NEW DELHI: A parliamentary panel on health and family welfare has reprimanded the government for failing to initiate action against doctors and officials, who it said 'colluded' with the pharma industry to approve new drugs in violation of the law.
It specially took note of specific cases, where approvals were granted for additional use for existing drugs without mandatory clinical trials being conducted.
The panel has asked the health ministry to forward the names of 'erring doctors' to theMedical Council of India and medical colleges and hospitals in the next seven days for appropriate action.
The panel headed by Member of Parliament Brajesh Pathak has cited instances of drugs-placenta extract gel and Letrozole -which were given a green signal for new usage in violation of the Drugs and Cosmetics Act.
"..in a clear case of extreme collusion and breach...an official of CDSCO (Drug Controller general of India's office) through a letter dated February 11, 2000, in spite of additional indications (burns and wounds, non-healing indolent ulcers, bedsore, mucositis, etc),...gave permission to promote the placenta extract gel. By including the term 'etc', loopholes were left wide open to add other indications, which is an unprecedented irregularity and illegality," noted the panel in a report tabled on Friday.
The collusive element was so overpowering that the letter of the manufacturer dated February 7, 2000, not only reached Delhi from Kolkata at breakneck speed, the permission, albeit wrong, was also granted within four days on February 11, 2000, the report says.
"The committee is aghast to note the paralytic inertia gripping the (health) ministry, which is preventing it from taking action against guilty official(s) of CDSCO and others involved in cases of delinquency and illegality," the report said.
In response, the health ministry had submitted to the parliamentary panel that it would be conducting an internal enquiry to investigate the matter of 'collusion'.
An earlier parliamentary panel probe report submitted in May last year had created a furore on the drug regulatory system in the country. The probe, after assessing a random sample, had alleged a total of 31 new drugs were approved between January 2008 and October 2010 without mandatory clinical trials on Indian patients.
The 2012 probe had also claimed that pharma companies had fudged opinions of medical experts recommending approvals. As proof, the panel furnished identically worded letters from doctors based in different cities recommending approval to the same drug. This led the panel to allege "many opinions were actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signatures".
It specially took note of specific cases, where approvals were granted for additional use for existing drugs without mandatory clinical trials being conducted.
The panel has asked the health ministry to forward the names of 'erring doctors' to theMedical Council of India and medical colleges and hospitals in the next seven days for appropriate action.
The panel headed by Member of Parliament Brajesh Pathak has cited instances of drugs-placenta extract gel and Letrozole -which were given a green signal for new usage in violation of the Drugs and Cosmetics Act.
"..in a clear case of extreme collusion and breach...an official of CDSCO (Drug Controller general of India's office) through a letter dated February 11, 2000, in spite of additional indications (burns and wounds, non-healing indolent ulcers, bedsore, mucositis, etc),...gave permission to promote the placenta extract gel. By including the term 'etc', loopholes were left wide open to add other indications, which is an unprecedented irregularity and illegality," noted the panel in a report tabled on Friday.
The collusive element was so overpowering that the letter of the manufacturer dated February 7, 2000, not only reached Delhi from Kolkata at breakneck speed, the permission, albeit wrong, was also granted within four days on February 11, 2000, the report says.
"The committee is aghast to note the paralytic inertia gripping the (health) ministry, which is preventing it from taking action against guilty official(s) of CDSCO and others involved in cases of delinquency and illegality," the report said.
In response, the health ministry had submitted to the parliamentary panel that it would be conducting an internal enquiry to investigate the matter of 'collusion'.
An earlier parliamentary panel probe report submitted in May last year had created a furore on the drug regulatory system in the country. The probe, after assessing a random sample, had alleged a total of 31 new drugs were approved between January 2008 and October 2010 without mandatory clinical trials on Indian patients.
The 2012 probe had also claimed that pharma companies had fudged opinions of medical experts recommending approvals. As proof, the panel furnished identically worded letters from doctors based in different cities recommending approval to the same drug. This led the panel to allege "many opinions were actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signatures".
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