low temperature and get the joshanda.

c)Filter the joshanda with the help of Cloth.

d)Then put oil into the stainless steel pot.

e)Point out the upper layer stainless steel pot.

f)Now put joshanda into pot and boil it.

g) Boils that specific point. Then away from the fire.

h)Tilla is ready for use.

In Process Controls ( BY Q.C. Department)

  1. Boiling of water upto 30 mins
  2. Maintenance of filling volume at the time of filling
  3. Monitoring of volume variation.
  4. Proper preparation of the extracts

(Annexure C)

Testing specification of Raw Material

(Manufacturer specification)

Testing specification

(Manufacturer’s Specification)

Average volume in a bottle:50 grams

Volume Variation:+/- 0.5 gm

pH of the OIL : ------

Color of the OIL:(As per the control)

Taste of the OIL:no flavor

(Annexure D)

Shelf life and storage

Shelf Life: For 2years

Storage:

Keep the product in cool and dry place at room temperature,Keep out of the children’s reach.

Letter of Commitment for Stability Data

This is to commit that we are working on the stability data of the said product. The moment the product completes its shell life we shall submit the stability data as monitored by our Quality Control department, for your perusal

Name of the owner

Hakeem & Dr. TARIQ MEHMOOD TASEER

Signature ………………….

Seal of the firm/ company

Dated…………………..

(Annexure E)

Recommended Conditions for use

Indications:

Erectile Dysfunction, Premature Ejaculation, Bended, Weak and Small Organ.

Dosage:

Rub tilla gently on the sexual organ (except the glands and bottom of the organ) at night before going to sleep.

References:

(Annexure F)

Packaging and labeling

Label:

Pack:

(Annexure G)

Maximum Retail price.

Maximum Retail Price. Rs: 1600/-

Undertaking

I undertake and certify that the contents stated above regarding the “FAST ACTION ENHANCEMENT TILLA” are correct true to the best of my knowledge. That the product is manufactured as per the good manufacturing practices.

Name of the owner

Hakeem & Dr. TARIQ MEHMOOD TASEER

Signature ………………….

Seal of the firm/ company

Dated…………………..