MINISTER OF THE STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NAM AZAD)
(a) to (e): A statement is laid on the fable of the Mouse.
STATEMENT REFERRED JO IN REPLY TO LOK SABHA STARRED QUESTION NO.614 FOR 07-05-2010
(a) & (b): Various anti-TB drugs like Rifampicin, Isonized, Pyrizinamide, Ethambutol,
Streptomycin etc. and combination of such drugs, including Resorine have been approved for
marketing in the country as per the provisions of the Drugs and Cosmetics Act and Rules.
These drugs are effective if taken as recommended.
(c) & (d): There is a system of routine quality surveillance of anti-TB drugs supplied
under the Revised National TB control Programme (RNTCP). Based on the results of routine
surveillance and the advice of the Expert Committee of the Ministry`, four batches of anti-TB
drugs were withdrawn in June 2009. These anti-TB drugs were supplied in 2007, after having
been fully compliant with Indian Pharmacopeia (IP)-1996, the standards prevailing at that time.
The Indian Pharmacopeia-2007 standards came into force in July 2008. During the tests conducted
in May 2009, these drugs were found to be not fully compliant with new; standards. Therefore,
on the advice of the Expert Committee, the drugs in question were withdrawn.
(e): With a view to ensuring supply of quality drugs, the Revised National TB Control
Programme (RNTCP) has put in place a quality assurance protocol. The procurement of anti-TB
drugs is carried out with the help of a professional procurement agency and through a
competitive bidding process. Prior to dispatch of drugs to the consignees, each batch
is subjected to inspection for quality testing at the supplier`s premises. In addition,
as an additional safeguard for continued stability and quality of these drugs under actual
field conditions, random samples are lifted from the field units and tested by NABL accredited
independent laboratories identified by the Ministry.
