Hyderabad: DCGI gives nod for use of Hydroxyurea in SCA treatment

Hyderabad: The Drugs Controller General of India (DCGI) gave its nod for the use of Hydroxyurea in the treatment of Sickle Cell Anaemia (SCA). The CSIR-SCA Mission, coordinated by the CSIR-Centre for Cellular and Molecular Biology (CSIR-CCMB) with the help of Cipla, one of the manufacturers of Hydroxyurea and with active support from CSIR-IIIM, approached the DCGI for approval of Hydroxyurea for SCA treatment.

The committee of experts constituted by Central Drug Standard Control Organisation (CDSCO), critically evaluated the proposal and approved marketing of Hydroxyurea for treatment for SCA, subject to post-marketing surveillance on December 9. The approval currently legalises the drug to be used at standard doses for treatment of SCA. It also sets up the stage for designing various formulations of smaller dose sizes that promise higher compliance rates in SCA children and may even lead to syrup-based formulations.

"This is a landmark achievement for Sickle Cell Anaemia community. This adds to the advantages of identifying the patients through a targeted screening programme. While one of the major focuses of the screening programme is to avoid the birth of affected children through genetic and social counselling, this approval provides comprehensive treatment to the identified patients. The message now needs to reach clinicians across the country so that they can use Hydroxyurea regularly for their patients," said Dr Giriraj R Chandak, Chief Scientist at CSIR-CCMB and Mission Director, leading the CSIR-SCA Mission.