Clinical Research News and Updates

New Begining

2014-07-10T11:52:00.002+05:30

Hello everyone,

This blog is back with new management after a long time..

Please do follow the blog for more info and latest updates related to,

Training
Job Opportunities
Seminars
Academic Projects
Books

Many more.

You can reach on the same Mail id for more info..

MBA -Pharma Management

2011-10-31T10:40:00.000+05:30

Global PG college offering MBA in pharma Management,Project Management through distance mode and regular.For more details contact us.

You can mail us :- clinilife@gmail.com

As patents expire, prescription drug prices will plummet

2011-08-01T15:27:00.000+05:30

Generic versions of big-selling drugs for blood pressure, asthma, diabetes, depression, high triglycerides, HIV and bipolar disorder also are coming by then. The flood of generics will continue for the next decade or so, as about 120 brand-name ...
Click on the link to read the full article at Detroit Free Press

Avoid Methylene Blue or Linezolid With Serotonergics

2011-08-01T11:55:00.000+05:30

Physicians generally should avoid prescribing either methylene blue or linezolid (Zyvox,Pfizer) in combination with serotonergic agents such as paroxetine or duloxetine to avoid a potential drug interaction causing a dangerous condition called serotonin syndrome, the US Food and Drug Administration (FDA) announced today.
Linezolid is an antibacterial agent, and methylene blue is a dye used in diagnostic procedures and in the treatment of conditions ranging from methemoglobinemia to cyanide poisoning.

Through its Adverse Event Reporting System (AERS) database, the FDA has learned of serious central nervous system reactions when either drug has been given to patients taking other drugs that work through the serotonin system of the brain.

Both linezolid and methylene blue — each the subject of separate FDA press releases — inhibit the action of monoamine oxidase A, an enzyme that breaks down serotonin. Either drug, it is believed, can cause high levels of serotonin to build up in patients taking serotonergics, leading to the toxic condition called serotonin syndrome. Signs and symptoms include confusion, hyperactivity, and other mental changes; muscle twitching, excessive sweating, shivering, or shaking; diarrhea; trouble with coordination; and fever. In the case of linezolid, some deaths have been reported.

The FDA is advising clinicians that certain emergencies or life-threatening conditions warrant the administration of linezolid or methylene blue in patients taking serotonergic drugs. Linezolid may be needed for such patients to treat vancomycin-resistant Enterococcus faecium infections, or infections caused by methicillin-resistant Staphylococcus aureus (MRSA). Methemoglobinemia, cyanide poisoning, or ifosfamide-induced encephalopathy may require the emergency administration of methylene blue, according to the FDA.

In nonemergency situations, most serotonergic drugs must be discontinued at least 2 weeks before the start of linezolid or methylene blue therapy. Fluoxetine requires a 5-week lead time because of its longer half-life.

The FDA said that these and important recommendations as well as safety information about the potential interaction with serotonergic drugs will be added to the label of linezolid. The labels for serotonergic drugs will also be revised accordingly.

The agency is instructing patients taking either combination of drugs not to discontinue their serotonergic medication without first talking to their healthcare professional.

Energy drinks are a health risk, says CSE study

2011-07-20T11:46:00.003+05:30

Energy drinks consumed to increase stamina do more harm to health than good and can lead to addiction to alcohol, a study released by NGO Centre for Science and Environment said. The CSE had tested two samples each of eight popular energy brands sold in India and found 44 % of the samples breached the safety limit of 145 particles per million (ppm) of caffeine prescribed under the Prevention of Food Adulteration Act, 1954.
Caffeine is a psycho-stimulant and can lead to seizure, strokes and even death.

"These drinks are touted to have major health benefits but could be doing irreparable harm instead, mainly to the young ones," the CSE said in a statement on Monday. Other sources of caffeine are tea and coffee.
The energy drink industry is worth 250 crore in India and is estimated to be growing at a rate of 20% per annum. Most of the energy drinks are consumed with alcohol in India, which the study says causes dependence on alcohol.
Red Bull, one of the biggest manufacturers of energy drinks in India, however, refused to comment on the study. The company had, however, got a stay on Food Safety and Standards Authority of India's 2009 notification of prescribing 145 ppm as safety limit of caffeine for propriety drinks.
The authority is now working on new standard of 320 ppm of caffeine for drinks having caffeine, CSE said. Some
In absence of proper standards, the CSE found that 25% of the samples did not mention the caffeine content on the label. And, 38% of the samples tested breached the caffeine limit mentioned on the label. This indicated that lack of standards is not helping the consumers in taking a proper decision before buying energy drinks.
Chandra Bhushan, associate director of CSE said: "What's more worrying is that these so called 'energy' drinks are being confused with sports drinks – this is how they are marketed and projected. But studies show that these drinks are not made to re-hydrate and replenish the body. In fact, consumed during intense physical activity, they can lead to dehydration."

Clinical trials: DCGI faults 9 more CROs

2011-07-20T11:46:00.000+05:30

Nearly a month after the licence of Axis Clinicals was suspended for irregularities in conducting trials on poor illiterate women, officials of the Drug Controller General of India (DCGI) found similar violations by nine Clinical Research Organizations (CROs) in the state. Highly-placed sources said that there are glaring violations in the recruitment process of `subjects' and in taking their informed consent in almost all these organizations, where the gullible are becoming guinea pigs.

In fact, Actimus Bio Sciences, Visakhapatnam, which is the latest to get embroiled in the clinical trial controversy, was one among the eight CROs recently inspected by the DCGI officials.
It was after Axis Clinicals was found to have administered anti-cancer drug to poor women from Piduguralla in Guntur district without securing their consent in June this year, DCGI had decided to investigate the working of all bioavailability and bioequivalence study centres in Andhra Pradesh within a period of two months to ensure that such studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines.
The officials, who are yet to submit the final report to DCGI, Delhi, revealed that they concentrated on the issues pertaining to the recruitment process and the ethical committee's approval process adopted by these CROs during their course of investigations. "None of them is fully following either the guidelines of the Indian Council for Medical Research or the rules framed in the Schedule Y, which are necessary for manufacturing new drugs," said an official adding that some documents were seized during the investigation.
Besides, the Standard Operating Procedure drafted for every study was given a go by. "They should practise and follow what is there in the SOP. Further, if video recording of subjects is done prior to the study, it would be beneficial for these organizations though it's not mandatory. None of them is adopting this practice," said the official adding that more than 50 studies are being done annually by these CROs.
Aizant, Sipra, Bio Serve, Vimta, CR Bio, Nicholas Piramal, GVK Bio are the other CROs operating in the state. The DCGI officials said that the final report would be submitted to DCGI in about a week or so. He added that a team would again visit Actimus Bio Sciences in Visakhapatnam on Wednesday to study the case of two students who were subjected to clinical tests for two days.

Alkoloids : Study Material

2011-06-25T17:10:00.001+05:30

Download Alkoloids study material here

Drug Storage as per IP

2011-06-24T17:11:00.000+05:30

DRUGS TO BE STORED
1.In a Frozen State:     Ceftazidime Inj

2° to 8° C:
Antisera
BCG Vaccine
Carbenicillin Sodium Inj. [Biopence™ Carbelin™ Pyopen™]
Carboprost Tromethamine Inj. USP [Prostodin™]
Desferrioxamine Mesylate Inj. [Desferal™]
Dilzem™ Inj.
Dinoprostone Gel [Cerviprime 0.5mg.™Primiprost™]
Ergometrine Maleate Inj.
Gas-Gangrene Antitoxin (Oedematiens)
Gas-Gangrene Antitoxin (Perfringes)
Gas-Gangrene Antitoxin (Septicum)
Hepatitis B Virus Vaccine (H B Vac™ Enivac HB™ Engerrix B™
Heppacine-B™ Shanvac-B™)

Human Normal Immunoglobulin [Histaglobulin ™ (lyophillised)
Insulin Inj. (e.g. Insuman ™ 50/50)
Measles Vaccine, Live (M-Vac™)
Methylergometrine Maleate Inj.
Mixed Gas Gangrene Antitoxin
Plague Vaccine
Poliomyelitis Vaccine, Live (oral)[Polio Sabin™ Oral Polio™]
Protamine Sulphate Inj.
Rabies Vaccine Human (Neural Tissue)
Rabies Vaccine, Human (Cell Culture)
Rubell Vaccine Live BP [R-Vac™ (lyophillised)]
Sandoglobulin™
Schick Control
Schick Test Toxin
Scorpion Venom Antiserum
Snake Venom Antiserum
Streptokinase Inj. [Embokinase™ Kabikinase™ Streptase™]
Succinylcholine Chloride Inj. [Midarine™ Scoline™]
Typhoid Paratyphoid A Vaccine
Typhoid Vaccine Oral [Typhoral™]
Typhoid Vaccine [Typhim VI™]
Typhus Vaccine
Vaccines
Vasopressin Inj. [Petresin™]
Vinblastine Sulphate Inj. [Cytoblastin™]
Vincristine Sulphate Inj. [Cytocristn™ Vincristine™ Oncristine
AQ™]
Yellow Fever Vaccine, Live

3. Below 10° C:
Japanese Encephalitis Vaccine, Human (Mouse Brain)
Methylprednisolone Acetate Inj.

4.At a temp. Not exceeding 20° C:     Chorionic Gonadotrophin Inj.
(Pubergen 2000 IU ™)
Urokinase™

5. Between 2° & 25° C:     Human Plasma Protein Fraction
6.Between 20° & 30° C:     Mannitol Inj.
7.In a Refrigerator:     Velocite ™ & Pregcolor ™ Test Kits
8.To Be Stored Below 25° C:     Cefotaxime Sodium Inj.
Cefuroxime Sodium Inj.

Human Chorionic Gonadotrophin [Profasi™]
Menotrophin (hMG)[Pergonal 75™]
Urofolliotrophin (FSH) 75 IU [Metrodin 75™]
PRECAUTIONS

1.Should not be allowed to freeze
Antisera Inj.
Cortisone Acetate Inj.
Fluorouracil Inj.
Gas Gangrene Antitoxin (Oedematiens)
Gas-Gangrene Antitoxin (Perfringens)
Gas-Gangrene Antitoxin (Septicum)
Hepatitis B Virus Vaccine [H B Vac™ Inj., Shanvac-B™]
Histaglobulin™ [lyophillised]
Insulins
Methylprednisolone Acetate Inj.
Mixed Gas-Gangrene Antitoxin
Oxytocin Inj.
Plague Vaccine
Rabies Vaccine, Human (Neural Tissue)
Scorpion Venom Antiserum
Snake Venom Antiserum
Succinylcholine Chloride Inj.
Typhoid Paratyphoid A Vaccine
Typhoid Vaccine
Vaccines
2.Avoid Long Exposure above 30° C
Cyclophosphamide Inj.

Monographs: Dosage forms: General monographs: Tablets

2011-06-24T17:01:00.001+05:30

Monographs: Dosage forms: General monographs: Tablets

Definition : Tablets are solid dosage forms containing one or more active ingredients. They are obtained by single or multiple compression (in certain cases they are moulded) and may be uncoated or coated. They are usually intended for oral administration, but preparations for alternative applications, such as implants, solution-tablets for injections, irrigations, or for external use, vaginal tablets, etc., are also available in this presentation. These preparations may require a special formulation, method of manufacture, or form of presentation, appropriate to their particular use. For this reason they may not comply with certain sections of this monograph.

The different categories of tablet that exist include soluble tablets, effervescent tablets, tablets for use in the mouth, and modified-release tablets. Unless otherwise specified in the individual monograph, tablets are normally circular in shape, and their surfaces are flat or convex. Tablets may have lines or break-marks, symbols, or other markings. They should be sufficiently hard to withstand handling, including packaging, storage, and transportation, without crumbling or breaking.

Tablets may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the dosage forms and the active ingredient(s) in the gastrointestinal tract, colouring matter, and flavouring substances.When such excipients are used, it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety, or efficacy of the active ingredient(s); there must be no incompatibility between any of the components of the dosage form.

Manufacture

The manufacturing processes should meet the requirements of Good Manufacturing Practice, especially with regard to cross-contamination. The following information is intended to provide very broad guidelines concerning the main steps to be followed during production, indicating those that are the most important.

The particle size of the active ingredient(s) is of primary significance in determining the rate and extent of dissolution, the bioavailability, and the uniformity of a drug product, especially for substances of low solubility in aqueous media. In order to obtain a suitable formulation, it is usually necessary to mix the active ingredient(s) with a number of excipients. It is essential that such mixing is carried out in a manner that ensures homogeneity. Sometimes, the physical characteristics of the mixture allow it to be directly compressed, but it is usually necessary to granulate before compression, either by wet granulation or precompression (slugging).

The granulate and powders normally need to be mixed with lubricants and/or disintegrating agents. The use of excessive amounts of lubricants should be avoided since these will deleteriously affect the tablets. The final tablet mixture is volumetrically fed into the die cavity to ensure that the tablets are of a uniform mass when compressed. The tablets may be coated, either in coating pans or by an air-suspension technique. A hydrophobic subcoat applied to the core of sugar-coated tablets may reduce dissolution.

Throughout manufacturing, certain procedures should be validated and monitored by carrying out appropriate in-process controls. These should be designed to guarantee the effectiveness of each stage of production. In-process controls during tablet production should include the particle size of the active ingredient(s), the homogeneity and moisture content of the mixture and/or granulate, the size of granules, the flow of the final mixture, and the dimensions (thickness, diameter), uniformity of mass, hardness and/or crushing force, friability, disintegration, or dissolution rate (e.g. for modified-release tablets) of the finished dosage form. Attention should be paid to the uniformity of mass of tablet cores before coating.

Packaging must be adequate to protect the tablets from light, moisture, and damage during packaging and transportation.

Visual inspection

Unpack and inspect at least 20 tablets. They should be undamaged, smooth, and usually of uniform colour.

Evidence of physical instability is demonstrated by:

    - presence of excessive powder and/or pieces of tablets at the bottom of the container (from abraded, crushed, or broken tablets);

    - cracks or capping, chipping in the tablet surfaces or coating, swelling, mottling, discoloration, fusion between tablets;

    - the appearance of crystals on the container walls or on the tablets.

Uniformity of mass

Tablets comply with the test for 5.2 Uniformity of mass for single-dose preparations, unless otherwise specified below or in the individual monograph.

Uniformity of content

A requirement for compliance with the test for 5.1 Uniformity of content for single-dose preparations is specified in certain individual monographs for sugar-coated or enteric-coated tablets, where the test for 5.2 Uniformity of mass for single-dose preparations does not apply. In addition, a requirement is specified in certain individual monographs where the active ingredient is 5% or less of the total formulation. In such cases the test for 5.2 Uniformity of mass for single-dose preparations is not required.

Dissolution test

Where a requirement for the "Dissolution test" is specified in the individual monograph, the 5.3 Disintegration test for tablets and capsules is not required.

Labelling

Every pharmaceutical preparation must comply with the labelling requirements established under Good Manufacturing Practice.

The label should include:

    (1) the name of the pharmaceutical product;

    (2) the name(s) of the active ingredient(s); International Nonproprietary Names (INN) should be used wherever possible;

    (3) the amount of the active ingredient(s) in each tablet and the number of tablets in the container;

    (4) the batch (lot) number assigned by the manufacturer;

    (5) the expiry date and, when required, the date of manufacture;

    (6) any special storage conditions or handling precautions that may be necessary;

    (7) directions for use, warnings, and precautions that may be necessary; and

    (8) the name and address of the manufacturer or the person responsible for placing the product on the market.

Storage

Tablets should be kept in well-closed containers and protected from light, moisture, crushing, and mechanical shock. Any special storage conditions should be stated on the label. Tablets should be able to withstand handling, including packaging and transportation, without losing their integrity. Moisture-sensitive forms, such as effervescent tablets, should be stored in tightly closed containers or moisture-proof packs and may require the use of separate packages containing water-adsorbent agents, such as silica gel.

Additional special packaging, storage, and transportation recommendations are specified in the individual monograph.

Requirements for specific types of tablets

Uncoated tablets

Definition

The majority of uncoated tablets are made in such a way that the release of active ingredients is unmodified. A broken section, when examined under a lens, shows either a relatively uniform texture (single-layer tablets) or a stratified texture (multi-layer tablets), but no signs of coating.

Disintegration test

Uncoated tablets, except effervescent tablets, tablets for use in the mouth, and chewable tablets, comply with 5.3 Disintegration test for tablets and capsules. Operate the apparatus for 15 minutes, unless otherwise specified in the individual monograph, and examine the state of the tablets.

Soluble tablets (tablets for solutions)

Definition

Soluble tablets are uncoated tablets that dissolve in water to give a clear solution.

Disintegration test

Soluble tablets comply with 5.3 Disintegration test for tablets and capsules. Use water at room temperature, and operate the apparatus for 5 minutes, unless otherwise specified in the individual monograph.

Effervescent tablets

Definition

Effervescent tablets are uncoated tablets generally containing acid substances and carbonates or hydrogen carbonates that react rapidly in the presence of water to release carbon dioxide. They are intended to be dissolved or dispersed in water before administration.

Labelling

The label should state: "Not to be swallowed directly".

Disintegration test

Effervescent tablets comply with 5.3 Disintegration test for tablets and capsules. Place one tablet in a 250-ml beaker containing 200 ml of water at room temperature. Numerous bubbles of gas are evolved. When the evolution of gas around the tablet or its fragments ceases, the tablet should have disintegrated, being either dissolved or dispersed in the water so that no agglomerates remain. Repeat the operation on five additional tablets. The tablets comply with the test if each of the six tablets used in the test disintegrates within 5 minutes, unless otherwise specified in the individual monograph.

Tablets for use in the mouth (sublingual, buccal) and chewable tablets

Definition

Tablets for use in the mouth and chewable tablets are usually uncoated. They are formulated to effect a slow release and local action of the active ingredient(s) (for example, compressed lozenges) or the release and absorption of the active ingredient(s) under the tongue (sublingual tablets) or in other parts of the mouth (buccal) for systemic action.

Coated tablets

Definition

Coated tablets are tablets covered with one or more layers of mixtures of substances such as natural or synthetic resins, polymers, gums, fillers, sugars, plasticizers, polyols, waxes, colouring matters, flavouring substances, and sometimes also active ingredients. A broken section, when examined under a lens, shows a core which is surrounded by a continuous layer of a different texture.

The tablets may be coated for a variety of reasons such as protection of the active ingredients from air, moisture, or light, masking of unpleasant tastes and odours, or improvement of appearance. The substance used for coating is usually applied as a solution or suspension.

Three main categories of coated tablet may be distinguished: sugar-coated, film-coated, and certain modified-release tablets.

Sugar-coated tablets

Uniformity of mass

The test for 5.2 Uniformity of mass for single-dose preparations, does not apply to sugar-coated tablets (see in-process controls under "Manufacture").

Disintegration test

Sugar-coated tablets comply with 5.3 Disintegration test for tablets and capsules. Operate the apparatus for 60 minutes, unless otherwise specified in the individual monograph, using water, and examine the state of the tablets. If any of the tablets has not disintegrated, repeat the test on an additional six tablets, using hydrochloric acid (0.1 mol/l) VS.

All six tablets must disintegrate.

Film-coated tablets

Definition

A film-coated tablet is covered with a thin layer of resins, polymers, and/or plasticizers capable of forming a film.

Disintegration test

Film-coated tablets comply with 5.3 Disintegration test for tablets and capsules. Operate the apparatus for 30 minutes, and examine the state of the tablets.

Modified-release tablets

Definition

Modified-release tablets are coated, uncoated, or matrix tablets containing excipients or prepared by procedures which, separately or together, are designed to modify the rate of release of the active ingredient(s) in the gastrointestinal tract.

    Extended-release tablets

    Definition

    Extended-release tablets are designed to slow the rate of release of the active ingredient(s) in the gastrointestinal tract.

    All requirements for these specialized dosage forms are given in the individual monographs.

    Delayed-release tablets (enteric-coated tablets)

    Definition

    Delayed-release tablets are intended to resist gastric fluid but disintegrate in intestinal fluid. This is achieved by using coating substances such as cellacefate (cellulose acetate phthalate) and anionic copolymers of methacrylic acid and its esters. It is sometimes necessary to apply more than one layer.

Uniformity of mass

The test for 5.2 Uniformity of mass for single-dose preparations does not apply to delayed-release tablets.

Disintegration test

Delayed-release tablets comply with 5.3 Disintegration test for tablets and capsules, using hydrochloric acid (0.1 mol/l) VS as the immersion fluid. Operate the apparatus for 2 hours, unless otherwise specified in the individual monograph (but in any case for not less than 1 hour), and examine the state of the tablets. No tablet should show signs of either disintegration (apart from fragments of coating) or cracks that would allow the contents to escape. Replace the acid by phosphate buffer solution, pH 6.8, TS. Operate the apparatus for 60 minutes and examine the state of the tablets.

Now check genuineness of pharma products through SMS

2011-06-24T16:42:00.002+05:30

US-based Sproxil on Tuesday announced the launch of its operations in India and unveiled a product to check the drug counterfeit market.

Mobile Product Authentication (MPA) enables consumers to verify the authenticity of a pharmaceutical product by sending the unique code on the drug as a free text message to the manufacturers in real time, Sproxil CEO Ashifi Gogo told reporters.

Sproxil established the first national mobile-based anti-counterfeit service in Africa and has already sold millions of anti-counterfeit labels which provide services to several global pharmaceutical companies, the company said.

India has one of the largest pharmaceutical markets in the world, but is plagued by counterfeit (spurious) medicines made elsewhere that tarnish brand India, Gogo said.

"Our services enable Indian companies to reduce the presence of counterfeit medicines by connecting companies directly to their consumers in a scalable manner, using mobile phones ", he added.

Sproxil recently received $1.8 million from Acumen Fund , a non-profit global venture fund, to expand operations in India (which would get the lion's share) and Eastern African countries such as Kenya, Tanzania and Uganda.

The company said MPA product delivers automatic protection, simple labels and back-end analytics, and enables consumers to SMS an item-unique code for a rapid response that confirms a brand's genuineness.

FDA Regulatory Affairs - A guide for prescription drugs, medical devices, and biologics

2011-06-21T19:11:00.000+05:30

This book is a roadmap to the U.S. Food and Drug Administration and drug, biologic, and medical device development. It is written in plain English, with an emphasis on easy access to understanding how this agency operates with respect to the practical aspects of U.S. product approval. It is meant to be a concise reference that offers current, real-time information. It has been written as a handy reference for use by students, staff, and professionals at corporations, organizations, and schools and colleges across the United States in need of a simple, concise text from which to learn and teach. The topics in FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition are covered in a straightforward format. It is a compilation and commentary of selected laws and regulations pertaining to the development and approval of drugs, biologics, and medical devices in the United States. It is not intended to take the place of an actual reading of the Laws of the United States of America or the regulations of the U.S. Food and Drug Administration, it’s agencies or any body that regulates the development or approval of drugs, biologics, and medical devices in the United States.

To Download this book please click here

Pre-clinical drugs testing lab yet to take off

2011-06-17T10:15:00.002+05:30

Several pharma companies in the country lately are heading towards China and Indonesia for pre-clinical testing of drugs. This, because the country does not as yet have a national facility which provides monkeys and dogs for carrying out such of those trials that require large animals. The national facility was proposed to set up in Hyderabad in 2004 but is yet to materialise due to bureaucratic hurdles. Because of the delay, the cost of setting up the facility has got escalated.

The facility is to be set up by the National Institute of Nutrition (NIN) at Shamirpet on a 100-acre of land that was sanctioned by the Andhra Pradesh government free of cost. The land was given through the Andhra Pradesh Industrial Infrastructure Corporation ( APIIC) so that bio-technology companies and pharma companies can be benefited.Though the Andhra Pradesh government acted promptly and handed over the land, the Union ministry of health and technology and Union ministry of health had to be convinced by ICMR on several matters for funds to be sanctioned for the proposed centre.

The Indian Council of Medical Research (ICMR) is still pursuing the project proposal with the Centre. Official sources said that one big question that had to be answered was how the proposed animal resource facility would sustain itself. It was informed that in some of the private facilities which have large animals that are available in the country, pharma companies are having to wait for long periods to carry out their pre-clinical trials for drug testing. Moreover, several companies are also going abroad, especially to Indonesia and China, which have such facilities, being offered for more affordable rates.In addition, because of lapse of time, the project proposals had to be reevaluated and now the project is estimated to cost Rs 400 crore.

Earlier, the national resource facility proposed as a private-public partnership venture but now the plan is to get it fully funded by the Centre itself. Sources said, since all the questions that have been raised were answered, the planning commission was now expected to sanction funds for the project.

In the large animal facility, there would be provision for pharma companies to carry out drug trials on rhesus monkeys and beagle dogs. While the monkeys can be caught in the forests in the nearby districts of Hyderabad, the proposal is to import beagle dogs from Germany. "The plan is to allow pharma companies to conduct their pre-clinical trials at the national facility itself following all the stipulated rules for such experiments," NIN director B Sesikeran told this reporter.Rules stipulate that as far as possible, clinical trials have to be conducted on small animals like mice, rats and rabbits. However, since some drugs will have to be tested on large animals, the animal resource facility was planned.

Banned drugs on sale, makers face action

2011-06-17T10:14:00.000+05:30

Several leading pharmaceutical companies face legal action after raids this week showed drugs manufactured by them continue to be available despite their having been banned by the government. Thirteen teams of officials raided some 135 pharmacists in Delhi and Rajasthan on Wednesday, and found 83 of them selling banned drugs.

Drug Controller General of India (DCGI) Dr Surinder Singh said the manufacturer is culpable, as is the retailer. "Once the drug is banned, it becomes the responsibility of the manufacturer to recall the batches of these banned drugs already in the market," Dr Singh said.

DCGI officials said the offending chemists have been issued 'Form 15', prohibiting them from disposing of the stocks of the drugs. The controller is now in the process of generating evidence against the manufacturers and distributors — a process that might take about another fortnight. After investigations are over, the controller will start proceedings for the prosecution of sellers, distributors and manufacturers, the officials said.The illegal sale of banned drugs is a non-bailable offence, and if proved, carries a punishment of three years in prison and a fine.The raids were carried out after repeated complaints at the DCGI office. Banned drugs recovered include the popular diabetes drug Rosiglitazone, the antibiotic Gatifloxicin, and Tegaserod, a medicine used to treat irritable bowel syndrome.

Rosiglitazone was banned late in 2010; the other two drugs were banned earlier this year. The government cracked down on the manufacture, sale and distribution of the drugs after they were found to have side-effects that could be harmful.

New essential drugs list finalized after eight years

2011-06-13T10:20:00.002+05:30

India has finalized the country's all new National List of Essential Medicines (NLEM). It has 348 essential medicines, while the 2003 list had 354.Drug Controller General of India (DCGI) told TOI that 47 dugs have been deleted from the 2003 list. However, no anti-cancer or anti-HIV drugs have been deleted. They said eight new cancer drugs have been added in NLEM 2011, aggregating the tally to 30.

Carboplatin, Chlorambucil, Daunorubicin, Filgrastim, Ifosfamide, Imatinib, Mesna and Oxaliplatin are the new cancer drugs that have been included in the list.About 43 new medicines have been added in NLEM 2011, which are from 27 therapeutic categories. "The list has been finalized by an expert group that was formed by the Union health ministry on July 6, 2010.

Clinical Research Executive

2011-06-07T10:19:00.000+05:30

Experience:0 - 3 Years
Location:Mumbai
Compensation:Rupees 2,00,000 - 3,50,000
Education:UG - B.Pharma - Pharmacy,B.Sc - Any Specialization PG - PG Diploma - Any Specialization

Role:Clinical Research Associate

Desired Candidate Profile:

Hands on experince in the field of clinical operations.
Hardworking, Adaptable.
CRO bakground will be preferable.
Science / Pharmacy background with knowledge clinical research.

Job Description
•To maintain & carry out the following responsibilities as-
•Study files & filing (CSF & ISF)
•Site Feasibility, Site assessments
•Investigator’s Meet
•Essential Documents
•Site Initiation, Monitoring & Closeout
•Trial Supply Management at Site
•IMP release, inventory check & accountability reconciliation
•Raising invoices
•SDV, CRF completion & retrieval, DCF resolution
•Preparation of Reports, Follow up reports
•Audit & to maintain & adhere quality data, Quality assurance.

Company Name:Piramal Life Sciences Ltd.
Website:http://www.piramallifesciences.com/
Telephone:22-91-30818000

HR Info of some CROs

2011-06-07T10:13:00.002+05:30

Actimus Biosciences Pvt. Ltd-vizag" <queries@actimusbio.com>,
Asian Clinical Trials Limited-HYD <info@act-india.com>,
"Asiatic Clinical Research Pvt. Ltd-BANGLORE" <info@asiaticlinical.com>,
Avra Laboratories-HYD <info@avralab.com>,
BioAxis DNA Research Centre-SECENDERBAD <dnaresearchcentre@gmail.com>,
"Bioserve Biotechnologies (I) Pvt Ltd-HYD" <info@bioserve.com>,
celestialbiolabs-HYD <sivasankar@celestialbiolabs.com>,
celestiallabs-HYD <hr@celestiallabs.com>,
Clinigene International Limited-BANGLORE <BD@clinigeneintl.com>,
CLINiREACH Clinical Services -BANGLORE <info@clinireach.org>,
"Clintrac International Pvt. Ltd-BANGLORE" <info@clintracinternational.com>,
"Cqua Research International Inc.-SECENDERBAD" <info@cquaint.com>,
D2L Pharma Research Solutions-BANGLORE <info@d2lpharma.com>,
"Darsan Clinica Life Sciences Pvt. Ltd-HYDERBAD" <info@darsanclinica.com>,
GVK Biosciences Pvt Ltd-HYDERBAD <bdcrd@gvkbio.com>,
"Helix Research Center Pvt. Ltd-HYDERBAD" <admin@helixresearchcenter.com>,
HETERO LABS-HYD <contact@heterodrugs.com>,
Manipal Acunova-BANGLORE <bd.asia@ecronacunova.com>,
"Merit Medical & Allied Sciences Pvt Ltd (SMO)-CHENNAI" <info@meritclinicalresearch.in>,
Omnicare Clinical Research-BANGLORE <Investigators@omnicarecr.com>,
"Quintiles Technologies Pvt. Ltd.-BANGLORE" <clinical.info@quintiles.com>,
Ranbaxy Laboratories Limited-GURGOAN <ramesh.adige@ranbaxy.com>,
RANBAXY- CONSULTANT <shruti.wadhwa@abcconsultants.net>,
Reametrix -BANGLORE <info@reametrix.com>,
Dr Reddy's Laboratories Limited-HYDERBAD <webmaster@ddreddys.com>,
"DR.REDDY'S LABS-HYD" <corporatehr@drreddys.com>,
Reliance Clinical Research Services- NAVI MUMBAI <ClinicalResearch.Enquiry@relclin.com>,
Rhenium Clinical Research Pvt Ltd-BANGLORE <info@rheniumresearch.com>,
SIPRA LABS <sipra@sipralabs.com>,
VIMTA LABS <vimtahq@vimta.com>,
vimtas labs hyd <mdo@vimta.com>,

90% of pharmacies are ‘fake’ in Andhra Pradesh

2011-05-02T14:45:00.000+05:30

Nearly 90 per cent of the 50,000 pharmacy stores in the state are being run by unqualified persons using the certificates of registered pharmacists. The store owners ‘borrow’ the certificates from registered pharmacists for a price and secure licences to run their stores, AP Pharmacy Council president Vijayabhaskar R Annapareddy has said.He told reporters here on Tuesday that the Pharmacy Act 1948 mandates that dispensing of prescription drugs must by done only by registered pharmacists. ‘’However, this is not being followed at 90 per cent of the pharmacy outlets in the state. Several pharmacy store owners are taking advantage of the unemployed pharmacy graduates or diploma-holders who are being forced to ‘lend’ their certificates to these pharmacy owners for a consideration of as meagre as Rs 3,000 to Rs 5,000 a month. Unfortunately, even some well-known pharmacy groups which are running chains of retail outlets are resorting to such practice,” he said.The APPC has decided to crack the whip on such outlets from July and ensure that only registered pharmacists are dispensing the prescribed drugs. On the other hand, the council has decided to facilitate unemployed pharmacists to get jobs by organising interactive workshops between the pharmaceutical companies and unemployed youth in the pharma sector. “For the last two years the retail sector in India has been growing at around 35 per cent,’’ Vijayabhaskar said and urged pharmaceutical firms to provide jobs to fresh graduates with minimum wages. He said the council would set up a Career Guidance Cell to provide jobs to fresh pharmacy graduates. A Pharmacy Registration Council Tribunal is also on the cards.

Useful Links for Clinical Research Professionals

2011-05-02T11:02:00.000+05:30

Charities
http://www.amrc.org.uk/
Association of Medical Research Charities (AMRC)

Dictionaries

http://www.pharma-lexicon.com/
A dictionary medical, pharmaceutical, biomedical & healthcare acronyms and abbreviations.
http://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-glossary/glossary-of-terms.html
Pharmaceutical Glossary
http://www.medterms.com
online medical dictionary
http://cancerweb.ncl.ac.uk/omd/
online medical dictionary
http://www.nlm.nih.gov/medlineplus/mplusdictionary.html
Medical Dictionary
http://medical-dictionary.thefreedictionary.com/
Medical Dictionary
http://medical-dictionary.com/
Medical Dictionary
http://www.online-medical-dictionary.org/
Medical Dictionary
http://www.medilexicon.com/
Medical Dictionary

News

http://news.bbc.co.uk/1/hi/health/default.stm
BBC Health News
http://www.pharmafocus.com

Wiki’s

http://wiki.eyeforpharma.com
Pharmaceutical Industry resource
http://en.wikipedia.org
Free encyclopedia that anyone can edit
www.pharmdot.wikidot.com
Clinical trials wiki for people working in the Pharmaceutical Industry

Professional Organisations

American Medical Writers Association
http://www.amwa.org/
40 West Gude Drive
Suite 101
Rockville
MD 20850-1192
United States
Tel: 301-294-5303
Fax: 301-294-9006
For more information contact mailto:info@amwa.org

American Society for Pharmacology and Experimental Therapeutics (ASPET)
http://www.faseb.org
9650 Rockville Pike
Bethesda
MD 20814-3995
United States
Tel: 00 1 301-530-7060
Fax: 00 1 301-530-7061
For more information contact aspetinfo@aspet.faseb.org

Association of British Healthcare Industries
http://www.abhi.org.uk
St George’s House
195-203 Waterloo Road
London
SE1 8WD
United Kingdom
Tel: 44 (0)20 7787 3060
Fax: 44 (0)20 7787 3061
For more information contact enquiries@abhi.org.uk

Association of Clinical Data Management (ACDM)
http://www.acdm.org.uk/
PO Box 129
Macclesfield
Cheshire
SK11 8FG
United Kingdom
Tel: 44 (0) 1625 511818
Fax: 44 (0) 1625 511750
For more information contact mailto:jspencer@technomark.com

Association of Clinical Research Professionals
http://www.acrpnet.org
500 Montgomery Street
Suite 800
Alexandria
VA 22314
United States
Tel: (703) 254-8100
Fax: (703) 254-8101
For more information contact mailto:office@acrpnet.org

Association of Consultants to the Bioscience Industries
Copper Beeches
Gayton Road
Milton Malsor
Northants
NN7 3AA
United Kingdom
Tel: 44 (0) 1604 859456
Fax: 44 (0) 1604 858894
For more information contact mailto:nigeld@cwcom.net

Association of the British Pharmaceutical Industry (ABPI)
http://www.abpi.org.uk/
12 Whitehall
London
SW1A 2DY
United Kingdom
Tel: 44 (0) 207 930 3477
Fax: 44 (0) 207 747 1414

BioIndustry Association
http://www.bioindustry.org/
14/15 Belgrave Square
London
SW1X 8PS
United Kingdom
Tel: 44 (0) 20 7565 7190
Fax: 44 (0) 20 7565 7191
For more information contact mailto:admin@bioindustry.org

Biotechnology Industry Association (BIO)
http://www.bio.org/
1225 Eye Street
N.W
Suite 400 Washington
Washington
DC 20005
United States
Tel: 00 1 202 857 0244
Fax: 00 1 202 857 0237
For more information contact mailto:info@bio.org

British Association of Pharmaceutical Physicians
http://www.brapp.org.uk/
Ground Floor
26-28 Bedford Row
London
WC1R 4EH
United Kingdom
Tel: 44 (0) 20 7404 3404
Fax: 44 (0) 20 7404 2505
For more information contact mailto:liz.langley@brapp.org.uk

British Association of Research Quality Assurance (BARQA)
http://www.barqa.com/
Suite 2
3 Wherry Lane
Ipswich
IP4 1LG
United Kingdom
Tel: 44 (0)1473 221411
Fax: 44 (0)1473 221412
For more information contact mailto:liz.langley@brapp.org.uk

British Healthcare Business Intelligence Association (BHBIA)
http://www.bhbia.org.uk/
105 St Peter’s Street
St Albans
Herts
AL1 3EJ
United Kingdom
Tel: 44 (0)1727 896085
Fax: 44 (0)1727 896026
For more information contact mailto:admin@bhbia.org.uk

British Standards Institution (BSI)
http://www.bsi.org.uk/
British Standards House
389 Chiswick High Road
London
W4 4AL
United Kingdom
Tel: 44 (0) 20 8996 9000
Fax: 44 (0) 20 8996 7001
For more information contact info@bsi.org.uk

Bundesverband der Pharmazeutischen Industrie Service GmbH
http://www.bpi-service.de/
Bundesverband der Pharmazeutischen Industrie Service GmbH
Karlstraße 21
60329 Frankfurt/Main
Germany
For more information contact mailto:inform@tion.com

Canadian Generic Pharmaceutical Association
http://www.canadiangenerics.ca
4120 Yonge Street
Suite 409
Toronto
Ontario
M2P 2B8
Canada
Tel: 1 (416) 223 2333
Fax: 1 (416) 223 2425
For more information contact info@canadiangenerics.ca

Drug Information Association (DIA)
http://www.diahome.org/
501 Office Center Drive
Suite 450
Fort Washington
Pennsylvania
19034-3211
United States
Tel: 1 215 628 2288
Fax: 1 215 641 1229
For more information contact mailto:dia@diahome.org

European Agency for the Evaluation of Medicinal Products (EMEA)
http://www.emea.eu.int/home.htm
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom
Tel: 44 (0)20 74 18 84 00
Fax: 44 (0)20 74 18 84 16
For more information contact mail@emea.eu.int

European Federation of Pharmaceutical Industries and Associations
http://www.efpia.org/
Rue du Trône 108, Brussels
B-1050
Belgium
Tel: 32 (0)2 626 25 55
Fax: 32 (0)2 626 25 66
For more information contact info@efpia.org

European Forum for Good Clinical Practice
http://www.efgcp.org/
c/o Intern. Ass. Centre
Washington Straat 40
B-1050 Brussels
Belgium
Tel: 32 2 774 16 14
Fax: 32 2 772 61 97
For more information contact pth@eortc.be

European Generic medicines Association
http://www.egagenerics.com
P.O. Box 193
B-1040 Brussels
Belgium
Tel: 32 2 736 84 11
Fax: 32 2 736 74 38
For more information contact info@egagenerics.com

European Medical Writers Association (EMWA)
http://www.emwa.org/
Baarerstrasse 110C
7th Floor, P.O. Box 2246
Switzerland
6302 Zug
Switzerland
Tel: 41 41 766 05 81
Fax: 41 41 766 05 86
For more information contact info@emwa.org

European Pharmaceutical Market Research Association (EphMRA)
http://www.ephmra.org/
54 Sunridge Avenue
Bromley
Kent
BR1 2QD
United Kingdom
Tel: 44 (0) 20 8466 8630
Fax: 44 (0) 20 8466 0767
For more information contact 101570.1357@compuserve.com

Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom
http://www.f-pharm-med.org.uk/
1 St Andrews Place
Regent’s Park
London
NW1 4LB
United Kingdom
Tel: 44 (0) 20 7224 0343
Fax: 44 (0) 20 7224 5381
For more information contact mailto:fpm@f-pharm-med.org.uk

Food and Drug Administration
http://www.fda.gov/
5600 Fishers Lane
Rockville
Maryland
20857
United States
Tel: 1-888-463-6332

Generic Pharmaceutical Association
http://www.gphaonline.org
2300 Clarendon Blvd
Suite 400
Arlington
VA 22201
United States
Tel: 1 (703) 647 2480
Fax: 1 (703) 647 2481
For more information contact info@gphaonline.org

German Association of Research-Based Pharmaceutical Companies
http://www.vfa.de/en/index_en.html/latesttopics.html
Verband Forschender Arzneimittelhersteller e.V.
Hausvogteiplatz 13
10117 Berlin
Germany
Tel: 49 30 20604-0
Fax: 49 30 20604-222
For more information contact mailto:info@vfa.de

German Federal Institute for Drugs and Medical Devices (BfArM )
http://www.bfarm.de/de/index.php
Federal Institute for Drugs and Medical Devices
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Germany
Tel: 49 (0)228 207 30
Fax: 49 (0)228 207 5207
For more information contact mailto:poststelle@bfarm.de

Indian Pharmaceutical Alliance
C/O Vision Consulting
201 Darvesh Chambers
743 P.D. Hinduja Road
Khar
Mumbai, 400 052,
India
Tel: 91 22 26 00 0632
Fax: 91 22 26 00 0633

Institute of Clinical Research
http://www.instituteofclinicalresearch.org/
Thames House
Mere Park
Dedmere Road
Marlow
Buckinghamshire
SL7 1XH
United Kingdom
Tel: 44 (0) 1628 899755
Fax: 44 (0) 1628 899766
For more information contact mailto:info@instituteofclinicalresearch.org

International Federation of Association of Pharmaceutical Physicians (IFAPP)
http://www.ifapp.org/
Rendementsweg 24 E-I
3641 SL Mijdrecht
The Netherlands
Tel: 31 297 285144
Fax: 31 297 256046
For more information contact mailto:ifapp@planet.nl

International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
http://www.ifpma.org/
30 rue de St-Jean
P.O. Box 9
1211 Geneva 18
Switzerland
Tel: 41 22 340 1200
Fax: 41 22 340 1380
For more information contact r.weber@ifpma.org

International Generic Pharmaceutical Alliance
http://www.egagenerics.com/igpa.htm
C/o Canadian Generic Pharmaceutical Association
4120 Yonge Street
Suite 409
Toronto
Ontario
M2P 2B8
Canada
Tel: 1 (416) 223 2333
Fax: 1 (416) 223 2425
For more information contact mailto:info@canadiangenerics.ca

International Pharmaceutical Congress Advisory Association
http://www.ipcaa.org/
IPCAA Secretariat
PO Box 182
Switzerland
CH-4013 Basle
Switzerland
Tel: 41 61 821 3133
Fax: 41 61 821 3144
For more information contact secretariat@ipcaa.org

International Society for Pharmacoepimediology
http://www.pharmacoepi.org/
5272 River Road
Suite 630
Bethesda
MD 20816
United States
Tel: 301-718-6500
Fax: 301-656-0989
For more information contact ISPE@paimgmt.com

International Society of Pharmacoeconomics & Outcome Research
http://www.ispor.org/
3100 Princeton Pike
Building 3
Suite E
Lawrenceville
NJ 08648
United States
Tel: 1-609-219-0773
Fax: 1-609-219-0774
For more information contact info@ispor.org

Japan Pharmaceutical Association
http://www.nichiyaku.or.jp/index_e.html
Nagai House 4F
2-12-15
Shibuya
Shibuya-ku
Tokyo 150-8389
Japan
Tel: 81-3-3406-1171
Fax: 81-3-3406-1499
For more information contact jpa@nichiykau.or.jp

Japan Pharmaceutical Manufacturers Association
http://www.jpma.or.jp
No address provided, Japan
Tel:

Medical Device Manufacturers Association (MDMA)
http://www.medicaldevices.org/
1900 K Street
NW
Suite 300
Washington, D.C.
20006
United Kingdom
Tel: (202) 496-7150
For more information contact mailto:mdmainfo@medicaldevices.org

Medicines and Healthcare Products Regulatory Agency
http://www.mca.gov.uk/
Medicines and Healthcare Products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
United Kingdom
Tel: 44 (0)20-7273 0000
Fax: 44 (0)20-7273 0353
For more information contact mailto:info@mca.gsi.gov.uk

National Association of Pharmaceutical Manufacturers
320 Old Country Road
Garden City
NY 11530-1752
United States
Tel: 1 516 741 3699
Fax: 1 516 741 3696

National Pharmaceutical Association
http://www.npa.co.uk/
National Pharmaceutical Association
Mallinson House
38-42 St. Peter’s Street
St. Albans
Hertfordshire
AL1 3NP
United Kingdom
Tel: 01727 832161
Fax: 01727 840858
For more information contact mailto:npa@npa.co.uk

Network for Senior Executives in Pharmaceuticals and Biotechnology
http://www.nsep.org/
54 Cross Road
Watford
WD19 4DQ
United Kingdom
Tel: 44 (0) 1923 256585
Fax: 44 (0) 1923 256790
For more information contact mailto:info@nsep.org

Nonprescription Drug Manufacturers Association (NDMA)
http://www.ndmainfo.org/
1150 Connecticut Avenue
N.W., Washington D.C.
20036-4193
United States
Tel: 1 202 429 9260
Fax: 1 202 223 6835
For more information contact mailto:mbalterman@***personal email not allowed***

Pharma Arbeitskreis Information & Dokumentation
http://www.paid.de/
Pharma Arbeitskreis Information & Dokumentation, Weismüllerstr. 45, 60314 Frankfurt/Main, Germany
Tel: 0 69 / 40 01 - 25 22
Fax: 0 69 / 40 01 - 12 44
For more information contact mailto:jaroslava.paraskevove@viatris.de

Pharmaceutical Advertising Advisory Board
http://www.paab.ca/index_en.html
Pharmaceutical Advertising Advisory Board, 375 Kingston Rd., Suite 200, Pickering, Ontario, L1V 1A3, Canada
Tel: (905) 509-2275
Fax: (905) 509-2486
For more information contact mailto:info@paab.ca

Pharmaceutical Business Intelligence and Research Group (PBIRG)
http://www.pbirg.com/
Pennsylvannia, , United States, United States
Tel: (215) 337 9301
Fax: (215) 337 9303
For more information contact pbirginfo@pbirg.com

Pharmaceutical Industry Contract Research Alliance
http://www.picra.org
PICRA, United Kingdom
Tel: 44 (0) 24 76639574
For more information contact mailto:andy@basanalytics.co.uk

Pharmaceutical Industry Project Management Group
http://www.pipmg.org.uk/index.html
The PIPMG Office, c/o Browncroft Events Ltd, 9 Maple Court, Grove Park, Maidenhead, SL6 3LW, United Kingdom
Tel: 44 (0)1628 829966
Fax: 44 (0)1628 829974
For more information contact events@browncroft.com

Pharmaceutical Information & Pharmacovigilance Association
http://www.aiopi.org.uk/
PI&PA, PO Box 254, Haslemere, Surrey, GU27 9AF, United Kingdom
Tel: 44 (0)1628 668 493
Fax: 44 (0)1628 604 344
For more information contact aiopi@aiopi.org.uk

Pharmaceutical Management Psychology Association (PsyPhaa)
http://ourworld.compuserve.com/homepages/hrhg/psyphaa.htm
75 Qualitas, Roman Hill, Bracknell, Berks, RG12 7QG, United Kingdom
Tel: 44 (0) 1344 451847
Fax: 44 (0) 1344 451847
For more information contact hughgibbons@psyphaa.com

Pharmaceutical Marketing Society
http://www.pmsociety.org.uk/
PO Box 200, Horsham, West Sussex, RH12 3FA, United Kingdom
Tel: 44 (0) 1403 264 898
Fax: 44 (0) 1403 217 022
For more information contact mailto:vivien@pmsociety.org.uk

Pharmaceutical Research and Manufacturers of America (PhMRA)
http://www.phrma.org/
1100 Fifteenth Street, NW, Washington, DC, 20005, United States
Tel: (202)-835-3400
Fax: (202)-835-3414

Pharmaceutical Sales Managers Group
http://www.psmg.info
PSMG Office, The Loft, 36 Theobald Way, Frimley, Surrey, GU16 9RF, United Kingdom
Tel: 44 (0) 1276 64031
Fax: 44 (0) 1276 64090
For more information contact secretary@psmg.info

Propriety Association of Great Britain (PAGB)
http://www.pagb.co.uk/
Vernon House, Sicilian Avenue, London, WC1A 2QH, United Kingdom
Tel: 44 (0) 20 7242 8331
Fax: 44 (0) 20 7405 7719
For more information contact mailto:info@pagb.co.uk

Regulatory Affairs Professionals Society (RAPS)
http://www.raps.org/
11300 Rockville Pike, Suite 1000, Rockville, MD 209852, United States
Tel: 1 301 770 2920
Fax: 1 301 770 2924
For more information contact raps@raps.org

Royal Pharmaceutical Society of Great Britain
http://www.rpsgb.org.uk/
1 Lambeth High Street, London, SE1 7JN, United Kingdom
Tel: 44 (0) 20 7735 9141
Fax: 44 (0) 20 7735 7629
For more information contact infocentre@rpsgb.org.uk

Society of Pharmaceutical Medicine
http://www.socpharmed.org/
20/22 Queensberry Place, London, SW7 2DZ, United Kingdom
Tel: 44 (0) 207 581 8333 ext 262/2
Fax: 44 (0) 207 589 3606
For more information contact spm@iob.org

Statisticians in the Pharmaceutical Industry (PSI)
http://www.psiweb.org/
Resources for Business, South Park Road, Macclesfield, SK11 6SH, United Kingdom
Tel: 44 (0) 1625 511750
Fax: 44 (0) 1625 267879
For more information contact admin@psiweb.org

The Organisation for Professionals in Regulatory Affairs
http://www.topra.org/Resource.phx/public/start.htx
TOPRA Ltd, Heron Quays, Marsh Wall, London, E14 4JB, United Kingdom
Tel: 44 (0) 207 538 9502
Fax: 44 (0) 207 515 7836
For more information contact mailto:info@topra.org

Lupin’s cholesterol-lowering drug Perindopril recalled in US

2011-04-26T10:51:00.000+05:30

The US Food and Drug Administration (USFDA) has recalled all lots of Lupin Pharma's cholesterol-lowering drug perindopril 2 and 4 mg packs of 100's for "not meeting specifications overtime", according to information on US drug wholesaler Morris & Dickson's website.

Lupin, however, has denied the recall. Perindopril is used in cholesterol reduction and also to treat hypertension and congestive heart failure. In February, Lupin recalled 14,000 bottles of Lisinopril 30 mg tablets from the US market, FDA website said.Cholesterol-lowering drug lisinopril, which is manufactured in the company's Goa facility, is one of its largest selling drugs by revenue. It has a total market size of $45 million. When contacted, the company's spokesperson said: "We received a complaint of one bottle of lisinopril tablets containing one tablet of Lupin's imipramine. As an abundant precaution, we voluntarily recalled the batch." The recall is limited to one batch worth around $15,000. However, analysts said the lisinopril recall is not likely to have any major impact on the company's revenue as it involves only a small batch.

Expiration Dates Matter

2011-04-22T14:16:00.000+05:30

If your medicine has expired, it may not provide the treatment you need. In this Consumer Update video, FDA Pharmacist Ilisa Bernstein explains how expiration dates help determine if medicine is safe to use and will work as intended.

Indian pharmaceutical industry to reach $20 bn by 2015

2011-04-22T14:09:00.002+05:30

Associated Chambers of Commerce and Industry (Assocham) has said it expects the Indian pharmaceutical industry to reach $20 billion by 2015, making it one of the world's top 10 pharmaceuticals markets.

Also, India's clinical trials business is expected to reach approximately USD 1 billion by 2011, further solidifying the subcontinent as one of the world's preferred destinations for clinical trials, Assocham added.

This has increased the need to address all aspects of pharmacovigilance to ensure delivering medical advances to patients, quickly and efficiently while protecting public health.

Pharmacovigilance Summit India will take place from 27-29 June in Mumbai this year with regards to these developments.In July 2010, the Ministry of Health and Family Welfare (MOHFW), India, had launched a road-map for pharmacovigilance in the country under the Pharmacovigilance Programme of India (PvPI).

The goal of this programme has been to provide safer medicines for the Indian population. However, the program is faced with many challenges.

"The sheer number of patients in India is quite sizeable and the issues sometimes conflict between the need to provide access to medicines versus the need to provide safer medicines," National Coordinator PvPI and a key note speaker at Pharmacovigilance Summit India Dr Y K Gupta said.

"The Ministry of Health and Family Welfare, India is planning to address these challenges by allocating a budget head under the MOHFW budget," he added.

International Society of Pharmacovigilance President Dr Alexander Dodoo will present a case study on Africa's experience in developing a robust pharmacovigilance system with limited resources at Pharmacovigilance Summit India.

The event will bring together regional and global experts to create a dialogue with local and international companies on setting up an advanced drug safety system to optimise resources, and ensure quality and regulatory compliance."Looking at India as the future pharmaceutical hub and with regulators embarking on new initiatives to update and expand methodologies to monitor drug safety, this event couldn't come at a better time," IQPC Conference Director Doaa said.

Diet Drug Orlistat Linked to Kidney, Pancreas Injuries

2011-04-15T09:31:00.000+05:30

A review of patients taking the diet drug orlistat over a seven-year period points to a 2% increase in acute kidney injuries within one year of patients starting the drug.
Separately, drug-safety centers demanding to remove both prescription and over-the-counter orlistat from the market, citing new data obtained from FDA adverse-reaction files, including 47 cases of acute pancreatitis and 73 cases of kidney stones. This is the second time Public Citizen has petitioned the FDA to pull the drug from the market.
Orlistat, which is sold as a prescription drug in Ontario (it is sold both by prescription and over the counter, at a lower dose, in the US), has been linked to "oxalate-induced acute kidney injury" in previous case reports. Back in May 2010, the FDA issued a warning about the risks of severe liver injury with orlistat use, based on 13 reports of liver toxicity in which two patients died of liver failure and three required liver transplants.
Two recent reports of renal injuries prompted Ontario investigators to look at the incidence of new reports of acute kidney injuries (acute dialysis or a hospital diagnosis of acute kidney injury) in their province in the year prior to patients filling orlistat prescriptions and in the year after filling them.
Among 953 new orlistat patients identified between January 2002 and March 2008, five patients experienced an acute kidney injury event in the 12 months prior to starting on the diet drug. By contrast, 18 patients experienced an event within 12 months after filling their prescription (p=0.01). As a "test of specificity," Weir et al also tracked upper-gastrointestinal bleeding in the same fashion ("since there is no plausible reason why orlistat would be associated with this outcome") and found no differences in rates of upper-GI bleeds before and after orlistat prescription.

Invention of Effective Nasal Vaccines could be Possible

2011-04-15T09:22:00.002+05:30

It has been reported that there is a possibility of making Nasal Vaccines that accurately protect against flu, pneumonia and even bioterrorism agents such as Yersinia pestis.Dr. Dennis Metzger, from Albany Medical College, explained in a conference how the inclusion of a natural immune chemical with the standard vaccines can boost their protective effect when delivered through the nose.
The respiratory tract is said to be a major entry site for viral and bacterial pathogens with few approved vaccines providing optimal protection against them, due to low immune response at mucosal surfaces such as the nasal passage.However, the combination of standard vaccines for respiratory pathogens with the immune chemical interleukin-12 using an intranasal application to mice has been shown to induce high levels of protection.
During a test done on Vaccines against various respiratory pathogens, it was discovered that Interleukin-12 was a powerful stimulator of the immune response through its interactions with other immune chemicals and the white blood cells that produce them.In addition, Dr. Dennis Metzger, stated that 25% of deaths worldwide and “major killers” are severe respiratory infections, which intranasal vaccination can tackle by inducing immunity in the pulmonary passage.

People With Epilepsy More Prone to Brain Tumors

2011-04-15T09:19:00.000+05:30

People with epileptic seizures are much more likely than others to be diagnosed with a brain tumor, a new study indicates. The findings suggest that epileptic seizures may indicate the presence of a very early-stage tumor or a tumor that hasn't been detected on brain scans, the researchers noted. They looked at data on hospital admissions between 1963 and 2005 and subsequent diagnoses of, or deaths from, brain tumors among those patients. The analysis revealed that people who had a first-ever hospital admission for epileptic seizure were nearly 20 times more likely to develop a brain tumor than people admitted to the hospital for other reasons.

Even when the researchers factored in the possibility that brain tumors might have been missed or not recorded in the first year after admission for epilepsy, the risk was still 7.5 to nine times higher for patients with epileptic seizures.The study also found that people with epilepsy were more than 25 times as likely to develop a cancerous brain tumor and more than 10 times as likely to develop a benign tumor than other patients.

The greatest risk was in epilepsy patients aged 15-44, who were 24 to 38 times more likely to develop a brain tumor than people of the same age without epilepsy.The risk of brain tumor persisted for some years after an initial epilepsy-related hospitalization -- up to a more than sixfold greater risk for as long as 14 years.

Brain tumors are rare, even among those with epilepsy, the researchers noted. The overall risk of a brain tumor in 15-to-44-year-olds, for example, was about 1 percent to 2 percent.

Reasons for Back Pain

2011-04-11T15:29:00.002+05:30