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)
