PPA issue: Grumbles versus concerns

By Emmy Fitri

JAKARTA (JP): Pharmaceutical industries grumble and suspect "business competition" is the motivation behind the new regulation reducing the content of phenylpropanolamine (PPA) in cough and flu medicines.

The Food and Drug Control Agency (BPOM) issued on Dec.8 a regulation requiring the amount of the substance be no more than 15 milligrams per dosage, to be effective as from April 8.

The regulation was issued following a decision made by the United States Food and Drug Administration (FDA) and several other countries to withdraw medicines containing the substance due to fears of possible side effects.

Phenylpropanolamine is an active substance commonly used as a decongestant.

The prolonged use of the substance is feared to cause hemorrhagic stroke and high blood pressure.

But some have remarked that the new ruling has been spurned by competition in the pharmaceutical industry, to give certain companies, whose products do not contain phenylpropanolamine, an unfair advantage.

BPOM director Sampurno rebuked the suspicions and allegations coming from certain sections of the industry.

"The people who say that must know nothing about the pharmaceutical business," Sampurno charged. "That's a low-level accusation."

"In this business they are not supposed to prioritize profits but to emphasize public service and protection."

Sampurno said recently he had summoned representatives of at least 20 large pharmaceutical companies and received a report on the recalling of their products which contain higher-than-allowed phenylpropanolamine content.

"None of them complains about the regulations," Sampurno claimed.

"Those talking about conspiracy must be those who don't have pharmaceutical backgrounds. They must be businesspeople," he charged.

Alex, a member of staff at the promotions division of Sanbe Farma, remarked that the whole brouhaha about phenylpropanolamine was similar to the affair which recently hit taste enhancer producer Ajinomoto.

"Many believe it was merely caused by business competition. Why aren't other seasonings being checked too?" Alex said of the popular taste enhancer which had to be pulled from shelves nationwide because the Indonesian Ulema Council declared it haram (unfit for consumption according to Islamic teaching) for containing pork enzymes.

But rules are rules and BPOM, as the authorized governmental agency, has full authority on such matters.

"What can I say. We have two products with PPA ingredients, Tuzalos with 25 milligrams of PPA and Sanaflu with 12.5 PPA per tablet. Both have been adjusted (to meet regulations) and have been distributed to replace the old ones," Alex said.

Bambang Subroto, a marketing supervisor at PT Combiphar, producer of Combi Flu regretted BPOM's failure to reveal figures on the number of Indonesians suffering from side effects as a result of the substance.

"BPOM has never issued precise figures on the number of people who have suffered side effects from our products. People don't catch the flu or get a cough every day so they won't be consuming our products every day," he remarked.

"Physically, Indonesians are different from Americans and Europeans. Effects on them might not be the same with us," he added.

Combi Flu had adjusted its PPA substance from 25 milligram to 15 milligram per tablet. However it has yet to be distributed, awaiting the complete recall of its old products from the market.

The company is also awaiting the new product license from BPOM, in order to start distributing the adjusted products.

"That means additional work for all sectors of the company. In production we have to change the standardized measurements of the ingredients and for promotion we have to completely change the advertising image because the old one will not work as BPOM placed our product name on a public list," Bambang said.

Without specifying, Bambang said additional costs were also to be incurred by registering at BPOM in order to obtain an advertising license for the products.

"I don't know the amount, it is between Rp 10 million and 12.5 million per license," he said.

However, Sampurno denied the allegations and said Indonesia was the sole country that did not charge for pharmaceutical registration.

"There are no charges," he said stressing that company officials can directly go to him if BPOM officials try to extort money.

According to BPOM, as of April 20, from a total of 65 brands of flu and cough medicines which had more than 15 milligrams of phenylpropanolamine, 47 had been adjusted while 18 others are no longer being produced.

"The agency also carries out regular checks on hospitals and major drug stores. There, we find no flu and cough medicines with more than 15 milligrams of PPA though smaller drug stores and kiosks do still have older products," Sampurno said.

"I think we have given enough time for producers to adjust their products and withdraw old ones," he added.

Medifarma Laboratories Inc. which produces Neozep and Decolgen, claimed that the new ruling "coincidentally" came at the same time they had decided to reduce the phenylpropanolamine content.

"We only needed to adjust Neozep from 25 milligrams to 15 milligrams per tablet and we had long planned to change the design of our commercials anyway, so we experienced virtually no problems at all," a company official, who request anonymity, said.