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: 44

9th February 2013

Content Prior approval of Ethics Committee, Registration at Clinical Trial registry etc. made mandatory by Govt. of India vide GSR 53 (E) dated 1st February 2013 Developing nations unite to fight drug-resistant TB Implementation of pharma policy to be delayed as civil groups plan to move Supreme Court for cost-based pricing USFDA's approval of generic version of Doxil could ease shortage Forthcoming Event

Prior approval of Ethics Committee, Registration at Clinical Trial registry etc. made mandatory by Govt. of India vide GSR 53 (E) dated 1st February 2013 Govt. of India has recently amended Drugs & Cosmetics Rules by inserting a new Rule 122 DAC to streamlining the process of conducting Clinical Trial in India. Important feature of this rule are Prior approval of Ethics Committee, Registration at Clinical Trial registry, submission of Annual status report, mandatory reporting SAE, compentation in case of Death or injury Etc. For details: www.cdsco.nic.in Developing nations unite to fight drug-resistant TB For the first time, five emerging-market nations with extensive infectious-disease problemsBrazil, Russia, India, China and South Africahave agreed to work

together to fight an epidemic of drug resistance in tuberculosis. The pact is the latest indication that the world is awakening to the threat of drugresistant TB, a killer that claims hundreds of thousands of lives annually and which is threatening to become all but incurable, in some instances, with current treatments. The agreement comes as the World Health Organization and other global health experts are acknowledging that the scope of the problem is far beyond what they had foreseen. Agreements like these are only a first step, as it can take years for nations to tame outbreaks of drug-resistant TB strains. "These countries and their governments can and should do more," said Paul Farmer, the physician-activist who co-founded Partners in Health, a Boston nonprofit running health programs in developing countries. Dr. Farmer, who participated in a meeting on drugresistant TB in Beijing last month where

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the new BRICS move was discussed, called the decision by the five nations a positive first step, but one that needs to be followed with specific actions. Over the past year, The Wall Street Journal has chronicled the failure of Indiahome to 2.2 million of the world's 8.7 million TB patientsto address its own epidemic of drug-resistant TB. The Journal revealed that the WHO's own program for combating TB had the unintended consequence of allowing drug-resistant strains to worsen and spread. Nearly 60% of the estimated 310,000 cases of multidrug-resistant TB in 2011 occurred in China, India, and Russia, according to the WHO, which has said that those countries must intensify their efforts in order for the global epidemic to be overcome. Multidrug-resistant TB is a form of the disease that doesn't respond to the two most powerful anti-TB medicines. The communiqu by the five nations comes after a year of dire reports about the worsening of drug-resistant TB globally despite progress in reducing the incidence of regular TB. Early last year, an Indian physician reported seeing patients whose TB had become so resistant that it didn't respond to virtually any of the 12 top medicines used against the disease. In June, a research team in China reported its first national survey of drug resistance, finding that 10% of TB patients had multidrug-resistant strains. With their flourishing economies and emerging middle classes, the five countriesoften collectively referred to as the BRICS nationsare under growing pressure to use more of their own funds to address their health issues, rather than

accept donations from wealthy developed nations such as the U.S. However, treating drug-resistant forms of the disease is much more costly and complicated than treating regular TB. For years, public-health experts feared that treating resistant strains would distract national health programs from fighting regular TB, which is far more prevalent. The BRICS countries sealed their pact after their health ministers met last month in New Delhi as part of a new effort by the five to work more closely together to tackle health problems. The joint plan also calls for the group to cooperate in addressing malaria, mental disorders and tobacco control. "When you consider the very large size of the populations of the BRICS and their large burden of drug-resistant TB, and the fact that they have agreed to collaborate and cooperate, I think it's going to make a huge difference," said Gail H. Cassell, a visiting professor in the department of global health and social medicine at Harvard Medical School and co-chair of the Beijing meeting, which was organized by the U.S. Institute of Medicine and the Chinese Academy of Sciences. The pact could help to raise the profile of a disease that, unlike HIV/AIDS or malaria, has lacked visible leadership that delivers funding, said Rifat Atun, professor of international health management at Imperial College, London. The five countries have substantial expertise in dealing with drug-resistant tuberculosis, he said. "They have the potential to transform this issue from a low-attention subject to a G-20-agenda item," he said.

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The BRICS countries plan to meet in coming months to develop a plan that will be presented at a January 2014 meeting of health ministers, officials said. India, for example, plans to share its experience in disease surveillance, said Jagdish Prasad, director general for health in India. India's system is set up to quickly inform central health officers of an outbreak of serious contagious diseases, such as cholera. "Within a minute of a case being reported anywhere in India, we get informed of it in Delhi," he said. Brazil, which has kept its prevalence of TB low for decades, would share its expertise in technology research and development, said Jarbas Barbosa da Silva Jr., Brazil's secretary of health surveillance. India and Brazil already have a technology transfer program, he said, citing a private Indian lab that is working with a Brazilian state lab to develop a combined form of four TB drugs. "We can leverage our research and know-how," he said. South Africa could share lessons learned in its large-scale deployment of a new device known as GeneXpert, which can diagnose a common form of TB drug resistance in under two hours, said Norbert Ndjeka, who heads the South African health ministry's drug-resistant TB directorate. Deployment of more than 143 machines so far has helped officials detect cases of drug-resistant TB much sooner and get them on treatment, to cut down on undetected spread of the disease, he said.
Source: The Wall Street Journal

move Supreme Court for cost-based pricing Though the new Pharmaceutical Pricing Policy has been notified by the government, the implementation of the same may be delayed further as some public interest groups are planning to join the pending case in the Supreme Court over the matter and press for cost-based pricing. Apart from the All India Drugs Action Network (AIDAN) which has been fighting for the policy over the years, a few other similar-minded organizations also are planning to file affidavit in the Supreme Court where the case may come up for hearing anytime this month. AIDAN had filed the public interest litigation in 2003, prompting the Apex Court to interfere in the case and taking the matter upto this level. The Supreme Court had asked the government to notify the policy before it takes up the matter for hearing. Accordingly, the policy was notified by the Department of Pharmaceuticals in December last year. The case was then scheduled for hearing on January 15, but it was not finally taken up that day and no fresh date was given yet. Even as the Supreme Court is slated to hear the arguments by petitioner AIDAN on the policy in the next hearing, some more groups working in the domain of public health want to join the case. Most of the health activist groups are against this market-based price mechanism and want cost-based pricing instead. That is why some groups are planning to move the Supreme Court, a spokesman of Public Health Foundation of India said. The civil groups will oppose the new

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Implementation of pharma policy to be delayed as civil groups plan to

policy in the court now, and it may delay the implementation of the policy further. The policy caps the prices of 348 essential medicines in all. In each segment of drugs, the simple average of prices of all drugs having a minimum market share of one per cent is set as the limit, the benchmark. But the groups feel that it would lead to rise in prices in many cases. The market-based approach is based on the brand value and not the actual cost of production. Hence, the benchmark price arrived at using this method will be definitely high. If the benchmark price in a particular category is arrived at Rs.60, then brands selling at a lower rate will be automatically hiked to Rs.60, according to Gopal Dabade of AIDAN. According to the analysis made by Jan Swasthya Abhiyan, the prices may go up in many cases. Anti-diabetes metformin can be sold for Rs.14 as per cost based pricing, but according to simple average, the price would be now Rs.35. Likewise, atorvastatin can be made available for Rs.17 but now will be Rs.127 if the price is based on simple average. High blood pressure Atenolol will be sold at Rs.38.50 as per the new pricing, but it could be sold at Rs.8, if the government implements cost-based pricing mechanism, the organization argued.
Source: pharmabiz.com

Sun's product is the first generic version of Doxil, which was approved in 1995 and is used to treat ovarian cancer, AIDSrelated Kaposi's sarcoma, and multiple myeloma. Doxil is made by Johnson & Johnson. Doxil fell into short supply after manufacturing problems at an outside contract manufacturer, Ben Venue Laboratories Inc, a unit of German drugmaker Boehringer Ingelheim, suspended operations in November 2011 due to quality control problems.
For details: MedCityNews.com

Forthcoming Event Workshop on Implementing Successful Stability Operation 2nd March 2013 Organized by: Indian Pharmaceutical Association Bengal Branch In association with Unique Instrument & Machineries, Kolkata For M/S. Newtronic Lifecare Equipment Pvt. Ltd., Mumbai Venue: Hotel Hindusthan International, Kolkata For registration contact: Mr. Pradip Kumar Mallick Hony. Secretary, IPA, Bengal Branch E-mail: ipabengalbranchn@gmail.com Mob.: 09830574612

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USFDA's approval of generic version of Doxil could ease shortage The U.S. Food and Drug Administration said on Monday it approved a version of Doxil, known generically as doxorubicin HCI liposome injection, that is made by Sun Pharma Global FZE, a subsidiary of India's Sun Pharmaceutical Industries Ltd . It will be available in 20 milligram and 50 milligram vials.