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Dietary amino acids can decrease levodopa’s ef- fectiveness by competing with it for absorption from the intestine and slowing its transport to the brain discount ranitidine 150mg fast delivery gastritis doctor. Both drugs are highly bound to albumin and therefore have limit- ed distribution to the tissues buy ranitidine 300mg on-line gastritis green stool. They’re almost completely metabo- lized in the liver to inactive metabolites and are excreted in urine order ranitidine 150mg with mastercard gastritis ginger. This results in more sus- tained dopaminergic stimulation in the brain and improvement in signs and symptoms of Parkinson’s disease purchase ranitidine 150 mg free shipping gastritis lower back pain. Although tapering sched- ules haven’t been evaluated, a slow tapering of the dosage is sug- gested. Calling an interference • Drugs that interfere with glucuronidation (erythromycin, ri- fampin, cholestyramine, and probenecid) may decrease enta- capone elimination. Patients • Dry mouth • Dyskinesia should be advised of the risks of liver in- • Back pain • Diarrhea jury and provide written informed con- • Diaphoresis • Brown-orange urine discoloration (en- sent before starting tolcapone. In addition, some anticonvulsants are used in the emergency treatment of status epilepticus (a continuous seizure state). Treatment of epilepsy should begin with a single drug whose dosage is increased until seizures are controlled or adverse reac- tions become problematic. Generally, a second alternative should be tried as monotherapy before combination therapy is consid- ered. The choice of drug treatment depends on seizure type, drug characteristics, and patient preferences. The most Hydantoins commonly prescribed anticonvulsant drugs The two most commonly prescribed anticonvulsants—phenytoin are phenytoin and and phenytoin sodium—belong to the hydantoin class. Extensively protein-bound, ethotoin is excreted in urine, primarily as metabolites. Pharmacodynamics In most cases, the hydantoin anticonvulsants stabilize nerve cells to keep them from getting overexcited. Phenytoin appears to work in the motor cortex of the brain, where it stops the spread of seizure activity. The pharmacodynamics of fosphenytoin and etho- toin are thought to mimic those of phenytoin. Pharmacotherapeutics Adverse Because of its effectiveness and relatively low toxicity, phenytoin reactions to is the most commonly prescribed anticonvulsant. It’s one of the hydantoins drugs of choice to treat: • complex partial seizures (also called psychomotor or temporal Adverse reactions to lobe seizures) hydantoins include: • tonic-clonic seizures. Here are some ventricular conduction drug interactions of major to moderate clinical significance: • ventricular fibrillation • Phenytoin’s effect is decreased when it’s taken with phenobarbi- (in toxic states) tal, diazoxide, theophylline, carbamazepine, rifampin, antacids, or • bradycardia, hypoten- sucralfate. Phenobarbital is sometimes used for long-term treatment of epilepsy and is prescribed selectively to treat status epilepticus if hydantoins are ineffective. Other barbiturates Mephobarbital, also a long-acting barbiturate, is sometimes used as an anticonvulsant. Primidone, which is closely related chemi- cally to the barbiturates, is also used to treat chronic epilepsy. Pharmacokinetics Each barbiturate has a slightly different set of pharmacokinetic properties. The drug is 20% to 45% bound to serum proteins and to a similar extent to oth- er tissues, including the brain. About 75% of a phenobarbital dose is metabolized by the liver, and 25% is excreted unchanged in urine. Mephobarbital undergoes extensive me- tabolism by the liver; only 1% to 2% is excreted unchanged in urine. Pharmacodynamics Barbiturates exhibit anticonvulsant action at doses below those that produce hypnotic effects. For this reason, they usually don’t produce addiction when used to treat epilepsy. Barbiturates ele- vate the seizure threshold by decreasing postsynaptic excitation. The ma- Adverse jor disadvantage of using phenobarbital for status epilepticus is that it has a delayed onset of action when an immediate response reactions to is needed. Adverse reactions to Consider this phenobarbital and me- Mephobarbital has no advantage over phenobarbital and is used phobarbital include: when the patient can’t tolerate the adverse effects of phenobarbi- • drowsiness, lethargy, tal. Because of monitoring, costs, and dosing frequency, phenobar- and dizziness bital is usually tried before primidone. Primidone may be effective • nystagmus, confusion, in patients who fail to respond to phenobarbital. As a group Reduced effects All three barbiturates Barbiturate use can decrease the effects can produce a hyper- of many drugs, including beta- sensitivity rash, other adrenergic blockers, corticos- rashes, lupus erythe- teroids, digoxin, estrogens, doxy- matosus–like syndrome cycline, oral anticoagulants, hor- (an inflammatory disor- monal contraceptives, quinidine, der), and enlarged lymph phenothiazine, metronidazole, tri- nodes. It effectively treats: • partial and generalized tonic-clonic seizures • mixed seizure types • complex partial seizures (drug of choice). Carbamazepine is distributed rapidly to all tissues; 75% to 90% is bound to plasma proteins. Pharmacodynamics Carbamazepine’s anticonvulsant effect is similar to that of pheny- toin. The drug’s anticonvulsant action can occur because of its ability to inhibit the spread of seizure activity or neuromuscular transmission in general. Pharmacotherapeutics Carbamazepine is the drug of choice, in adults and children, for treating: Be aware that • generalized tonic-clonic seizures (sniff! Drug interactions Carbamazepine can reduce the effects of several drugs, including haloperidol, bupropion, lamotrigine, tricyclic antidepressants, oral anticoagulants, hormonal contraceptives, doxycycline, felbamate, theophylline, protease inhibitors, antipsychotics, and valproic acid. Other drug interactions can also occur: • Increased carbamazepine levels and toxicity can occur with the use of cimetidine, danazol, diltiazem, erythromycin, isoniazid, se- lective serotonin reuptake inhibitors, propoxyphene, ketocona- zole, valproic acid, and verapamil. Don’t confuse Tegretol (a brand name for carbamazepine) with Adverse Toradol (a brand name for ketorolac). Because carba- mazepine is related Benzodiazepines structurally to the tri- The four benzodiazepine drugs that provide anticonvulsant ef- cyclic antidepressants, fects are: it can cause similar toxi- • clonazepam cities and affect behav- • clorazepate iors and emotions. Safe and sound Sound-alikes: Diazepam and lorazepam Be careful not to confuse the sound-alike drugs diazepam and lor- azepam. Di- azepam provides only short-term effects and isn’t recommended for long-term treatment because high serum concentrations are needed to control seizures and long-term use can lead to addiction. Metabolism and excretion Benzodiazepines are metabolized in the liver to multiple metabo- lites and are then excreted in urine. Pharmacodynamics Benzodiazepines act as: • anticonvulsants • antianxiety agents • sedative-hypnotics • muscle relaxants. Pharmacotherapeutics Each of the benzodiazepines can be used in slightly different ways.

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Chapter 1 focuses on the pharmaceutical chemicals and their respective purity and management buy discount ranitidine 150 mg online chronic gastritis grading. Critical information with regard to description of the finished product order ranitidine with a visa gastritis diet nuts, sampling procedures buy 150mg ranitidine overnight delivery gastritis diet handout, bioavailability order genuine ranitidine line gastritis child, identification tests, physical constants and miscellaneous characteristics, such as : ash values, loss on drying, clarity and color of solution, specific tests, limit tests of metallic and non-metallic impurities, limits of moisture content, volatile and non-volatile matter and lastly residue on ignition have also been dealt with. Each section provides adequate procedural details supported by ample typical examples from the Official Compendia. Chapter 2 embraces the theory and technique of quantitative analysis with specific emphasis on volumetric analysis, volumetric apparatus, their specifications, standardization and utility. It also includes biomedical analytical chemistry, colorimetric assays, theory and assay of biochemicals, such as : urea, bilirubin, cholesterol; and enzymatic assays, such as alkaline phosphatase, lactate dehydrogenase, salient features of radioimmunoassay and automated methods of chemical analysis. Chapter 3 provides special emphasis on errors in pharmaceutical analysis and their statistical validation. The first aspect is related to errors in pharmaceutical analysis and embodies classification of errors, accuracy, precision and makes ( x ) an attempt at minimizing systematic errors. The second aspect is mainly devoted to statistical validation and comprises of statistical treatment of finite samples, distribution of random errors, significant errors, comparison of results, method of least squares and criteria for rejection of an observation. Each chapter has its unique style of presentation that essentially comprises of the following vital features, namely : brief introduction, theory with necessary details and relevant reactions, instrumentation, assay methods—with typical appropriate examples invariably selected from the Official Compendia including brief theoretical treatment of individual pharmaceutical substance and dosage form, materials required, procedures, calculations wherever applicable, cognate assays and lastly citation of relevant literature under ‘Recommended Readings’. Section— A deals on treatment by ‘titrimetric methods’ based on acidimetry and alkalimetry. The first arm of this section deliberates on aqueous titrations (Chapter 4), while the second on non-aqueous titrations (Chapter 5). Section—B relates to ‘redox methods’ with specific reference to permanganate, dichromate and ceric sulphate titration methods (Chapter 6); and also the iodimetric and iodometric titrations (Chapter 7). Section—C concerns with the ‘precipitation methods’ and focuses on argentometric methods (Chapter 8). Particular stress has been laid on the effect of pH on complexation, stability of complexes, usage of pM indicators and masking and demasking agents (Chapter 9). The topic has been treated with respect to Law of Mass Action, reversible reactions, principle of solubility of product and common-ion effect. Typical examples have been included of pharmaceutical substances assayed after conversion to free acid, or free base, or free compound and lastly to derivatives or substitution products (Chapter 10). Section—G particularly embodies the ‘miscellaneous methods’ which do not fall into the regimen of Section—A through Section—F. It deals with diazotization (Chapter 12), estimation of phenols and related compounds (Chapter 13) using bromine or potassium bromate, potassium iodate solutions; Karl Fischer method for determination of water (Chapter 14); and lastly tetrazolium assay of steroids (Chapter 15). Two important methods, namely; potentiometric methods (Chapter 16) deal with various types of reference electrodes and indicator electrodes, automatic titrator; besides typical examples of nitrazepam, allopurinol and clonidine hydrochloride. Amperometric methods (Chapter 17) comprise of titrations involving dropping-mercury electrode, rotating—platinum electrode and twin-polarized microelectrodes (i. Polarimetry (Chapter 19) describes optical rotation and specific optical rotation of important pharmaceutical substances. Nephelometry and turbidimetry (Chapter 20) have been treated with sufficient detail with typical examples of chloroetracyclin, sulphate and phosphate ions. Ultraviolet and absorption spectrophotometry (Chapter 21) have been discussed with adequate depth and with regard to various vital theoretical considerations, single-beam and double-beam spectrophotometers; besides typical examples amoxycillin trihydrate, folic acid, glyceryl trinitrate tablets and stilbosterol. Emission spectroscopy (Chapter 24) provides a brief introduction, theory and instrumentation with regard to its excitation sources, electrodes, sample handling, monochromators, detectors, spectrographs and its applications. Flame spectroscopy (Chapter 25) widely used in the quantitative estimation of various elementse. Both simple flame photometer and internal-standard flame photometer have been discussed in sufficient detail. The assay of Na, K and Ca in blood serum and water; assay of Ba, K and Na in calcium lactate have been described followed by cognate assays. Part—V is solely confined to the ‘Assay Methods based on Separation Techniques’ and is spread over five chapters. Liquid-liquid extraction (Chapter 27) mostly treats the subject theoretically and is supported by appropriate examples. Errors due to the volume change and effectiveness of an extraction have been dealt with adequately. Various factors that influence solvent extraction, such as : temperature and inert solutes, pH ion-pair formation and synergistic extraction have been described. Size Exclusion Chromatography (Chapter 31) has also been included as a means of analysis for substances that undergo separation more or less as per their molecular size, viz. It is earnestly believed that ‘Pharmaceutical Drug Analysis’ will fulfill the entire requirements of both penultimate and final year students of B. It may also help the post-graduate students in their compulsory paper on ‘Modern Analytical Techniques’ to a great extent. Academicians and researchers engaged in the evaluation of pharmaceutical drug substances either in pure or dosage forms will also enormously benefit from ‘Pharmaceutical Drug Analysis’ by virtue of its ultimate goal of maintaining very high standards of quantitative analysis. Finally, I wish to record here my special thanks to the numerous colleagues and friends who have not only extended their invaluable help by providing me with relevant sources of material but also by taking an active participation in the discussion of various chapters. It is hoped that ‘Pharmaceutical Drug Analysis’ will soon prove to be an invaluable guide to both undergraduate and postgraduate students and to my esteemed colleagues in the teaching profession. Those working in Research & Development Laboratories, Quality Assurance Laboratories and Drug Testing laboratories will also find the book helpful in solving many of their intricate problems. Applications of Karl Fischer Method for Determination of Water in Pharmaceutical Analysis............................................................................................... Amperometric Titrations with Twin-Polarized Microelectrodes (Biamperometric Titrations or Dead-Stop-End-Point Method).................... To Distinguish and Characterize the pri-, sec- and tert-amine Salts from One Another............................................................................................ Determination of Specific Organic Compounds as Impurities in Official Pharmaceutical Substances............................................................... Medicinal chemists, pharmacologists, biochemists, analytical chemists and medical professionals have paved the way with their single goal objective to combat the sufferings of human beings. In this integrated effort the role of an analyst vis-a-vis the chemical purity of pharmaceutical substances and drugs made therefrom and finally the dosage forms that are usually available for direct patient’s usage, has become not only extremely crucial but also equally important and vital. As on date product safety has to be an integral part of all product research in pharmaceutical substances. Inspite of all the qualified successes of synthetic drug research achieved in the last four decades to combat infectious diseases of the more than 80,000 different ailments, unfortunately only about one third can be treated with drugs, most of them only symptomatically. In order to meet these challenges one needs to adopt novel approaches in pharmaceutical research. Both molecular biology and genetic engineering will be exploited duly in opening up new routes. It is, however, pertinent to mention here that pharmaceutical chemicals must maintain a very high degree of chemical purity. It is quite obvious that a state of absolute purity may not be achievable, but a sincere effort must be exercised to obtain the maximum freedom from foreign substances.

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The authors speculated that heparin was being bound or destroyed by the circuit or that the prolonged exposure to the circuit resulted in it being bound or destroyed by blood products (Green 300mg ranitidine fast delivery gastritis ulcer disease, 1990) buy ranitidine 150mg mastercard gastritis low blood pressure. A retrospective study confirmed the findings of an increased volume of distribution and decreased half- life (Bhatt-Metta purchase ranitidine with a mastercard gastritis symptoms toddler, 199217) order 150mg ranitidine amex gastritis diet zantrex. The authors did observe a prolonged half-life and elimination rate constant when compared with controls (Buck, 199822). Based on the above findings, a suggested dosing regimen for infants would be 15 to 20 mg/kg every 18 to 24 hours (Buck, 200319). Interestingly, they also found considerable interpatient variability, and they estimated nonrenal clearance to be 47 to 97% higher than expected. They speculated that this could be related to drug loss in the circuit (Wells, 199224). Similar findings with regard to adsorption by the circuit were observed in for furosemide in in vitro circuits. Like the other drugs, the volume of distribution was increased, clearance decreased, and the plasma half- life nearly doubled when compared with controls (Wells, 199826). Amrinone and Milrinone Twenty percent of an initial Amrinone dose was taken up by the circuit. Milrinone seemed to be less bound, as would be expected, because it is less lipid soluble and protein bound and has a greater volume of distribution (Williams, 199528; Bailey, 199429). Physiological tolerance and dependence are common in this population because of their length of treatment and need to maintain high levels of sedation. As dis- cussed earlier, it is also known that there is some loss of drug in the circuit. This rapid increase in clearance after decannulation may play a role in opioid withdrawal (Dagan, 199438). The primary site of sequestration is the membrane oxygenator, and the binding seems to be irreversible (Rosen, 198639; Koren, 198440; Hynynen, 198741). The increasing concentrations with time would be observed if circuit _binding sites became saturated. Lorazepam Lorazepam, an agent commonly used for sedation in this patient population, was demonstrated to have 30 to 50% lower concentrations at 3 hours in an in vitro circuit. Drug levels were significantly below expected for the first 24 hours, but by 48 hours, they exceeded the expected concentration. His findings suggested an increased volume of distribution and circuit sequestration in the first 24 hours. However, by 48 hours, dosing could be reduced because of an increased half-life, probably because of reversible circuit binding. The authors further suggested that midazolam be administered directly to the patient rather than to the circuit (Mulla, 2003a44; Mulla, 2003b45). Propofol levels can fall to 45% of their expected level after the initiation of cardiopulmonary bypass, and to 37% after 10 minutes. In an in vitro preparation, 75 to 98% of the drug was bound by the circuit (Hynynen, 199446; Mulla, 20006). Phenobarbital Phenobarbital, which is used to treat seizures, has also been studied. As noted earlier, Dagan observed a 17% loss of phenobarbital in an in vitro circuit (Dagan, 199438). As with many of the other drugs, there is a greater apparent volume of distribution with variable clearance (Elliot, 199948). Drugs with small volumes of distribution are more greatly affected than those with large volumes of distribution. The increased volume of distribution and decreased clearance results in prolonged drug half-life. These alterations in drug pharmacokinetics are clearly most acute when the circuit is new, and they diminish over time. The binding process may be irreversible or reversible and may contribute to drug tachyphylaxis, dependency, and prolonged action after discontinuation. Extracellular fluid and total body water changes in neonates undergoing extracorporeal membrane oxygenation. Effect of extracorporeal membrane oxygena- tion on body water content and distribution in lambs. Preliminary studies of the effects of extracorpor- eal membrane oxygenator on the disposition of common pediatric drugs. In vitro evaluation of sedative drug losses dur- ing extracorporeal membrane oxygenation. Effects of injection site and flow rate on the distribution of injected solutions in an extracorporeal membrane oxygenation circuit. Pro: pulsatile flow is preferable to nonpulsatile flow during cardiopulmonary bypass. Thiopentone pharmacokinetics during car- diopulmonary bypass with a nonpulsatile or pulsatile flow. Pharmacokinetics of gentamicin in neonates on extracorporeal membrane oxygenation. Gentamicin pharmacokinetics in neonates under- going extracorporeal membrane oxygenation. Population pharmacokinetic models: effect of explicit versus assumed constant serum concentration assay error patterns upon parameter values of gentamicin in infants on and off extracorporeal membrane oxygenation. Gentamicin pharmacokinetics in term neonates receiving extracorporeal membrane oxygenation. Pharmacokinetics of gentamicin in neonatal patients supported with extracorporeal membrane oxygenation. Pharmacokinetic changes during extracorporeal membrane oxy- genation: implications for drug therapy in neonates. Vancomycin pharmacokinetics in patients undergoing extracorporeal membrane oxygenation. Pharmacokinetics in critically ill infants undergo- ing extracorporeal membrane oxygenation. Vancomycin pharmacokinetics in neonates receiving extracorporeal membrane oxygenation. Population pharmacokinetics of vancomycin in patients receiving extracorporeal membrane oxygenation. Pharmacokinetics and pharmacodynamics of bumetanide in neonates treated with extracorporeal membrane oxygenation. Pharmacokinetics and pharmacodynamics of ranitidine in neonates treated with extracorporeal membrane oxygenation.

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A copy of letter (notarised) issued by the Competent Authority stating that the imported drug will be used in the manufacture of said finished product and not as an active principle but as feed cheap 300 mg ranitidine amex gastritis symptoms australia. A copy of Certificate of Analysis of the drug to be imported discount 300mg ranitidine mastercard gastritis diet , issued by the manufacturer in the country of origin (not by exporter) discount ranitidine 150 mg otc gastritis diet . For subsequent permission purchase ranitidine paypal gastritis with hemorrhage, Reconciliation data of previously permitted quantity in addition to above details. Anticoccidiostats 1) Maduramycin 1% Feed grade 2) Salinomycin 12% Feed grade Any other product included in the list of poultry/ Animal Feeds shall be included after approval from the Animal Husbandry Department. Such permissions are considered for those manufactures which does not have manufacturing permission in the country for imported drug, however they got permission for manufacture of other drug using imported drug. The following documents are required to be submitted to the Zonal Office for grant of necessary permission under Schedule- D, preferably before importing the consignment. Covering letter- The applicant should submit covering letter by clearly specifying purpose of application, the drugs to be imported, quantity to be imported, name and address of the manufacturer and list of documents that are being enclosed (Index with page numbers). The covering letter should be duly signed and stamped by the Authorised Signatory, indicating name and Designation of the Authorised Signatory. A copy of Valid Drug Manufacturing Licence for the Drug to be manufactured, issued by the Drug Licensing Authority wherein the imported drug will be used. A copy of Master Formula Record of the product to be manufactured Signed and Stamped by the Authorised Signatory of the Firm. A copy of Certificate of Analysis of the drug to be imported, issued by the manufacturer. Brief Manufacturing Process including Flowchart wherein the imported product will be used. For Subsequent permission, Reconciliation data of previously permitted quantity in addition to above details. I state that that consignment document like Certificate of Analysis, Bill of Entry, invoice etc. That the bags/containers carrying (Name of the drug) along with other requirements of labelling and packaging also mentions –―Not For Medicinal Use‖ or (―for use as pharma aid‖). That the bags/containers of the said drug along with other requirements of labelling and packaging also mentions ―Not For Medicinal Use‖. That the data of my previous transaction is annexed with this undertaking (Optional in cases of subsequent transaction). It may be advised that a period of two months before the actual import will be effective for smooth clearance of consignment. For review, correction & approval of checklist and draft - Should be done by Technical Head of the Department. Other relevant documents as prescribed in note 1 of Yes/No Form 27C Opinion: All the relevant documents submitted along with the forwarding letter of S. Any action for contravention of section 10 of the Drugs and Cosmetics Act is resorted to by advising the Commissioner of Customs to take action under section 11 of Drugs & Cosmetics Act, read with relevant provisions of customs Act 1962. All the port offices are headed by Assistant Drugs Controller (India) and assisted by Technical Officers/Drugs Inspectors along with some ministerial staff members. Requirements and check list for import of drugs (The documents required to be submitted by the importer and exporter should be displayed in the official notice board for perusal of the applicants and common public. No registration certificate is required for non-critical in- vitro diagnostic kits and reagents (Rule 24(2)) and inactive bulk substances (Rule 24 A (8)) However Form 10 is required for non critical invitro diagnostic kits and reagents. A Registration Certificate (Form 41), unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of issue: provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current registration certificate shall be deemed to continue in force until orders are passed on the application. Small quantities of new drugs the import of which is otherwise prohibited under section 10 of the act may be imported by a Govt. Hospital or Autonomous Medical Institution for the treatment of patients under a license in form 11-A(Rule 33-A). Patent and proprietary medicines shall be imported only in containers intended for retail sale. No drug having the shelf life of less than 60% is allowed for the import: provided that in exceptional cases the licensing authority may, for the reasons to be recorded in writing, allow the import of any drug having lesser shelf life period, but before the date of expiry as declared on the container of the drug (Rule 31). No drug, the manufacture, sale or distribution of which is prohibited in the country of origin shall be allowed to be imported under the same name or under any other name (Rule 30 B). All the drugs imported in India are required to be stored at drug/product specific temperature conditions. All the drugs imported should comply to the standards as specified in the Second Schedule to the Act and Rules there under. All the drugs/formulations imported into the India shall fulfil the labelling requirements as prescribed in Drugs and Cosmetics Rules1945. Self Certified copy of Form10 or 10A and Registration Certificate (Form 41) as the case may be 2. Original license in Form 11/11-A to make the debit for the quantity imported under respective bill of entry. If goods are not directly supplied from the manufacturer then the port officer may verify the authenticity of goods at manufacturer‘s end through e-mail/fax or his authorized registered agent in India. After scrutiny of the aforesaid documents and making the necessary entry in the records/computer, the technical staff to put up the Bill of entry (B/E) to the port officer. The Port officer should examine B/E and should decide at this stage whether:- a) Labelling & marking need to be checked by the port officers and samples may be drawn (If the drug imported is in small container of 5 kg or less than the original container may be called for to check the markings/label) b) When required Samples to be sent for testing / analysis to the Government / Approved testing lab. However, the port officer may draw more samples depending on the previous test reports, number of consignments and the reputation of the manufacturer/ importer. There are no proper labels/markings or no markings on the containers or the markings are illegible. Drugs imported from a supplier/manufacturer have been reported to be not of standard quality/spurious etc at this port or any other port in India. The price of the drug imported is abnormally low as compared with the previous imports. Pending testing report, to avoid demurrage if the importer gives an undertaking (Rule 40 (1)) in writing not to dispose of the drugs without the consent of Customs commissioner etc. Drugs requiring cold storage such as sera, vaccines, may be released forthwith conditionally on L/G for test etc. If there are any labelling defects and importer desire to rectify the defects at their place, they may be allowed to be clear the consignment on L/G for rectification of labelling and/or test. Samples are drawn as far as possible under the direct supervision of a technical representative of the port office. Also, sampling should invariably be carried out in the presence of the importer‘s representative. In case of drugs requiring special precautions due to their hygroscopic, thermo labile nature etc. If the drug is sterile, the importers should be asked to make arrangement for drawing of samples under sterile conditions. Usually √n+1 number of 417 samples may be drawn, where n is number of containers / batches as per requirements. No samples should be drawn from the consignments imported for the purpose of registration only. It is responsibility of the Port Officer to ensure that all samples intended for test, are sent to laboratory as early as possible.