SRO 373(I)/2000

GOVERNMENT OF PAKISTAN MINISTRY OF FINANCE, ECONOMIC AFFAIRS, STATISTICS AND REVENUE (REVENUE DIVISION) *** Islamabad, the 17th June, 2000 NOTIFICATION (CUSTOMS) SRO 373 (I)/2000.- In exercise of the powers conferred by section 19 of the Customs Act, 1969 (IV of 1969) and in supersession of it's Notification Nos. SRO 349(I)/85, dated the 15th April,1985, SRO1147(I)/89, dated the 27th November,1989 and SRO 587(I)/90, dated the 7th June.,1990, the Federal Government is pleased to direct that the goods specified in Tables-I, II and III below shall be exempt from so much of the customs-duty leviable under the First Schedule to the Customs Act 1969 (IV of 1969), as is in excess of ten per cent 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 for 1976), for manufacture of pharmaceutical products registered as drugs under the Drugs Act, 1976 (XXXI of 1976), subject to the conditions given below 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 given below that Table; and (c ) the raw materials, specified in Table-III below, are imported for the basic manufacture of pharmaceutical active ingredients specified therein, subject to the conditions given below the said Table:- Table-I A. List of Raw Materials: DESCRIPTION Acyclovir. Adenosine Triphosphate. Adiphenine Hydrochloride. Alminoprofen

Alprazolam USP Aluminium Hydroxide paste/driedgel/ compressed Aluminium Hydroxide-magnesium Carbonate Co-Drieed Aluminium Magnisium -Silicate (Veegum) Amicarbional Amidopyrinne/Aminopyrine Aminoglute Thinmide Amphotercin-B Ampicillin and its salts excluding ampicillin Trihydrate and Ampicillin anhydrous Ampicillin Sodium + Sulbactoum Sodium pre-blended/pre-mix. Anti foam emulsion Attapulgite. Azaapropazone Dihydrate Azelaic Acid Micronized Benzilic Acid Dimethul Octyl Bromide. Betatab 75 Bezafibrate Biological and Chemical Indicators Bisacodyl Brotianide Broxyquinoline Butobarbitione Butor-phanol tartrate Butabital Buzepide Mthiodide Captopril Carbachol Cefoperazone and its salts Cloxacillin and its salts excluding cloxacillin (compacted/powder form for oral use) Co-enzyme Q 10 Colistin sulphate Collagen strep (catgut) Concentrate of lactoserum brocein of 65% nitrogen Dextrose(injectabale grade) Diamphenethide Divalproex sodium Doxepin and its salts Eriodictyon Exracepae Extract Quassia + Extract absinthii Extract Aconite Extract belladonna Liq or sicc

Extract benzoin Extract Buchu Extract capsicum Extract colae siccum Extract colchicine Extract coltsfoot Extract ginkgo biloba Extract glyoyrrhiza (liquid/siccum) Extract hyoscyamous Extract Ipecac Extract krameira Extract liriosma ovate Extract lobelia Extract myrrh Extract nuxvomica Extract pine bark Extract rhei Extract scillae Extract stramonium Extract strychnos Extract thyme Extract valerian Extract witch hazel Eyeless sucures needles Flucloxacillin sodium Gentain roots/extracts. Gentain Violet. Gentain/pluv Gentain Ginkgo Biloba Extract. Glassine Sleeve. Gluethimide Glyceryl Trinitrate Triturate Gramicidin Gumbenzoin, Styrax, trageacanth, xanthan Hemicellulase-Ox-bilo-Pancreatin-Sodium Chloride Mixture Hemicellulose Hyaluronidase Hyoscyamus Leaves Imidapril Hcl Intrinsic Factor Ipecac Ispaghule Husk(B.P) Chlorzoxazone Ivermectin Kanamycin Sulphate Ichaamnol Latoserum Spray dried Lincomycin and its salts Lipoic Acid

Lobeline & salts Loratadine Losartan Potassium Lovastatin Lyophlised Saccharomyces Boulardii Macloxamine Dihydrogen Citrate Magaldrate Gel Sulphate Magaldrate powder USP Magnesium Probencid Marvelon Medicamycin Acetate Fine granules Methisoprinol Midecamycin Acetate (fine Granules/powder) Midodrine Hydrochloride Mometasone Fursate Momochloracarvacrol Mozantel Tartazate Monensin Mucoproteose Mucpirocin Myrrh Neomycin and its salts Raubasine. Rhubarb leaves/roots Rice Hulls Rifampicin Rifater Pre-mix Risperidone Roxatidine Acetate Hcl Roxithromycin Rufloxacine Ruscogenine Secrosteron Selenium Sulfide with Bentonite Senega Senidazole Septocemobin Serratiopeptidase Seuzm Silymarine Simvastatin Sodium Chloride injectable grade Sodium Fusidate Sodium Lodohepartinate. Sodium Parrolodone Carboxylate. Sodium Succinate 6H20. Spfeen Powder. Spironolactone.

Spraydried sodium polyhydoxyaluminium Streptohyrazine Sultamicillia Tosylate. Sultamicillin. Surfen. Tergitol Tetanus Toxoide. Thiamulin Hydrogen Fumarate. Tibolone. Tincture Asafoetide Tincture Gimdcifugee, Tincture Gimdcifugee, Tincture Myrrh. Tincture Oucbracho. Tincture Primula. Tincture Strychors. Tincture Thyme. Tincture Bronchicum. Tincture Capsicum Tobcoat TC. Tobramycin Tribulus Terrestris Triple Antigen Concentrate. Trothricin Trysine Tylosin and itssalts. Valerine roots. Vancornycin HCL. Viomycin sulfate. Virginiamycine. Zinc Bacitrain zinc Monomethionine Complex B. List of Packing Materials. Ampoule Cutter. Aerosol therapy apparatus and its components. Aluminium foil printed, indicating particulars of drug and manufacturer, in roll for strip/blister packing of tablets/capsules. Canaleur and its caps for infusion sets. Edible ink. Empty Glass infusion bottle with and without Graduation USP II. Metallic Twisters for flow regulators. Plastic Nebuliser/Dropper bottles for ear, eye and nasal drops with or without assembly.

Plastic Nebuliser. Stoppers for I.V. solutions. Neutral glass cartridges with rubber dices and pungers and aluminium seals. Plastic eye baths. Printed Aluminium Foil for sachet/I.V. infusion Bag. Printed Viskerings. Tear off aluminium seals for injectables. Non-toxic plastic bags for I.V. solutions of dextrose and other infusions. Filp off Seals for injectable vials. Conditions:- (i) The importer, makes 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 (ii) The importer-cum-manufacturer shall maintain record of the goods imported and the pharmaceutical products manufactured there from 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 10% 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 repacking 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 Drugs Act, 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 mentioned above.

Table-II A. List of Raw Materials: DESCRIPTION Acesulfame potassium acetanilide Acid undecenoic B.P. Alkyl Aryl sulfonate Ampnocerin 'K' or 'KS' Amylase Amylopectin Anethol Animal charcoal (Activated carbon) Anthydrous di-sodium carbonate Antifoam F.D. Benzene calcium sulphonate Bevaloid dispersant Biotin 1% in calcium phophate Bismuth citrate, subcarbonate, subgallate, subnitrate & subiodide Boric Acid Butyl phthalate Capsicum Oleoresin (Caposicin) Carbonate, Chloride, Hydroxide Carboxypolymethylene/caboxy vinyl polymer(carbopol/carbomer) Carbpoxymethyl cellulose and its salts Carnauba wax Casein formaldehyde Catalyst Catastay powder Cellulose and its derivatives Cetearyl octanoate Cetostearyl alcohal Cetylester wax Chlorophyll Citric acid Coal tar distillate/solution Cocoa Powder/Shell Collone wax Colophony resin Cremoophor Decelite

Diascorea roots / powder Diastase Diffutabe base E2 Dodecylbenzensulphonic acid salts Emulsional Endracite - E Essences in powder for use in Ors(Demon,Lime, Orange,Pineapple,Cherry only) Essential oils (Avisi, Cinnanon, Caraway, Cardamom, Nutneg,Lemon,Peppermint only) Ethanol Ethyl acetate Ethyl oleate Eucalyptus oil, eucalyptol Eucerin Eudragit all kinds Explotab Extract bitter oranger peels Extract wild cherry Food Colour (pharmaceutical grade) Glycofurol Gum acacia powder BP Gum benjamin BP Hard fat Hydorxy Propyl Methyl Cellulose Hydrated silica Hydrogenated Methyl Abietate Hydrogenated oil Igepon AC-78 and TC-42 Infusorial Earth(Kieselguhr/Hyflo-supercel/celite) Instant Rice lactose Lanette Wax Lanolin (Wool Alcohol / Fat) Laponite SLG Laury Dimethyl Aminoxide Lemon, lime and orange Essences(in powder) Linseed Oil Liquid Parrafin Lucryl Amidoletaine Lunacera M Macrogol Lauryl Ether Malt Extract Maltadextrin Megyol -W Mixture Methyl Methacrylate Copolymer(Mana copolymer) Methylene Blue

Methyvinyl Ether Maleic Anhydride copolymer Microcrystalline Cellulose its derivatives & salts Microcrystalline Waxes. Migloyl -812 Mono and Diglycerides Monofilament stainless steel/Nylon/Polypropylene WP/BPC/USP Myristy Ethanol N-Hexyl Nicotinate Nylon / Polypropylene WP/ Orthotolunen Sulfonamide OTSA Palm kernel Oil PEG-6 Complex Papain Paraffin Hard Pectin PEG-75 Stearate (and) Glyceryl Stearate Persnganate, Sulphate, Succinate Pharmacoat plaited (braided) Polyster coated BPC/USP plaited (braided) Silk USP/BPC Plastibase Polacrilin Postassium Polyethylene Glycol and its derivatives Polygalacuronic Acid Polygel Polyglyceryl Ricinoleates Polymerised Acrylic Acid Polyoxyethylene Glycol/Glycerides/Polyoxyl stearate Prepared Storax Primojel Promulgen Propl Gallate Propyl Ether Propylene Glycol and its derivatives Peuronic L-62 pyrophosphate Quinaldine and its salts Rhodigel ( Food Grade) Sandarac Sesame Oil ( for Injection) Silicon Emulsion Sodium Croscarmellose Sodium Lauryl Alcohol/Sulphate Sodium Linear Alkylatesultonate Sorbhilan and its derivatives(Tweens and spans) Sorbitol Crystalline Powder Spermacetic Sterilisable Maize Starch Talc (Pharmaceutical Grade )

Texapon E- 13. Texapon K- 12. Triglycerides Viscarin Wax Emulsifying Witepsol Witepsol Zinc Oxide and Carbonate 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 Flim. 9. Printed Poly Bags for Infusion Sets. 10. 13 mm Rubber stoppers for injections. 11. 20 mm and 32 mm Rubber stopper for Injections. 13. Soft Non-Toxic PVC Film/lay flat tube for medical application. 14. PVC Non-Toxic Tubing for medical application. 15. Preformed printed pet Slvees. 16. Glass Bottle USP Type I.

17. Pre-printed Polypropylene tubes with tamper proof closures (with or without dessicant) indicating particulars of registered drug and manufacturer. 18. Bottle Pack Caps FK-28 including a rubber disc and a compound ring for Haemaccel, Sterilized. 19. Lupolen 1840H Q211 for molding Haemaccel Bottles. 20. Neutral, clear glass, USP type I (Presterilized) close mouth, glass ampoules with long straight stem. Conditions:- (1) The manufacturer shall furnish to the Health Division the quantities of the raw/packing materials alongwith the details of the drugs to be manufactured therefrom, and the Director General Health or any other officer authorised in this behalf will certify for each consignment requirements of raw/packing materials alongwith the names of the drugs to be manufactured therefrom in the Form-I set out below. (2) At the time of import of raw/packing materials, the manufacturer shall make a written declaration on each copy of the bill of entry to the effect that the raw/packing materials have been imported in accordance with his entitlement in terms of condition (1). (3) The Collector shall allow release of the raw materials against bank guarantee or indemnity bond alongwith post-dated cheque equivalent to the amount of customs duty exempted under this notification. (4) 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. (5) The manufacturer shall within 15 months of the date of filing of bill of entry for home consumption relating to the raw/packing materials, apply to the Collector of Customs for discharging the bank guarantee or insurance guarantee, the application being supported by a certificate in the Form-II set out below, issued by the Director General Health or any other officer authorised in this behlaf. (6) The concession shall take effect from the date of the registration of the drug under the Drugs Act, 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 mentioned above.

Table-III. Products to be List of imported raw manufactured materials Caphalexin Hydrate Celite J-2 Caphradine Hydrate Charcoal Darko KB Ethyl Acetate Betamethasone and Norit CN3 Clobetasol 17-Proprinate Clarcel flo(Celite) Ethyl Acetate Methane sulphonyl chloride Sodium dichromate Sodium Sulphate Anhydrous Yeast Extract Powder(Oxoid/Difco) Salbutamol Charcoal CN3 Ethyl Acetate Hyflo Supercel N-Propanol Sodium Hydroxide B.P. Ranitidine Hydrocloride Celite J-2 Charcoal CN3 Dimethylamine Hydrochloride Hyflo Supercel Trichloroethyl Phosphate Sodium Mehtoxide Trimethoprim(Pure) Sodium Mehtoxide Chrcoal Powder(Activated Carbon) Griseofulvin Antifoam CLRS: Oil.Substitute Charcoal Powder SX Plus Clarcel Flo CR. Soya Bean Oil Degummed. Dexamethasone Sodium Phosphate. Sodium Hydroxide. Cephalexin Demulsifier. N-Butyl Acetate. Glibenclamide Cyclohexyl isocynate. Norit supra A. Sodium hydroxide flakes. Pheniramine maleate. Dicalite 4258. Maleic Acid. Norit Acetone. . Frusemide Lasamide Norit SX2 Trilon B.

Cephalexin and cephradine Crude pencillin ‘G’ Ampicillin Trihydrate Concentrated (Tech Hydrochloric Acid Grade) Concentrated Ammonium Hydroxide -do- Ethylacetoacetate -do- 2-Ethylhexanoic acid -do- Amoxycillin Trihydrate. D-(-)-P-Hydrexy- -do- phenylglycine Concentrated Hydrochloric acid -do- Concentrated Ammonium Hydroxide -do- Cloxacillin sodium Ethyl Acetate. 2-Ethyl Hexanoate Acid. Doclofenac. Cuprous Oxide. Cuprous iodide. T-Butyl methyl ether. Charcoal CN3 Methylene chloride. Glibenclamide. Dicalite 4258; and Frusemide. Dicalite 4258. Polygeline.(This is subsequently used for Gelatine No.17471 Acetone. The formulation of finished drug ‘Haemaccel). Clacium Chloride,Sodium Hydroxide Hydrochloride Acid,Hexa Methylene Di-isocynate. Betamethasone Acetone Cephalexin Hydrate/Cephradine Hydrate -do- Griseofulvin -do- Triclofos -do- Betamethasone/Clobetasol 17-Propionate 16-DPA. Salicylic Acid Sodium Hydroxide. Aspirin Sodium Hydroxide. Methyl Salicylate Sodium Carbonate Sodium Salicylate Activated Carbon Paracetamol/Para aminophenol Sodium Nitrite. Ampicillin Anhydrous. 2-Ethyl Hexanoic Acid. Alprazolam U.S.P. ALP-Chloride.

(Methanone,(5,chlore-2-2 (3(Chloromethyl)-5- Methyl-4H-1,2,4-Triazol-4yl) Phenyl) Phenyl. Ethyl Acetate)Technical Grade Undenatured) Ammonium Hydroxide Solution (Technical Grade 29% NH3) Acetone Extra Pure B.P.N.F.EUP Sulphamethoxazole Carbon. Isoxamine, (3 Methyl 5 Amino Isozazole) BUPROFEN Sodium Dichoromate. Acetone Carbon. Ciprofloxacin Carbon Norfloxacin 3 Chloro 4-Fluoro Aniline. EMME(Diethyl Ethoxy Methylene Malonate) Parafin. Acetone Diethyl sulphate Carbon Supercel Pefloxacin Carbon Pencillin Crude Corn Steep Liquor. (Phenylacetamide pencillanic Acid Potassium salts) Gemex. Filter Pads Prod + Floc Nadar Cento Linqquad Liquid Glucose(Dextrose) Stearic Acid Pharmamedia N.Butyl Acetate Acetone Celite Activated Carbon Formaline. Pencillin, its derivatives and slats Carboxy Methyle Cellulose Sodium Filter Pads N-Butyl Acetate Acetone Celite Activated Carbon Carbonate Potassium Carbonate Sulphuric Acid. Magnesium Hydroxide Magnesium Oxide. Spironolactone Aldona(17-Hydroxy-3-OXO-17-a- Pregna-4-ene;17 B Carbolactone) Dimethyl formamide Acetone

Hyflosupered(Diatomeceous Earth) Aldadiene(17-Hydroxy-3-OXO-17-a- _regna-4,6- diene-21-Carboxylic Acid Y-Lactone) Activated Carbon Norit CN3. Haloperidol Acetone Hyflosupercel(Diatomaceous Earth) Ephedrine Acetone Filter Aid Santonin Activated Charcoals. Cephradine. N.N-Dimethyl Acetamide(DMA). Cephalosporanic Acid(7-ADCA) Acetone Cephalexin Hydrate. D(-)Alpha Phenyl Glycine. N.N-Dimethyl Acetamide(DMA). Diethylamine. Penciallin salts. Crude pencillin. Ciprofloxacin Hel. Activated Carbon. Norfloxacine Activated carbon. Acetone. Peefloxacin. Formic acid. Methane. Betamethasone products. Triene(21-Acetoxy-17-Hydroxy-16-Beta- Methyl-Pregna-1,49,(II)-Triene-3, 20 Dione. Furazolidone Cephradine Ethylenediaminetetra-acetic acid sodium salts(EDTA-NA) Activated Carbon(Animal Porous) Daetomite(Filter aid) Conditions:- (1) The manufacturer shall furnish to the Ministry of Health or any other officer authorized by 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 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 alongwith the quantities required for the basic drugs. (2) The manufacturer shall furnish to the Health Authorities concerned the quantities of the raw materials imported alongwith the details of the products or basic drugs manufactured therefrom and the Director General

of Health, Government of Pakistan or any other officer authorized by him in this behalf shall certify for each consignment the requirements of raw materials alongwith the names of the products to be manufactured therefrom in Form-I set out below. (3) 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 (1). (4) The Collector shall allow release of the raw materials against a bank guarantee or indemnity bond alongwith post-dated cheque equivalent to the amount of customs-duty exempted under this notification. (5) 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. (6) 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 of 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. (7) The Bank Guarantee or the Indemnity Bond alongwith post-dated cheque, as the case may be, shall be discharged by the Collector on receipt of application from the party duly accompanied by a certificate from Director General of Health, Government of Pakistan or by any other officer authorized by him in this behalf, as required in condition (5) above. FORM-I I (Name) ……………………………… Directorate General of Health, Government of Pakistan, duly authorized in this behalf by the Director General of Health, Government of Pakistan, do hereby certify that the raw/packing materials mentioned in the schedule below have been imported for the manufacture of pharmaceutical active ingredients,products,drugs, i.e., ……………………………… under bill of entry No. ……………dated ……………………IGM No…………………………dated ……………………… Index No………………….

Name of the importer-cum-manufacturer Name and quantity of the raw/packing And the quantity to be manufactured. 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 of Health, Government of Pakistan, do hereby certify that the raw/packing materials imported by (Name of the importer.............) for the manufacture of pharmaceutical active ingredients/products/drugs i.e. ......................under bill of entry No...........dated......, IGM No.............. dated.........Index No........ importer................) according to the details given below have been used for the manufacture/packing of ______________ (name of product,drug) in accordance with the scale laid down by the Health Division vide certificate No. ________________ dated ______. Name of the importer-cum-manufacturer Name and quantity of the raw/packing And the quantity to be manufactured. materials imported for the manufacture. Signature............... Designation............. [C.No. 6(4)/2000-CB] ( MIR FUAD ) Additional Secretary