Volume: 05

Drug Information Centre (DIC) Indian Pharmaceutical Association, Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Drug Information Bulletin (Electronic)

th

Year

Number: 13

10th July 2011

Content

Details of Samples of drug declared Not of standard quality during the Month of June 2011 by Delhi Drugs control Drugs controller of Rajasthan has declared the list of Not of Standard Quality Drugs during 1.6.11 15.6.11 vide letter No. Dc-2/11/Bulletin dated 17.6.11 Drug scandal exposes French regulators to public ire State drug controller of Punjab suspended Trial of Dronedarone halted over concerns of Heart-Related side effects Forthcoming Events:

Details of Samples of drug declared Not of standard quality during the Month of June 2011 by Delhi Drugs control Sl. Name of No. Batch No. Date of Name of Reason Sampling Manufacturer M/S Zydus Healthcare, NH No. 31A, Majhitar Rangpoo East Sikkim 737132

Drug

&

Remarks

Inspector

Etofylline & Theophylline(Deriphyllin 11-05Retard 300) 2010 B.No. ZHK 1046

Failed with Under Sh. Abhijit respect to Investigation Ghosh test for dissolution

*As per letter No.-No.F.2(24)DTL/L.R./2011/DTL/223/11 on dated: 01-07-2011 Drugs controller of Rajasthan has declared the list of Not of Standard Quality Drugs during 1.6.11 15.6.11 vide letter No. Dc-2/11/Bulletin dated 17.6.11 Sl. No. 1. Name of Drugs Nimesulide Dispersible the B. No. Mfd. by /Exp. Date VBT-9186 M/S. Madhab Sep/2012 tech Pvt. Reason Bio- The sample does not confirm Ltd. to the claim with respect to

2 Tablets (Nimven-MD) Nimesulide & RABTParacetamol 10379 Tablets (Jonim P) 09/13 Diclofenac Sodium & Paracetamol Tablets (Dolopen Plus) Chambaghat (HP) uniformity of Dispersion. The sample does not confirm to the claimas it does not contains Sunset yellow colour. The sample does not confirm to the claim with respect to disintegration. (40 Minutes against 15 minutes prescribed for uncoated Tablets) The sample does not confirm to the claim as it does not contains Sunset yellow colour. The sample does not ccomply with the test for surface active substances and water soluble substances.

2.

3.

4.

5.

Diclofenac Sodium & Paracetamol Tablets (NicgesicK) Absorbant Cotton Wool I.P.,

M/S. Regent Ajanta Biotech, 86-87 Vill. Makhiyali Dundi, Peerpura Road, Roorkee (U.A) PCT-04/12 M/S. Pentachem Pharmaceuticals Chunari Road, Kishanpura, Nalagarh Baddi Highway, NH21 A, P.O.: Gurumajra Solan HP E-575 M/S. Ethics Health 06/12 Care Pvt. Ltd., Jourian Sarkan, Saphera-147001 M/S. Daiwik Cotts 018 Wool, H I-494 (A) M/D RIICO Ind. Area, 08/2010 E/D 3 Jhotwara, Ext. 11, Doongar, years from Sarna the date of Jaipur packing

Drug scandal exposes French regulators to public ire PARIS The scandal over the diabetes drug benfluorex, which is alleged to have caused an estimated 500 to 2,000 deaths from valvular heart disease in France, is on course to trigger a major overhaul of the country's drug and health safety system. A devastating 244-page report on the affair, published last month by the governmental General Inspectorate of Social Affairs (IGAS), accused the pharmaceutical company Servier, headquartered in the suburbs of Paris, of misleading authorities about the true nature of benfluorex, which was sold under the brand name Mediator. Commenting on the IGAS findings, Health Minister Xavier Bertrand of France told reporters at a press conference on 15 January that Servier was the prime culprit

in the debacle but conceded that there were also serious malfunctions in the drug regulatory system. The next day, he said on Europe 1 radio that he and all French health ministers since 1976, when benfluorex first hit the market here, should speak at the parliamentary hearings on the issue, now getting underway. The drug, which was often prescribed as an appetite suppressant to people without diabetes, was withdrawn in France in 2009, several years after other European countries. Servier, France's second largest drug maker, never sought authorization for sale in the US. Inspectors have questioned how benfluorex was kept on the market after studies had established it produced the same dangerous metabolite as an ingredient in the diet drug FenPhen, which

3 was withdrawn from the market in 1997 for causing heart problems. Although benfluorex was taken off France's market two years ago, it was not until pulmonologist Irne Frachon's book Mediator 150 mg was published last June that the issue blew up into a scandal in France. The subsequent campaign to uncover the facts has been led mainly by Grard Bapt, cardiologist and chair of a parliamentary commission of inquiry into the drug, along with the independent monthly medical review journal Prescrire (Prescribe) and Philippe Even, president of the Necker Institute, a Paris-based think tank and funding institute tied to the Necker Medical School. There is now every reason to be optimistic that the French system will be reformed structurally, although there will be opposition from some politicians, the administration and the pharmaceutical industry, says Even. Bapt adds, this is the biggest medical scandal France has ever known. Bertrand promised urgent and radical measures to build a new health safety system so there would not be a new Mediator tomorrow. On 17 January, he said on France Inter radio that a bill would be debated by Parliament before the end of the year. And in June, IGAS will present the government with a second report proposing ways to reform the pharmocovigilance system and the French Health Products Safety Ref. http://www.nature.com/nm/journal/v17/n2 /full/nm0211-144a.html State drug controller of Punjab suspended The Punjab government, on Thursday, suspended the state drug controller following reports of availability of banned drugs in shops outside National Institute of Sports, Patiala. 'The Punjab Health Department suspended Bhag Singh, State Drug Controller with immediate effect,' a spokesman said. 'Bhag Singh has been suspended for negligence of duties,' he added. During suspension, he will report at the Punjab Health System Corporation, Mohali and cannot leave without permission. The health department today began cancellation of licenses of chemist shops for selling banned steroids without prescription to the players of National Institute of Sports. The health department found three shops around NIS Patiala selling banned steroids seven shops' records were not in order. The depatment issued show cause notice to 10 shops. Trial of Dronedarone halted over concerns of Heart-Related side effects The Los Angeles Times "Booster Shots" blog reported that "a trial of the drug Multaq [dronedarone], used to treat abnormal heart rhythm, has been halted over concerns of other heart-related side effects, drug maker Sanofi announced." The study, called PALLAS, "was testing Multaq's usefulness in patients with permanent atrial fibrillation (more than 6 months of the abnormal rhythms)." Reuters reports that the drugmaker had decided to halt the study when a safety monitor reported a "significant increase in cardiovascular events" among study participants who had been given Multaq. HeartWire reported that "details of just what those events are have not been released. In both arms of the trial, patients were also receiving antithrombotic and rate-control medications."

Forthcoming Events: