The
following drugs have been banned/suspended during last three years and current
year keeping in view the likely risk to human beings and availability of safer
alternatives in the country:-
1. Serodiagnostic
test kits for diagnosis of tuberculosis on 7th June, 2012.
2. Dextropropoxyphene
and formulations containing Dextropropoxyphene for human on 23rd
May, 2013.
3. Analgin and all
formulations containing Analgin on 18th June, 2013. [Suspension of
this drug was subsequently revoked on 13th February, 2014 subject to
the certain conditions.]
4. Suspension of
fixed dose combination of Flupenthixol + Melitracen on 18th June,
2013. It was subsequently prohibited on 11th July, 2014.
No
case of manufacturing and marketing of unapproved New Drugs / Fixed Dose
Combinations (FDCs) have been reported in the recent past. The manufacturing
and marketing of banned drugs is a punishable offence under the Drugs &
Cosmetics Act, 1940 and the State Licensing Authorities are empowered to take
action in such cases.
The Central
Government has, on 1st October 2012, issued statutory directions
under Sections 33P of the Drugs and Cosmetic Act, 1940 to all the State/Union
Territory Governments to instruct their respective Drug Licensing Authorities
to abide by the provisions of the Drugs and Cosmetics Rules, 1945 while
granting manufacturing licenses for drugs falling under the definition of the
term “New Drug” and not to grant licenses for manufacture, for sale or for
distribution or for export of such new drugs, except in accordance with the
procedure laid down under the said Rules including obtaining approval of the
Drugs Controller General (India) before granting such licenses. The State Drug
Controllers have also been requested to ensure that New Drugs and FDCs are not
permitted without approval from the office of DCG (I) and the drugs prohibited
by the Central Government are withdrawn from the market with immediate effect.
The Health
Minister, Shri J P Nadda stated this in a written reply in the Lok Sabha here
today.
*****
MV/BK