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)

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Year

Number: 37

23rd December 2011

Content Top 10 drugs used in Govt. health care system in Australia Takeda to buy Intellikine for as much as $310 million Deadline to affix barcodes on drugs extended till Jan 2013 Pfizer India takes National Pharmaceutical Pricing Authority to court over Benadryl price cut New Malaria vaccine may protect against P. Falciparum strains Ranbaxy reaches settlement with FDA Novartis terminates Rasilez/Tekturna trial Forthcoming Event

Top 10 drugs used in Govt. health care system in Australia These tables show the top 10 subsidized drugs for the year July 2010 June 2011. Table 1 Table 2 Top 10 drugs by DDD/1000 pop/day * Top 10 drugs by prescription counts Constituent drug 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. atorvastatin irbesartan rosuvastatin perindopril paracetamol ramipril candesartan simvastatin esomeprazole amlodipine PBS/RPBS 82.87 33.02 32.37 29.94 26.88 26.16 25.25 23.90 21.32 19.92 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Drug atorvastatin esomeprazole rosuvastatin paracetamol simvastatin perindopril pantoprazole metformin hydrochloride irbesartan atenolol PBS/RPBS 11 020 969 6 099 877 5 975 902 4 840 331 4 245 616 3 995 257 3 549 374 3 383 078 3 098 162 3 070 515

DDDs in this table include use in combination products * The defined daily dose (DDD)/thousand population/day is a more useful measure of drug utilisation than prescription counts. It shows how many people, in every thousand Australians, are taking the standard dose of a drug every day.

2 Based on date of supply. Does not include private prescriptions or prescriptions under PBS co-payment. PBS Pharmaceutical Benefits Scheme, RPBS Repatriation Pharmaceutical Benefits Scheme The World Health Organization has not allocated a DDD for this drug This combination does not have a DDD allocated Source: Drug Utilisation Sub-Committee (DUSC) Database, as at September 2011. Takeda to buy Intellikine for as much as $310 million Dow Jones Newswires reports Takeda Pharmaceutical Co. Ltd will purchase Intellikine, a company which produces small molecule medications often used for cancer treatments. The deal could bring in around $330 million cash for Intellikine. Takada stated that Intellikine has an investigational medication with promising early stage results and is projected to start a mid-stage trial some time next year. Deadline to affix barcodes on drugs extended till Jan 2013 In a move that will provide relief to drug exporters, the Commerce Ministry today extended the deadline for mandatory barcoding of pharma products meant for overseas markets till January, 2013. (See Public Notification) In June, the Directorate General of Foreign Trade (DGFT) said that from July 2012, medicines exported from India would be required to have barcodes. A barcode is an optical machine-readable representation of data on the product it is attached to and facilitates its tracking. "Earlier, the requirement of affixing barcodes on primary level packaging was to come into effect from July 1, 2012. Now more time is being allowed," DGFT said. The Indian pharmaceutical industry had sought more time to implement the process required for mandatory barcoding as the small-scale pharma firms lack infrastructure. "We are in constant talks with Commerce Ministry in this regard. The implementation is not feasible for small-scale pharma firms because the cost is very high," Pharmaceuticals Export Promotion Council Chairman N R Munjal said. DGFT said the deadline for bar coding on primary packaging -- the material that first envelops the product and is in direct contact with the contents such as ampoule, vial, bottle, cartridge, blisters -is extended till early 2013. For secondary packaging -- intermediate medical packing -- it has been extended till July 1, 2012. Earlier, the set time line was January 1, 2012, it said. DGFT had said exporters will need to affix barcodes entailing unique product identification code, unique serial number of the respective packs, batch number and expiry number. Munjal said the DGFT itself doesn't have the adequate infrastructure to read barcodes. "Only barcoding will not benefit...The DGFT itself must have the central server system that enables the barcode reader," he added. According to experts, the move is not only aimed at improving reputation of the Indian pharma industry in the international market but it also aims at curbing illegal channels of trade. For instance, spurious drugs found in Nigeria in 2009 were

3 labelled 'Made in India' but were finally traced to China. Pharmaceutical companies and exporters have been raising concerns that affixing barcode is "not feasible" and expensive. It cannot resolve the problem of spurious drugs, he added. Pfizer India takes National Pharmaceutical Pricing Authority to court over Benadryl price cut Pfizer India Ltd has taken the drug price regulator to court for reducing the price of a popular cough syrup, Benadryl, a brand it no longer owns. The Indian arm of the $68-billion US company has challenged the National Pharmaceutical Pricing Authority's (NPPA) price notification and penalty notice alleging overcharging, a company spokeswoman said. Benadryl, sold by Pfizer to Johnson and Johnson in 2008, has annual sales of Rs 14 crore, according to pharma market research firm IMS Health India. The brand logged sales of Rs 30 crore in 2007. The NPPA had slashed prices of Benadryl 100 ml to Rs 38.61 four years ago citing "public interest" after its study found that Pfizer had increased the maximum retail price of the medicine by more than the then permissible 20% limit in 12 months. This margin is currently 10%. The Mumbai High Court, which is hearing the case, has scheduled the next hearing on January 17. Benadryl does not fall under the list of drugs whose prices are directly fixed by the government. But under India's drug price monitoring laws, NPPA can force companies to slash their profit margins if they increase more than the 20% (then) in 12 months to ensure that prices of drugs don't go unchecked. Pfizer had filed a review petition contesting the price watchdog's order with the department of pharmaceuticals (DoP), which in turn upheld NPPA's order. Last month, NPPA levied a penalty of Rs 6-7crore on the American company for overcharging consumers. According to Indian laws, companies have to follow the revised price during the pendency of the settlement of the dispute. The Pfizer spokeswoman declined to say which firm would bear the financial liability, but a person close to the development said Pfizer would be accountable for the charges. NPPA has a dismal track record of recovery of overcharged amount, having received just Rs 217 crore of the total demand of Rs 2,357 crore at the end of October 2011 as most of its notices have been challenged and are under litigation. Pfizer share ended at Rs 1,109, up 0.91% on the BSE on Thursday. New Malaria vaccine may protect against P. Falciparum strains The Time "Healthland" blog reports, "British scientists report they have developed an experimental vaccine that shows early potential to neutralize many, perhaps all, strains of the deadliest malaria parasite. Preliminary findings in animal tests of the vaccine found that it stopped every strain of Plasmodium falciparum, the parasite that is responsible for nine out of 10 malaria deaths." The study was published in the journal Nature Communications. BBC News reports that researchers are "to start safety trials in human volunteers." The vaccine is made against PfRh5, a "receptor on the surface of red blood cells," which has been shown to be "crucial to the success of malaria [parasites] in invading blood cells." According to Reuters experts have pointed out that GlaxoSmithKline's previously published vaccine works against liver

4 stages, while this vaccine works against the blood stage, suggesting that the two vaccines are potentially complementary. Ranbaxy reaches settlement with FDA The AP reports that Indian generic drug maker Ranbaxy Laboratories Ltd. "said Tuesday that it has signed a settlement with the US Food and Drug Administration, committing to bolster its product manufacturing practices. The company also said it intends to set aside a provision of $500 million to cover any potential criminal and civil liability stemming from an investigation by the US Department of Justice. Ranbaxy said it has committed to further strengthen its procedures and policies to ensure data integrity and to comply with good manufacturing practices." The Wall Street Journal reports that Japanese drug maker Daiichi Sankyo Co. cut its profit forecast nearly in half and announced executive pay cuts, as it set aside $500 million to resolve a dispute between the FDA and its Ranbaxy subsidiary. The settlement, if approved by a federal court in Maryland, will resolve a ban the FDA placed in 2008 on imports of drugs made at two plants in India due to alleged violations of good-manufacturing rules and other infractions. Reuters adds that Ranbaxy, which had also been accused of falsifying data in drug applications, said that the $500 million reserve provision will be adequate to cover all potential civil and criminal liability in a separate Justice department action. Bloomberg News also reports the story. Novartis terminates Rasilez/Tekturna trial Switzerlands Novartis said today it will end the Rasilez/Tekturna trial on the recommendation of its DMC. Novartis said the DMC concluded that patients were unlikely to benefit from treatment added on top of standard anti-hypertensives, and identified higher adverse events patients receiving the drug combo. Forthcoming Event in

12 International Congress of Ethnopharmacology February 17-19, 2012, Kolkata, India Jointly Organized by: Jadavpur University, Kolkata & International Society of Ethnopharmacology
Venue Science City J.B.S Haldane Avenue, Kolkata www.ise-snpsju.org

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ISE-2012

Inaugurater: His Excellency Dr. A. P. J. Abdul Kalam, former president of India Keynote speaker: Prof. Luc Montagnier, the Nobel laureate in Medicine