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Alarm over sale of unregistered drugs

FITNESS
By | April 8th 2009

By Amos Kareithi

A major controversy pitting one of Kenya’s oldest drug manufacturing company and a government agency over the legality of its drugs is shaping up.

The controversy has brought fears that some pharmaceutical companies could be selling unregistered drugs to Kenyans. Interestingly, the drugs could be passing through the hands of other unsuspecting government agencies.

Should this be so, Kenyans are at risk since some of the companies could be selling drugs whose quality has not been verified by the Pharmacy and Poisons Board.

The controversy is over the registration of some of the drugs manufactured and sold by Dawa Limited, whose registration has allegedly expired and are yet to be registered afresh by the Pharmacy and Poisons Board as required by the law.

Dawa Limited facility (left). The company is contesting claims by Pharmacy and Poisons Board that some of its drugs are not re-registered.

Interestingly, Dawa Limited has previously won tenders to supply the government with drugs, through Kenya Medical Supplies Agency (Kemsa). However, the Pharmacy and Poisons Board claims some of its drugs are not properly re-registered with the board.

The board’s records show that out of 113 drugs manufactured and sold by Dawa Limited, only 35 of them have current registration.

"You can quote me on that. This is the correct position. We have no reason to withhold anything from the public. Our work is to tell the truth and nothing else," says Dr Ahmed Mohamed, the deputy chief pharmacist in charge of licensing at the Pharmacy and Poisons Board.

According to Mohamed, the latest data on the registration of drugs was last updated in December, last year. He says there is no possibility that a mistake has been done on these records.

When asked about the registration status of some of Dawa products, the company’s quality assurance manager, Dr Titus Kieni explains that a majority of their drugs are up to date with registration.

"We do not sell that which has not been registered. Once our drug has been registered for five years, we normally apply for registration three months before the expiry of the registration," Kieni explains.

He says some of the products were evaluated and approved for registration last year by the board. But their fate now is in limbo as no registration has been granted.

"The committee for drug registration gave artificial approval but owing to some in-house issues like the composition of the board, the registrations have not been granted," Kieni said.

Release of certificates

The pharmacist explained that 2007 certificates had not yet been released adding that drug manufacturers were now using approval letters issued by the board.

"What do you mean our drugs are not registered? This is not true. You people must start investigating matters of importance to Kenyans. We are one of the oldest drug manufacturing companies in East and Central Africa," Dawa’s Public relations officer, Cosmus Musyimi said.

"If our products had not been registered," he added, "our 16 vehicles branded with Dawanol would not be bearing the advertisement. Neither would we be advertising on radio."

The public relations officer added: "The Pharmacy and Poisons Board officers come here almost on weekly basis to inspect our products because we do a lot of export."

The government Chief Pharmacist, Dr Kipkerich Koskey, told CCI that registration of drugs in Kenya is not an optional matter but a mandatory legal requirement, which must be adhered to by all companies.

"We do not issue interim registration. The drugs must be analysed and tested before they can be used. Nobody should market any product before it is registered," he says. "All drugs whether tablets or syrups, if not taken appropriately can be dangerous or toxic."

"I know there are a few companies which have been caught selling drugs which are not registered. Once we catch such people, we take them to court," Koskey said. He referred further enquiries on this issue to the deputy registrar at the Pharmacy and Poisons Board.

The law (cap 244) stipulates that if one is found guilty of selling a drug which is not duly registered, or contravening any of the rules regulating drug registration, they will be liable to a fine not exceeding Sh6,000 or to a jail term not exceeding six months or both.

Koskey says before a drug is registered, Pharmacy and Poisons Board must analyse it and determine its formulation and dosage.

Dr Kipkerich Kosgey, the Chief Government Pharmacist.

Photos: Jonah Onyango and File/standard

Early last year, Dawa Limited supplied 14 million tablets of erythromycin, an antibiotic, in 14 batches to Kemsa, which were then supplied to health facilities across the country.

However, the drug had to be recalled after it emerged that it had quality problems.

"It is true there was a problem with erythromycin. The coating was worn out a little. The product was coarse and this allowed moisture in. When complaints came from Kemsa, we checked the process," Dr Kieni explains.

"We asked them to return the product and it was 100 per cent replaced. They have the documents and delivery notes," adds the company’s pharmacist.

Kieni says the company had to buy a film-coating machine so as to rectify the problem.

However, Kemsa’s Public Relations Officer Mr Dominic Kabiru has a different version to the erythromycin saga.

He says Kemsa rejected the product when it was initially delivered.

Rejection of drug

"The erythromycin referred to was rejected by KEMSA at pre delivery stage (while in quarantine) by Quality Assurance Officers when it failed to meet the set quality standards. The supplier was compelled to collect it back in total. Further the matter was reported to the pharmacy and poisons board for appropriate action," Kabiru says.

Dawa’s founding Director, Raju Mohindra, denied any wrongdoing by his company.

He told CCI on telephone that although he was not actively involved in the day-to-day operations of Dawa Limited, he could not allow any malpractices in his company.

"I am a radiologist and a professional. We have employed 160 people and I would not want their future jeopardised. Whatever your reasons or source of information, you must know that we are beyond doing these things," he said.

Kabiru said Kemsa is keen to ensure it does not deal with counterfeits, stressing that it follows stringent procurement procedures, which only allow the most competent, to be awarded tenders.

"Kemsa’s procurement procedure is watertight with regard to quality. All bidders must provide a valid certificate of drug registration by pharmacy and poisons board," he said. He added that companies were expected to provide a valid manufacturer’s GMP (Good Manufacturing Product) certificate as well as a certificate of analysis of the product.

So as to lock out counterfeiters, all bidders must produce proof of authorisation from a recognised regulatory authority to manufacture or sell products they wish to supply to avoid any counterfeits.

During a visit to Dawa industry at Ruaraka, Nairobi, the company’s chief pharmacist and the public relations officer differed over the registration and ownership of Amoxil, another drug, which Dawa had recently supplied to Kemsa.

Musyimi said Dawa has been supplying drugs to the government, citing the most recent deal where 12,000 million 250 mg Amoxil capsules were delivered.

"We also supplied a further 2,400 tins of 500 mg Amoxil. Each tin has 500 capsules. We do a lot of business with government. No company can be contracted by the government if its products do not meet the required standards," he explained.

But in an interesting twist, Kieni, the pharmacist, contradicted Musyimi disowning Amoxil. The Pharmacy and Poisons Board’s records show the drug is yet to be re-registered.

Ownership controversy

"I do not need to look into our records. This is not our product; another company makes it. I am quite sure about this because I am involved in the production process," Kieni told CCI in the presence of Musyimi.

However, in the eyes of the government and its records, Amoxil, an antibiotic, is the product of Dawa.

According Pharmacy and Poisons Board list of registered drugs, Amoxil was first registered as belonging to Dawa Pharmaceutical on November 12,1982 vide application number 1701 for capsules and 136 for syrup. The law says drugs are supposed to be reregistered after every five years.

This controversy over registration of drugs could just be pointer to how many other unregistered drugs are in the market.

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