The Department of Health and Family Welfare vide notification dated the 13th January, 2022 has issued the New Drugs and Clinical Trials (Amendment) Rules, 2022. The amendment has extended the scope of new drugs to include cell or stem cell derived product. Previously the definition of new drug under the New Drugs and Clinical Trials Rules only included stem cell derived product.
Consultation paper on Maintenance of Record of Mandatory Communication by Regulated Entities
It is proposed that the regulated entities maybe mandated to maintain the record of all such communication, which are mandated to be communicated under the