Pointing to a collusive nexus between drug manufacturers, officials of Drugs Control Organisation and medical experts in granting approvals to new drugs, a Parliamentary Panel said drugs banned, discarded or withdrawn in developed countries are in circulation in India.
The Parliamentary Standing Committee on Health and Family Welfare also pointed to serious lapses and irregularities on the approvals of new drugs and pointed out that 33 such drugs were approved without conducting clinical trials on Indian patients.
Alarmed at concerns of safety of Indian patients using such new drugs approved by the Central Drugs Standard Control Organisation (CDSCO), the top body handling approval of drugs, the Committee held "this matter needs to be reviewed to ensure safety of patients, fair play, transparency and accountability."
The Committee said scrutiny of 42 drugs picked up randomly involving grant of drug approvals in utter disregard of regulatory procedures and violation of rules and pointed out to files of approval of three controversial drugs (pefloxacin, lomefloxacin and sparfloxacin) found missing and untraceable.
These drugs were either never marketed or withdrawn in the US, Canada, Britain, Australia and other countries.
The Committee also pointed to a nexus between drug industry and medical experts who give their opinion on "personal perception" to push "unsafe" drugs for use.
"The Committee expresses its deep concern, extreme displeasure and disappointment at the state of affairs...The Ministry should ensure that the staff at CDSCO does not indulge in irregularities in approval process of new drugs that can potentially have adverse effect on the lives of people. It is difficult to believe that these irregularities on the part of CDSCO were merely due to oversight or unintentional. Hence, all cases should be investigated," the Committee held.
On the three drugs whose files went missing, the Panel held "all these drugs were approved on different dates and years creating doubts if their disappearances were accidental.
In India, these drugs are on sale. It is not posible to monitor if manufacturers are abiding by conditions of approval."
Citing the example of Deanxit, the Panel pointed out that the drug continued to be prohibited for sale and use in Denmark, the country of its origin, and thus permission to import and market it in India was given unlawfully.
"There must be some very good reasons for Danish Medical Agency not to approve a domestically developed drug where an anti-depressant drug would be in greater demand as compared to India. Curiously, Deanxit is allowed to be produced and exported but not allowed to be used in Denmark," it said.
The panel cited another example of Letrozole by Novartis, used as an anti-cancer drugs used only in post-menopausal women, is used only in India where it is permitted for use in female infertility.
The Panel also found that in some drugs like Buclizine administered to babies for appetite stimulation was unlawfully approved in India without clinical trials and without consulting experts. Latest scientific evidence from countries like Belgium, where the drug originated, was sought by the panel while seeking review of its approval.
After scrutiny of 39 drugs documented, the panel said 13 drugs (33 per cent) like buxlizine for appetite stimulation, nimuselid injection, Dozoflylline, Foxed Dose Combination of of Pregabalin with other agents, FDC of Ofloxacin with Ornodazole did not have permission for sale in any major developed countries like US, Canada, Australia, UK or EU and none had special relevance to medical needs here.
It held that in 11 drugs (28 per cent) like Everolimus of Novartis, Colistimethate of Cipla, Exemestane of Pharmacia, Ademetionine of Akums, Pemetrexid of Eli Lilly, Ambrisentan of GlaxoSmithKline, mandatory Phase III clinical trials were not conducted.
The Parliamentary Standing Committee on Health and Family Welfare also pointed to serious lapses and irregularities on the approvals of new drugs and pointed out that 33 such drugs were approved without conducting clinical trials on Indian patients.
Alarmed at concerns of safety of Indian patients using such new drugs approved by the Central Drugs Standard Control Organisation (CDSCO), the top body handling approval of drugs, the Committee held "this matter needs to be reviewed to ensure safety of patients, fair play, transparency and accountability."
The Committee said scrutiny of 42 drugs picked up randomly involving grant of drug approvals in utter disregard of regulatory procedures and violation of rules and pointed out to files of approval of three controversial drugs (pefloxacin, lomefloxacin and sparfloxacin) found missing and untraceable.
These drugs were either never marketed or withdrawn in the US, Canada, Britain, Australia and other countries.
The Committee also pointed to a nexus between drug industry and medical experts who give their opinion on "personal perception" to push "unsafe" drugs for use.
"The Committee expresses its deep concern, extreme displeasure and disappointment at the state of affairs...The Ministry should ensure that the staff at CDSCO does not indulge in irregularities in approval process of new drugs that can potentially have adverse effect on the lives of people. It is difficult to believe that these irregularities on the part of CDSCO were merely due to oversight or unintentional. Hence, all cases should be investigated," the Committee held.
On the three drugs whose files went missing, the Panel held "all these drugs were approved on different dates and years creating doubts if their disappearances were accidental.
In India, these drugs are on sale. It is not posible to monitor if manufacturers are abiding by conditions of approval."
Citing the example of Deanxit, the Panel pointed out that the drug continued to be prohibited for sale and use in Denmark, the country of its origin, and thus permission to import and market it in India was given unlawfully.
"There must be some very good reasons for Danish Medical Agency not to approve a domestically developed drug where an anti-depressant drug would be in greater demand as compared to India. Curiously, Deanxit is allowed to be produced and exported but not allowed to be used in Denmark," it said.
The panel cited another example of Letrozole by Novartis, used as an anti-cancer drugs used only in post-menopausal women, is used only in India where it is permitted for use in female infertility.
The Panel also found that in some drugs like Buclizine administered to babies for appetite stimulation was unlawfully approved in India without clinical trials and without consulting experts. Latest scientific evidence from countries like Belgium, where the drug originated, was sought by the panel while seeking review of its approval.
After scrutiny of 39 drugs documented, the panel said 13 drugs (33 per cent) like buxlizine for appetite stimulation, nimuselid injection, Dozoflylline, Foxed Dose Combination of of Pregabalin with other agents, FDC of Ofloxacin with Ornodazole did not have permission for sale in any major developed countries like US, Canada, Australia, UK or EU and none had special relevance to medical needs here.
It held that in 11 drugs (28 per cent) like Everolimus of Novartis, Colistimethate of Cipla, Exemestane of Pharmacia, Ademetionine of Akums, Pemetrexid of Eli Lilly, Ambrisentan of GlaxoSmithKline, mandatory Phase III clinical trials were not conducted.
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