The Drugs Technical Advisory Board (DTAB), the highest authority under the Union health ministry on technical matters rejected a proposal to make amendment in the Drugs and Cosmetics Rules, 1945 demanding to sell remaining quantities of unused clinical trial batch of a biological drug within its shelf life. This came into discussion on the 68th annual meeting of DTAB which was held on 16 February. The members of the meeting said that, only after the assurance of consistency, biological products can be permitted to sell.

The proposal is to make use of the valuable drugs which is manufactured under test license for the purpose of clinical trials. Currently, as it is manufactured on a test license, it cannot be sold and remaining unused drugs will be destroyed. After the discussions, the DTAB rejected the proposal to sell remaining unused clinical trial batch of a biological drug within its shelf life. DTAB was reconstituted recently with the appointment of Dr. Jagdish Prasad, director general of health services (DGHS) as the chairman and Dr. G N Singh, Drugs Controller General (India) as one of its member secretary.

PharmaBiz

 

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