Registration of Drugs Has Been a Slow Process

A move to put stickers on registered drugs has been hailed by experts and officials as a needed weapon in the fight against counterfeit drugs, but it has been slow to get needed approval from higher officials at the Health Ministry.

A first draft of the regulation, which would require companies to mark drugs that have been registered by the government with an identifying sticker, was first submitted to top ministry officials for approval in April, said Heng Huot, chief of the Bureau of Regulation at the Ministry of Health, who was in charge of drafting the letter. So far, there has been no response.

He re-submitted an updated draft of the proposal on Monday to Eng Huot, director-general of health promotion at the ministry, he said.

On Tuesday, Heng Huot said the draft was received positively by most ministry officials. But, he added, some rejected it, saying the ministry’s budget was insufficient to fund all of the suggestions included in the draft.

Eng Huot confirmed that he received the proposal but refused to comment further.

After Eng Huot reviews and approves the proposal, he will submit it to the Minister of Health for his approval, said Chhieng Phana, director of the Bureau of Drugs and Cosmetic, who was also involved in writing the proposal.

“I cannot presume when we will get approval,” he said. “But I think we want to expedite the process.” He said that he doesn’t think the proposal will be rejected.

The regulation is a good idea, said Pamela Messervy, program manager for the World Health Organization in Cambodia. “The main thing is that registered drugs are less likely to be counterfeit and so to have a way to identify registered drugs makes sense.”

There is currently no way to look at medicine and tell if it has been registered, said Chhieng Phana, head of the bureau that oversees the registration process. The only way to tell is to look in the Bureau’s log of registered drugs, he said.

Registered drugs are safer, according to a 2001 Ministry of Health survey, supported by the World Health Organization, which found that 5 percent of registered drugs were either counterfeit or substandard, compared to 20 percent of unregistered drugs.

Substandard drugs are those that do not meet accepted re­quirements, while counterfeit drugs are intentionally fraudulent. Taking either can be harmful or deadly if the disease gets worse due to improper treatment, or if the pills contain harmful ingredients.

The issue of counterfeit drugs has received more attention in the last few years. But it is still an enormous problem, said Chroeng Sokhan, vice director of the Department of Drugs and Food.

Part of the problem is that illegal pharmacies, which operate without a license, are rampant and tend to sell more counterfeit drugs, he said. The department gathered information that led to the prosecution of five pharmacies in 2002, but no formal decisions were returned, he said, adding that the department only gathers evidence that is used by court prosecutors.

“In Cambodia, an inspector only has to make a report and collect samples, not confiscate and prosecute them,” said Chhieng Phana. “We need the military and the police.”

Both men emphasized the importance of collaboration be­tween their investigators and authorities as well as officials from foreign countries, where most counterfeits originate, and local pharmacies and consumers. They were reluctant to directly criticize any one group, but both talked about how the government’s strategy was now focusing on education.

“I think the first issue is to educate poor people, raise the awareness of people,” said Chhieng Phana. “After that it is strengthening the implementation of the law and then prosecution and punishment.”

Putting a sticker on registered drugs is one such effort, he said.

The system of drug registration started in 1994. Legally all drugs sold in pharmacies must be registered, Chhieng Phana said.

“But the implementation of the law is not 100 percent,” he said. “We estimate that about 30 to

40 percent of drugs sold are not registered.”

The registration process in­volves four steps that require manufacturers or distributors to submit a range of documents verifying business practices and factory conditions, as well as samples of the medicine, data on dosage, and pre-clinical and clinical tests, Phana said.

The process is a good foundation, Messervy said, though they still need to increase the capacity of registration, allowing them to register more drugs, and clarify the rules.

The problem remains that many people, including pharmacists, are unaware that the government registers medicines.

“I did not know that the Mini­ster of Health registers medicines,” said Thong Leng, owner of Mohaleap Pharmacy. He agreed it would be good to put stickers on registered drugs if it would help prevent counterfeits.

Concerned customers have their own, more subjective ways of gauging quality. Sivleng Haing, an employee for a local pharmaceutical company, said she worries about not being able to tell counterfeit drugs from authentic medicine.

“I buy what I am used to,” she said.

She tries to buy imported medicine, her first choice being French, though the 2001 survey found counterfeit or substandard drugs among those marketed as imported.

“In Cambodia people like to buy medicine from France,” she said. “I think the French product is the best quality.”

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