New Delhi:
Some drugs, which are banned in other countries, have been allowed to be sold in India subject to certain provisions, the Lok Sabha was informed on Friday.
Minister of State for Health Faggan Singh Kulaste in a written reply said that the drugs which have been allowed are nimesulide, analgin and pioglitazone.
“Safety and efficacy issues which are related to certain drugs which have been banned in some countries have been examined and some of these have been allowed for continued marketing subject to stipulated conditions or restrictions.
“They include Nimesulide - the manufacture, sale and distribution of nimesulide formation for human use in children below 12 years of age has been prohibited in the country.
“Analgin - The manufacture for sale, sale and distribution of analgin and its formulations containing analgin for human use was initially suspended into the country w.e.f June 18, 2013. Subsequently, the ban was revoked subject to the condition that manufacturers will be required to mention the following on their package insert and promotional literature of the drug,” the Minister said.
Elaborating about the literature, the Minister said that “The drug is indicated for severe pain and pain due to tumour and also for bring down temperature in refractory cases when other antipyretics fail to do so” should be mentioned.
In case of Pioglitazone, the manufacture for sale, sale and distribution of the drug and formulations containing pioglitazone for human use was initially suspended w.e.f 18.6 2013.
Subsequently the suspension was revoked subject to condition that the manufacture shall mention “the drug should not be used as first line of therapy for diabetes” and the manufacturer should clearly mention in bold red in a warning box “Advice for healthcare professionals patients with active bladder cancer or with a history of bladder cancer and those with investigated haematuria should not receive pioglitazone” among others.
