Human Placental Extract and its Formulations is back in India vide the Gazette Notification No. G.S.R 418(E) dated May 30, 2011 - the Ministry of Health & Family Welfare...... USE OF PLACENTREX CONTINUES!
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Sunday, March 13, 2011

Application under Section 6 of the Right to Information Act, 2005 - INDIA

The issue of Human Placental Extract has been raised at the Right to Information forum (India), the RTI Community.  The Right to Information has been requested for the following issues, which many in India would vouch for the same. The questions asked are:

(I) Which are the drugs prepared from Human Placenta Extracts that are 
available in the Indian market?

(II) What are the indications in which the products manufactured from Human Placental Extract are used in India ?

(III ) Whether there is any scientific or clinical research report or any document with your office in respect of the safety and efficacy of the drugs prepared from Human Placenta Extracts? If so, please provide copy of any such report (s) anddocuments?

(IV)Whether there is any report prepared by the Drug Technical Advisory Board on the safety and efficacy of the drugsprepared from Human Placenta Extracts? If so, please provide copy of any such report?

(V) What are the drawbacks and if so why the Central Government had planned to fund a project of amniotic waste in Southern India ?

(VI) How many patients have reported any adverse reaction with Human Placental Extract and How many patients have died ? Is there any clinical data available against the Human placental extract. If so please provide the copy of the same ? 

The aforesaid information is not barred by any of the provisions of the Right to Information Act, 2005.

Please read the original post at the :RTI Question forums, part of the RTI Community category

1 comment:

Piyali said...

Human Placental aqueous Extract is a very safe drug. We the team of IICB, Kolkata ( A Unit of CSIR,India) are working with the drug ‘Placentrex’ since 1999 with extension in every alternate year. A committee constituted by experts approved renewal of the project. Ours is a CSIR owned biomedical research institute of national importance. As per CSIR guidelines on human and animal ethics, it is not possible to undertake any research in the institute, which is hazardous or unsafe to human or animal health or the environment.

Two research scholars Dr. Sangeeta Nath and Ms. Debashree De, were awarded CSIR-senior research fellowship for continuation of their work on ‘Placentrex’ in 2004 and 2007 respectively. The expert committee of CSIR, New Delhi, awarded fellowships after extensive reviewing of research proposals. The committee members were fully aware of the manufacturing of the drug.

Three theses describing research on ‘Placentrex’ have been submitted to Jadavpur University for the award of Ph.D. degree by National and foreign examiners who are experts in the respective fields have evaluated these theses. Nobody raised doubts about bio-safety of the starting materials.

Since 1999, in many occasions we presented research work in front of national and international audiences. The question of safety of the drug has never been raised.Once the germination period was over, we are publishing research articles on ‘Placentrex’ since 2004, in different national and international peer-reviewed journals. It should be noted that no journal would accept a manuscript until the ethical aspects like safety of products are satisfied. Thus it is clear that identified experts have endorsed the safety of the drug in a worldwide fashion. Significantly, a review article is also in print.

List of Publications on Placentrex from IICB (Kolkata, A Unit of CSIR, India)
1. J. Pharma. Biomed. Res. (2004) USA
2. J. Pharma. Biomed. Res. (2004) USA
3. J. Chromat. B (2005) Netherlands
4. Current. Science (2005) India
5. Inter. Immunopharmacol. (2006) UK
6. Indian J. Expt. Biol. (2007) India
7. J. Chromat. B (2009) Netherlands
8. J. Wound Care (2009) U.K. (Review article)
9. Physiol. Update (2009) India
10. J. Cell. Physiol. (2010) USA

In conclusion, it may be summarized that experts of biomedical research have approved the safety of the drug ‘Placentrex’ worldwide since 1999 i.e., as long as we are associated with its research. None of these experts are beneficiaries of ‘Placentrex’ research. So the concern for safety of the drug does not stand on any foundation.

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