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Pharma industry hits government steps regarding ranitidine ban
  • By Lee Han-soo
  • Published 2019.10.21 17:16
  • Updated 2019.10.22 16:31
  • comments 0

The local pharmaceutical industry is expressing its distrust and displeasure with the government's moves to support the supply of ranitidine alternatives.

The industry points out that the government's countermeasures, such as the quicker approval of Ranitidine alternatives, are lacking in reality at a time when the production of finished Ranitidine alternatives has hit a snag faced with the shortage of raw materials.

The Ministry of Food Drug and Safety officials met with the representatives of local pharmaceutical companies last Friday to discuss the production, import, and supply status of ingredients such as cimetidine and famotidine, which are considered as alternatives of ranitidine as the demand for such raw materials has increased.

The ministry had asked pharmaceutical companies for data on the stockpile of ranitidine alternatives. The purpose of such requests was to examine the supply gap, inventories, raw material supply and demand, and the status of ranitidine alternatives, which are aimed to prepare measures against possible incidents that may arise from the ranitidine ban.

During the meeting, the ministry promised pharmaceutical companies that they would spare no effort in supporting the production and imports of prescription and marketable ranitidine alternatives.

The ministry's efforts include a plan to shorten the screening period for drugs with indications similar to ranitidine and speed up the drug master file of such alternative drugs, according to the industry officials who were on hand at the meeting.

"After discontinuing the sale of ranitidine, we are considering various support measures to prevent the discontinuation of alternative treatments," a ministry official was quoted as saying.

Despite the ministry's measures, pharma companies did not express much expectation about the policy to quicken the approval of ranitidine replacement drugs as the market is already seeing a supply shortage for cimetidine, a histamine H2 receptor antagonist drug with a similar structural component as ranitidine.

The industry officials also noted that securing cimetidine is not easy, because a plant in China, which had supplied raw materials for cimetidine, recently stopped production.

Famotidine, another histamine 2-receptor antagonist, is also in short supply.

Amid the dwindling supply of ranitidine alternatives, the local pharma industry criticizes the government for banning the sale of ranitidine without making any preparations, even though the surge in demand for similar drugs could have been fully predicted.

“As of now, NDMA (Nitrosodimethylamine), a carcinogen, has only been detected in the raw materials of ranitidine, and the drug's effect on patients has not been confirmed," a local industry official said. "In the U.S. and EU, only some companies have voluntarily decided to stop selling and recall the drug, and the regulatory agencies in those countries have not announced a ban on ranitidine on a national level."

The government decided to ban selling ranitidine, thinking there were a lot of alternative drugs, but it should have checked the availability of alternative medications first, the official added.

corea022@docdocdoc.co.kr

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