Govt to look into the GVK Bio issue on alleged manipulation
A government panel is reported to have been constituted to look into the matter of alleged manipulation of clinical trials by GVK Bio. The issue came under the government consideration after ANSM, the French drug regulator raised concerns over the data integrity. A government official, directly associated with investigating the matter has however commented that even though the issue has no bases, we are still pursuing the matter, as reported by PTI.
Read Also: EU bans 700 generic drugs, accuses GVK for manipulation of trials
The official further implied that the aim of the panel is to look into the matter with objectiveity and give it a fair trial on the allegations laid by ANSM. The panel now just simply wants to know what has been alleged is true or not. The allegation of data integrity - we have gone through the data extensively and no data manipulation has been found.", further confirmed the official.
Read Also : India seeks legal advice on imposed ban by EU on GVK Biosciences
A government-appointed committee comprising officials from various departments visited the facility of GVK Bio here yesterday and will soon submit its report, said Sudhanshu Pandey, Joint Secretary, Department of Pharmaceuticals.
"The government is still pursuing the matter. The government has set up a panel and that panel visited GVK Bio (unit) yesterday, interacted with the company and went into the primary data and a whole lot of things," Pandey told reporters.
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EU drug regulator, the European Medicines Agency (EMA), in January had suspended the marketing authorisation of some of the drugs on grounds that they were based on clinical trials allegedly manipulated by the Hyderabad-based company.
EMA issued the order based on the French regulator's (ANSM) allegation that data were manipulated by the company.
Replying to a query, Pandey said they have sought some more details from ANSM (French National Agency for Medicines and Health Products Safety) which are yet to be received.
The official said discussions are going on with health regulators of 11 South Asian countries on the issues related to inspection of drug manufacturing facilities.
He said the government is of the opinion that common standards can be set up for inspections and related issues so as to cut down repeated and multiple scrutiny of a manufacturing unit by regulators.
Read Also: EU bans 700 generic drugs, accuses GVK for manipulation of trials
The official further implied that the aim of the panel is to look into the matter with objectiveity and give it a fair trial on the allegations laid by ANSM. The panel now just simply wants to know what has been alleged is true or not. The allegation of data integrity - we have gone through the data extensively and no data manipulation has been found.", further confirmed the official.
Read Also : India seeks legal advice on imposed ban by EU on GVK Biosciences
A government-appointed committee comprising officials from various departments visited the facility of GVK Bio here yesterday and will soon submit its report, said Sudhanshu Pandey, Joint Secretary, Department of Pharmaceuticals.
"The government is still pursuing the matter. The government has set up a panel and that panel visited GVK Bio (unit) yesterday, interacted with the company and went into the primary data and a whole lot of things," Pandey told reporters.
Read Also :
EU's ban on medicines clinically tested by GVK Biosciences is a big disappointment, says Nirmala Sitharaman
EU drug regulator, the European Medicines Agency (EMA), in January had suspended the marketing authorisation of some of the drugs on grounds that they were based on clinical trials allegedly manipulated by the Hyderabad-based company.
EMA issued the order based on the French regulator's (ANSM) allegation that data were manipulated by the company.
Replying to a query, Pandey said they have sought some more details from ANSM (French National Agency for Medicines and Health Products Safety) which are yet to be received.
The official said discussions are going on with health regulators of 11 South Asian countries on the issues related to inspection of drug manufacturing facilities.
He said the government is of the opinion that common standards can be set up for inspections and related issues so as to cut down repeated and multiple scrutiny of a manufacturing unit by regulators.
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