Drug Information Bulletin (Electronic)

Volume: 4

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

Number: 45

19th February 2011

Content Govt. of India has banned four drugs with effect from 10th February 2011 including Nimesulide suspension (below 12 years of age), Cisapride, Phenylpropanolamine (PPA) and Human Placenta extracts Genzyme agrees to be acquired by Sanofi-Aventis for about $19 Billion Biophosphanates may reduce colon cancer risk in postmenopausal women Antibiotic policy of India is on the offing USP launches free online medicine compendium Forthcoming Event

Govt. of India has banned four drugs with effect from 10th February 2011 including Nimesulide suspension (below 12 years of age), Cisapride, Phenylpropanolamine (PPA) and Human Placenta extracts Nimesulide an anti-inflammatory drug has already been banned by several countries including Britain, Canada, Sweden, Denmark, Australia, New Zealand, Japan and other 168 countries and its use has been restricted by several countries even in Bangladesh since last few years due to its severe hepatotoxicity. This drug has never been approved by USFDA the inventor country. Cisapride, a drug which increases motility in the upper gastrointestinal tract, has been either withdrawn from the market or had its indications limited in many countries due to its side effects like- Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and QT prolongation. Due to its potential to cause stroke, phenylpropanolamine (PPA) used in cold and cough remedies was banned in all North American countries including US and western Europe. But in India, phenylpropanolamine-containing cough and cold remedies are available in the market. According to reports, all products containing extract of human placenta have been banned by the US FDA since they can transmit diseases and pose serious health hazards to consumers. Placenta extract was never permitted for use as medicine in the western countries such as US, UK, Australia, Canada and European Union states due to lack of efficacy and safety data. However, some companies in US were importing products containing human placenta as dietary supplements. However, on April 14, 2008, all products containing human placenta extracts even for use as cosmetics have been banned by the US government.

2 But in India, human placenta extract sold as Placentrex lotion, gel, and injection is being actively promoted as a remedy for a variety of unrelated disorders such as vitiligo, wound dressing, prevention of adverse effects due to radiotherapy, fallopian tube blockage, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc Several consumer and health care groups like- HAI, CDMU, AIDAN etc. are campaigning for the last few years for a long time for banning drugs to protect the health of the people. This bulletin also published ADR and present status of those four drugs in several past issues. Ultimately Govt. of India has banned these four drugs vide a notification dated 10th February 2011.

Genzyme agrees to be acquired by Sanofi-Aventis for about $19 Billion In a front page article, the Boston Globe reports, "Genzyme Corp., the largest biotechnology company in Massachusetts and one of the industry's historic pioneers, has struck a definitive agreement to be bought by French pharmaceutical giant Sanofi-Aventis SA, in a deal valued at about $20.1 billion." The deal, which the parties "unveiled this morning, is the biggest corporate acquisition worldwide so far this year and the secondlargest in the history of the biotechnology industry." Sanofi, which is best known for "the blood thinner Plavix (clopidogrel bisulfate) and the anticlotting treatment Lovenox (enoxaparin)," is hoping Genzyme will "give it a foothold in the US market and help it replenish a portfolio of drugs hurt by low-cost generic competition." The AP notes that Sanofi has "seen its sales decline as patents on some of its top drugs expire." The patent on Plavix, the "world's second best-selling medication, expires in May 2012." Although Genzyme has "built a multibillion-dollar business around high-priced treatments for rare diseases" such as Gaucher disease, the company "made a series of stumbles that left it vulnerable for a takeover, beginning with a viral contamination issue in June 2009." The New York Times "Deal Book" blog reported, Sanofi is "poised to raise its bid for Genzyme to about $74 a share," according to a person briefed on the matter, "who spoke on condition of anonymity because the deal was still being negotiated." A deal would include "what is known as a contingent value right, which would allow for additional payments if one Genzyme drug, known as Campath (alemtuzumab) or Lemtrada, hits the company's sales expectations." Biophosphanates may reduce colon cancer risk in postmenopausal women Reuters reports that post-menopausal women taking bisphosphonates may be less likely to

develop colon cancer, according to a study in the Journal of Clinical Oncology. The analysis compared 933 women with colon cancer to a comparable group of women without the disease, who took alendronate (Fosamax) for at least a year. The researchers found that those taking the bisphosphonates had a significantly lower risk of developing colon cancer later. They cautioned, however, that additional studies are needed to confirm their results. Antibiotic policy of India is on the offing A high-level panel of experts including the drug controller general of India, Dr Surinder Singh, additional director general of health services H Jani and health ministry joint secretary Arun Panda, for the first time on Monday made a formal presentation of the draft antibiotic policy to Union health minister Ghulam Nabi Azad. Confirming this, Union health secretary K Chandramouli told TOI, "We are giving utmost importance to the antibiotic policy and how to stop third and fourth generation antibiotics from being misused or used in bulk. On Monday, the minister saw the expert committee's presentation of the draft policy. We will now have to formalize it. Before bringing in a regulatory mechanism, we will have to inform all hospitals. I will meet the experts once again and decide how to go about it." Under the proposal, several drugs will now be sold only against prescription while several others would be available only for hospital use and not in pharmacies. The policy calls for the creation of a new schedule under the Drugs and Cosmetics Act called Schedule HX which will be mentioned on the label of the drug itself as a direction to consumers and physicians. Schedule H will denote those drugs which would be given only on prescription while Schedule X denotes

4 those drugs which will have to be kept under lock and key in hospitals. A Schedule HX drug would come with a label warning, "Dangerous to take this preparation except in accordance with medical advice and not to be sold on retail without prescription of a registered medical practitioner." The policy would also entail a prescription audit. Doctors will have to give two copies of prescriptions to every patient. One copy will have to be kept for two years by the chemists while the other one will be audited by the DCGI. Schedule HX would have two parts. Part A of Schedule HX (only to tertiary hospitals) would include 16 drugs like Moxifloxacin, Meropenem, Imipenem, Ertapenem, Doripenem, Colistin, Linezolid and Cefpirome. Part B of Schedule HX (against prescription only) would include 75 drugs like Gentamicin, Amikacin, Pencillin, Oxacilin, Zolpidem, Cefalexin, Norfloxacin, Cefaclor and Cefdinir. USP launches compendium free online medicine USP and the IPC, Indian regulators, scientists and pharmaceutical manufacturers. The USP states that standards in the compendium are intended for use by manufacturers, regulators and donor organizations in India seeking rigorous quality assurance measures where they otherwise might not exist. Documentary standards in the compendium will be offered for free online only and may be adapted or adopted by the IPC if desired. Criteria for inclusion in the MC emphasize public health impact measures such as exposure to the population.
Source: DrugsControl.org

Forthcoming Event:

The United States Pharmacopoeia (USP), a non-governmental, official public standardssetting authority for prescription and overthe-counter medicines and other healthcare products manufactured or sold in the United States, launched a free online medicines compendium (MC). According to the USP, it initially comprises quality standards for drugs approved by the Drug Controller General of India (DCGI) for use in India. The USP has constituted a body of volunteer experts to assess and approve standards for the compendium. It is chaired by Dr Antony Raj Gomas, an industry expert and scientist, and includes 11 distinguished Indian scientists. The Indian Pharmacopoeia Commission is serving as a government liaison to the work of the expert committee. It marks the latest cooperative effort among

Felicitation of Dr. C. M. Ghosh by IPA, Bengal Branch on his assuming the responsibility of Director, Directorate of Drugs Control, Govt. of West Bengal Date: 26 February 2011 Venue: IPA Auditorium 22 B Panchanontola Road, Kolkata700029 Time: 6.00 pm
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ipabengal.dic@gmail.com

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