Substandard and spurious: PPMA dismayed at decision to bracket the two
Association laments government’s policy to put drugs in same category.
Manufacturing companies throughout the world keep testing their products for quality and efficacy till the expiry date of that preparation. PHOTO: REUTERS
LAHORE:
Pakistan Pharmaceutical Manufacturers Association (PPMA) has registered its disappointment at the government’s decision to bracket substandard drugs as spurious drugs, treating scientific error as a criminal act.
The association clarified that if any product is damaged during packaging or marketing it can be categorised as substandard, however, this does not mean that the drug is illegal or expired.
PPMA representatives, while addressing media in Lahore, pointed out that globally spurious drugs are defined as those that are considered counterfeit and produced by unlicensed manufacturers. “Spurious drug do not contain active ingredients to cure a particular ailment, and should definitely be treated as criminal products.”
However, the group elucidated that the case of substandard drugs is different as the manufacturer does not intentionally damage the drug. “For this the maximum authorities should do is place heavy fines. Even globally no jail time is given.”
PPMA representatives further said that when any duly qualified and licensed manufacturer produces drug it is released for marketing only after its quality is thoroughly tested. They added that many times it may happen that the quantity of active drug in the preparation process may be compromised due to faulty storage or any other reason and is then designated as a substandard drug.
Manufacturing companies throughout the world keep testing their products for quality and efficacy till the expiry date of that preparation. Many times the substandard drugs, if detected, are withdrawn by the manufacturer. Sometime the regulators detect the substandard drug.
In such cases, since the fault is not intentional, the manufacturers are heavily fined. Some globally renowned drug manufacturers have been fined around the globe when their preparations were not found to the exact specification, they said.
From 2010 to-date GSK has been fined $3 billion, Pfizer $2.3 billion, Abott $1.98 billion and Bayer $500 million, representatives said. Similarly, they added, companies like Baxter, Hospira, GSK, Bayer, Novartis, and Ranbaxy recalled their drugs due to flaws in manufacturing practices or for being substandard. They faced no criminal charges anywhere in the world.
PPMA representatives added that treating the manufacturer of spurious and substandard drug as one in the same is a flaw. They added that they do not condone substandard drugs but are simply asking the government to separate this from the larger crime of manufacturing spurious drugs, they added.
“What the government really needs is a strengthened and transparent regulatory institution that proactively checks the quality of drugs and takes action against any non-compliant manufacturers.” They said in a weak regulatory environment such draconian laws would simply increase the rate of bribe instead of improving the quality of medicines.
Published in The Express Tribune, August 16th, 2015.
Pakistan Pharmaceutical Manufacturers Association (PPMA) has registered its disappointment at the government’s decision to bracket substandard drugs as spurious drugs, treating scientific error as a criminal act.
The association clarified that if any product is damaged during packaging or marketing it can be categorised as substandard, however, this does not mean that the drug is illegal or expired.
PPMA representatives, while addressing media in Lahore, pointed out that globally spurious drugs are defined as those that are considered counterfeit and produced by unlicensed manufacturers. “Spurious drug do not contain active ingredients to cure a particular ailment, and should definitely be treated as criminal products.”
However, the group elucidated that the case of substandard drugs is different as the manufacturer does not intentionally damage the drug. “For this the maximum authorities should do is place heavy fines. Even globally no jail time is given.”
PPMA representatives further said that when any duly qualified and licensed manufacturer produces drug it is released for marketing only after its quality is thoroughly tested. They added that many times it may happen that the quantity of active drug in the preparation process may be compromised due to faulty storage or any other reason and is then designated as a substandard drug.
Manufacturing companies throughout the world keep testing their products for quality and efficacy till the expiry date of that preparation. Many times the substandard drugs, if detected, are withdrawn by the manufacturer. Sometime the regulators detect the substandard drug.
In such cases, since the fault is not intentional, the manufacturers are heavily fined. Some globally renowned drug manufacturers have been fined around the globe when their preparations were not found to the exact specification, they said.
From 2010 to-date GSK has been fined $3 billion, Pfizer $2.3 billion, Abott $1.98 billion and Bayer $500 million, representatives said. Similarly, they added, companies like Baxter, Hospira, GSK, Bayer, Novartis, and Ranbaxy recalled their drugs due to flaws in manufacturing practices or for being substandard. They faced no criminal charges anywhere in the world.
PPMA representatives added that treating the manufacturer of spurious and substandard drug as one in the same is a flaw. They added that they do not condone substandard drugs but are simply asking the government to separate this from the larger crime of manufacturing spurious drugs, they added.
“What the government really needs is a strengthened and transparent regulatory institution that proactively checks the quality of drugs and takes action against any non-compliant manufacturers.” They said in a weak regulatory environment such draconian laws would simply increase the rate of bribe instead of improving the quality of medicines.
Published in The Express Tribune, August 16th, 2015.