The Union Health Ministry is planning to regulate the functioning of umbilical cord blood collection and stem cell harvesting centres in the country. The ministry has proposed changes in the Drugs and Cosmetics Rules to prescribe the standards and procedures that are to be maintained while collecting umbilical cord blood. The centres engaged in the preparation of umbilical cord blood stem cells will have to apply for license under the D & C Act once the amendment comes through.

According to a recent draft notification, the criteria of the donor evaluation and selection have been proposed to be as per that of blood donor selection. The umbilical cord blood shall be tested for freedom from HIV 1 and HIV 2 antibodies, HBsAg, HCV, Malaria and Syphilis. The umbilical cord blood collected shall be stored at minus 196 degree centigrade continuously. The final product is to be tested for nucleated cell count (CD 34), cell viability freedom from infectious diseases and HLA matching before issue.

The umbilical cord blood stem cells are collected from the placental and/or umbilical vessels after the umbilical cord is clamped and / or sectioned. The draft notification proposes changes in Rule 122 E A to include the definition of 'umbilical cord blood' under the Drugs and Cosmetics Act and Rules. It also proposes to make change in Rule 122F and 122 G to insert the term 'umbilical cord blood'.

The changes will be effective after it is approved by the Drugs Technical Advisory Board constituted under the D&C Act.

As pharmabiz had reported, there is an increasing interest among domestic and international firms to get into the business of cord blood banks for harvesting umbilical cord blood stem cells in India.