Drug Information Bulletin (Electronic)

Volume: 4

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

Number: 23

19th September 2010

Content Report: Medical Device Industry to See "Strongest Growth." Eliminating Drug Company Reps, Free Samples May Modestly Reduce Prescribing Of Promoted Drugs AIIMS, WHO launch national initiative on patient safety Violation of price ceiling is rampant event in the 74 drugs Prevent Gelatin Crosslinking with Excipient P Violation of price ceiling is rampant event in the 74 drugs Forthcoming Events Situation vacant Readers Column gross domestic product during the same period." Eliminating Drug Company Reps, Free Samples May Modestly Reduce Prescribing Of Promoted Drugs. Med Page Today reported that a singlecenter study shows that banishing drug company representatives and "eliminating free samples leads to modest reductions in the prescribing of heavily promoted drugs." The study of Oregon-based Madras Medical Group, reported in the Annals of Family Medicine, found "that aggregate levels of brand-name drug use didn't change significantly after policy implementation,

Report: Medical Device Industry to See "Strongest Growth." The Orange County Business Journal reports that "as Americans grow older and live longer, there will be greater public and private spending on healthcare, which should allow hospitals and other providers to upgrade their equipment" which will make the medical device industry an area with "strongest growth" potential. A report by Ibis World "projects device industry revenue to grow at an average annualized rate of 4.8% to $50.7 billion from now until 2015, outpacing the expected 1.8% growth rate on average for the country's

2 although it did vary across classes." In addition, "there was a trend toward reduced prescribing of branded antihypertensive and lipid-lowering drugs, but it was not significant, while branded drugs prescribed for respiratory disease declined significantly, by 11.34%, compared with the control group." AIIMS, WHO launch national initiative on patient safety All India Institute of Medical Sciences (AIIMS) has taken the lead to launch a national initiative to improve the patient safety, taking forward the 'WHO- global patient safety challenge' further in the country. The National Initiative on Patient Safety (NIPS), taken in collaboration with WHO and INCLEN Trust, got off with a threeday workshop, the first of a series of events, in Delhi on Thursday with the Union health minister inaugurating it. Superintendents and nursing officers from various medical colleges and hospitals across India are attending the event. Once properly trained, these experts will act as force multipliers in improving the level of knowledge and practice of patient safety throughout the country. The initiative proposes to cover over 60 healthcare institutions across India in the next two years with 10 15 institutions being covered in each workshop. Patient safety is one of the main health care challenges faced by India. There are so many incidents of medical negligence happening in the country, which are usually swept under the carpet. The programme has at its core a participatory mode of learning whereby one on one interaction is encouraged between the resource persons and the participating teams. The USP of the programme is the inbuilt replicability by others in the field of healthcare delivery, according to Dr Shakti Kumar Gupta of AIIMS. World Health Organization has estimated that almost 10 per cent of patients get admitted in hospitals in developed countries suffer from unsafe healthcare practices followed in hospitals even with excellent facilities. Annually, millions of patients thus suffer from disabling injuries or death due to unsafe medical care and hospital acquired infections throughout the world. Hospital-acquired infections are usually related to procedures or treatments used to diagnose or treat the patient's initial illness or injury, the organizers said. Patient safety is a new healthcare discipline that emphasizes the reporting, analysis, and prevention of medical error that often lead to adverse healthcare events. The frequency and magnitude of avoidable adverse patient events was not well known until the 1990s, when multiple countries reported staggering numbers of patients harmed and killed by medical errors. Recognizing that healthcare errors impact 1 in every 10 patients around the world, the World Health Organization calls patient safety an endemic concern, said Dr Gupta who is the programme director.
Source: Pharmabiz.com

Violation of price ceiling is rampant event in the 74 drugs

3 The issues regarding drug prices are horrific. In a report tabled in Parliament on 4 August 2010, the parliamentary standing committee on health and family welfare has suggested drastic measures like increasing the number of drugs under price control, a blanket cap on profit margins of all medicines and promoting the use of generic drugs to make medicines more affordable. We know that healthcare in India is in a mess. But, while the public is somewhat aware of the problems of health insurance (insurers are losing money, thanks to over-billing and exorbitant charges by some hospitals), hardly anything is known about drug price abuse. According to the parliamentary standing committee on health and family welfare report of 4 August 2010, medicines constitute 40%-80% of insurance claims. On detailed investigation, we found that there is an enormous difference in the price of the same drug, branded differently by each pharmaceutical company and consumers are completely unaware of it. Doctors and hospitals end up dictating what you pay-they can prescribe an expensive or cheaper drug with the same efficacy. So clearly, there is a good case for insurers demanding price control or parity to reduce claim costs. This is not easy; but it is not impossible either-the urgent need is for customer awareness and the political will to make the healthcare industry healthier.
Source: DrugsControl.org

well as destabilize emulsions thus promoting gelatin cross-linking in both soft gelatin and hard gelatin. The purity achieved by Crodas proprietary Super Refining process has provided the pharmaceutical formulator the highest quality option for maintaining the integrity of gelatin capsules and Active Pharmaceutical Ingredient chemical profile, stability and performance. Gelatin cross-linking studies have been conducted showing the purity benefits of Super Refined PEG 400 and Super Refined Sesame Oil as compared to their standard pharmaceutical grade counterparts. It was shown that the high purity sesame oil showed a faster disintegration time than the standard material at 2 and 6 months by up to 2.5 minutes while it was shown that the high purity PEG 400 showed faster disintegration time than the standard material at 1, 2, 3 and 6 months. In another study conducted only on Super Refined PEG 400, it was again shown that the chromatographically purified PEG 400 prevented the gelatin from crosslinking while the impurities in the standard pharmaceutical grade PEG 400 caused the gelatin to crosslink and form a precipitate that was seen upon centrifugation (spun at 10,000 rpm). DCGI proposed to introduce Mobile Drug Testing Laboratories The Drugs Controller General of India (DCGI) Dr Surinder Singh said they are mulling to introduce mobile drug testing vans as part of their drug testing methodologies. He said they are in touch with their counterparts in the USA-the USFDA, and would soon launch a pilot project. According to him currently, about

Prevent Gelatin Crosslinking with Excipient Purity Excipient impurities have been shown to accelerate the degradation of APIs as

4 40,000 drug samples from across the country are collected for verification. The DCGI is targeting to increase this to about two lakh by next year. "Drugs that were sold in pharmacies and manufacturing sites would be considered as part of the random testing procedures. Within minutes we will get to know the drug analysis," Singh told media persons on the sidelines of national seminar on 'Indian Pharma Industry- Challenges and Opportunities.' He said as far as India is concerned spurious drugs were not much of a concern, however standard and quality of drugs is. "Of the 40,000 drugs tested, spurious drug comprise a mere 0.01 per cent. But about 5-6 per cent of these drugs are those that do not have standard quality and that's a significant challenge," he said. The Drug controller would issue guidelines for regulation of clinical trials ethics committee and lay down norms for sites where clinical trials would be conducted. "We want to establish a robust and dynamic mechanism for clinical trials. Soon, we will be dividing the country into zones to conduct audits of all sites where trials would be conducted," Singh said. Currently, only 1-2 per cent of the global clinical trials are done in India as opposed to the US, which takes up more than 50 per cent trials. The DCGI said it would initiate overseas inspection of drugs in countries including China and Europe early next year. It was awaiting approval from the Union Government that would allow it to conduct audits and certify the manufacturing quality of the pharmaceutical products, it said. Currently, India imports about 12,00013,000 crore drugs, of which 60-70 per cent are from China. Forthcoming Events: International Training Course on Promoting Rational Use of Drugs in the Community Institute of Health Management Research, Jaipur, India February 27 to March 10, 2011 For further details contact Jawahar S. Bapna MD, PhD prudc.india@gmail.com Situation Vacant: Technical Data Associate/Data Entry Operators and Office Assistants for CDSCO Last Date: 20.09.2010 For details: www.cdsco.nic.in Readers Column: Respected Sir,

I am Nabanita Chatterjee, I am a M. Pharm. (Pharmacology) student in W.B.U.T... Sir I am wanted your drug information bulletin... I am highly obliged if you kindly help me on this regards. Yours faithfully Nabanita Chatterjee, CIPT, Uluberia

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