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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: 38
Content

29th December 2012

FDA expands Oseltamivir indication to treat Infants Madras HC dismisses petition against barcoding paves way for its implementation Top Pharma regulatory stories of 2012 Govt to crack down on pharma-doctor nexus common side effects were vomiting and diarrhea." Madras HC dismisses petition against barcoding paves way for its implementation The Madras High Court has dismissed the industry's petition against the implementation of barcode on pharma exports, clearing the legal hurdle in the way of implementation of barcoding for all pharma exports by the commerce ministry from January 1, 2013. Delivering its much awaited final judgement in the case, which has been pending for the last more than one year, the court on December 21 said that it accepted the government's argument for the implementing the barcode on pharma packs for exports for maintaining quality. The court did not accept the industry's argument on cost aspects on implementing barcode as it said that no cost is too much when it relates to quality. Page However, the full details of the judgement is yet to come as the court has gone on

FDA expands Oseltamivir indication to treat Infants It has been reported that the US Food and Drug Administration announced Friday that it has approved the expanded use of Roche's Tamiflu (oseltamivir) to treat children as young as 2-weeks old who have exhibited symptoms of influenza for no longer than two days. However, the treatment is not approved a flu preventive for this age group, the FDA said. The agency already approved Tamiflu to prevent flu in adults and children ages 1 year and older. FDA said the "age range was expanded based on the extrapolation of data from studies of older children and adults -which is allowed under the Pediatric Research Equity Act of 2003 -- and on safety and pharmacokinetic studies conducted by Roche, which makes oseltamivir, and the NIH." The data showed "a safety profile in the younger age group that was similar to that seen in older children and adults. The most

10-day Christmas recess from December 22. Meanwhile, sources from the union commerce ministry said that the ministry may further extend the date of implementation of bar code to April 1, 2013, keeping in view the technical difficulties involved in the implementation of bar coding for which the industry is not yet fully prepared. The court order is a big setback for the industry as it has been banking on the court to dismiss the commerce ministry's attempt to implement barcoding, which the industry termed as impracticable, both economically as well as logistically. The barcoding issue dates back to January 10, 2011 when the commerce ministry issued a notification as per which bar coding was to be enforced in phased manner in the country for tertiary packaging from October 1, 2011, for secondary packaging from January 1, 2012 and for primary packaging from July 1, 2012. But, there was stiff resistance from the industry to the commerce ministry's decision. Ever since the ministry rolled out its plans, the industry has literally been on warpath against the ministry's decision. When its repeated pleas to defer the barcode implementation fell on the deaf ears of the officials of the commerce ministry, the industry moved Madras high court on December 19, 2011, and the court stayed the second phase of barcode implementation. The court was jointly moved by Confederation of Indian Pharmaceutical Industry (CIPI) and Indian Drug Manufacturers' Association. Ref. Pharmabiz.com

Top Pharma regulatory stories of 2012 One of the impacts of globalisation is that drugmakers that want to sell products in multiple markets must comply with multiple sets of regulations, covering everything from drug discovery and development to manufacture and distribution.Here is inPharmatechnologist.com's roundup of some of the best read regulatory news stories to feature on our site in 2012. ACCESS FULL STORIES Use of subcontractors a strain on GCP compliance, EMA says The EMA has warned sponsors must take "great care" when outsourcing to niche subcontractors to avoid violating GCP. Read FDA and EMA set out efforts to mitigate GMP-related shortages Regulators on both sides of the Atlantic address the shortages that occur when drugmakers fail to comply with GMP in documents published this week. Read EMA biosimilar guidance welcomed but has further to go, say EGA, Aptuit and Charles River Latest EMA biosimilar guidance on reference products is a "major breakthrough" but there is still work to do, say industry experts. Read FDA takes on oversight of ClinicalTrials.gov The US FDA will make sure data in ClinicalTrials.gov is genuine from now on after the HHS delegated the job to the agency. Read FDA stresses importance of IRB role in new draft guidelines The US FDA wants IRBs to remember it is their responsibility to check investigator

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qualifications, make sure sites are up to code and say if an IND is necessary for the proposed trial. Read MHRA says 1,200 API plants may need inspecting under new import laws The MHRA says 1,200 API plants may need to be inspected to secure UK drug supplies when new EU import laws come into effect next year. Read Access to Medicines says outsourced clinical trials need to be codified The group whose comments on sponsor oversight drew criticism from ACRO says that 'trust and verify' model only works if verification efforts are robust. Read Indian regulations will hike costs but market will remain competitive, Government tells IPT Domestic regulatory efforts to improve ingredient quality will increase costs but Indian industry will remain competitive, according to the Secretary of Commerce. Read EFCG says EU API import laws ineffective and calls for mandatory inspection A European industry group says EU efforts to ensure the quality of API imports are inadequate and that mandatory inspections of overseas plants are a must. Read What Obama means for Pharma this time Barack Obama's re-election will mean millions more US citizens have health insurance, which has significant implications for the pharmaceutical industry. Read Non-EU regulators can use EMA/FDA data for API export letters Regulators in Non-EU countries can use results of previous inspections of API plants by EU or equivalent authorities

according to the European Commission. Read SFDA publishes final excipient guidelines in wake of chromium-tainted gelatin scandal The Chinese Food and Drug Administration (SFDA) has confirmed that drugmakers and suppliers will take on more responsibility for ensuring excipient quality under new provisions. Read SFDA to keep a public blacklist of pharma manufacturing offenders The SFDA will name and shame companies and individuals responsible for violations of drug and medical device laws in a public blacklist. Read SFDA clamps down on chromium-tainted gel capsules The SFDA has closed down 10 gel capsule factories and revoked two licenses after finding 23 batches of products tainted with "excessive levels" of the toxic metal chromium. Read India launches 'similar biologics' guidelines at BIO2012 New 'similar biologics' guidelines will curb the rising cost of innovation, attract overseas investment and ensure patients have access to drugs according to the Indian Government team which launched them at BIO 2012. Read
Ref.:pharmatechnologist.com

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Govt to crack down on pharmadoctor nexus NEW DELHI: The government is all set to crack the whip on India's shameful pharma-doctor nexus. The National Development Council (NDC), led by Prime Minister Manmohan Singh, will meet on December 27 to discuss bringing a legislation requiring drug companies to mandatorily disclose

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payments made to doctors for research, consulting, lectures, travel and entertainment. Doctors involved in ghost writing to promote pharma products will also be disqualified. The official NDC document says, "Mandated disclosure by pharmaceutical companies of the expenditure incurred on drug promotion, and penalty on the company and vetting of drug related material in continuing medical education would be considered." The Planning Commission says pharmaceutical marketing and aggressive promotion contributes to irrational use of drugs and therefore there is a need for a mandatory code to identify and penalize unethical promotion by pharma companies. The government will also make compulsory the use of generic names or the International Nonproprietary Name (INN), instead of brand names, at all stages of government procurement, distribution, prescription and use. "Brand manufacturers will be encouraged to bid for government procurement, but should provide medicines in generic names," the document says. Health Minister Ghulam Nabi Azadrecently said the ministry had received several complaints on this unholy pharma-doctor nexus. According to the Medical Council of India (MCI), it received 702 such complaints in 2011-12 of which 343 were referred to state medical councils. In 2010-11, MCI received 824 such complaints following which it cancelled the registration of 10 doctors and warned four others. Drug companies were recently caught red-handed writing scientific recommendations of their own products and submitting them to the Drug Controller General of India (DCGI) after getting them endorsed by top doctors for quicker marketing approval.

Usually, scientific recommendations are submitted by experts after they have studied a drug's content. The endorsement is considered a crucial testimony that convinces the DCGI to trust the drug's effectiveness, in turn, allowing it to be launched in the market. Some of India's top medical experts "even heads of departments" from the country's most prestigious medical institutes such as PGI Chandigarh, CMC Vellore, AIIMS Delhi and St John's Medical College, Bangalore had signed recommendations for drug companies which may have been written by the companies themselves. A recent study by the Planning Commission's high-level expert group (HLEG) said the pharmaceutical industryspent more than 25% of its annual turnover on sales promotion alone as compared to a paltry 7% on research and development in 2008-09. India plans to soon introduce the 'Uniform Code of Pharmaceutical Marketing Practices' after which the word "safe" cannot be used on a drug without qualification and it must be stated categorically that a medicine has no sideeffects, toxic hazards or risk of addiction. The code says, "No gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply by a pharmaceutical company. Gifts for the personal benefit of healthcare professionals (such as tickets to "entertainment"events) also are not be offered or provided. Companies must not organize meetings to coincide with sporting, entertainment or other leisure events. Venues that are renowned for their entertainment must not be used." Ref. http://articles.timesofindia.indiatimes.com/20 12-12-26/india/36007441_1_drug-companiesdrug-promotion-dcgi

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