Drug Information Bulletin - Indian Pharmaceutical Association
Drug Information Bulletin - Indian Pharmaceutical Association
Drug Information Bulletin - Indian Pharmaceutical Association
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<strong>Drug</strong> <strong>Information</strong> <strong>Bulletin</strong><br />
(Electronic)<br />
<strong>Drug</strong> <strong>Information</strong> Centre (DIC)<br />
<strong>Indian</strong> <strong>Pharmaceutical</strong> <strong>Association</strong>, Bengal Branch<br />
Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com<br />
Web Site: http://www.ipabengal.org<br />
Contact: 09830136291<br />
Volume: 4 Number: 45 19 th February 2011<br />
Content<br />
• Govt. of India has banned four drugs with effect from 10 th February 2011 including<br />
Nimesulide suspension (below 12 years of age), Cisapride, Phenylpropanolamine<br />
(PPA) and Human Placenta extracts<br />
• Genzyme agrees to be acquired by Sanofi-Aventis for about $19 Billion<br />
• Biophosphanates may reduce colon cancer risk in postmenopausal women<br />
• Antibiotic policy of India is on the offing<br />
• USP launches free online medicine compendium<br />
• Forthcoming Event<br />
Govt. of India has banned four drugs with effect from 10 th February 2011 including<br />
Nimesulide suspension (below 12 years of age), Cisapride, Phenylpropanolamine (PPA)<br />
and Human Placenta extracts<br />
Nimesulide an anti-inflammatory drug has already been banned by several countries including<br />
Britain, Canada, Sweden, Denmark, Australia, New Zealand, Japan and other 168 countries and its<br />
use has been restricted by several countries even in Bangladesh since last few years due to its<br />
severe hepatotoxicity. This drug has never been approved by USFDA the inventor country.<br />
Cisapride, a drug which increases motility in the upper gastrointestinal tract, has been either<br />
withdrawn from the market or had its indications limited in many countries due to its side effects<br />
like- Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and QT<br />
prolongation.<br />
Due to its potential to cause stroke, phenylpropanolamine (PPA) used in cold and cough remedies<br />
was banned in all North American countries including US and western Europe. But in India,<br />
phenylpropanolamine-containing cough and cold remedies are available in the market.<br />
According to reports, all products containing extract of human placenta have been banned by the<br />
US FDA since they can transmit diseases and pose serious health hazards to consumers. Placenta<br />
extract was never permitted for use as medicine in the western countries such as US, UK,<br />
Australia, Canada and European Union states due to lack of efficacy and safety data. However,<br />
some companies in US were importing products containing human placenta as dietary<br />
supplements. However, on April 14, 2008, all products containing human placenta extracts even<br />
for use as cosmetics have been banned by the US government.
But in India, human placenta extract sold as Placentrex lotion, gel, and injection is being actively<br />
promoted as a remedy for a variety of unrelated disorders such as vitiligo, wound dressing,<br />
prevention of adverse effects due to radiotherapy, fallopian tube blockage, female infertility,<br />
scarring, post-phlebitic ulcers, scars due to acne, etc<br />
Several consumer and health care groups like- HAI, CDMU, AIDAN etc. are campaigning for the<br />
last few years for a long time for banning drugs to protect the health of the people. This bulletin<br />
also published ADR and present status of those four drugs in several past issues. Ultimately Govt.<br />
of India has banned these four drugs vide a notification dated 10 th February 2011.<br />
2
Genzyme agrees to be acquired by<br />
Sanofi-Aventis for about $19 Billion<br />
In a front page article, the Boston Globe<br />
reports, "Genzyme Corp., the largest<br />
biotechnology company in Massachusetts and<br />
one of the industry's historic pioneers, has<br />
struck a definitive agreement to be bought by<br />
French pharmaceutical giant Sanofi-Aventis<br />
SA, in a deal valued at about $20.1 billion."<br />
The deal, which the parties "unveiled this<br />
morning, is the biggest corporate acquisition<br />
worldwide so far this year and the secondlargest<br />
in the history of the biotechnology<br />
industry." Sanofi, which is best known for<br />
"the blood thinner Plavix (clopidogrel<br />
bisulfate) and the anticlotting treatment<br />
Lovenox (enoxaparin)," is hoping Genzyme<br />
will "give it a foothold in the US market and<br />
help it replenish a portfolio of drugs hurt by<br />
low-cost generic competition."<br />
The AP notes that Sanofi has "seen its sales<br />
decline as patents on some of its top drugs<br />
expire." The patent on Plavix, the "world's<br />
second best-selling medication, expires in<br />
May 2012." Although Genzyme has "built a<br />
multibillion-dollar business around high-priced<br />
treatments for rare diseases" such as<br />
Gaucher disease, the company "made a series<br />
of stumbles that left it vulnerable for a<br />
takeover, beginning with a viral<br />
contamination issue in June 2009."<br />
The New York Times "Deal Book" blog<br />
reported, Sanofi is "poised to raise its bid for<br />
Genzyme to about $74 a share," according to<br />
a person briefed on the matter, "who spoke<br />
on condition of anonymity because the deal<br />
was still being negotiated." A deal would<br />
include "what is known as a contingent value<br />
right, which would allow for additional<br />
payments if one Genzyme drug, known as<br />
Campath (alemtuzumab) or Lemtrada, hits<br />
the company's sales expectations."<br />
Biophosphanates may reduce colon<br />
cancer risk in postmenopausal women<br />
Reuters reports that post-menopausal women<br />
taking bisphosphonates may be less likely to<br />
develop colon cancer, according to a study in<br />
the Journal of Clinical Oncology. The analysis<br />
compared 933 women with colon cancer to a<br />
comparable group of women without the<br />
disease, who took alendronate (Fosamax) for<br />
at least a year. The researchers found that<br />
those taking the bisphosphonates had a<br />
significantly lower risk of developing colon<br />
cancer later. They cautioned, however, that<br />
additional studies are needed to confirm their<br />
results.<br />
Antibiotic policy of India is on the offing<br />
A high-level panel of experts including the<br />
drug controller general of India, Dr Surinder<br />
Singh, additional director general of health<br />
services H Jani and health ministry joint<br />
secretary Arun Panda, for the first time on<br />
Monday made a formal presentation of the<br />
draft antibiotic policy to Union health minister<br />
Ghulam Nabi Azad.<br />
Confirming this, Union health secretary K<br />
Chandramouli told TOI, "We are giving<br />
utmost importance to the antibiotic policy and<br />
how to stop third and fourth generation<br />
antibiotics from being misused or used in<br />
bulk. On Monday, the minister saw the expert<br />
committee's presentation of the draft policy.<br />
We will now have to formalize it. Before<br />
bringing in a regulatory mechanism, we will<br />
have to inform all hospitals. I will meet the<br />
experts once again and decide how to go<br />
about it."<br />
Under the proposal, several drugs will now be<br />
sold only against prescription while several<br />
others would be available only for hospital<br />
use and not in pharmacies.<br />
The policy calls for the creation of a new<br />
schedule under the <strong>Drug</strong>s and Cosmetics Act<br />
called Schedule HX which will be mentioned<br />
on the label of the drug itself as a direction to<br />
consumers and physicians. Schedule H will<br />
denote those drugs which would be given<br />
only on prescription while Schedule X denotes
those drugs which will have to be kept under<br />
lock and key in hospitals. A Schedule HX drug<br />
would come with a label warning, "Dangerous<br />
to take this preparation except in accordance<br />
with medical advice and not to be sold on<br />
retail without prescription of a registered<br />
medical practitioner."<br />
The policy would also entail a prescription<br />
audit. Doctors will have to give two copies of<br />
prescriptions to every patient. One copy will<br />
have to be kept for two years by the chemists<br />
while the other one will be audited by the<br />
DCGI.<br />
Schedule HX would have two parts. Part A of<br />
Schedule HX (only to tertiary hospitals) would<br />
include 16 drugs like Moxifloxacin,<br />
Meropenem, Imipenem, Ertapenem,<br />
Doripenem, Colistin, Linezolid and Cefpirome.<br />
Part B of Schedule HX (against prescription<br />
only) would include 75 drugs like Gentamicin,<br />
Amikacin, Pencillin, Oxacilin, Zolpidem,<br />
Cefalexin, Norfloxacin, Cefaclor and Cefdinir.<br />
4<br />
USP and the IPC, <strong>Indian</strong> regulators,<br />
scientists and pharmaceutical manufacturers.<br />
The USP states that standards in the<br />
compendium are intended for use by<br />
manufacturers, regulators and donor<br />
organizations in India seeking rigorous quality<br />
assurance measures where they otherwise<br />
might not exist. Documentary standards in<br />
the compendium will be offered for free<br />
online only and may be adapted or adopted<br />
by the IPC if desired. Criteria for inclusion in<br />
the MC emphasize public health impact<br />
measures such as exposure to the population.<br />
Source: <strong>Drug</strong>sControl.org<br />
Forthcoming Event:<br />
USP launches free online medicine<br />
compendium<br />
The United States Pharmacopoeia (USP), a<br />
non-governmental, official public standardssetting<br />
authority for prescription and overthe-counter<br />
medicines and other healthcare<br />
products manufactured or sold in the United<br />
States, launched a free online medicines<br />
compendium (MC).<br />
According to the USP, it initially comprises<br />
quality standards for drugs approved by the<br />
<strong>Drug</strong> Controller General of India (DCGI) for<br />
use in India. The USP has constituted a body<br />
of volunteer experts to assess and approve<br />
standards for the compendium. It is chaired<br />
by Dr Antony Raj Gomas, an industry expert<br />
and scientist, and includes 11 distinguished<br />
<strong>Indian</strong> scientists. The <strong>Indian</strong> Pharmacopoeia<br />
Commission is serving as a government<br />
liaison to the work of the expert committee.<br />
It marks the latest cooperative effort among<br />
Felicitation of Dr. C. M. Ghosh by IPA,<br />
Bengal Branch on his assuming the<br />
responsibility of Director, Directorate of<br />
<strong>Drug</strong>s Control, Govt. of West Bengal<br />
Date:<br />
26 th February 2011<br />
Venue:<br />
IPA Auditorium<br />
22 B Panchanontola Road, Kolkata-<br />
700029<br />
Time:<br />
6.00 pm<br />
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