FMRAI passes resolution against DCGI's recent decision to ban 4 drugs

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Courtsey: Pharmabiz.com

Peethaambaran Kunnathoor, Chennai

Saturday, February 26, 2011, 08:00 Hrs  [IST]

The Federation of Medical and Sales Representatives Associations of India (FMRAI) has passed a resolution against Drugs Control General of India’s recent decision to ban certain drugs produced and marketed in the country. The Federation passed the resolution in this regard in its general council meeting that held in Kota in Rajasthan last week.

According to FMRAI, the DCGI is deliberately creating ground for MNCs to capture markets for certain segments of drugs which have been in use and in circulation for several years in India.

Recently, the Union health ministry has banned four drugs based on the recommendations by 

Drugs Technical Advisory Board. The unsafe drugs are nimesulide, cisapride, phenylpropanolamine (PPA) and placentrex. FMRAI office-bearers said these drugs have been banned by the ministry without making a proper scientific study on each of the drug.

While quoting placentrex as an example, the office-bearers said it has been manufactured and marketed in India by the Kolkota based company Albert David for more than fifty years. The medicine was available in the form of lotion, gel, and injection and 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. For conducting surgery, orthopaedic treatments and in gynaecology also this medicine was being used widely.

One medical representative of Albert David said he is marketing this medicine in Tamil Nadu for several years and so far no doctor has suspected its safety  and no adverse effect has been reported. He said the company, which has a turnover of 70-80 crores, has got more than 350 medical representatives and it employs about 750 people in various capacities. The ban of placentrex will make these employees and representatives jobless, he believes.

The resolution of FMRAI says comprehensive and scientific studies should be conducted to ban the use of any drug. It alleges that the present ban on four drugs is because of pressure from vested interests which will adversely affects the nation’s economy and the pharma industry.


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Rethink ban on placenta extract drug, plead docs

Courtsey: | DNA. Sunday; Mumbai, Feb 20, 2011

If you are suffering from 'white patches' on your skin, you will now have to choose an expensive alternative of medicine.

A cheap medicine widely used for white patches and other skin ailments in India was banned for production and marketing and now doctors are writing to the Drug Controller General of India (DCGI) to reconsider it. The medicine is made from the extract from human placenta.

The drugs watchdog had banned human placental extract and its formulation from production and marketing in the country, with four other medicines, including nimusulide for children below 12 years of age.

"Human aqueous placental extract is a very effective drug. We, the team of Indian Institute of Chemical Biology, are working for the past 12 years with the extract. The drug's trade name is 'Placentrex' and has been identified with different molecules with potent therapeutic efficacy. Banning this drug is a huge loss for the people suffering from chronic, non-healing /diabetic wounds, burn injuries and surgical trauma among others," Dr Piyali Datta Chakraborty, in a letter, wrote to the DCGI.

Without knowing its efficacy and safety, banning this reputed product in India is very unethical. Banning of such a globally-accepted drug must be reconsidered, she added.

Recent scientific research has shown mitogenic actions of cytokines from placenta show an array of physiological effects - anti-inflammatory, regulation of autonomous nerve system, improvement of circulation, wound tissue healing, inhibition of protease, enhancement of nerve regeneration, balancing multiple hormone levels, immune boosting (anti-allergic), analgesic effect and the improvement of intestinal environment.

"The cheap medicine is available in cream and gel form. I have not come across any side effect from human placenta extract," Dr Puneet Goyal, a cosmetic dermatologist at Fortis Escort Hospital, said.


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Efficacy of Human Placental Extract

While looking for the views on efficacy of human placenta from the researchers outside India, I come up with a few articles available on the net. Would like to share the same. The copyright of the same remains with the respective authority (a link to the original article has been provided)

ARTICLE 1:

Clinical assessment of injecting human placental extract into acupuncture points: A case series

Accession number;06A0055986

Title;Clinical assessment of injecting human placental extract into acupuncture points: A case series

Author;NAGASE MAHIKO(Tepposu Shinryosho)  

Journal Title;Eastern Medicine

Journal Code:L0095A

ISSN:0911-7768

VOL.21;NO.3;PAGE.19-23(2005)

Figure&Table&Reference;REF.13

Pub. Country;Japan

Language;Japanese

Abstract: This study is a retrospective single case series. There are two types of injections containing extract of human placenta, "Melsmon" and "Laennec" available in Japan. Both injections can be covered by health insurance system. Normally "Melsmon" is used for climacterics syndrome and suppression of lactation. (hypogalactia) On the other hand "Laennec" is used for liver dysfunction. Both drugs are injected subcutaneously and intramuscularly. In addition to these methods, injecting human placental extract into acupuncture points is known to have efficacy for various kinds of diseases through many years of clinical experience. On this paper this method's potential of efficacy for many diseases is presented with a discussion of their mechanism of action, and some cases in which they showed remarkable improvement compared with using conventional therapy are also presented. (author abst.)

Courtesy: Science Links Japan

http://sciencelinks.jp/j-east/article/200603/000020060306A0055986.php

ARTICLE 2:

Efficacy and safety of human placenta extract in alleviating climacteric symptoms: prospective, randomized, double-blind, placebo-controlled trial.

Lee YK, Chung HH, Kang SB.

Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea.

Abstract

AIM: To assess the efficacy and safety of human placenta extract in the relief of climacteric symptoms.

METHODS: A prospective, randomized, double-blind, placebo-controlled trial was performed on 108 women with menopausal symptoms. Human placenta extract or placebo was administered to the women for 4 weeks. Climacteric symptoms were assessed with the Kupperman Index (KMI).

RESULTS: Both groups showed a significant reduction in the KMI score at the end of treatment. However, the decrease in the KMI score was significantly greater in the product group than in the placebo group (-12.30 +/- 10.44 vs -7.15 +/- 9.11, P = 0.012) after 4 weeks of treatment. The level of lipid profiles and liver function tests demonstrated no significant changes before and after treatment in both groups.

CONCLUSION: Human placenta extract reduced climacteric symptoms more than the placebo. The safety evaluation showed a good safety and tolerability profile in the placenta extract group. The results of the present study suggest that human placenta extract can be an alternative therapy in women with menopausal symptoms.

Courtesy:

PMID: 20144174 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/20144174