Concessionary customs duty on import of pharmaceutical raw materials and packing materials.

GOVERNMENT OF PAKISTAN MINISTRY OF FINANCE, ECONOMIC AFFAIRS, STATISTICS AND REVENUE (REVENUE DIVISION) *** Islamabad, the 15th June, 2002 NOTIFICATION (CUSTOMS) SRO. 372 (I)/2002. - In exercise of the powers conferred by section 19 of the Customs Act, 1969 (IV of 1969), and in supersession of its Notification No. S.R.O. 416(I)/2001, dated the 18th June, 2001, the Federal Government is pleased to direct that the goods specified in Tables I and II below shall be exempt from so much of the customs-duty leviable thereon under the First Schedule to the Customs Act, 1969 (IV of 1969), as is in excess of ten per cent ad valorem, and the goods specified in Table-III below shall be exempt from so much of the customs-duty leviable thereon under the First Schedule to the aforesaid Act, as is in excess of five percent ad valorem, if,- (a) the raw materials and packing materials, specified in Table I below, are imported by a manufacturer, approved by the Director General, Health, Government of Pakistan, under the Drugs Act, 1976 (XXXI of 1976), for manufacture of pharmaceutical products registered as drugs under the aforesaid Act, subject to the conditions specified in that Table; (b) the raw materials and packing materials specified in Table II below, are imported for the manufacture of drugs registered under the Drugs Act, 1976 (XXXI of 1976), subject to the conditions specified in that Table; and (c ) the chemicals, specified in list A of Table III below are imported for the basic manufacture of pharmaceutical active ingredients specified in list B of Table III subject to the conditions specified in the said Table:- Table I A. List of raw materials: S.No. DESCRIPTION P.C.T. HEADINGS (1) (2) (3) 1. | Acriflavine and its salts. | 3824.9099 8 [1A | Acrinol pad | 3005.9010 2. | Activated glucronate. | 3824.9099 3. | Acyclovir. | 3824.9099 4. | Alkylphenoxypoly ethanol. | 3824.9099 5. | Aluminium hydroxide-magnesium carbonate co-dried. | 3824..9090 6. | Aluminium sucrose sulphate. | 3824.9099 7. | Amicarbional. | 3824.9099 8. | Amidopyrine/Aminopyrine. | 3824.9099 9. | Amino acid mixture L form. | 3824.9099 10. | Aminogluethimide. | 3824.9099 5 [10A | Amoxicillin Sodium Sterile BP | 2941.1000] 11. | Ammonium salt of sulphated alkylphenoxypoly ethanol. | 3402.1200 5 [11A. | AmpicillinSodium Sterile USP/BP | 2941.1000] 12. | Azapropazone dihydrate. | 3824.9099 13. | Bacampicillin HCL. | 2941.1000 14. | Beccampicillin HCL microcapsule 65-85%. | 3824.9099 15. | Befunolol HCL. | 3824.9099 16. | Benzilic acid dimethyl octyl bromide. | 3824.9099 6 [16.A | Benzyl Pencillin Sodium/Potassium | 2941.1000] 17. | Betatab 75. | 3824.9099 18. | Bezafibrate. | 3824.9099 19. | Biological and chemical indicators. | 3824.9099 20. | Bisacodyl. | 3824.9099 21. | Brobenzonalidine. | 3824.9099 22. | Brobenzoxaldine. | 3824.9099 23. | Brotianide. | 3824.9099 24. | Buzepide mthiodide. | 3824.9099 25. | Calamine. | 3824.9099 26. | Calcium carregeenan. | 3824.9099 27. | Captopril. | 3824.9099 28. | Carbachol. | 3824.9099 29. | Carbenicillin and its salts. | 2941.1000 30. | Carfecillin. | 2941.1000 31. | Castor Oil(injection grade only). | 1515.3000 32. | Ceftazidime pentahydrate(blend). | 3824.9099 33. | Cetomacrogol 1000(Texofor). | 3402.1990 34. | Cetrimide. | 3808.4000 35. | Cloxacillin and its salts excluding cloxacillin (compacted/ powder form for oral use). | 2941.1000 5 [35A. | Cloxacillin Sodium Sterile USP/BP | 2941.1000] 36. | Coated granules for moriamin capsules. | 3824.9099 8 {36A | Cold Seal Coated paper | 4811.4100 37. | Collagen strip (catgut). | 4206.1000 38. | Concentrate of lactoserum brocein of 65% nitrogen. | 3824.9099 39. | Dioctahedral smeltite. | 3802.9000 40. | EPL substances (essential Phospholipids). | 3824.9099 41. | Exracepae. | 3824.9099 42. | Extract absinthii. | 1302.1900 43. | Extract Aconite. | 1302.1900 44. | Extract belladonna liq or sicc. | 1302.1900 45. | Extract benzoin. | 1302.1900 46. | Extract buchu. | 1302.1900 47. | Extract capsicum. | 1302.1900 48. | Extract colae siccum. | 1302.1900 49. | Extract colchicine . | 1302.1900 50. | Extract coltsfoot. | 1302.1900 51. | Extract ginkgo biloba. | 1302.1900 52. | Extract glyoyrrhiza (liquid/siccum). | 1302.1900 53. | Extract hyoscyamus. | 1302.1900 54. | Extract ipecac. | 1302.1900 55. | Extract krameira. | 1302.1900 56. | Extract liriosma ovate. | 1302.1900 57. | Extract lobelia. | 1302.1900 58. | Extract myrrh. | 1302.1900 59. | Extract nux vomica. | 1302.1900 60. | Extract pine bark. | 1302.1900 61. | Extract quassia +. | 1302.1900 62. | Extract rhein. | 1302.1900 63. | Extract scillae. | 1302.1900 64. | Extract stramonium. | 1302.1900 65. | Extract strychnos. | 1302.1900 66. | Extract thyme. | 1302.1900 67. | Extract valerian. | 1302.1900 68. | Extract witch hazel. | 1302.1900 69. | Extraxct senega. | 1302.1900 70. | Eyeless sutures needles. | 9018.3200 71. | Flucloxacillin sodium. | 2941.1000 72. | Gentain roots/extracts. | 1302.3900 73. | Gentian/ Pluv Gential. | 3204.1300 74 | Ginkgo Biloba Extract. | 1302.1900 74. | Glassine sleeve. | 4819.5000 75. | Gluethimide. | 3824.9099 76. | Hemicelluloses. | 1302.3900 77. | Imidapril HCL. | 3824.9099 78. | Intrinsic factor. | 3824.9099 79. | Ipecac. | 3824.9099 80. | Iron (III) Hydroxide Polymaltose complex. | 3824.9099 81. | Iron-dextran or sorbitol- citric acid complex. | 3824.9099 82. | Loratadine. | 3824.9099 83. | Losartan potassium. | 3824.9099 84. | Lovastatin. | 3824.9099 85. | Lyophlised saccharomyces boulardii. | 3824.9099 86. | Macloxamine dihydrogen citrate. | 3824.9099 87. | Magaldrate gel sulphate. | 3824.9099 88. | Magaldrate powder USP. | 3824.9099 89. | Magnesium probencid. | 3824.9099 90. | Marvelon. | 3824.9099 91. | Medicamycin acetate fine granules. | 3824.9099 92. | Methisoprinol. | 3824.9099 93. | Midodrine hydrochloride. | 3824.9099 94. | Mometasone fursate. | 3824.9099 95. | Momochloracarvacrol. | 3824.9099 96. | Mozantel tartazate. | 3824.9099 97. | Mucoproteose. | 1302.3900 98. | Opalux, Opadry, Opaspray, Opglos. | 3824.9099 99. | Ossein mineral complex. | 3505.1090 100. | Polyvinylpyrrolidone (pharmaceutical grade). | 3905.9990 5 [100A. | Pencillin Benzathin | 2941.1000] 6 [100B | Pencillin V.Potassium | 2941.1000 100C | Polysaccharide Iron Complex | 3824.9099] 101. | Polyvinylpyrrolidone iodine. | 3905.9990 6 [101A | Procaine Pencillin G.Fortified Sodium/Potassium | 2941.1000] 8 {101B | Potassium Clavulanate Stablised | 3824.9099 8 {101C | PVC Tape in Rolls | 3919.1090 3919.9000 102. | Raubasine. | 3824.9099 2 [102A | Pravastatin sodium | 3824.9099] 103. | Rice hulls. | 1104.2900 104. | Rhubarb leaves or roots. | 1404.9090 105. | Rifater pre-mix. | 3824.9099 106. | Risperidone. | 3824.9099 107. | Roxatidine acetate HCL. | 3824.9099 108. | Ruscogenine. | 3824.9099 109. | Secrosteron. | 3824.9099 110. | Senega. | 3824.9099 111. | Senidazole. | 3824.9099 112. | Septocemobin. | 3824.9099 113. | Seuzm. | 3824.9099 8 {113A | Siliconised paper | 4811.5990 114. | Silymarine. | 3824.9099 115. | Simvastatin. | 3824.9099 116. | Sodium chloride (injectable grade). | 2501.0090 117. | Sodium lodohepartinate. | 3824.9099 118. | Sodium parrolodone crboxylate. | 3824.9099 119. | Spfeen powder. | 3824.9099 120. | Spironolactone. | 3824.9099 121. | Spraydried sodium polyhydoxyaluminium. | 3824.9099 122. | Sultamicillia tosylate. | 2941.1000 123. | Sultamicillin. | 2941.1000 124. | Surfen. | 3824.9099 125. | Tibolone. | 3824.9099 126. | Tincture asafoetid. | 1302.1900 127. | Tincture bronchicum. | 1302.1900 128. | Tincture capsicum. | 1302.1900 129. | Tincture myrrh. | 1302.1900 130. | Tincture Gimdecifugee. | 1302.1900 131. | Tincture oucbracho. | 1302.1900 132. | Tincture primula. | 1302.1900 133. | Tincture strychors. | 1302.1900 134. | Tincture thyme. | 1302.1900 135. | Tabcoat. | 3824.9099 136. | Tribulus terrestris. | 3824.9099 137. | Triple antigen concentrate. | 3824.9099 138. | Valerine roots. | 1404.9090 139. | Virginiamycine. | 3824.9099 7 [139A. | Vitamin C Calcium Granules | 3824.9099] 140. | Zinc bacitracin zinc monomethionine complex. | 3824.9099 B. List of packing materials. 1. Ampoule cutter. 2. Aerosol therapy apparatus and its components. 3. Aluminum foil printed, indicating particulars of drug and manufacturer, in roll for strip or blister packing of tablets or capsules. 4. Cannulae and its caps for infusion sets. 5. Edible ink. 6. Empty glass infusion bottle with and without graduation USP II. 7. Metallic twisters for flow regulators. 8. Plastic nebuliser or dropper bottles for ear, eye and nasal drops with or without assembly. 9. Plastic nebuliser. 10. Stoppers for I.V. solutions. 11. Neutral glass cartridges with rubber dices and plungers and aluminium seals. 12. Plastic eye baths. 13. Printed aluminium foil for sachet or I.V. infusion bag. 14. Printed viskerings. 15. Tear off aluminium seals for injectables. 16. Non-toxic plastic bags for I.V. solutions of dextrose and other infusions. 17. Flip off seals for injectable vials. 8{18. Anodized Aluminium Bottle. 19. Rubber Plug with Tear off seal. 20. Closing lid (Aluminium A1. High density polyethylene/polypropylene).] Conditions for Table-I:- (a) the importer shall make, at the time of clearance from Customs, a declaration on the bill of entry that the goods will not be used for any purpose other than the manufacture of pharmaceutical products registered as drugs under the Drugs Act, 1976 (XXXI of 1976); and (b) the importer-cum-manufacturer shall maintain record of the goods imported and the pharmaceutical products manufactured therefrom and shall produce the same whenever so required by the appropriate officer of Customs or the Director General, Health, or an officer authorized by him in that behalf: Provided that the exemption in excess of ten per cent ad val., granted by this notification shall not apply to the import of raw materials and packing materials for the purpose of manufacture by way of repackaging of drugs: Provided further that the availability of the aforementioned facility will be restricted to drugs manufacturers for such raw materials which have duly been registered and approved by the Director-General, Health, in accordance with the provisions of the Drugs Act, 1976 (XXXI of 1976). The said facility shall take effect from the date of the registration of the drug under the aforesaid Act, as per registration certificate issued by the Ministry of Health to the pharmaceutical manufacturers using any one or more of the pharmaceutical raw materials mentioned above. Table II A. List of raw materials: S.No. | DESCRIPTION P.C.T HEADINGS (1) | (2) (3) 1. | Acesulfame potassium acetanilide. | 3824.9099 2. | Acid undecenoic B.P. | 3824.9099 3. | Alkyl aryl sulfonate. | 3402.9000 4. | Aluminium hydroxide, paste /dried/gel/compressed | 2813.9000 5. | Ampnocerin “K” or “KS”. | 3402.9000 6. | Amylopectin. | 3505.1090 7. | Anhydrous di-sodium carbonate. | 2836.3000 8. | Animal charcoal (activated carbon). | 3802.1000 9. | Anti foam emulsion. | 3824.9099 10. | Antifoam F.D. | 3824.9099 11. | Balsam, Tolu BP/USP. | 1301.9090 12. | Bevaloid dispersant. | 2707.9990 13. | Biotin 1% in calcium phophate. | 3824.9099 14. | Butyl phthalate. | 2917.3100 15. | Calcium Sulphate Natural. | 2520.1010 16. | Capsicum oleoresin (caposicin). | 3301.9090 17. | Carboxypolymethylene/caboxy vinyl polymer (carbopol/ carbomer). | 3906.9090 18. | Carboxymethyl cellulose and its salts. | 3912.3100 19. | Casein formaldehyde. | 1521.090 20. | Catastay powder. | 3824.9099 21. | Cellulose and its derivatives. | 3501-9000 22. | Cetearyl octanoate. | 3824.9099 23. | Cetostearyl alcohol. | 3823.7000 24. | Cetylester wax. | 3404.9090 25. | Chlorophyll. | 3203.0090 26. | Collone wax. | 3404.9090 27. | Colophony resin. | 3906.9090 28. | Copra fatty acid diethanolamide. | 3823.7000 29. | Cremoophor. | 3402.1300 30. | Decelite . | 3802.9000 31. | Dextrate. | 1 [1702.3000] 32. | Dextrose (injectable grade). | 3505.1010 33. | Diascorea roots / powder. | 1302.3900 34. | Dibutylphthalate. | 2917.3100 35. | Emulsional. | 3823.7000 36. | Essences in powder for use in ORS (lemon, lime, orange, pine apple and cherry only). | 2106.9030 37. | Essential oils (anisi, cinnamon, caraway, cardamom, nutmeg, lemon, peppermint only). | 3301.9000 38. | Ethyl Alcohal. | 2207.1000 39. | Ethyl acetate. | 2915-3100 40. | Ethyl oleate. | 3824.9099 41. | Eucalyptus oil, eucalyptol. | 3301-9090 42. | Eucerin. | 3824.9099 43. | Methaerylic Acid Co-Polymer. | 3906.1000 44. | Explotab. | 3824.9099 45. | Extract bitter orange peels. | 2106.9030 46. | Extract wild cherry. | 2106.9030 47. | Ferric oxide phosphate and pyrophosphate. | 3824.9099 48. | Food colour (pharmaceutical grade). | 3205-0000 49. | Gelatin. | 3503.0000 50. | Gentian violet. | 3204.1300 51. | Glyceryl mono stearate, distearate and mono ricinoleate. | 3404.9090 52. | Glycofurol. | 3824.9099 53. | Gum acacia powder BP. | 1301-9090 54. | Gum benjamin BP. | 1301-2000 55. | Gumbenzoin, Styrax, Tragacanth, Xanthan | 1301.9090 56. | Hard fat. | 1501-0090 57. | Hydorxy propyl methyl cellulose. | 3912-3100 58. | Hydrogenated methyl abietate. | 3806-9000 59. | Hydrogenated oil. | 1516.2000 60. | Instant rice. | 1104.2900 61. | Iron Oxide/Silica/Zeolite. | 3824.9099 62. | Lanette wax. | 2712-9010 63. | Lanolin (wool alcohol / fat). | 1505.1010 64. | Laponite SLG. | 1505-1090 65. | Laury dimethyl aminoxide. | 3823.7000 66. | Lemon pippermint only. | 3301.9090 67. | Lemon, lime and orange essences(in powder). | 2106.9030 68. | Linseed oil. | 1515.1900 69. | Lauryl amidobetaine. | 3824.9099 70. | Malt extract. | 1901-9010 71. | Maltadextrin. | 1702.9030 5 [70A. | Mastercote | 3205.0000] 72. | Methyl methacrylate copolymer(mana copolymer). | 3906.1000 73. | Methylene blue. | 3824.9099 74. | Methyvinyl ether maleic anhydride copolymer. | 3906.9090 75. | Microcrystalline waxes. | 3404.9090 75A. | 9 [O-2(Hydroxyethyl)Amylopectin Hydrolysate Polly (O-2 Hydroxyethyl)Starch} | 3505.1090] 76. | Monofilament stainless steel/ Nylon/Polypropylene WP/ BPC/USP. | Respective heading 77. | Palm kernel Oil.PEG-6 Complex. | 1513.2900 78. | Paraffin hard. | 2712.9000 79. | PEG-75 Stearate and Glyceryl Stearate. | 3404.2000 80. | Persnganate, Sulphate, Succinate. | 3824.9099 81. | Pharmacoat. | 3912.3900 82. | Plaited (braided) polyester coated BPC/USP. | Respective heading 83. | Plaited (braided) silk USP/BPC. | -do- 84. | Plastibase. | 2710.9900 85. | Polyethylene glycol and its derivatives. | 3404.2000 86. | Polyoxyethylene-polymer. | 3402.1300 87. | Polygel. | 3824.9099 88. | Polyglyceryl ricinoleates. | 3907.9900 89. | Polymerized acrylic acid. | 3906.9090 90. | Polyoxyethylene. Glycol/Glycerides/Polyoxyl stearate. | 3404.2000 91. | Polyoxyl stearate. | 3824.9099 92. | Pregelled/pregelatinized starch. | 3505.1090 93. | Prepared Storax. | 3824.9099 94. | Primojel. | 3505.1090 95. | Promulgen. | 3824.9099 96. | Propandiol mona distearate. | 3824.9099 97. | Propyl gallate . | 3824.9099 98. | Quassin solution. | 3824.9099 99. | Quinaldine and its salts. | 3824.9099 100. | Rhodigel ( food grade). | 3824.9099 101. | Sandarac. | 3824.9099 102. | Sesame oil ( for injection). | 3301.2100 103. | Sodium carraghenate. | 3505.1090 104. | Sodium croscarmellose. | 3912.3100 105. | Sodium formaldehyde hydrogen 3 [sulphite]. | 3824.9099 106. | Sodium lauryl alcohol/sulphate. | 3402.1990 107. | Sodium linear alkylatesultonate. | 3402.1990 108. | Sarbitan and its derivatives. | 3402.1300 109. | Sorbitol crystalline powder. | 2905-4400 110. | Spermaceti. | 1521.9090 111. | Sterilisable maize starch. | 1108.1200 5 [110A | Supectrablend | 3824.9099] 112. | Talc (pharmaceutical grade). | 2526.2000 113. | Tenox-2. | 3824.9099 114. | Tergitol. | 3402.1300 115. | Vinylpyrrolidinone vinyalaectate Copolymer. | 3905.9990 116. | Viscarin. | 3824.9099 117. | Wax emulsifying witepsol. | 3404.9090 118. | Witepsol. | 3404.9090 B. List of packing materials. 1. Aluminium foil printed, indicating particulars of drug and manufacturer in roll for wrapping. 2. Un-printed aluminium foil with coating of Mylar Polyester adhesive or Surlyn Iononer resin on one side and vinyl coating on the other side. 3. Polyester polyethylene film of polyester (Melinerxor Mylar) and low density poly-ethylene. 4. Medical bleached kraft paper metalized on the smooth side and coated on the rough side with heat seal coating lacquer. 5. Medical kraft paper with heat seal coating of EVA resin base; White tag board of bleached wood pulp. 6. Neutral Glass Vials 1-2 ml U.S.P-1. 7. Moulded Glass Vials U.S.P. Type III (for antibiotics Inj-powder). 8. Printed Cellophane Viscose packing and wrapping Film. 9. Printed Poly Bags for infusion sets. 10. 13 mm Rubber stoppers for injections. 11. 20 mm and 32 mm Rubber stopper for injections. 12. Soft non-toxic PVC Film/lay flat tube for medical application. 13. PVC non-toxic tubing for medical application. 14. Preformed printed pet Sleeves. 15. Glass bottle USP type I. 16. Pre-printed Polypropylene tubes with tamper proof closures (with or without dessicant) indicating particulars of registered drug and manufacturer. 17. Bottle pack caps FK-28 including a rubber disc and a compound ring for Haemaccel, Sterilized. 18. Lupolen 1840H Q211 for molding haemaccel bottles. 19. Neutral, clear glass, USP type I (pre-sterilized) close mouth. Conditions for Table II:- (a) the manufacturer shall furnish to the Health Division the quantities of the raw or packing materials along with the details of the drugs to be manufactured therefrom, and the Director General Health or any other officer authorized in this behalf will certify for each consignment requirements of raw or packing materials along with the names of the drugs to be manufactured therefrom in the Form-I set out below. (b) at the time of import of raw or packing materials, the manufacturer shall make a written declaration on each copy of the bill of entry to the effect that the raw or packing materials have been imported in accordance with his entitlement in terms of condition (a); (c) the Collector of Customs shall allow release of the raw materials against bank guarantee or indemnity bond along with post-dated cheque equivalent to the amount of customs duty exempted under this notification; (d) the manufacturer shall maintain records of the materials imported and drugs manufactured therefrom, and shall produce the same whenever so required by the appropriate officer of customs or the Health Division; (e) the manufacturer shall within fifteen months of the date of filing of bill of entry for home consumption relating to the raw or packing materials, apply to the Collector of Customs for discharging the bank guarantee or indemnity bond along with post dated cheque, the application being supported by a certificate in the Form-II set out below, issued by the Director General, Health or any other officer authorized in this behalf; and (f) the concession shall take effect from the date of the registration of the drug under the Drugs Act, 1976 (XXXI of 1976), as per registration certificate issued by the Ministry of Health to the pharmaceutical manufacturers using any one or more of the pharmaceutical raw materials specified in this notification. TABLE III List A Chemicals required for the manufacture of pharmaceutical active ingredients as indicated in list B of the Table III Sl.No . | List of Chemicals 1. | 1,2 Dichlorobenzene. 8 {1A. | 1-H-tetrazole-1-acetic acid (TAA) 1B. | 2-2-benzothiazolyl disulphite] 2. | 2,6- Dichloroaniline. 7 [2A. | 2-Cholorobenzoic Acid] 3. | 2-Cynopyrazine. 4. | 2-Ethyl Hexanoic Acid. 7 [4A. | 2,3 Dimethylaniline.] 8 {4B | 2-Mercaptobenzothiazolyl (Z_-2-(2-Aminothiazole-4-yl_-2-(Tert-Butoxycarbonyl)-Isopropoxyimino]Acetate [TAEM]. 4C. | 2-Mercatobenzothiazolyl(Z)2-2(2-Aminothiazole-4-yl)-2-(Tert-Butoxycarbonyl)-Methoxyimino Acetate (MBT) 4D. | 2-Mercaptobenzothiazolyl(Z)-2-(Aminothiazole-4-yl)-2-Methoxyimino Acetate (MAEM). 4E | 2-Methyl-5-Mercepto-1,3,4-thaizole(MMTD).] 5. | 3 Chloro 4-Fluoro Aniline. 6. | 3-(2-Chlorophenyl)-5-Methyl Isoxazole-4-Carbonyl Chloride (Cmic Chloride). 7. | 3,4,5, Trimethoxy-Benzaldehyde (TMBA). 8. | 3-Morpholinopropionitrile. 9. | 5 Nitro Furfural Dicetate. 10. | 6-Aminopenicillanic Acid (6-APA). 8 {10A | 7-[[2-furany(sin-methoxyimino)acetyl]amino]-3- hydroxymethyl ceph-3-em-4-carboxyclic acid. 10B. | 7-Amino-3-[[2,5-dihydroxy-2-methyl-5-oxo-1,2,4-trizin-3-yl)-thio]methyl]-Cephalosporanic acid (7-ACT). 10C. | 7-Amino-3(1H-thiadiazole-)-Cephalosporanic Acid (7-TDA). 10D. | 7-Amino-3(1-methyl-1H-tetrazol-5-yl)thiomethyl-3-cephem-4-carboxylic acid (7-TMCA) 10E. | 7-Amino 3-vinyl Cephalosporanic Acid (7-AVCA). 10F. | 7-Amino 3-vinyl Cephalosporanic Acid [7-ACA]. 10G. | 7-Amino Chloro Cephalosporanic Acid (7-ACCA) ] 11. | 7-Amino Desacetoxy Cephalosporanic Acid. 8 {11A. | (7-phenyl-acetamido-3-chloromethyl cephalosporanic acid p=methoxybenxzyl ester (GCLE). 11B. | __{[4-ethyl-2,3dioxo-1-piperazinyl)Carbonyl]amino} -4-hydroxy-benzene acetic acid [HO-EPCP]] 12. | Acetic Acid. 13. | Acetic Anhydride. 14. | Acetone (Technical Grade Absolute). 15. | Acetonitrate. 16. | Acetyl Chloride. 17. | Activated Carbon. 18. | Activated Carbon (Animal Porous). 19. | Aldadiene (17-Hydroxy-3-OXO-17-a- regna-4,6-diene-21-Carboxylic Acid Y-Lactone). 20. | Aldona (17-Hydroxy-3-OXO-17-a- Pregna-4-ene, 17 B Cabrlactone). 21. | ALP-Chloride (Methanone) (5-chlore-2-2 (3, chloromethyl) -5- Methyl-4H-1, 2,4-Triazol -4-yl) Phenyl) Phenyl. 22. | Aluminium Chloride Anhydrous. 23. | Aluminium Hydroxide. 24. | Amlodipine. 25. | Ammonium Hydroxide Solution (Technical Grade 29% NH3). 26. | Aniline. 27. | Antifoam CLRS.Oil .Substitute. 28. | ASC (Acetyl Sulphonic Chloride). 29. | Atorvastatin. 30. | Benzaldehyde. 31. | Benzene. 3 [31A | Bangzoyl chloride] 8 {31B. | Boric Acid. 32. | Bromine. 33. | Bromo Benzene. 34. | Bromodone. 35. | Bromothymol Blue. 36. | Butanol. 5 [36A. | Butyl ortho propionate] 37. | Calcium Carbonate. 38. | Calcium Chloride Anhydrous. 39. | Calcium Hydroxide. 40. | Calcium Hydroxide (Limbux Lime). 41. | Carbon Tetra Chloride. 42. | Carboxy Methyl Cellulose Sodium. 43. | Carvedilol. 44. | Cephalosporanic Acid (7-ADCA). 45. | Cetirizine. 7 [45A. | Citric Acid (Monohydrated)] 46. | Chloro Acetyl Chloride. 8 [46A. | Chloro sulfonly isocynate (CSI)] 47. | Chlorofom (technical). 48. | Chlroform technical grade. 49. | Chromium Trioxide. 50. | Clacium Chloride. 51. | Concentrated Hydrochloric Acid (Technical grade). 52. | Concentrated Ammonium. 53. | Concentrated Ammonium Hydroxide (Technical grade). 54. | Crude Pencillin. 55. | Cuprous Iodide. 56. | Cuprous Oxide. 57. | Cyclohexyl Isocynate. 58. | Cyclopropylamine. 59. | Cysteamine HCL. 60. | D( -) Alpha Phenyl Glycine. 61. | D(-) Alpha Phenylglycine Dane's Salt. 62. | D(-) Dihydro Phenylglycine. 63. | D(-) Dihydro Phenylglycine Dane's Salt. 64. | D(-) P-Hydroxy Phenylglycine Dane's Salt. 65. | D-(-)-P-Hydroxyphenylglycine (Technical grade). 66. | Demulsifier. 67. | Di Sodium Sulphate. 68. | Diatomite (Filter aid). 69. | Dichloromethane. 70. | Di-Ethyl Amine. 71. | Diethyl Oxalate. 72. | Diethyl sulphate. 8 [72A. | Dimethyl Formamide (DMF)] 73. | Dimethyl Sulphoxide. 74. | Dimethylamine Hydrochloride. 75. | Dimethylamine Sulphate 60%. 5 [75A. | 2-3, Diethylaniline] 8 [75B | Diphenylmethyl (6R,7R)-7-amino-3-Carbonoyloxymethylceph -3-4-carboxylate Toluene-p-sulfonic Acid Salt (MDCC) 75C | Disodium Edetate (EDTA-Na) 75D | Disodium Ethylenediaminetetraccetate(EDTA-Na) 75E | Disodium Ethylenediaminetetra-acetic Acid Sodium salt (EDTA-Na)] 76. | Disodium Phosphate. 77. | EMME (Diethyl Ethoxy Methylene Malonate). 78. | Ethanol. 79. | Ethyl Acetate. 80. | Ethyl Acetate (Technical grade). 81. | Ethyl Chloroformate. 82. | Ethylacetoacetate (Technical grade). 83. | Ethylbenzolsulfonamide. 84. | Ethylene Oxide Gas Mixture. 85. | Ethylenediaminetetra-acetic Acid Sodium salts (EDTA-Na). 8 [85A. | FCMIC Chloride] 86. | Filter Pads. 87. | Formaldehyde. 88. | Formaline. 89. | Formic Acid. 90. | Furfurylamine. 1 [90A. | Gelatin.] 91. | Glimepride. 92. | Gunaidine Nitrate. 93. | Hexa Methylene Di-isocynate. 3 [93A. | Hexamethyldisilazane] 94. | Hydrochloric Acid pure. 5 [94A | Hydrofurane] 95. | Hydrogen Floride (Anhydrous). 96. | Hydroxalmine Sulphate. 7 [96A. | Hydroxy Benzoic Acid] 97. | Hyflo Super Celite. 98. | Hyflosupercel(Diatomaceous Earth). 3 [98A. | Imidazole] 5 [98B. | Hyoscine Hydrobromide[ 99. | Iodine. 100. | Iron Powder. 101. | Iso Amyl Alcohol. 5 [101A. | Iso butyl Acetophenone] 102. | Iso Propyl Acetate. 103. | Iso Propyl Alcohol. 5 [103A. | Iso propyl chloro acetate] 104. | Iso Propyl Ether (DI). 105. | Isobutyl Benzene. 106. | Isoxamine, (3 Methyl 5 Amino Isoxazole). 8 [106A | L-Arginine] 107. | Lasamide. 108. | Liquid Glucose (Dextrose). 109. | Lithium Bromide Anhydrous. 5 [109A. | Lithium Chloride Anhydrous] 110. | Magnesium Oxide. 111. | Magnesium Silicate (Magnesol) (Technical grade 30/40). 112. | Maiz Oil. 113. | Maleic Acid. 114. | Methane Sulphonic Acid. 115. | Methane Sulphonyl Chloride. 116. | Methane. 117. | Methanol. 118. | Methanol (Technical Grade Absolute). 8 [118A | Methoxamine HCI.] 119. | Methyl Acetoacetate (MAA). 3 [119A. | Methyl chloroformate] 120. | Methyl Ethyl Ketone. 121. | Methyl Iso Butyl Ketone. 122. | Methyl Malonate. 123. | Methylamine HCl. 124. | Methylene Chloride. 125. | Methylene Chloride (Technical grade). 8 [125A | MICA ESTER] 126. | Methyl-Pregna-1, 49, (II)-Triene-3,20 Dione. 5 [126A. | Mono chloro Benzene] 127. | Mono Ethanolamine. 128. | Mono Methylamine. 129. | Mono Sodium Phosphate. 130. | Monochloro Acetic Acid. 5 [130A. | N-Acetyl sulphanilyl Chloride 130B. | N-benzyl-N-Butylamine 130C. | N-Bromosuccinamide] 131. | N.-Butyl Acetate. 132. | N.N. Dimethyl Pharmamide. 133. | N.N-Dimethyl Acetamide (DMA). 134. | N-Butanol. 135. | N-Butyl Acetate. 5 [135A. | N-butyl bromide] 136. | N-Butyl Orthopropinate. 137. | N-Butyl Valerate. 138. | N-Hexane. 139. | Nitric Acid. 3 [139A. | N-Methyl Morrpholine] 140. | N-Methyl-S-Methyl Compound (N MSM). 141. | Nor-acid. 8 [141A | N,O-bistrimethyl silylacetamide (N,O BSA). 142. | N-Propanol . 5 [142A. | o-ChlorobenzoicAcid 142B. | Ortho Nitro chloro benzene] 143. | Orthophosphoric Acid. 144. | Para Amino Phenol. 5 [144A | Para Toulene Sulphonic Acid] 145. | Paraffin. 146. | Parahydroxy Acetophenone. 147. | Perchloric Acid 60%. 148. | Pharmamedia. 149. | Phenol. 150. | Phenoxy Acetic Acid. 151. | Phenyl Acetic Acid. 152. | Phosphoric Acid. 153. | Phosphorous Pentaoxide. 5 [153A. | P-Hydroxy Acetophenone] 154. | Piperazine. 155. | Pivaloyl Chloride. 156. | Platinum Catalyst. 157. | Platinum Metal. 158. | Polypropylene Glycol-2000. 159. | Potassium Acetate BP. 160. | Potassium Aluminium Sulphate. 161. | Potassium Carbonate. 162. | Potassium Carbonate Anhydrous. 163. | Potassium Chloride. 164. | Potassium Dihydrogen Phosphate. 165. | Potassium Hydroxide BP. 166. | Potassium Sulphate (commercial). 167. | Procaine HCL. 168. | Propylene Oxide. 8 [168A | p-Toluene Sulphinc Acid.] 169. | Pyridine. 170. | Pyridine-Hydromide. 171. | Q-Acid. 172. | Quetiapine. 173. | Raloxifene. 174. | Rosiglitazone. 175. | Salbutamol. 176. | Salicylic Acid. 177. | Sertraline. 178. | Silicon Emulsion. 179. | Silicon Emulsion (Antifoam) Type RD Solvalex AFA. 8 [179A. | Sin-Methoxyimino Furanyl Acetic Acid Ammonium Salt (SMIA).] 180. | Sodium 2-Ethyl Hexanoate. 181. | Sodium Acetate (Anhydrous). 8 [181A. | Sodium Acetate Trihydrate 181B | Sodium bicarbonate] 182. | Sodium Borohydride. 183. | Sodium Carbonate. 184. | Sodium Chloride. 185. | Sodium Citrate. 186. | Sodium Dichromate. 187. | Sodium Hydrosulphite. 188. | Sodium Hydroxide 8 [[Pharmaceutical Grade]. 189. | Sodium Hydroxide flakes. 190. | Sodium Iodide. 5 [190A. | Sodium Iso propoxide] 191. | Sodium Metabisulphide BP. 3 [191A. | Sodium metabisulphite] 192. | Sodium Metal. 193. | Sodium Methoxide. 194. | Sodium Methylate. 195. | Sodium Nitrite. 196. | Sodium Pyro Sulphite. 197. | Sodium Sulphate. 198. | Sodium Sulphate Anhydrous. 199. | Sodium Sulphite. 200. | Soya Bean Oil Degummed. 201. | Soya Meal High-Pro-Con/STA. 202. | B-Naphtol. 203. | Stearic Acid. 204. | Sulphuric Acid. 205. | T-Butanol 99%. 206. | T-Butyl Methyl Ether. 207. | Teraline (Tetra Hydronephthaline). 208. | Tetrahydrofuran. 209. | Toluene. 210. | Tolune p. Sulphonic Acid. 211. | Triene (21-Acetoxy-17-Hydroxy-16-Beta- Methyl-Pregna 1,4,9(II)-Triene-320-Dione. 212. | Triethanolamine Stearate. 213. | Triethylamine. 3 [213A. | Trimethyl chlorosilane] 5 [213B. | Trimethoxy Diphenyl Propylidene 213C. | Trimethyl ortho Valerate] 214. | Trimethyl Phosphite. 215. | Tri-N-Butyl Phosphate. 216. | Yeast Extract Powder (Oxoid or Difco). 217. | 8 [(Z)-2-(2-aminothaizole-4-yl)-2-(tert-Butoxycarbonyl)-Isopropoxyimino Acetic Acid (ATIBAA or ATBA). 218. | (Z)-2-(2-aminothaizole-4-yl)-2-(tert-Butoxycarbonyl)-Methoxyimino Acetic Acid (ATMA); and. List B Pharmaceutical active ingredients to be manufactured out of the chemicals as indicated in List-A of Table III S.No. | List of Pharmaceutical Active Ingredients 1. | Alprazolam USP. 2. | Aluminum phosphate Dried Gel. 3. | Amlodipine HCl. 4. | Amoxycillin Trihydrate. 5. | Ampicillin Anhydrous. 6. | Ampicillin Trihydrate. 7. | Aspirin. 8. | Atorvastatin Citrate. 5 [8A. | Betamethasone 17-valerate] 9. | Betamethasone. 3 [9A. | Cefadroxil] 8 [9B | Cefaclor 9C | Cefazolin Sodium 9D | Cefixime 9E | Cefoperazone Sodium 9F | Cefotaxime Sodium 9G | Ceftazidime 9H | Ceftriaxone Sodum 9I | Cefuroxime Axetil 9J | Cefuroxime Sodium.] 10. | Cephradine Hydrate. 11. | Cephalexin Hydrate. 12. | Carvedilol Potassium. 13. | Cephalexin. 8 [13A | Cephalexin Sodium] 14. | Cephradine. 8 [14A | Cephradine Sterile/Cephradine L-Arginine] 15. | Cetirizine Citrate. 16. | Ciprofloxacin. 17. | Ciprofloxacin HCL. 18. | Cloxacillin Sodium. 19. | Clobetasol and their derivatives and salts. 5 [19A. | Dexamethasone Base] 20. | Dexamethasone Sodium Phosphate. 21. | Diclofenac. 22. | Ephedrine. 23. | Ephedrine HCL BP Grade. 8 [23A | Flucloxacillin Sodium] 24. | Furazolidone BP Grade. 25. | Frusemide (Furosemide). 26. | Glibenclamide. 27. | Glimepiride Potassium. 28. | Griseofulvin. 29. | Haloperidol. 5 [29A | Hyoscine N-Butyl bromide] 30. | Ibuprofen. 31. | Magnesium Hydroxide. 5 [31A. | Mefenamic Acid] 32. | Methyl Salicylate. 5 [32A. | Nimesulide] 33. | Norfloxacin. 7 [33A. | Parabens] 34. | Paracetamol/Para aminophenol. 35. | Pefloxacin. 36. | Penicillin, its derivatives and salts. 37. | Pheniramine Maleate. 7 [37A. | Piperazine Citrate] 38. | Polygeline. 39. | Potassium Iodide. 40. | Pseudoephedrine HCL BP Grade. 41. | Pyrazinamide. 42. | Quetiapine Citrate. 43. | Raloxifene HCL. 44. | Ramipril Sodium. 45. | Ranitidine Hydrocloride. 46. | Rosiglitazone HCL. 47. | Salbutamol. 48. | Salicylic Acid. 49. | Santonin. 50. | Sertraline Citrate. 51. | Sodium Salicylate. 52. | Spironolactone. 53. | Sulphamethoxazole. 54. | Trichloroethyl Phosphate. 55. | Triclofos. 56. | Trimethoprim (pure). Conditions for Table III:- (a) the manufacturer shall furnish to the Ministry of Health or any other officer authorized by the Ministry of Health in this behalf in the prescribed Form, the details of the raw materials required for manufacturing pharmaceutical active ingredients who will get the unit surveyed by an inspection team constituted by the Ministry of Health and consisting also a member nominated by the Central Board of Revenue. The team shall certify the annual capacity of the unit for the manufacture of basic drugs and the total annual requirements of various types of raw materials along with the quantities required for the basic drugs; (b) the manufacturer shall furnish to the Health Authorities concerned the quantities of the raw materials imported along with the details of the products or basic drugs manufactured therefrom and the Director General, Health, Government of Pakistan, or any other officer authorized by him in this behalf shall certify for each consignment the requirements of raw materials along with the names of the products to be manufactured therefrom in Form-I set out below; (c) at the time of import of the raw materials the manufacturer shall submit a declaration in writing on each copy of the bill of entry to the effect that the raw materials have been imported in accordance with his entitlement in terms of condition (a); (d) the Collector of Customs shall allow release of the raw materials against a bank guarantee or indemnity bond along with post-dated cheque equivalent to the amount of customs duty exempted under this notification; (e) the manufacturer shall maintain record of such materials imported and the end products manufactured therefrom, and shall produce the same on demand by the appropriate officer of Customs or the Health Authorities; (f) the manufacturer shall, within fifteen months of the date of filing of bill of entry for home-consumption relating to the raw materials, apply to the Collector of Customs for discharging the bank guarantee or indemnity bond and post-dated cheque. Such application shall be supported by a certificate in Form-II set out below, issued by the Director General Health, Government of Pakistan, or by any other officer authorized by him in this behalf to the effect that the basic drug for which the raw materials were imported has been made out of those materials; and (g) the Bank Guarantee or the Indemnity Bond along with post-dated cheque, as the case may be, shall be discharged by the Collector of Customs on receipt of application from the party duly accompanied by a certificate from the Director General Health, Government of Pakistan, or by any other officer authorized by him in this behalf, as required in terms of condition (f). FORM-I I (Name) ……………………………… Directorate General of Health, Government of Pakistan, duly authorized in this behalf by the Director General, Health, Government of Pakistan, do hereby certify that the raw or packing materials mentioned in the Schedule below have been imported for the manufacture of pharmaceutical active ingredients, products, drugs, i.e., (Name of product) ……………………………………………………………………..………………… under bill of Lading No. ……………dated …………………IGM No… dated ……………………… Index No………………….. Name of the importer- cum -manufacturer and the quantity to be manufactured. | Name and quantity of the raw or packing materials imported for the manufacture. Signature_______________. Designation.________________. FORM-II I (Name) ...........................Directorate General of Health, Government of Pakistan duly authorized in this behalf by the Director General, Health, Government of Pakistan, do hereby certify that the raw or packing materials imported by (Name of the importer) …………………..........……………….. for the manufacture of pharmaceutical ative ingredients or products or drugs i.e. ...................... under bill of entry No...........dated....……….., IGM No.............. dated.......………Index No........ ............... according to the details given below have been used for the manufacture or packing of …………………… in accordance with the scale laid down by (Name of drug in case of multiple drugs, add sheet) the Health Division vide certificate No. ________________ dated ______. Name of the importer- cum -manufacturer and the quantity to be manufactured. | Name and quantity of the raw or packing material imported for the manufacture. Signature _________________. Designation ________________. __________________________________________________________________________ [C.No.6(5)Tar-I/2000-Pt-C ] (DR. MANZOOR AHMED ) Additional Secretary As amended: 1. Substituted/Inserted vide S.R.O.517(I)/2002 dated 10.08.2002 2. Inserted vide S.R.O.661(I)/2002 - dated 25.09.2002 3. Inserted vide S.R.O.48(I)/2003 - dated 16.01.2003 4. Inserted vide S.R.O.196(I)/2003 - dated 22.02.2003 5. Inserted vide S.R.O.745(I)/2003 - dated 29.07.2003 6. Inserted vide S.R.O.8 (I)/2004 - dated 03.01.2004 7. Inserted vide S.R.O.607(I)/2004 - dated 15.07.2004 8. Inserted vide S.R.O.__(I)/2004 - dated 08.12.2004 9. Inserted vide S.R.O.__(I)/2005 - dated 28.02.2005