Mumbai, 20 Apr: The union health ministry has finalised the 9-member expert committee to go into the issue of efficacy and safety data of human placental extract which has been banned by the government along with some other controversial drugs including the non-steroid anti-inflammatory drug nimesulide suspension, gastroprokinetic agent cisapride and decongestant drug Phenylpropanolamine (PPA) on February 10 this year.
Renowned pharmacologist Dr YK Gupta of AIIMS will head the panel. Other members of the committee include Dr Ajay Kumar of IMA, Dr Vijay Kumar of IDRI, Dr Sharma of ICMR, Dr Kotwal of AIIMS, Dr VK Tiwari, Dr VK Chakravorthy, Dr CM Sharma and Dr Lakhbir Dhaliwal of PGI, Chandigarh.
The expert panel has been constituted by the ministry on the directive of the Delhi High Court which heard a petition on April 6 by the Kolkatta-based pharma company Albert David Ltd, which was a pioneer in human placental extract therapy, for staying the government notification in which the controversial drugs were banned in the country.
Refusing to grant stay on the ministry's notification banning the controversial drug human placental extract, the court asked the government to constitute a 9-member expert committee to go into the issue of efficacy and safety data of human placental extract. The expert committee has been asked to submit a report on the matter by May 15 this year.
The union health ministry had banned several controversial drugs including human placental extract following the Drugs Technical Advisory Board (DTAB)'s recommendation to the ministry to ban these drugs after it was found by the Board that these drugs will have adverse effects on human health. The DTAB is the highest decision-making body under the Union health ministry on technical matters.
Human placental extract was one of the controversial drugs which was under the radar of the health ministry for some time. In India, human placenta extract sold as Placentrex lotion, gel and injection is 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.
But, that is not the case in the international market, especially in the developed countries. According to reports, all products containing extract of human placenta have been banned by the US FDA since they can transit diseases and pose serious health hazards to consumers. Placenta extract was never permitted for use as medicine in the western countries such as US, UK, Australia, Canada and European Union states due to lack of efficacy and safety data. However, some companies in US were importing products containing human placenta as dietary supplements. However, on April 14, 2008, all products containing human placenta extracts even for use as cosmetics have been banned by the US government.
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