Drug Information Bulletin

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: 06

Number: 30

4th November 2012

Content West Bengal Narcotic Drugs and Psychotropic Substances Rules 1986 amended to improve Access of Morphine for Pain and Palliative care in India Could a Black Mamba be what we have been waiting for? 12th Five year Plan will triple spending on health: Prime Minister New US Generic fees Pfizer to cut 300 Canadian jobs Drug pricing formula: Lawyers differ with Supreme Court Announcement

West Bengal Narcotic Drugs and Psychotropic Substances Rules 1986 amended to improve Access of Morphine for Pain and Palliative care in India West Bengal Narcotic Drugs and Psychotropic Substances Rules 1986 amended vide a notification no. 1013Ex/O/1A-02/12 dated 4th October 2012 by insertion of rule 8A (Details are available at http://www.wbexcise.gov.in/writereaddat a/NDPS120001.pdf ). This amendment has simplified the process of possession, transport, purchase, sale and import inter-state of Morphine or any preparation containing Morphine by Recognized Medical Institution. In order to simplify the multi agency control the responsibility has been given to the Drugs Controller appointed by the state Govt.

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Scientific studies show, that an estimated 4.8 million people suffering from moderate to severe cancer pain do not receive treatment. Similarly, about 1.4 million people suffering from moderate to severe pain at terminal stages of HIV annually, remain untreated. In India, a million people with cancer and an unknown number of people with other incurable and disabling diseases like HIV/AIDS, need opioids for pain relief and only a minute fraction (0.4%) of the population in need of opioids have access to the drugs. Major barriers to gain access to opioids are complicated regulations and problems related to attitude and knowledge among health professionals, regulators, administrators and the public regarding pain relief and opioids. This is a welcome step by the patients and those involved in Palliative care. They are also expecting such further steps to improve access to other Opoids including Methadone.

It may be noted that WHO is also advocating for the same for the last few years. Could a Black Mamba be what we have been waiting for? Currently, opioids form the mainstay of pain management, at least in cancer pain and in post-operative pain. True, opioids are safer than most other currently available analgesics, but still the side effects are a nuisance. May be tomorrow, snake venom may offer us a powerful and safe pain killer, the BBC reports:

Long way to go yet, though. It is early days still, as far as research on the subject is concerned. 12th Five year Plan will triple spending on health: Prime Minister Prime Minister Manmohan Singh on Saturday said the 12th Five Year Plan will enhance spending on health up to three times and that more medical and nursing colleges were needed to overcome a shortage of trained human resources in the sector. Speaking at the foundation stone laying of the Lady Hardinge Medical College project here, the prime minister also said that health indicators reflected a countrys overall well-being. Recognising the need to provide for the complex challenges in the health sector, the allocation for health has been enhanced three times in the 12th Plan as compared with the 11th Plan allocation, he said. He said the government was paying more attention to medical education. In the last three years, the number of MBBS seats in medical colleges rose by over 30 per cent and the seats for post-graduate programmes by 51 per cent. However, the availability of trained human resources remains a challenge. We need to set up more nursing and medical colleges to increase both undergraduate and postgraduate seats in the 12th Plan, he said. The prime minister said that nutrition, drinking water, sanitation, housing and education, particularly of the girl child, were increasingly being underlined as the social determinants of health.

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Black mamba venom is better painkiller than morphine A painkiller as powerful as morphine, but without most of the side-effects, has been found in the deadly venom of the black mamba, say French scientists. The predator, which uses neurotoxins to paralyse and kill small animals, is one of the fastest and most dangerous snakes in Africa. However, tests on mice, reported in the journal Nature, showed its venom also contained a potent painkiller. They admit to being completely baffled about why the mamba would produce it. The researchers looked at venom from 50 species before they found the black mambas pain-killing proteins called mambalgins.

He added that generic drugs would be made available free in all public hospitals across the country to help the poor reduce their out of pocket expenditure on health.
Source: IANS

found at:http://www.fda.gov/ForIndustry/UserF ees/GenericDrugUserFees/ucm319568.ht m 4. Facility fees will be published no later than January 13, 2013. Any person who owns a facility that is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce one or more generic drug finished dosage forms and/or active pharmaceutical ingredients is required to pay facility fees. Additional information about facility fees can be found at:http://www.fda.gov/ForIndustry/UserF ees/GenericDrugUserFees/ucm319566.ht m Please refer to FDAs GDUFA website at: www.fda.gov/gdufa to find additional helpful information and to sign up to receive emails any time new materials become available. Contact information is also listed at this website. European Commission approves use of Tadalafil to treat Enlarged Prostate The AP reports, "The European Union has approved Eli Lilly and Co.'s erectile dysfunction drug Cialis [tadalafil] to treat symptoms tied to an enlarged prostate." The European Commission "approved a 5-milligram, once-daily dose to treat the signs and symptoms of the condition also known as benign prostatic hyperplasia. ... The US Food and Drug Administration approved the expanded use last fall." Pfizer to cut 300 Canadian jobs Page Pfizer is to cut about 300 jobs at several locations in Canada. The amount is

New US Generic fees 1. Backlog Fee: Any original Abbreviated New Drug Application (ANDA) that has not been withdrawn, tentatively approved, or approved by September 28, 2012, is considered pending and is subject to a backlog fee. The backlog fee is $17,434. It is due no later than November 23, 2012. Additional information about backlog fees can be found at: http://www.fda.gov/ForIndustry/UserFees /GenericDrugUserFees/ucm319565.htm 2. Drug Master File (DMF) Fee: DMFs that cover the manufacture of an API (Type II API DMFs) for use in a generic drug application incur fees. The DMF fee is a one-time fee, incurred on first reference of the DMF on or after October 1, 2012. The DMF fee for FY 2013 (October 1, 2012 to September 30, 2013) is $21,340. Additional information about DMF fees can be found at: http://www.fda.gov/ForIndustry/UserFees /GenericDrugUserFees/ucm319567.htm 3. Abbreviated New Drug Application (ANDA) and Prior Approval Supplement (PAS) Fees: The FY 2013 ANDA fee is $51,520; the PAS fee is $25,760. In FY 2013, fees will be incurred at the time of submission for each ANDA and PAS submitted on or after October 1, 2012. However, fees will not be due earlier than November 23, 2012. Additional information about ANDA/PAS fees can be

equivalent to about 11% of the company's total workforce in the country, a spokesperson for Pfizer Canada, JulieCatherine Racine said. The company will cut most of the jobs at its headquarters in the Montreal suburb of Kirkland, Racine said. The decision follows an extensive review of Pfizer's business in Canada, where it employs approximately 2,700 people, she said. Ref. http://www.businessmonitor.com
Drug pricing formula: Lawyers differ with Supreme Court

In its order dated October 11 and October 3, the Supreme Court asked the government not to change the cost-base pricing mechanism for fixing prices. The pharmaceuticals industry is lobbying for market-based pricing, while health activists and NGOs are in favour of costbased pricing, which would sharply reduce the prices of all essential medicines. The Cabinet, which bought time till November 27 from the Supreme Court to present their policy, had sought a legal opinion from its solicitor general on the validity of the Supreme Court order. The Cabinet's brief to the solicitor general covered two points, first being whether the directions of the Supreme Court would be binding on the Cabinet while deciding on the pricing policy, and secondly if it does, what defence will the government have against such a move. The government believes that the judiciary has little role to play in framing policies based on various past judgements. Announcement: IPA Bengal Branch Celebrates 51st NPW Cultural Evening on 2nd December 2012 Bengal Branch members and their family members are requested to enroll their name for performing any cultural event scheduled to be held at Dr. Triguna Sen Memorial Hall, Jadavpur on 2nd December 2012 at 6.00 P M. Contact: Mr. Alok Dasgupta, Chairman- 51st NPW Cultural Programme Sub Committee

The government's top lawyers have said that it is not bound by a recent Supreme Court order asking the government not to tweak the cost-based formula for fixing prices of essential drugs. "The government can keep in mind the directions of the honourable court while determining policy, but the government cannot be restricted in framing policy and issuing delegated legislation through an order under section 3 of the essential commodities act, 1955," Siddharth Luthra, the country's additional solicitor general has said in a note to the cabinet. The opinion could be significant in light of the dispute over the formula for fixing the prices of essential drugs. After 12 long years, the government finally approved a policy last month bringing 348 drugs from the National List of Essential Medicines under price control. It also decided that the prices of these drugs will be fixed by taking weighted average price ( WAP) of all brands having at least 1% or more market share by volume.

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