A grouping of pharmaceutical companies will lobby for a review of a Health Ministry regulation that revokes the right of some of its members to register, and thus sell, drugs they import.
The regulation, issued last Monday, applies in particular to PBFs -- a corporate classification set by the ministry's Drug and Food Monitoring Agency (BPOM) for companies that have no production facilities but sell drugs in massive amounts here.
Thierry Powis, chairman of the International Pharmaceutical Manufacturers Group (IPMG), said Thursday the regulation posed a threat to 14 IPMG members classified as PBFs, out of a total of 29 members.
"This issue is very serious because it blocks those firms, already established here, from continuing their business as was granted in their business license by the BKPM (Investment Coordinating Board)," he said at a press conference.
"We'll review (the regulation's) legality."
The newly issued ministerial regulation on drug registration, first proposed by the BPOM, officially replaces a 2003 Health Ministry regulation on the same issue.
The earlier regulation allowed PBFs to register drugs they imported or procured from local producers with the BPOM, before marketing the drugs in the country.
BPOM chairwoman Husniah Rubiana Thamrin Akib argued the new regulation was aimed at guaranteeing the quality, safety and security of drugs being sold nationwide.
"Manufacturers are the ones who should register their drugs, not trading firms that are basically distributors," she told The Jakarta Post.
"How can a distributor be held responsible for, say, a drug's impurity and substandard quality when it doesn't have a production facility?" she said.
IPMG executive director Parulian Simanjuntak said the 14 PBF firms were undecided over future plans.
"These PBFs have no plans yet for the future of their businesses. The regulation gives them a two-year period to set up their next strategies," he said.
If no action is taken over the regulation, Parulian went on, a total of 5,600 employees working at the PBF firms under the IPMG could be affected.
However he refused to disclose projected losses that might be incurred.
The projected number of affected employees may be larger because there are more than 2,500 big trading firms registered with the Indonesian Pharmaceutical Manufacturers Association (GP Farmasi).
The IPMG is an international pharmaceutical research and development-based manufacturers group, while GP Farmasi consists of local players.
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