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)

th

Year

Number: 10

18th June 2011

Notification GSR 418(E): Prohibition to Manufacture, Sale and distribute the Drug Human Placenta Extract and its formulation, 30-May-2011 CDSCO Letter F. No. 12-01/11-DC (Pt.27): Clarification regarding continued availability of Gatifloxacin Ophthalmic formulations - 03-Jun-2011 Office Order DCG (I)/Misc/2011/: Transfer of certain functions & delegation of powers to Zonal Offices of CDSCO under Rule 22 of Drugs & Cosmetics Rules, 01Jun-2011 Implementation of bar code date extended to 1st October 2011 Vaccinating girls will cut rates of cervical cancer Scientists come up with new molecule that may lead to better drug for TB House cuts FDA's budget ASEAN members sign new action plan to fight Dengue Forthcoming Event

Content

Notification GSR 418(E): Prohibition to Manufacture, Sale and distribute the Drug Human Placenta Extract and its formulation, 30-May-2011 This notification amends item No. (4) of the third paragraph of notification GSR 82(E) (120484) as under: "4 Human Placental Extract and its formulations for human use except its (i) Topical application for wound healing, and (ii) Injection for pelvic inflammatory disease subject to the condition that the manufacturers of Human Placental Extract and its formulations for human use shall maintain meticulous details and traceability of the donors of the Placenta so as to ensure that the Placenta is collected from the donors who are free from HIV, HBsAg, HCV and other viruses." For details www.cdsco.nic.in CDSCO Letter F. No. 12-01/11-DC (Pt.27): Clarification regarding continued availability of Gatifloxacin Ophthalmic formulations - 03-Jun-2011 With this Letter, the Central Drugs Standard Control Organization, Office of Drugs Controller General clarified that Gatifloxacin ophthalmic formulations, like eye drops and ointments which are topical formulations and are not for systemic use, are not covered under the Gazette notification no. GSR 218(E) dated 16-Mar-201. Office Order DCG (I)/Misc/2011/: Transfer of certain functions & delegation of powers to Zonal Offices of CDSCO under Rule 22 of Drugs & Cosmetics Rules, 01Jun-2011 This office order informs that it has been decided to delegate the powers listed below to the zonal officers: 1. No Objection certificates for grant of license to manufacture drugs for the

2 purpose of examination, test or analysis and provided under Rule 89 of the Drugs & Cosmetics Rules (65251). 2. No objection certificate for grant of permissions for manufacture for export only of unapproved/approved new drugs and drugs banned under sanction 26-A of the Drugs &.Cosmetics Act (91230). 3: Permit for import of small quantities of drugs for personal use under Form-12B of the Drugs & Cosmetics Rules. 4. No objection certificates for grant of permissions for import of dual use items, not for medicinal use. Following officers of the respective zone will exercise the powers within the jurisdiction with effective from 20Jun-2011 till further order.

Implementation of bar code date extended to 1 October 2011

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4 Vaccinating girls will cut rates of cervical cancer The first evidence has emerged that Australias nationwide vaccination program for young women against HPV, the virus that triggers cervical cancer, are likely to cut the numbers who get the disease. A study in Australia, one of the first countries to introduce the vaccination, has shown a drop in high-grade cervical abnormalities changes to the cells in the neck of the womb that can be the precursor to cancer. Source: http://pharmalive.com/news/index.cfm?arti cleID=788786&categoryid=9&newsletter= 1 Scientists come up with new molecule that may lead to better drug for TB Scientists at the Tuberculosis Research Centre (TRC) here have hit upon a new molecule with anti-bacterial and anti-viral properties that could potentially lead to a better drug for the treatment of TB and common HIV sub-types. The team at TRC extracted the molecule, Transitmycin, from the marine microorganism Streptomyces sp. isolated from a soil sample off the Rameswaram coral reef. The brominated and pigmented (yellow) antibiotic was found effective during in vitro tests against dormant and active forms of Mycobacterium tuberculosis the pathogen that triggers one of the leading infectious diseases worldwide. For details https://conferences.niaid.nih.gov/TBIndia/ Presentations/Posters/12_Poster_Vanaja_K umar.pdf House cuts FDA's budget The Washington Post reports that on Thursday "House Republicans cut millions of dollars...from the Food and Drug Administration's budget, denying the agency money to implement landmark food safety laws approved by the last Congress." The lawmakers said the cuts "were needed to lower the national deficit" and argued that "the US food supply is 99 percent safe" as is. The House also reduced funding for the USDA's food safety inspection service. Additionally, they barred the FDA from "approving the sale of genetically engineered salmon." The Post states that the "White House opposed many of the cuts, saying they would force the USDA to furlough inspectors at meat and poultry processing plants and leave the FDA unable to meet the requirements of a food safety law passed in December." ASEAN members sign new action plan to fight Dengue Members of the Association of Southeast Asian Nations (ASEAN) on Wednesday as part of an event marking ASEAN Dengue Day signed a new action plan aimed at fighting dengue in the region, the Jakarta Post reports. The Jakarta Call for Action on the Control and Prevention of Dengue "calls upon stakeholders in the region to strengthen regional cooperation on dengue prevention, to combat the disease in sustainable ways, and promote intersectoral collaboration," the newspaper writes (6/15). Forthcoming Event:

Annual General Meeting of IPA, Bengal Branch

26th June, 2011 IPA Auditorium 22 B Panchanontola Road Kolkata-700029 at 5.00 pm