LAHORE - The Pakistan Pharmaceutical Manufacturers Association has rejected amendments in the Drug Regulatory Authority of Pakistan Act (DRAP), 2012 and Drug Act 1976, announcing to launch a series of protest against the amended act while they have already started closing industrial units across the province.

PPMA former vice chairman Kh Shahzeb Akram talking to The Nation said that more than 70 per cent industry out of total 260 pharma units have been closed in protest while rest of the units will be shut on Monday.

“We are also starting a series of protest against this anti industry decision of the provincial government which empower the drug inspector to sentence the manufacturers for 10-year imprisonment at the spot. Our association has decided to handover keys of factories to Punjab govt as they are unable to work in this atmosphere. Now CM Shahbaz and its cabinet should run the industry.”

Shahzeb Akram said that quality of the drugs manufactured by its members is close to their heart; however they feel insulted when the government bracketed substandard drugs with spurious drugs treating scientific error with criminal act.

He said what the government really needs is a strengthened and transparent regulatory institution that proactively checks the quality of drugs and take action against any non-compliant manufacturer. He said in weak regulatory environment such draconian laws would simply increase the rate of bribe instead of improving the quality of medicines.

He pointed out that globally the spurious drugs are the one which are mostly fake and produced by unlicensed manufacturers. Additionally, he added, the spurious drug does not contain the active ingredient required to cure a particular ailment. He said this is definitely a criminal act and ought to be severely punished.

“There is a global consensus on this issue. Case of substandard drugs is different as the manufacturer usually did not do anything intentionally that result in lower quantity of the active ingredient in the preparation. This calls for heavy fines as is practiced universally but no jail terms,” he added.

Earlier, PPMA representatives while addressing the media, here at a local hotel, said when any duly qualified and licenced manufacturer produces an approved drug it is released for marketing after testing its quality. He said the quantity of active ingredient in the drug is according to the range provided in the British or US pharmacopeias.

He said it may sometime happen that the quantity of active drug in a preparation is reduced due to faulty storage or any other reason. This drug he added is then designated globally as substandard drug.

They said manufacturing companies the world over keep testing their products for quality and efficacy till the expiry date of that preparation.

PPMA former chairman Amjad Ali Jawa said that many times the substandard drugs if detected are withdrawn by the manufacturer from the market. Sometimes the regulators detect the substandard drug. In such cases since the fault is not intentional the manufacturers are heavily fined.

He said some globally renowned drug manufacturers have been fined around the globe when their preparations were not found to the exact specification. He said from 2010 to-date GSK has been fined $3 billion, Pfizer $2.3 billion, Abott $1.98 billion and Bayer $500 million. Similarly he added companies like Baxter, Hospira, GSK, Bayer, Novartis, and Ranbaxy recalled their drugs due to flaws in good manufacturing practices or for being substandard. They faced no criminal charges anywhere in the world.

Amjad Jawa said treating the manufacturer of spurious and substandard drug as same crime the government is like treating a road accident and a murder as same offence. He said the PPMA is in no way defending the substandard drugs but is simply asking the government to separate this from a larger crime of manufacturing spurious drugs.