"..at the port for months were on the verge of expiry."
Why don't you wait for the green light first, then import.
"..at the port for months were on the verge of expiry."
Why don't you wait for the green light first, then import.
Odias3mpa 10 years ago
Ghanaian penchant to always 'short-circuit' existing systems in place!
What is all this 'nonsense' about giving the FDA`s clientele visibilty into its activities? The onus is clearly on the local pharmaceutical companies and ... read full comment
Ghanaian penchant to always 'short-circuit' existing systems in place!
What is all this 'nonsense' about giving the FDA`s clientele visibilty into its activities? The onus is clearly on the local pharmaceutical companies and their overseas partners to PROVIDE the regulator,FDA, with as much information as possible on drugs they intend to bring into the country!
Btw, why is IMANI dumping so much on the FDA, but not on the head-honchos at the MOH and the various health establisments, who drive the importation of medications into the country?
terry 10 years ago
There seem to be no respite for troubled Indian drug manufacturers Ranbaxy. Reports say that, after facing U.S. Food and Drug Administration (FDA) action last week for manufacturing lapses, the company, acquired by Japanese d ... read full comment
There seem to be no respite for troubled Indian drug manufacturers Ranbaxy. Reports say that, after facing U.S. Food and Drug Administration (FDA) action last week for manufacturing lapses, the company, acquired by Japanese drug maker Daiichi Sankyo in 2008, now faces regulators agencies in Australia and Europe which are also assessing if drugs manufactured and exported by the Indian firm to their regions are affected.
Reuters
A Ranbaxy office building in Mohali
Media reports said that regulators in Australia and Europe, including the UK, have sought information from the U.S. FDA about the alleged lapses, which led to a U.S. ban last week on imports of products made at the Ranbaxy's Mohali facility.
Action by these regulators will be taken after assessing response from the FDA, reports said.
The Mohali plant was commissioned by the company in 2011 and had started drug exports in 2012. It is the third Ranbaxy facility in India to face FDA axe after two of its plants in Dewas and Paonta Sahib. The company has 16 manufacturing units in eight countries and ground operations in 43 nations.
The U.S. FDA banned import of drugs made at the Mohali unit last week after it found lapses, including tablets embedded with "black fibre" suspected to be hair from an employee's arm and "black spots" of oil from machines in tablets.
Meanwhile, Ranbaxy said it will continue to fully cooperate with the FDA and take steps to resolve the concerns at the earliest.
A spokesperson for Australia's Therapeutic Goods Administration (TGA), quoted by the media agency, said action will determined after FDA information is assessed.
"The TGA is in communication with the US FDA and is awaiting details to determine whether any Australian medicines may be affected by the FDA findings," the spokesperson was quoted in the report as saying.
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is also reported to have said that an impact assessment is underway.
"We are currently working with the FDA and other European regulators to assess the impact the FDA's action has on the medicines from the Mohali site that are destined for the UK and European market," the MHRA was quoted as saying.
"There is currently no evidence that medicines on the UK and EU market manufactured at this site are defective, so people should continue to take their medicines," the agency said.
Meanwhile, report said the World Health Organisation did not comment on its action plan, saying only that it had taken note of the U.S. FDA's past actions against Ranbaxy.
In related news, the Indian regulatory authorities, including the Drug Control General of India (DCGI) said they will be looking into complaints against Ranbaxy's Mohali unit.
Ranbaxy clocked sales worth over $1 billion in the Americas in 2012, while it garnered over $420 million in Europe and over $270 million from Asia and Africa, reports said.
Nii Ashitey 10 years ago
The FDA must be applauded for doing a good job not denigrate it.Unlike our attitude which says that anything is possible with money,the FDA for once is proving that it is above board and that it is putting the interest of th ... read full comment
The FDA must be applauded for doing a good job not denigrate it.Unlike our attitude which says that anything is possible with money,the FDA for once is proving that it is above board and that it is putting the interest of the country above parochial considerations.
Instead of Imani appreciating the stand of the FDA it has chosen this time to divert attention from the burning issue of greedy companies by- passing laid down rules and regulation at the expense of human life.
After the sixties drug thalidomide disasters the world realize even more urgently the need for drug control and regulations.The various drug agencies of the world were charged with ensuring the safety,quality and efficacy of drugs before being released for human use.For Imani to choose this time to raise its concern about the efficiency of the FDA, is not only suspicious of its role to limit the damage caused by this company but also the improper conduct to place its interest above Ghanaian lives because of personal considerations.This is irresponsible of this imnai so called think thank.
What Imani must know is that the FDA is under a legal duty to ensure that that the FDA would rely on scientific testing and that new drug approvals would be based not only upon proof of safety, but also on "substantial evidence" of a drug's efficacy which means it must be given time to do its work and not rushed.In this case the company involved has accepted wrong doing and had apologized and express regret for not following laid down procedure.This is the burning issue and any other thing at this time is an exercise at diverting attention.
The FDA must be given time to do its work.The Imani think thank should not pressurize the agency into cutting corners.It is not in the interest of Ghanaian life for them to do so and imani must know that.This raises the motive behind this Imani petition.I think it is in bad faith and must be condemned.
"..at the port for months were on the verge of expiry."
Why don't you wait for the green light first, then import.
Ghanaian penchant to always 'short-circuit' existing systems in place!
What is all this 'nonsense' about giving the FDA`s clientele visibilty into its activities? The onus is clearly on the local pharmaceutical companies and ...
read full comment
There seem to be no respite for troubled Indian drug manufacturers Ranbaxy. Reports say that, after facing U.S. Food and Drug Administration (FDA) action last week for manufacturing lapses, the company, acquired by Japanese d ...
read full comment
The FDA must be applauded for doing a good job not denigrate it.Unlike our attitude which says that anything is possible with money,the FDA for once is proving that it is above board and that it is putting the interest of th ...
read full comment