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DTAB again turns down health ministry's proposal to amend Rule 3-A of D&C Rules to notify NIB as CDL for testing vaccines
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Ramesh Shankar, Mumbai
May 26 , 2016
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The Drugs Technical Advisory Board (DTAB), the highest authority under
the Union health ministry on technical matters, has once again turned
down the ministry's proposal to amend Rule 3-A of the Drugs &
Cosmetics Rules, 1945 to notify the National Institute of Biologicals
(NIB) as Central Drug Laboratory for testing of some of the vaccines
such as BCG vaccine. These vaccines are currently being tested at
Central Drug Laboratory, CRI, Kasauli.
According to sources, the
DTAB in its 71st meeting held on May 13, 2016 once again decided
against the ministry's proposal to amend Rule 3-A of the Drugs &
Cosmetics Rules, 1945. Rules 3-A of the Drugs and Cosmetics Rules
prescribes the functions which a laboratory may discharge as Central
Drugs Laboratory in respect of the drugs specified therein. “The DTAB
after deliberations agreed that CDL CRI Kasauli has been notified as
Central Drugs Laboratory for vaccines and is functioning satisfactorily
and there is no need to notify another lab for the purpose at present,”
it said.
This is not the first time that the DTAB is rejecting a
proposal in this regard by the health ministry. Earlier, the issue of
notifying NIB as Central Drug Laboratory for testing of vaccines such as
BCG vaccine, live attenuated measles vaccine, live attenuated rubella
vaccine and cell culture rabies vaccines came up for discussion during
the DTAB's 70th meeting held on August 18, 2015 at CDSCO Bhawan, New
Delhi. After detailed deliberations, the DTAB did not agree to the
proposed amendment of Rules 3-A of the Drugs and Cosmetics Rules.
The
health ministry once again placed the proposal before the DTAB for its
reconsideration and directed that the recommendations may include
specific reasons or grounds to support the recommendations for the
purpose of transparency.
The NIB, Noida is a notified lab under
sub-rule (8) of Rule 3-A for testing of certain categories of drugs as
appellate laboratory. These drugs include blood grouping reagents;
diagnostic kits for human immunodeficiency virus, hepatitis B surface
antigen and hepatitis C virus; blood products; and recombinant products
such as biochemical kits.
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