|
DTAB to consult ICMR for including stem cell & cell based products under definition of new drug
|
|
Ramesh Shankar, Mumbai
March 30 , 2015
|
|
|
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.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|