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.