To,
The Editor,
Clinical Research News
Sir,
I am writing this letter in connection with the recent ban of human placenta extract as a drug (vide REGD.No.D.L.-33004/99). This is to draw your kind attention that the research on aqueous extract of human placenta for its evaluation as a drug for wound healing had already been established globally. The extensive 12 yrs research work at Indian Institute of Chemical Biology, Kolkata (a unit of CSIR, India) produced many a number of scientific publications which glorified India at global scientific community.
‘Aqueous extract of Human Placenta’ is a very effective drug. It contains several bioactive therapeutic molecules. We (the team of Indian Institute of Chemical Biology, a unit of CSIR India) are working for the last 12 years with the extract the trade name is ‘Placentrex’ 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). We have been invited several times abroad (Europe, especially in France) to deliver lectures on 'Placentrex' research findings. So far we have not found any adverse effect of the drug. DCGI recently put a ban on the drug without giving any explanation except the fact that this kind of drug is banned in US. It is ridiculous that thousands of drugs which are really toxic and banned in US and other countries are still exists in the Indian market. Regarding Placental extract! , India is the forerunner in proper scientific and thorough clinical research.
Is it the policy of Govt. of India to ban a product which has been proved its unquestionable efficacy through extensive research work? Ironically this high quality research work has been conducted by a reputed research institute of CSIR, India.
1. The project on ‘Biochemical Characterization of the drug ‘Placentrex’ has been running successfully at this institute 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.
2. Two research scholars of IICB, Kolkata (Dept. of Structural Biology and Bioinformatics), Dr. S Nath and Ms. D. 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.
3. Thesis describing research on Placentrex have been submitted to the Jadavpur University for the award of Ph.D. degree by the following students:
Dr. Piyali Datta Chakraborty (2004)
Dr. Sangeeta Nath (2006)
Dr. Debashree De (2010)
National and foreign examiners who are experts in the respective fields have evaluated these thesis. Nobody raised doubts about bio-safety of the starting materials.
4. Since 1999, in many occasions we presented research work in front of national and international audiences (see below). The question of safety of the drug has never been raised.
Major events of presentations are:
I. Debashree De, Piyali Datta Chakraborty, Jyotirmoy Mitra, Somnath Mandal, and Debasish Bhattacharyya, Peptide Fraction Isolated from an Aqueous Extract of Human Placenta has Proteolytic Activity, 12th International Symposium of Biochromatography and Nanoseparations, Lyon, France, October 2010, at Ecole Centrale de Lyon.
II. Debashree De, Piyali Datta Chakraborty and Debasish Bhattacharyya, Interaction of lysozyme with human placental extract used as wound healer, presented in 10th International Symposium on Biochromatography, University of Sciences end Technologies, Lille, France, 2006.
III. Sangeeta Nath and Debasish Bhattacharyya, Regulation of collagenase activity in presence of placental extract used as wound healer, presented in 10th International Symposium on Biochromatography: University of Sciences end Technologies, Lille, France, 2006.
IV. Piyali Datta Chakraborty, Debashree De and Debasish Bhattacharyya, Stabilization of trypsin against autodigestion by human placental extract used as wound healer, presented in 10th International Symposium on Biochromatography, University of Sciences and Technologies, Lille, France, 2006.
V. Piyali Datta Chakraborty and Debasish Bhattacharyya, Presence of fibronectin type III like peptide in human placental extract used as wound healer, presented in 9th International Symposium on Biochromatography,Bordeaux, France, 2004.
VI. Piyali Datta Chakraborty and Debasish Bhattacharyya, Fingerprinting of the drug Placentrex by fluorescence EEM plots, presented in 9th International Symposium on Biochromatography,Bordeaux, France, 2004.
VII. Piyali Datta, Gargi Maiti and Debasish Bhattacharyya `Antimicrobial activity of the drug Placentrex`, poster presented in National Symposium on Recent Challenges in Chemistry, Department of Chemistry, Tripura University, India, March 29-31, 2001. (First prizewinner).
VIII. Piyali Datta and Debasish Bhattacharyya, Human placental distillate as wound healer: Presence on NADPH oral presentation delivered in National Seminar on Harnessing Science and Technology for HEALTH FOR ALL with Special Reference to North-East India, Department of Pharmaceutical Sciences, Dibrugarh University, India, September 24-25, 2001.
5. Once the germination period was over, we are publishing research articles on Placentrex since 2004, in different national and international peer-reviewed journals (see below). 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:
Journal Year country of origin
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. Moreover, Several clinical studies have also been done on it and these are also published in different peer-reviewed medical journals.
It’s a demand for proper justice regarding reconsideration of banning of such a good product of India for the sake of the sufferer of chronic/non healing wounds, burn injuries and surgical trauma. This ban is very much unethical with all respect and must be reconsidered.Without knowing the actual fact banning of such a successful Indian formulation is a shame for the country itself.
This is for your perusal and kind consideration.Thanking You,
Sincerely,
Dr. Piyali Datta Chakraborty, Ph.D. (Science)
The Editor,
Clinical Research News
Sir,
I am writing this letter in connection with the recent ban of human placenta extract as a drug (vide REGD.No.D.L.-33004/99). This is to draw your kind attention that the research on aqueous extract of human placenta for its evaluation as a drug for wound healing had already been established globally. The extensive 12 yrs research work at Indian Institute of Chemical Biology, Kolkata (a unit of CSIR, India) produced many a number of scientific publications which glorified India at global scientific community.
‘Aqueous extract of Human Placenta’ is a very effective drug. It contains several bioactive therapeutic molecules. We (the team of Indian Institute of Chemical Biology, a unit of CSIR India) are working for the last 12 years with the extract the trade name is ‘Placentrex’ 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). We have been invited several times abroad (Europe, especially in France) to deliver lectures on 'Placentrex' research findings. So far we have not found any adverse effect of the drug. DCGI recently put a ban on the drug without giving any explanation except the fact that this kind of drug is banned in US. It is ridiculous that thousands of drugs which are really toxic and banned in US and other countries are still exists in the Indian market. Regarding Placental extract! , India is the forerunner in proper scientific and thorough clinical research.
Is it the policy of Govt. of India to ban a product which has been proved its unquestionable efficacy through extensive research work? Ironically this high quality research work has been conducted by a reputed research institute of CSIR, India.
1. The project on ‘Biochemical Characterization of the drug ‘Placentrex’ has been running successfully at this institute 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.
2. Two research scholars of IICB, Kolkata (Dept. of Structural Biology and Bioinformatics), Dr. S Nath and Ms. D. 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.
3. Thesis describing research on Placentrex have been submitted to the Jadavpur University for the award of Ph.D. degree by the following students:
Dr. Piyali Datta Chakraborty (2004)
Dr. Sangeeta Nath (2006)
Dr. Debashree De (2010)
National and foreign examiners who are experts in the respective fields have evaluated these thesis. Nobody raised doubts about bio-safety of the starting materials.
4. Since 1999, in many occasions we presented research work in front of national and international audiences (see below). The question of safety of the drug has never been raised.
Major events of presentations are:
I. Debashree De, Piyali Datta Chakraborty, Jyotirmoy Mitra, Somnath Mandal, and Debasish Bhattacharyya, Peptide Fraction Isolated from an Aqueous Extract of Human Placenta has Proteolytic Activity, 12th International Symposium of Biochromatography and Nanoseparations, Lyon, France, October 2010, at Ecole Centrale de Lyon.
II. Debashree De, Piyali Datta Chakraborty and Debasish Bhattacharyya, Interaction of lysozyme with human placental extract used as wound healer, presented in 10th International Symposium on Biochromatography, University of Sciences end Technologies, Lille, France, 2006.
III. Sangeeta Nath and Debasish Bhattacharyya, Regulation of collagenase activity in presence of placental extract used as wound healer, presented in 10th International Symposium on Biochromatography: University of Sciences end Technologies, Lille, France, 2006.
IV. Piyali Datta Chakraborty, Debashree De and Debasish Bhattacharyya, Stabilization of trypsin against autodigestion by human placental extract used as wound healer, presented in 10th International Symposium on Biochromatography, University of Sciences and Technologies, Lille, France, 2006.
V. Piyali Datta Chakraborty and Debasish Bhattacharyya, Presence of fibronectin type III like peptide in human placental extract used as wound healer, presented in 9th International Symposium on Biochromatography,Bordeaux, France, 2004.
VI. Piyali Datta Chakraborty and Debasish Bhattacharyya, Fingerprinting of the drug Placentrex by fluorescence EEM plots, presented in 9th International Symposium on Biochromatography,Bordeaux, France, 2004.
VII. Piyali Datta, Gargi Maiti and Debasish Bhattacharyya `Antimicrobial activity of the drug Placentrex`, poster presented in National Symposium on Recent Challenges in Chemistry, Department of Chemistry, Tripura University, India, March 29-31, 2001. (First prizewinner).
VIII. Piyali Datta and Debasish Bhattacharyya, Human placental distillate as wound healer: Presence on NADPH oral presentation delivered in National Seminar on Harnessing Science and Technology for HEALTH FOR ALL with Special Reference to North-East India, Department of Pharmaceutical Sciences, Dibrugarh University, India, September 24-25, 2001.
5. Once the germination period was over, we are publishing research articles on Placentrex since 2004, in different national and international peer-reviewed journals (see below). 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:
Journal Year country of origin
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. Moreover, Several clinical studies have also been done on it and these are also published in different peer-reviewed medical journals.
It’s a demand for proper justice regarding reconsideration of banning of such a good product of India for the sake of the sufferer of chronic/non healing wounds, burn injuries and surgical trauma. This ban is very much unethical with all respect and must be reconsidered.Without knowing the actual fact banning of such a successful Indian formulation is a shame for the country itself.
This is for your perusal and kind consideration.Thanking You,
Sincerely,
Dr. Piyali Datta Chakraborty, Ph.D. (Science)
What I have 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 with their Govt. approvals and what could be the consequences of it (esp. in India) if such restrictions are withdrawn in western countries.
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.
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.
My strongest support is with the above comments. Research findings on indigenous human placental extract which is available at pubmed (www.pubmed.com) is very rational, based on extremely scientific foundation. Efficacy of the drug is unquestionable and it has been accepted by the global scientific community through several high rated international as well as national scientific journals. Banning of such a successful Indian formulation is a shame for the country itself. Through the research on this placental extract our country has been glorified several times. Without knowing the actual fact, banning the drug is shameful as per my opinion.
D. Chakraborty
Kolkata, India
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 boost up the ongoing research work on Human Placental Extract in India.
I wish to thank all the supporters of human placental extract. I am also grateful to all of them.
Dr. Piyali Datta Chakraborty. Ph.D.
Kolkata, India
Food Recruitment
Thanks for your great information, the contents are quiet interesting.I will be waiting for your next post.