To, The Deputy Drugs Controller, Health and OTC products, Drug Regulatory Authority of Pakistan, Islamabad. Subject: Product Enlistment of BRONZE ENHANCEMENT TILLA Respected Sir, We M/s TASEER HERBAL PHARMA, A-780A, Mohan Pura, Rawalpindi-Pakistan are herewith, submitting the product dossier of our locally manufactured natural product “BRONZE 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 FOR ENLISMENT OF LOCALLY MANUFACTURED INDIGENOUS UNANI MEDICINE, HER BAL MEDICINAL PRODUCTS (PHYTOMEDICINE) HOMOPATHIC, MEDICINE OR HEALTH PRODUCTS FOR THERAPEUTIC OR DISEASE REDUCTION CLAIMS (Attached readable soft copy with application) I, Hakeem & Dr. TARIQ MEHMOOD TASEER owner of M/s TASEER HERBAL PHARMA hereby 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. Brand Name of Product: BRONZE ENHANCEMENT TILLA N Common Name of Recommended o List of Ingredients with Strength Ingredients Uses 1. 2. 3. 4. 5. White Rooster’s spleen water Mimusops elengi L 6 mg Rosa Pandanus Lawsonia inermis Ambergris Moschus moschiferus Crocus sativus Opium poppy Mimusops elengi L 1 mg 1 mg 1 mg 3 mg 6 mg 6 mg 1 mg 1 mg Coccinia grandis Lumbricina Aquilaria malaccensis Wax 1 mg 3 mg 6 mg 6 mg Q.S White Rooster’s spleen water Mimusops Elengi Flower Rose screwpine Henna Ambergris Pure Musk Saffron Poppy seeds extrat Mimusops Elengi Extract Arania Coccinia Earthworms Eagle Wood Wax Erectile Dysfunction, Premature Ejaculation, Bended, Weak and Small Organ. Pack Size 50gm Maximum Retail Price Rs.2200/- Master Formula. (Annexure A) Manufacturing process and in process controls (Annexure B) Testing specification for Raw Material and finished products. (Annexure C) 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: White Rooster’s spleen water Mimusops elengi L 6 mg Rosa Pandanus Lawsonia inermis Ambergris Moschus moschiferus Crocus sativus Opium poppy Mimusops elengi L 1 mg 1 mg 1 mg 3 mg 6 mg 6 mg 1 mg 1 mg Coccinia grandis Lumbricina Aquilaria malaccensis Wax 1 mg 3 mg 6 mg 6 mg Excipients: nil Q.S (Annexure B) Manufacturing process Manufacturing process is consisted of following: a) b) c) d) e) f) g) h) Purify all the ingredients completely and wash with distilled water. Boil on low temperature and get the joshanda. Filter the joshanda with the help of Cloth. Then put oil into the stainless steel pot. Point out the upper layer stainless steel pot. Now put joshanda into pot and boil it. Boils that specific point. Then away from the fire. Tilla is ready for use. In Process Controls ( BY Q.C. Department) 1. 2. 3. 4. Boiling of water upto 30 mins Maintenance of filling volume at the time of filling Monitoring of volume variation. 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 2 years 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: 2200/- Undertaking I undertake and certify that the contents stated above regarding the “BRONZE 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…………………..