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: 25

2nd October 2010

Last date for recommendation for A.P.C.Ray Memorial Gold Medal Award extended Novartis to Pay $422.5 Million for Off-Label Marketing MHRA Inspectors Will Look for Risk Registers, SOPs and Periodic Review in Quality Risk Management Systems

Content

UK to Revise Drug Prices to Align Them With Value For Patients More Patients Gaining Access to HIV/AIDS Interventions IMA won't endorse products against MCI norms Readers Column

Last date for recommendation for Acharya P. C. Ray Gold Medal Award, 2010 extended up to 25th October 2010
The Indian Pharmaceutical Association, Bengal Branch gives annually Gold Medal on the occasion of celebration of National Pharmacy Week during 3rd week of November of each year to perpetuate the memory of great national figure Acharya P. C. Ray, the pioneer designer of Pharmaceutical Industry in our country since 1962. IPA, Bengal Branch Council selects the awardee amongst the Pharmaceutical scientists, teachers, pharma regulators, hospital Pharmacists, administrators, etc. for outstanding contribution in their respective field and for overall development of the profession of pharmacy. Any member of IPA can recommend names of the persons with their detailed Bio-data for 2010 award, which may be sent by 25th October 2010 to: The Hony. Secretary, Indian Pharmaceutical Association, Bengal Branch, 22 B Panchanontola Road, Kolkata 700029 E-mail: ipabengalbranchn@gmail.com N.B.: Biodata should include the following points1. Qualification. 2. Experiences in the selected field. 3. Achievements in advancement of sciences/Administration/relevant field. 4. a. Whether member of IPA? If yes, how many years? b. Whether member of allied pharmaceutical profession other than IPA? If yes, how many years? 5. Services rendered (in years) on the executive Council of IPA Centre or any of its Branches in the capacity as: a. President/Vice President/Hony. Secretary/Treasurer/Editor of Official Publication of IPA. b. Executive Council Member. 6. Recognition/Award received from other professional organizations including industry/trade associations. 7. Award/Recognition/Honour received from international/national Govt. authorities or prestigious institution/organization by way of award or membership of their constituted body/committee other than sl. No. 6 above. 8. Performance in growth/ improvement of any of the field of pharmacy and shown creditable leadership in the chosen field. 9. Involvement and outstanding achievements in professional development in national/international arena. 10. Notable achievements in any other field or profession excluding pharmacy for which the nominee is nominated for the award including social welfare activities with Govt. and Non Govt. organizations.

Novartis to Pay $422.5 Million for OffLabel Marketing Switzerland's Novartis has agreed to pay $422.5 million in civil and criminal fines for promoting drugs for uses that had not been approved by the FDA, the U.S. DOJ announced yesterday. Under the settlement, which requires approval by federal court in Philadelphia, Novartis agreed to plead guilty and pay a criminal fine of $185 million for offlabel marketing of the antiepileptic drug Trileptal.It also will pay $237.5 million in civil penalties for off-label marketing of that drug and for offering financial inducements for doctors to prescribe Trileptal and five other Novartis medicines -- Diovan, Exforge, Tekturna, Zelnorm, and Sandostatin. The "kickbacks" included payments for speaker programs, advisory board memberships, entertainment, travel, and meals to encourage doctors to prescribe the drugs.
Source: Pharmalive.com

defines how the firms QRM system operates and includes a periodic review. The SOP should include scope, responsibilities, controls, approvals, management systems, applicability and exclusions. MHRA expects risk mitigation plans to be identified and implemented where any risk to patient safety is possible, and notes that the degree of risk tolerated depends on the circumstances, proximity to the patient, and other controls in place prior to product use by the patient.
Courtesy: Mr. Kaushik Desai

UK to Revise Drug Prices to Align Them With Value For Patients. The Financial Times reports that the UK government is going to move forward with a plan to revise its drug prices so they are more aligned with the value they provide for patients. Andrew Lansley, the health secretary, said, "We need a system that encourages the development of breakthrough drugs addressing areas of significant unmet need...I am determined that not only will we have a reimbursement price for medicines which reflects their benefit to patients, but one which incentives for innovation." The Times notes that this announcement comes as the government crafts a consultation document due later in 2010 on drug pricing, as well as a document on a new fund for cancer drugs. More Patients Gaining HIV/AIDS Interventions. Access to

MHRA Inspectors Will Look for Risk Registers, SOPs and Periodic Review in Quality Risk Management Systems British inspectors when inspecting drug manufacturers will be looking for a risk register and a defined document management control system including periodic reviews of risk management assessments, according to a frequently asked questions (FAQ) document recentlypublished by the UKs Medicines and Healthcare products Regulatory Agency (MHRA). The FAQ is comprised of a set of 16 probing questions into how the EU will be evaluating and enforcing quality risk management (QRM) under the new QbD/ICH Q8-10 regulatory paradigm. The FAQ states that drug firms should embody quality risk management as per the EU GMPs Chapter 1. This includes having a standard operating procedure (SOP) in place that is integrated with the quality system,

The Washington Post "The Checkup" blog reported, "There's some encouraging news out about the" global fight against HIV/AIDS:

3 expanded access to treatment. A report released by WHO, the United Nations Children's Fund and the Joint United Nations Program on HIV/AIDS reveals that the "number of people who got access to treatment for the AIDS virus rose to 5.2 million in 2009." It's an "increase of more than 1.2 million from 2008, the largest increase yet in any single year, and means 36 percent of those who need the drugs are getting them, the report said." Taking a closer look, the data indicate that 14 "countries, including Brazil, Namibia and Ukraine, provided HIV treatment to more than 80 percent of their HIV-positive children in need," the AP (9/29) reports. In addition, eight countries -- Botswana, Cuba, Guyana, Cambodia, Croatia, Oman, Romania, and Rwanda -- "provided HIV treatment to more than 80 percent of adults in need," while "another 21 countries are getting close to that treatment target." Zimbabwe has also "increased access by 50% in the past year -- despite being heavily compromised, politically and economically," BBC News reports. "South Africa has had an incredible catch-up phase, despite being a late starter," and altogether, "just over half of pregnant women who tested positive for HIV were assessed for drug treatment -- up from 34% the previous year." These gains are being applauded and called "hard-won," but the report "also makes clear how much work remains to be done." In fact, "despite accelerating progress, the report covering 183 nations underlined that only one-third of those in need worldwide have access to life-saving anti-retroviral drugs," AFP reports. Indeed, "some 5.2 million people received such treatment last year in low to middle income countries, the key battleground for the fight against the near three decades old pandemic with the highest burden of the disease," but "another 10 million people approximately did not have such treatment in those countries." The authors of the "Towards Universal Access" report "also estimated that most people with HIV were still unaware that they were infected -- about 60 percent of people in low and middle income countries." What's more, the report "warns that the economic crisis could imperil even these treatment gains if investments in the global fight from poor and rich countries alike falter," the UK's Press Association reports. "'It's an important moment. We need to sustain the momentum,' WHO's Aids director, Dr Gottfried Hirnschall, said." The United Nations had set 2010 targets regarding universal access to treatment, care, and prevention, according to the Financial Times. The organization says that some $26 billion dollars will be needed to support the programs aiming to hit the target set for 2015. IMA won't endorse products against MCI norms Bringing a two-year tussle to an end, the Indian Medical Association (IMA) has decided that it will not endorse any products as that would be against the Medical Council of India's (MCI) regulations. The decision comes soon after the MCI's ethics committee issued a show cause notice to the IMA for endorsing products like Tropicana juices and Quaker Oats. The ethics

4 committee, which met a couple of days back, decided to issue a show cause notice and has sought a reply by September 1. Dr Dharam Prakash, secretary general of the IMA, when contacted, confirmed that they had received the show cause notice and said the IMA was preparing the reply. "We have not endorsed any product in the last two years, 2009 and 2010. And whatever endorsements were done before that, will be coming to an end in 2011. Some of the MoUs for endorsements have lapsed and we have not renewed them. We have also written to the companies that we will not be continuing the endorsement. As a policy, IMA has decided that we will not be doing any more endorsements," said Dr Dharam Prakash. However, he said that commitments IMA had made before the law against endorsements came into force in December 2009 will have to be completed. "We are trying to get out of it, but we can't just shrug out of commitments made as an organization," added Dr Dharam Prakash. Dr K V Babu of Payyanur in Kerala had objected to the endorsements by IMA. He had filed a complaint as far back as June 2008 on the grounds that it was against MCI's own code of ethics for any professional body of doctors to endorse any product. However, no action has been taken so far despite even the NHRC, on a complaint from Dr Babu, seeking appropriate action on the issue. In November 2008, the Central Working Committee of the IMA had approved the MoU signed with Pepsi to endorse Quaker Oats and Tropicana juices and the MoU with Dabur to endorse its Odomos cream, gel and lotions. The endorsements, to be in operation till March 2011, brought in Rs 2.25 crore for the IMA. When contacted, Dr Babu said that he was happy that his two-year long fight against his own community had finally borne fruit. However, he did not agree with the IMA's decision to continue commitments that extend till 2011. "Endorsement is clearly against the code of ethics. Nobody should be given a safe passage to continue the endorsement. Once a law has been enacted, it has to be implemented at all cost. Hence, the endorsement should be cancelled with immediate effect instead of waiting till 2011," said Dr Babu.
Source: The Times of India 26th August 2010

Readers Column: Dear Dr. S C Mandal, It will be highly appreciated if you please send the DRUG INFORMATION BELLETIN to my Dhaka University colleagues regularly, published by Drug Information Center, Indian Pharmaceutical Association, Bengal Branch, Kolkata. Thank you very much. Dr. Sitesh C Bachar Professor Department of Pharmaceutical Technology Faculty of Pharmacy University of Dhaka. Bangladesh.
Note: Dr. Bachars Colleagues are receiving this Bulletin from this issue.

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