Kolkata-based pharma company Albert David has received a shot in the arm following the Delhi High Court asking the Centre to allow use of human placental extracts for its topical application for wound healing and injectibles for pelvic inflammatory diseases. A division bench comprising justices Sanjay Kishen Kaul and Rajiv Shakdher while noting the health ministry?s submissions that the government had accepted the recommendation’s of a expert panel to amend its earlier notification, which banned the drug, said that the company ?would be able to carry the necessary activities in terms of the notification? (amended).
The ministry represented by counsel Neeraj Chaudhari had agreed to amend its notification of February 10 this year in which it had banned several controversial drugs, including human placental extract following the Drugs Technical Advisory Board’s recommendation. Other banned controversial drugs included non-steroid anti-inflammatory drug nimesulide suspension, gastroprokinetic agent cisapride and decongestant drug Phenylpropanolamine.
In India, human placenta extract, sold as Placentrex lotion, gel and injection, is being used to cure vitiligo, for wound dressing, for prevention of adverse effects due to radiotherapy, to cure fallopian tube blockage, besides in the treatment of female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc.
After examining the reports submitted by the 9-member expert committee headed by renowned pharmacologist Dr YK Gupta of AIIMS, the high court ordered that human placental extracts should be allowed for the two indications.
The high court, on Albert David’s plea, had asked the government to constitute a nine-member expert panel to give a comprehensive report.