NEW DELHI, Apr 26:
The Government has banned 344 fixed dose combination drugs in March this year as they lacked therapeutic “rationality and justification”, Rajya Sabha was informed today.
“The Central government has banned 344 fixed dose combinations on March 10 this year as these combinations lacked therapeutic rationality or justification,” Health Minister J P Nadda said in a written reply.
He said safety and efficacy issues relating to certain drugs which have been banned in some countries have been examined and some of these have been allowed for continued marketing with stipulated restrictions.
These drugs include ‘Nimesulide’ whose manufacture, sale and distribution for human use in children below 12 years of age has been prohibited in the country.
The other drug is ‘Analgin’ whose manufacture for sale, sale and distribution for human use was initially suspended in the country on June 18, 2013 but subsequently Drug Testing Advisory Board (DTAB) examined the issue and the ban was revoked.
However, it was subject to the condition that manufacturers will be required to mention on the package that the drug is indicated for severe pain and pain due to tumour and also for bringing down temperature in refractory cases when other antipyretics fail to do so, Nadda said.
Elaborating about the third drug ‘Pioglitazone’, the minister said the manufacture for sale, sale and distribution of this drug for human use was also initially suspended on June 18, 2013.
“Subsequently, DTAB, after examination, recommended revocation of the suspension on certain conditions and accordingly, the suspension was revoked subject to the condition that the manufacturer shall mention on the package that the drug should not be used as first line of therapy for diabetes.
The manufacturers also needed to mention ‘Advice for healthcare professionals’ on their package which includes patients with active bladder cancer or with a history of bladder cancer, and those with uninvestigated haematuria, should not receive pioglitazone while prescribers should review the safety and efficacy of pioglitazone in individuals after 3–6 months of treatment.
Replying to another question, Nadda said many State Licensing Authorities (SLAs) had, despite not having the authority to grant licences for new FDCs, continued to grant licences without approval of the Drugs Controller General (IndiaDCG(I).
Nadda said the Department Related Parliamentary Standing Committee (PSC) on Health Ministry had observed that some SLAs had issued manufacturing licences to a very large number of fixed dose combinations without prior clearance from CDSCO which had resulted in the availability of many FDCs in the market which have not been tested for efficacy and safety.
“DCG(I) had requested all state and UT Drug Controllers to ask the concerned manufacturers to prove the safety and efficacy of such FDCs as had been licensed by SLAs prior to October 1, 2012 without obtaining the approval of DCG(I).
“In reply, CDSCO received approximately 6320 applications from manufacturers for proving the safety and efficacy of these FDCs. On scrutiny, it was observed that many FDCs are being manufactured by a number of applicants,” Nadda said.
He said a ten-member expert committee was then constituted in 2014 for examining the safety and efficacy of these FDCs.
“The expert committee, after detailed examination and deliberations recommended that some of these FDCs that lacked therapeutic justification, were found to be pharmacokinetically or pharmacodynamically incompatible, had abuse potential or could lead to antibiotic resistance in the population. (PTI)
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