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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withdrawn from the market or had its indications limited in many countries due to its side effects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 />

Subscribe / unsubscribe:<br />

ipabengal.dic@gmail.com

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