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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Thursday, March 24, 2011

Fate of indigenous human placental extract

By Swapan Das, Calcutta


What I have personally noted is that there's lack of general awareness regarding human placental extract. Just for the sake - that’s Western countries not using it, so we should also "discard" one of our own products is not done. Today there's country restrictions apply for HPE products but one should analyze under what circumstances they have been enforced while its currently being used in Oriental countries like Japan and South Korea with their Govt. approvals and what could be the consequences of it (esp. in India) if such restrictions are withdrawn in western countries.
When I asked Dr. Piyali Datta Chakraborty who is working on Aqueous extract of Human Placenta  and is part of the research team for it at  Indian Institute of Chemical Biology (IICB), a unit of CSIR India about her feedback on this issue, she came up with the following: 

“Aqueous Extract Human Placenta is an effective and safe drug. The team of Indian Institute of Chemical Biology, Kolkata (A Unit of CSIR, India) are working with the drug ‘Placentrex’ since 1999 and identified different molecules with the potent therapeutic efficacy e.g. fibronectin type III peptide, NADPH, PDRNs (Polydeoxyribonuleotide fragments), small peptides with protease regulatory property etc. (ref. www.Pubmed.com). Placenta is treasure house of all bioactive molecules can never be synthetically generated. Without knowing the rationality, efficacy and safety banning this highly reputed product of India, by DCGI, is very unethical.”

This following link of 'Clinical Research News' is for public awareness: 
We can just appeal to Indian Govt. to rethink on this issue……..esp. it’s being an Indian project (Indian Govt. research organization doing the research, an Indian Pharmaceutical manufacturing Co. producing the product) -  so that the fate of indigenous human placental extract remains alive in India and can serve its patients like before.

15 comments:

mamon said...

Placentrex research gained a momentum with the description of the preparation of its extract by renowned Russian ophthalmologist Prof. V.P. Filatov. Prior to his research, there were no documents of therapeutic efficacy of the extract, though its use had increasing popularity in Europe and parts of Asia primarily China, Korea and Japan for over a century. A rich source of varied bioactive components, placenta naturally becomes a biomedical waste immediately after child-birth. Use of human placenta as a therapeutic agent, therefore, no way hampers ecological balance, but rather promotes resource recovery from a designated biomedical waste. Since most of the natural products of medicinal value have a vast repertoire of potent biological components, there has been an increasing realization to shun synthetic and semi-synthetic medicines mostly owing to their harmful side-effects.
Over a period of time, it has been demonstrated that only an aqueous extract of human placenta has potent therapeutic potential. In India, this extract is sold under the trade name ‘Placentrex’, manufactured by the sole proprietor Albert David Ltd, Kolkata, India. The clinical efficacy of the drug is well proven and an insight into its biochemical composition led to the identification of potent active components, as already mentioned by Dr. Datta Chakraborty. As an active researcher in this field since past 5 years, I have also had the opportunity to contribute to the research on placental extract. A few publications of international standards in this perspective include :
– De D.†, Chakraborty P.D.† and Bhattacharyya D. (2010) Stabilization of trypsin by human placental extract used as a wound healer. (In Press).
– De D., Chakraborty P.D. and Bhattacharyya D. (2009) Analysis of free and bound NADPH in aqueous extract of human placenta used as wound healer. Journal of Chromatography B, 877: 2435-2442.
– Chakraborty P.D., De D., Bandopadhyay S. and Bhattacharyya D. (2009) Human aqueous placental extract as a wound healer. Journal of Wound Care. 18: 462 – 467 [Review].
– D. De and P.D. Chakraborty, Human Placental extract: Biochemical evaluation as a wound healer, Physiology Update, (2009), Vol 1., p.p. 76-90,
These works, compiled with many more scientific validations have revealed that placental extract has anti-microbial, anti-inflammatory properties coupled with the identification of important components like NADPH, PDRN, fibronectin type III-like peptide etc. It has also shown to induce cell adhesion, regulate collagen synthesis and regulate other protease activity to effectively induce wound healing. The wound healing efficacy of the extract has already been reviewed at an international journal (Chakraborty P.D. et al, 2010) which also became the focus of a press release.
The safety of Placentrex as a therapeutic agent is unquestionable. The CSIR had also approved two project proposals from Indian Institute of Chemical Biology (IICB), and awarded senior fellowship grants to scholars Dr Sangeeta Nath (2006) and myself (Dr. Debashree De, 2007) of IICB. Had safety issues been a concern and the observed scientific evidences been false, the forum of scientists at the Centre would not have approved the projects!! Further, these findings were also acknowledged at international presentations in France, ‘Society of Biochromatography and Nanoseparation’ (SBCN).
Considering the strong research background on Placentrex, and the subsequent failure to produce a strong counter evidence to prove its efficacy otherwise, banning of the medicine will hamper the development of medicines from the vast repertoire of natural resource in the near future.
I therefore vote for the plea put forth by Dr. Piyali Datta chakraborty and also invite people world wide to support our concern.

Thanking you for your patience,Sincerely,

Dr. Debashree De,
Research Scholar,
Indian Institute of Chemical biology,
Kolkata,
India.

Swapan Das said...

Welcome to our site Dr. Debasree De!

We really appreciate feedbacks from people like you who are actually into Placental Extract research and can share the ground realities of HPE with the public.

BTW, your feedback touched many aspects of the kind of research work going on from your unit regarding this, and hope many readers were not aware of these actual facts.

Keep up the good work, and do visit again!

Dr Piyali D Chakraborty said...

It is my pleasure to inform all of you that on 30th May 2011, based on the recommendations of the an expert committee constituted by the Indian Union Health Ministry at the direction of the Delhi High Court, the Government has released an amended version of gazette notification [vide G.S.R. 418(E)] allowing the use of Human Placental Extract and its formulations for topical application for wound healing and the injections for pelvic inflammatory disease.
The rational review of the issue by the 9-member expert committee and Delhi High Court's judgment will definitely encourage the ongoing research work on Human Placental Extract in India.

I wish to thank all the supporters of Human Placental Extract.

Regards,

Dr. Piyali Datta Chakraborty(Ph.D.)

Kolkata, India

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