Drug Information Bulletin (electronic)

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 Volume: 3 Number: 45

Indian Congress of Pharmacy & Pharmaceutical Sciences 2010 and Indian Pharmaceutical Association Convention -2010 13th & 14th March 2010
Venue Sri Ramchandra University No. 1 Ramchandra Nagar, Porur, Chennai 600116 Contact: http://www.ipapharma.org/events/Pharma_Times_IPA_Brochure.pdf

IPA-RAD-AAPS workshop on Stability Testing for Global Submission 12th & 13th March 2010 Venue
Sri Ramchandra University No. 1 Ramchandra Nagar, Porur, Chennai 600116 Contact: http://www.ipapharma.org/even ts/Pharma_Times_IPA_Brochure .pdf

IPA-CPA workshop on Pharmacists preparing to face Challenges in HIV/AIDS, TB & MCH 12th & 13th March 2010 Venue
Sri Ramchandra University No. 1 Ramchandra Nagar, Porur, Chennai 600116 Contact: http://www.ipapharma.org/events/ Pharma_Times_IPA_Brochure.pdf

Morphine laws leave millions in pain The PPSG wishes to share this story by Hannah Gardner about pain relief in India. Progress has been made in some Indian states and medical institutions to improve patient access to palliative care and oral morphine. However, great unmet needs remain and will not be satisfied until there is a nationwide expansion of palliative care and a truly national reform of the regulatory framework for opioid analgesics. For additional information about opioid trends and the work in India, please visit the Country Profile for India at http://www.painpolicy.wisc.edu/internat/SE ARO/India/index.htm. Study: Docs oppose DTC for Drugs Treat Mental Disorders The majority of physicians think drug companies should not be allowed to advertise medications that treat mental illnesses on television, according to a new study. The study also addresses the proposed changes to the Diagnostic and Statistical Manual of Mental Disorders by the American Psychiatric Association. The study says "the majority of physicians (54%) reported that the proposed changes would have a positive impact on the diagnosis and treatment of mental illness." Technology may allow vaccines to be preserved without refrigeration The Time Wellness blog reported that "new technology, developed by British firm Nova Bio-Pharma Technologies and tested at Oxford University, may represent a sea change in vaccine preservation -minimizing the need for long-term storage in refrigerators or freezers, and improving access and global health as a result." The study, published this week in the journal Science Translational Medicine, found that

"the technology, which utilizes special membranes stabilized with a sugar compound, was shown to preserve two different types of virus-based vaccines for four months at a temperature" of 113 degrees Fahrenheit or 45 degrees Celsius "with no degradation." Reuters notes that the researchers also found the vaccines could be stored for a year or more at 37 degrees Celsius with only minimal losses of vaccine. Brazil Set to Announce List of US Goods for Sanctions, Takes First Step to Cross-Retaliate Brazil has announced that on 1 March it will release a substantive list of retaliatory duties to be imposed on US goods. The retaliation results from a dispute between the United States and Brazil over the subsidies that the US provides its cotton farmers. A WTO panel ruled in August that Brazil should be allowed to impose retaliatory duties on US$830 million worth of trade with the United States. That ruling came on the heels of a 2008 Appellate Body decision that concluded that US cotton subsidies contravene WTO rules. But the subsidies remain in place, thanks in large part to the US agriculture lobby, which wields significant influence on Capitol Hill. What Brazil is doing is to take all the internal steps necessary to apply these sanctions, said Brazilian Foreign Minister Celso Amorim. We prefer a noncontentious path but we cannot bow down just because another country is stronger. The idea is not to retaliate but we need a specific policy proposal, added Amorim. Of the US$830 million worth of trade that Brazil can sanction, US$560 million will be detailed in the list of goods to be released

in March. The other US$270 million will be applied in the form of cross- retaliation measures, which would target services as well as intellectual property rights (IPRs). Leading US trade associations are calling on the White House to intensify efforts to reach a negotiated solution. In separate letters to the administration and Congress, dated 28 January and 4 February respectively, these groups urged engagement with the Brazilian government and for the US to act swiftly to present alternatives in order to avoid retaliation. Brazils leading industrial sectors have also favoured a negotiated compromise and have expressed concerns that they might lose their American suppliers and be forced to import at a higher price from other nations, given that the United States is the largest source of Brazils imports. Cross-retaliation, which is allowed under WTO rules, can be a powerful retaliatory tool. By restricting or suspending IPRs, a relatively small country can inflict economic damage upon a larger country without making its consumers suffer from higher prices. In a recent ICTSD publication, Professor Frederick Abbott of Florida State University College of Law addressed the multiple complex practical and legal questions raised in the context of designing and implementing a cross-retaliation programme. On 11 February Brazils president, Luiz Incio Lula da Silva, approved legislation that allows the suspension and limitation of the IP rights of citizens or companies domiciled in countries that violate WTO rules. The legislation, which effectively enables cross- retaliation, comprised the following measures: (a) suspension and limitation of IP rights; (b) alteration of the rules and procedures that secure IP protection, mainly provided by the Brazilian Patent Office and the Ministry of Agricultural for plant variety; (c) alteration

3 of the measures to apply IP rights; (d) temporary prohibition of royalty remittances from licensing and technology transfer and (e) additional tax application to remuneration of IP owners. However, additional administrative action is still needed before Brazil can be in a position to effectively implement the crossretaliation. If Brazil follows through with the duties on IP rights and services, many believe that the measures would target the economically and politically strong US pharmaceutical industry. By suspending or breaching the IP rights of pharmaceutical companies, Brazil would be able to seize royalty payments or even produce cheaper generic versions of the targeted drugs. Jose Gomes Temporao, Health Minister of Brazil, has compiled a list of medicines that could face retaliation. However, he cautioned that a decision must be made, slowly, by the entire government. The threat of cross-retaliation is not new to international trade disputes. Crossretaliation has been authorized twice before: once between Ecuador and the EU and again between Antigua and the United States. However, the Brazilian cotton case may be the first time that cross-retaliation will be put into action. Brazilian officials claim that the United States seems unwilling to address Brazilian grievances at the heart of the dispute, despite public statements by US Trade Representative Ron Kirk that he is interested in avoiding Brazilian retaliation.

ICTSD reporting; WTO Panel Allows Brazil to Cross-Retaliate on IP, Services in US Cotton Row, ICTSD, 9 September 2009. Brazil to Announce Trade Sanctions List Against U.S. March 1 MARKET NEWS INTERNATIONAL, 10 February

2010. Lula Sets Law for Brazil to Retaliate on U.S. Patents, BLOOMBERG, 11 February 2010.
** Copied for fair use from Bridges Weekly Trade News Digest th Volume 14 Number 6 17 February 2010

4 6.8.1 In dealing with Pharmaceutical and allied health sector industry, a medical practitioner shall follow and adhere to the stipulations given below:a) Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied health care industry and their sales people or representatives. b) Travel facilities: A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship , cruise tickets, paid vacations etc. from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME programme etc as a delegate. c) Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext. d) Cash or monetary grants: A medical practitioner shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext. Funding for medical research, study etc. can only be received through approved institutions by modalities laid down by law / rules / guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed. e) Medical Research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfillment of the following items (i) to (vii) will be an imperative for undertaking any research assignment / project funded by industry - for being proper and ethical. Thus, in accepting such a position a medical practitioner shall:(i) Ensure that the particular research

MEDICAL COUNCIL OF INDIA AMENDMENT NOTIFICATION New Delhi, the 10th December, 2009 No.MCI-211(1)/2009(Ethics)/55667 - In exercise of the powers conferred by Section 33 of the Indian Medical Council Act, 1956 (102 of 1956), the Medical Council of India with the previous sanction of the Central Government, hereby makes the following Regulations to amend the "Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002:1. (i) These Regulations may be called the "Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009 Part-I". (ii) They shall come into force from the date of their publication in the Official Gazette. 2. In the "Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002", the following additions/modifications/deletions/ substitutions, shall be, as indicated therein: 3 The following clause shall be added after clause 6.7:-

"6.8 Code of conduct for doctors and professional association of doctors in their relationship with pharmaceutical and allied health sector industry.

proposal(s) has the due permission from the competent concerned authorities. (ii) Ensure that such a research project(s) has the clearance of national/ state / institutional ethics committees / bodies. (iii) Ensure that it fulfils all the legal requirements prescribed for medical research. (iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself. (v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research project(s). (vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way. (vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document / agreement for any such assignment. f) Maintaining Professional Autonomy: In dealing with pharmaceutical and allied healthcare industry a medical practitioner shall always ensure that there shall never be any compromise either with his / her own professional autonomy and / or with the autonomy and freedom of the medical institution. g) Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities, as consultants, as researchers, as treating doctors or in any other professional capacity. In doing so, a medical practitioner shall always:

5 (i) Ensure that his professional integrity and freedom are maintained. (ii) Ensure that patients interest are not compromised in any way. (iii) Ensure that such affiliations are within the law. (iv) Ensure that such affiliations / employments are fully transparent and disclosed. h) Endorsement: A medical practitioner shall not endorse any drug or product of the industry publically. Any study conducted on the efficacy or otherwise of such products shall be presented to and / or through appropriate scientific bodies or published in appropriate scientific journals in a proper way". (Lt. Col. (Retd.) Dr. A.R.N. Setalvad) Secretary Medical Council of India Foot Note: The Principal Regulations namely, "Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002" were published in Part - III, Section (4) of the Gazette of India on the 6th April, 2002, and amended vide MCI notification dated 22/02/2003 & 26/05/2004.

National Workshop held at Kolkata during 19th-20th February 2010 National workshop on Towards a Pharmaceutical Policy in India in the changed Perspective Organized by: CDMU in collaboration with HAI-AP & JSA