A proposed regulation on drug registration aimed at protecting consumers may eventually shut down the operations of dozens of big pharmaceutical traders (PBF), an association says.

The Food and Drug Monitoring Agency (BPOM) has drafted a regulation requiring drug manufacturers to register their drugs before selling them in Indonesia, annulling the current practice where registration can be made by the traders.

The International Pharmaceutical Manufacturers Group (IPMG) said the traders would need to register the drugs with the BPOM in order to get a license to import the drugs or procure them from local producers.

"Should the new policy ban the traders from being able to register, many of them will cease operations because they cannot get a license to import the drugs," IPMG executive director Parulian Simanjuntak told The Jakarta Post recently.

"From June 15, the BPOM has declined registration applications from traders although it has no legal grounds to do so yet."

The planned regulation will replace a Health Ministry law on drug registration issued in 2000, which enables traders to register the drugs.

Parulian said the recent move by the BPOM severely affected 11 IPMG members as well as other companies grouped in the Indonesian Pharmaceutical Manufacturers Association (GPFarmasi).

IPMG is an international pharmaceutical manufacturer grouping, while GPFarmasi consists of local producers.

GPFarmasi chairman and PT Doxa Manggalya Utama president director Anthony Charles Sunarjo said dozens of association members were declined registration due to the planned regulation.

There are over 2,500 trading firms registered with GPFarmasi, Anthony said.

"The firms will automatically have to close down in the near future if the proposed bylaw forbids them from registering the drugs that they will import," he said.

BPOM chairwoman Husniah Rubiana Thamrin Akib said the agency had been suspending the registration proposals, not rejecting as claimed by associations, as part of information dissemination on the planned regulation.

"Manufacturers are those who should register their drugs, not trading firms that are basically distributors," she told the Post, adding that the new policy was designed to ensure drug safety and security.

"How can a distributor be held responsible for a drug's impurity and substandard quality when it doesn't have a production facility?" she said.

Indonesian Health Consumer Empowerment Foundation chairman Marius Widjajarta welcomed the planned regulation, saying it would protect consumers.

"Trading firms should carry out their businesses in other countries if they object to the regulation," he said.

The BPOM submitted the proposed regulation to the Health Ministry a month ago for approval.

The ministry's director general for pharmaceutical management, Kustantinah, said her office was still deliberating the regulation but refused to specify a timeline for completion. --Mustaqim Adamrah

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