Drug Information Bulletin (electronic)

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: 3 Number: 47

Content
G.S.R. 578 (E) dated 23rd July 1983 amended vide G.S.R. 738 (E) dated 9th October, 2009 Banning Fixed dose combination of corticosteroid with any other drug for internal use. Vaccine for Asbestos-Related Cancer Mesothelioma May Be Safe. CDSCO Starts office at Indore. PhRMA pushes for data exclusivity in 2010 Special 301 comments. NPPA recovers Rs. 190 crore out of total overcharging dues of Rs. 2147 crore as on 31st January 2010. Droxychloroquine May Help Delay Skin Damage in SLE Patients. Lift ban on morning-after pill adverts: Expert panel.

G.S.R. 578 (E) dated 23rd July 1983 amended vide G.S.R. 738 (E) dated 9 October, 2009 Banning Fixed dose combination of corticosteroid with any other drug for internal use 14. Fixed dose combination of corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers
th

Vaccine for Asbestos-Related Cancer Mesothelioma May Be Safe Health Day reported, "An investigational vaccine for the asbestos-related cancer mesothelioma is safe," according to a study published in the American Journal of Respiratory and Critical Care Medicine. Researchers found that the vaccine effectively "induced an immune T-cell response against mesothelioma tumors." The vaccine works by

2 infusing "a patient's own dendritic cells with antigen from the patient's tumor." CDSCO Starts office at Indore The Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, has opened a new office of the Assistant Drugs Controller (India), Indore at the premises of Container Corporation of India Ltd., , Inland Container Depot (ICD), 113-Concor Complex, Sector -3, Pithampur Industrial Area, Pithampur, Dist. Dhar, Madhya Pradesh, (Contact No. 07292403486) w.e.f. 22nd February 2010, to regulate the Export of Drugs & Cosmetics from Indore. Any further details about the O/o. Asstt. Drugs Controller (I), Indore may be obtained from the O/o. Deputy Drugs Controller (India), 4th Floor, Zonal FDA Bhawan, GMSD Compound, Bellasis Rd, Mumbai Central, Mumbai-400 008. Tel: 022 23002279 / 23002215, Fax : 022-23002271, Email:cdscowz@gmail.com.
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evidence of safety and efficacy for the successful registration of a product. While data protection can take many forms, data exclusivity regimes grant a period of exclusive rights to the originator during which generic manufacturers are banned from relying on the original data to meet registration standards of safety and efficacy. In its submission, PhRMA relentlessly advocates for, indeed makes demands of several countries to implement data exclusivity provisions that go far beyond their obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). As noted by KEI and others in submissions to USTR, a number of public health and development NGOs have been highly critical of data exclusivity regimes, citing the large barriers to the introduction of generic medicines, and the conflicts between data exclusivity and medical ethics, when generic firms are required to replicate experiments with humans where the results of trials are already known. KEI will focus on the issue of pharmaceutical test data protection in its testimony on the Special 301 list on March 3, 2010. They have made country-specific statements on this subject. We are including only India specific submission: INDIA TRIPS Article 39.3 requires India to provide protection for certain pharmaceutical test and other data, but India has yet to do so. India conditions the approval of pharmaceutical products on the prior approval by a Regulatory Authority in another country rather than requiring submission of the entire dossier for review by the Regulatory Authority. An applicant in India needs only to prove that the drug has been approved and marketed in another country accompanied by confirmatory test and other data from clinical studies on only 100 Indian patients.

PhRMA pushes for data exclusivity in 2010 Special 301 comments The Pharmaceutical Research and Manufacturers of America (PhRMA) 2010 Special 301 submission [1] (a 200 plus page document) systematically lists in great detail, grievances against 41 countries for, in its view, the insufficient implementation and enforcement of national IP legislation. A primary focus of attention and frequent "area of concern" in the submission is the inadequate protection of pharmaceutical regulatory data. Regulatory data refers to test and clinical trial data generated by drug developers and submitted as requisite

3 By linking approval in other countries that require the submission of confidential test and other data to its own drug approval process, India, in effect, uses those countries as its agents. In effect, India relies on test data submitted by originators to another country. This indirect reliance results in unfair commercial use prohibited by TRIPS. NPPA recovers Rs. 190 crore out of total overcharging dues of Rs. 2147 crore as on 31st January 2010 The National Pharmaceuticals Pricing Authority (NPPA) has announced that it has completed recovery of Rs 190.95 crore till January 31, 2010, out of its total claim of around Rs 2147 crore on overcharging drug prices and its interest. According to a latest statement of the NPPA, the price regulator had issued overcharging dues in 739 cases on pharma companies marketing their products in the country. The pharma majors including Cipla Ltd, Ranbaxy Lab, Dr Reddy's Lab, Cadila Healthcare (Zydus) and Cadila Pharmaceuticals along with multinational companies like Pfizer India Ltd, GlaxoSmithKline, Merck and Johnson & Johnson were among the companies which has allegedly violated the drug price norms till date. The list also includes a large number of small scale pharma companies, details the statement. Out of the Rs 1956.05 crore pending dues from the pharma companies, almost Rs 1386.65 crore is from Cipla Ltd, the largest drug manufacturer in the country while the rest of the companies together have to pay Rs 569.4 crore. The dues declared by the authority includes the interest on the actual amount to be payed over the time period. As reported earlier, the authority has collected almost Rs 35 crore in the first nine months of financial year 2009-10.
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Droxychloroquine May Help Delay Skin Damage In SLE Patients MedPage Today reported that, according to a study published in March issue of Arthritis Care & Research, "treatment with hydroxychloroquine (Plaquenil) may help delay the occurrence of skin damage in patients with systemic lupus erythematosus (SLE)." In a study of "580 patients who had not yet developed skin damage at baseline," researchers found that use of hydroxychloroquine "was associated with a longer time until integument damage -defined as scarring alopecia, extensive skin scarring, and skin ulcers -- was present." Moreover, "the cumulative probability of damage at five years was 5% for those taking hydroxychloroquine, compared with 24% for those who were not on the drug." Lift ban on morning-after pill adverts: Expert panel Morning-after pills should be back on air. And not just private companies but even the Union health ministry should advertise them. This is the view of a four-member expert committee set up by the Drug Technical Advisory Board (DTAB) recently to assess the pros and cons of allowing advertising of emergency pills. The Drug Controller Generals office banned advertising of all emergency contraceptives like Unwanted-72 and I-pill on January 11 this year, after concerns were raised that the ads were promoting the drugs as regular contraceptives and misrepresenting abortion. The committee, headed by Dr Sunita Mittal, head of the department of gynaecology at AIIMS, has told the DCGI to allow advertising

4 and proper use of emergency contraceptives even in rural India. DCGI Dr Surinder Singh told TOI: All forms of advertising of emergency contraceptives have been banned in India and the matter is being further examined. Concerns were being raised that women were popping the pills as a means to be free of tension after unprotected sex. Women also werent being told that the pill should be popped as an emergency measure, not a routine one. The ban, however, wont be revoked for at least the next six months. Ministry officials said: Dr Mittals committee feels that the pill should empower women and not be discriminatory. It has also suggested that maybe the information and broadcasting ministry can scan the ads before they come on air. The committee feels that women should be better educated about how to use, when to use and the side-effects of emergency pills. Seven companies market emergency contraceptives in India, which are being sold over the counter (OTC) since September 2005. The DTAB, however, did not revoke the OTC status as no woman would want to go to a doctor for prescription to buy I-Pills, defeating the basic purpose of an emergency pill. India records 7 million abortions annually and 20,000 women die because of abortionrelated complications. Only two in five of these abortions are safe. Emergency pills should be taken as early as possible as and not later than 72 hours after unprotected sex. Doctors strongly advocate against its indiscriminate use. Around 8.2 million pills were sold in India last year. One of the most common misconceptions about the drug is that it is equivalent to an abortion pill. This is, however, not true because an emergency contraceptive works in the time-frame before a pregnancy is established. The emergency contraceptive acts as an interceptive agent and not an abortive one. In the case of I-pill, lack of proper knowledge about its functioning has led to women popping them as regular oral contraceptives. What people dont understand is that emergency contraceptives are comparatively heavier in dosage than regular oral contraceptives or birth control pills and therefore cannot be taken regularly. ** Copied for fair use from the report of Kounteya Sinha of Times
of India

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