Govt urged to differentiate between spurious, substandard drugs

LAHORE: Pakistan Pharmaceutical Manufacturers Association (PPMA) has said that the substandard drugs are not the same as spurious drugs and both should not be charged with similar punishment.
PPMA representatives, while addressing the media, pointed out that globally the spurious drugs are the ones which are not genuine and produced by unlicensed manufacturers. “The spurious drug does not contain the active ingredient required to cure a particular ailment,” they said, adding that as a criminal act and approving its severe punishment.
They said there is a global consensus on this issue, but the case of substandard drugs is different in comparison with spurious drugs. “The manufacturers usually do not intentionally lower the quantity of the active ingredient in the preparation and is very much a scientific error,” they added. However, the punishment for such crime is usually a heavy fine, not a jail term, the PPMA representatives said.
“When any duly qualified and licensed manufacturer produces an approved drug, it is released for marketing after testing the quality,” they said, adding that the quantity of active ingredient in the drug is according to the range provided in the British or US pharmacopoeias.
“It may sometimes happen that the quantity of active drug in a preparation is reduced due to faulty storage or any other reason. This drug is then designated globally as substandard drug,”
They said manufacturing companies around 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 Many times the substandard drugs if detected are withdrawn by the manufacturer from the market. However, sometimes the regulators detect the substandard drugs.
In such cases the fault is not intentional, but still the manufacturers are heavily fined. They said some globally renowned drug manufacturers have been fined around the globe when their preparations were not found to the exact specification. From 2010 to-date GSK has been fined $3 billion, Pfizer $2.3 billion, Abott $1.98 billion and Bayer $500 million.
Similarly, the companies like Baxter, Hospira, GSK, Bayer, Novartis, and Ranbaxy recalled their drugs due to some flaws in good manufacturing practices or for being substandard. For that they faced no criminal charges anywhere in the world, the representatives added.
“Treating the manufacturer of spurious and substandard drug as the same crime is like treating a road accident and a murder as same offence,” they said. The PPMA asked the government to separate this from a larger crime of manufacturing spurious drugs.
They said the government needs a strengthened and transparent regulatory institution that proactively checks the quality of drugs and such draconian laws would simply increase the rate of bribe instead of improving the quality of medicines.