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DTAB to consult ICMR for including stem cell & cell based products under definition of new drug

Ramesh Shankar, Mumbai
Monday, March 30, 2015, 08:00 Hrs  [IST]

The Drugs Technical Advisory Board (DTAB) of the Union health ministry will further consult experts from the Indian Council of Medical Research (ICMR) and other related fields for including stem cell and cell based products under the definition of the term new drug and prescribe forms for licensing of these products.


The issue of  including stem cell and cell based products under the definition of the term new drug came up for discussion at the DTAB's 68th meeting held on February 16 this year.

The DTAB after deliberations recommended that the issue of regulating the stem cells and cell based products require wider consultation with the experts from ICMR and other related fields for having stringent regulatory control. The Chairman was requested to consult the ICMR or other expert in the matter. The proposal would then be considered by DTAB in the light of the opinion so generated.

During the meeting, the members were briefed that the Union ministry of health and family welfare had constituted a High Powered Committee in June, 2013 under the chairmanship of Prof. Lalji Singh, Vice-Chancellor of Banaras Hindu University to regulate the usage of stem cell and other cell based products in India as the stem cells and other cell based products are being used for the treatment of human diseases by the clinicians. The committee recommended that Stem Cell and Cell Based Products (SCCPs) should be considered as a drug and included in the definition of the term new drug and necessary provisions may be made for their licensing under the Drugs and Cosmetics Rules, 1945.

Dr. Jagdish Prasad, Director General of Health Services (DGHS), is the chairman of the DTAB which is the highest authority under the Union health ministry on technical matters and Dr G N Singh, Drugs Controller General (India), is its member secretary.

 

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