Health ministry amends notification allowing use of human placental extract & its formulations
The union health ministry has amended its earlier notification dated February 10, 2011 thereby allowing the use of human placental extract and its formulations for two indications---topical application for wound healing and injection for pelvic inflammatory disease.
In the notification issued by the ministry said: the Central government hereby amends item No. (4) of the third paragraph of the aforesaid notification no. G.SK 82(E) dated 10.2.2011 as under: “4. Human Placental Extract and its formulations for human use except its (i) Topical application for wound healing, and (ii) Injection for pelvic inflammatory disease subject to the condition that the manufacturers of Human Placental Extract and its formulations for human use shall maintain meticulous details and traceability of the donors of the Placenta so as to ensure that the Placenta is collected from the donors who are free from HIV, HBsAg, HCV and other viruses.”
The health ministry's action comes after an order issued by the Delhi High Court on a petition moved by the Kolkatta-based pharma company Albert David Ltd after the ministry banned Human Placental Extract and its formulations for human use on February 10 this year.