PPA issue: Grumbles versus concerns<\/p>\n
By Emmy Fitri<\/p>\n
JAKARTA (JP): Pharmaceutical industries grumble and suspect
\n\"business competition\" is the motivation behind the new
\nregulation reducing the content of phenylpropanolamine (PPA) in
\ncough and flu medicines.<\/p>\n
The Food and Drug Control Agency (BPOM) issued on Dec.8 a
\nregulation requiring the amount of the substance be no more than
\n15 milligrams per dosage, to be effective as from April 8.<\/p>\n
The regulation was issued following a decision made by the
\nUnited States Food and Drug Administration (FDA) and several
\nother countries to withdraw medicines containing the substance
\ndue to fears of possible side effects.<\/p>\n
Phenylpropanolamine is an active substance commonly used as a
\ndecongestant.<\/p>\n
The prolonged use of the substance is feared to cause
\nhemorrhagic stroke and high blood pressure.<\/p>\n
But some have remarked that the new ruling has been spurned by
\ncompetition in the pharmaceutical industry, to give certain
\ncompanies, whose products do not contain phenylpropanolamine, an
\nunfair advantage.<\/p>\n
BPOM director Sampurno rebuked the suspicions and allegations
\ncoming from certain sections of the industry.<\/p>\n
\"The people who say that must know nothing about the
\npharmaceutical business,\" Sampurno charged. \"That's a low-level
\naccusation.\"<\/p>\n
\"In this business they are not supposed to prioritize profits
\nbut to emphasize public service and protection.\"<\/p>\n
Sampurno said recently he had summoned representatives of at
\nleast 20 large pharmaceutical companies and received a report on
\nthe recalling of their products which contain higher-than-allowed
\nphenylpropanolamine content.<\/p>\n
\"None of them complains about the regulations,\" Sampurno
\nclaimed.<\/p>\n
\"Those talking about conspiracy must be those who don't have
\npharmaceutical backgrounds. They must be businesspeople,\" he
\ncharged.<\/p>\n
Alex, a member of staff at the promotions division of Sanbe
\nFarma, remarked that the whole brouhaha about phenylpropanolamine
\nwas similar to the affair which recently hit taste enhancer
\nproducer Ajinomoto.<\/p>\n
\"Many believe it was merely caused by business competition.
\nWhy aren't other seasonings being checked too?\" Alex said of the
\npopular taste enhancer which had to be pulled from shelves
\nnationwide because the Indonesian Ulema Council declared it haram
\n(unfit for consumption according to Islamic teaching) for
\ncontaining pork enzymes.<\/p>\n
But rules are rules and BPOM, as the authorized governmental
\nagency, has full authority on such matters.<\/p>\n
\"What can I say. We have two products with PPA ingredients,
\nTuzalos with 25 milligrams of PPA and Sanaflu with 12.5 PPA per
\ntablet. Both have been adjusted (to meet regulations) and have
\nbeen distributed to replace the old ones,\" Alex said.<\/p>\n
Bambang Subroto, a marketing supervisor at PT Combiphar,
\nproducer of Combi Flu regretted BPOM's failure to reveal figures
\non the number of Indonesians suffering from side effects as a
\nresult of the substance.<\/p>\n
\"BPOM has never issued precise figures on the number of people
\nwho have suffered side effects from our products. People don't
\ncatch the flu or get a cough every day so they won't be consuming
\nour products every day,\" he remarked.<\/p>\n
\"Physically, Indonesians are different from Americans and
\nEuropeans. Effects on them might not be the same with us,\" he
\nadded.<\/p>\n
Combi Flu had adjusted its PPA substance from 25 milligram to
\n15 milligram per tablet. However it has yet to be distributed,
\nawaiting the complete recall of its old products from the market.<\/p>\n
The company is also awaiting the new product license from
\nBPOM, in order to start distributing the adjusted products.<\/p>\n
\"That means additional work for all sectors of the company. In
\nproduction we have to change the standardized measurements of the
\ningredients and for promotion we have to completely change the
\nadvertising image because the old one will not work as BPOM
\nplaced our product name on a public list,\" Bambang said.<\/p>\n
Without specifying, Bambang said additional costs were also to
\nbe incurred by registering at BPOM in order to obtain an
\nadvertising license for the products.<\/p>\n
\"I don't know the amount, it is between Rp 10 million and 12.5
\nmillion per license,\" he said.<\/p>\n
However, Sampurno denied the allegations and said Indonesia
\nwas the sole country that did not charge for pharmaceutical
\nregistration.<\/p>\n
\"There are no charges,\" he said stressing that company
\nofficials can directly go to him if BPOM officials try to extort
\nmoney.<\/p>\n
According to BPOM, as of April 20, from a total of 65 brands
\nof flu and cough medicines which had more than 15 milligrams of
\nphenylpropanolamine, 47 had been adjusted while 18 others are no
\nlonger being produced.<\/p>\n
\"The agency also carries out regular checks on hospitals and
\nmajor drug stores. There, we find no flu and cough medicines with
\nmore than 15 milligrams of PPA though smaller drug stores and
\nkiosks do still have older products,\" Sampurno said.<\/p>\n
\"I think we have given enough time for producers to adjust
\ntheir products and withdraw old ones,\" he added.<\/p>\n
Medifarma Laboratories Inc. which produces Neozep and
\nDecolgen, claimed that the new ruling \"coincidentally\" came at
\nthe same time they had decided to reduce the phenylpropanolamine
\ncontent.<\/p>\n
\"We only needed to adjust Neozep from 25 milligrams to 15
\nmilligrams per tablet and we had long planned to change the
\ndesign of our commercials anyway, so we experienced virtually no
\nproblems at all,\" a company official, who request anonymity,
\nsaid.<\/p>",
"url": "https:\/\/jawawa.id\/newsitem\/ppa-issue-grumbles-versus-concerns-1447893297",
"image": ""
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