9 October 2012

Tanzania: TFDA Should Be Cautious on Fake ARV Drugs

THERE have been reports that substandard and fake products are flooding the local market due to ineffective control machinery. Among them are foodstuffs and medical supplies.

As a result, the health of consumers is at risk due to their side effects. It has been recently established that some people living with HIV/Aids have been using an illegal and fake anti-retroviral drug (ARV) under a brand name TT-VIR 30 in Tarime District, Mara Region.

Following these reports, Deputy Minister for Health and Social Welfare Dr Seif Rashid on October 4 this year confirmed there had been in the country the fake anti-retroviral drug in circulation under a brand name TT-VIR 30.

"On September 21 this year, TFDA carried out a routine inspection at Tarime District Hospital and discovered some fake ARVs with a brand name TT-VIR 30.

Accordingly, TFDA decided to inspect public health centres in Mara Region and afterwards carried out an intensive inspection in other regions throughout the country in collaboration with security organs between August 6 and 31 this year," he explained. According to Dr Rashid, the inspection involved the Medical Stores Department (MSD) at the headquarters and the zone and was carried out at the Tanzania Pharmaceutical Industries Limited (TPI Ltd) of Arusha.

"Some drug samples were taken from the company for further laboratory tests and later on it came to light that the drugs (TT-VIR 30) were fake," he noted. According to reliable information, after TFDA discovered unearthed the scandal involving the local drug manufacturing campany (TPI), in the first stage, the second phase of investigation has also been launched to ensure that culprit is taken to task.

The government has decided to take the fake drug (TT-VIR 30) out of the circulation, as the investigations continue. Commenting on this, Dr Rashid said this investigation involving security organs was still going on, noting however, that the Ministry of Health and Social Welfare would ensure there was adequate supply of ARVs at all public health centres. Therefore, he asked people living with HIV/Aids to continue using ARVs since the fake drug (TT-VIR 30) had been removed from the circulation.

Among other measures taken included informing all regional medical officers in the country and instructing them to supervise and ensure there was no distribution of drug, TT-VIR 30 batch No 0C.01.85, at all public health centres in their jurisdictions. They were also instructed to remove the fake drug from to the circulation and return it to the sole distributor, the MSD. Laboratory results and the follow-up have shown that the drug under the brand name TT-VIR 30 batch No 0C.01.85 was fake, according to applicable laws.

Available documents show that Tanzania Pharmaceutical Industries Limited sold the drug batch No OC.01.85 to the MSD. The Ministry of Health and Public Welfare through TFDA has so far suspended the production of ARVs at TPI Ltd until the on-going investigation is completed and the issue is cleared. It has formed a special team of experts to follow-up the provision of treatment and care for people living with HIV/Aids.

The team will remind health experts how to receive, ascertain the quality and right use of ARVs. The team is composed by experts from the Ministry of Health and Human Welfare, the National Aids Control Programme (NACP), Muhimbili National Hospital, the National Institute for Medical Research (NIMR) and TFDA.

It has also reminded regional and district medical officers to strengthen medicine and therapeutic committees with the responsibility of supervising the reception, ascertaining the quality and right use of drugs. TFDA says the ingredient of fake ARVs is efavirenz and others have a combination of NVP, 3TC and d4T. The fake ARVs normally change colour and grow fungi after a while. Last month TFDA said about 1,360 containers with between 30 and 60 tablets each had been issued to patients in Mara Region.

Speaking on the importation and circulation of fake drugs in the country, Sikika HIV/Aids department head Tusakile Mwambetania questioned the effectiveness of drug control mechanisms in the country. "How did fake drugs enter the distribution system?" Where was MSD and how did fake drug reach public health facilities if everything is in control?" queried Mwambetania. Medical experts are worried about side effects associated with TT-VIR 30 batches No 0C.01.85.

National Institute for Medical Research (NIMRI) Dr Alex Mwita said HIV/Aids patients were prone to health risks because of using TT-VIR 30 tablets, which had nothing to with CD4 count. The Ministry of Health and Social Welfare (MOHSW) through TFDA in collaboration with Management Sciences for Health (MSH) and Regional and Local Government Authorities piloted a programme in Ruvuma from 2002-2005 with the support from the Bill and Melinda Gates Foundation.

The programme established a network of ADDO (Maduka ya Dawa Muhimu) to provide selected basic medicines and other medical supplies in rural and peri-urban areas. The aim was to ensure over 80 per cent of rural and peri-urban areas in Tanzania Mainland purchased quality basic medicines from well-regulated and properly operated private medicine outlets manned by trained personnel by 2010.

"Among other functions, ADDO are used as centres for advising people living with HIV virus, across the country, on how to access proper health care and services," said Gaudensia Simwanza, TFDA Public Relations Officer. The government thought that ADDO could serve as strategic points for Tanzanians infected by HIV virus, to get medical advice, they could access appropriate treatment, including life-prolonging drugs.

The idea was that, since ADDO outlets are spread throughout the country, covering more than 20 regions so far, they are better place to assist infected people--in terms of where they will get ARVs who are offered for free in public health facilities. "In some areas, especially in the rural settings, the perception of many AIDS suffers is ARVs are sold at a market price. That's why the government thought it a worthwhile idea to use ADDO outlets as centres for directing infected people to go to the hospitals and get the drugs freely," said Simwanza.

For years, the public perception was that most of the fake drugs were imported from outside the country, but latest inspections by TFDA have discovered that even local pharmaceutical manufacturing companies are also involved in the illegal business of producing and selling fake drugs. Hassan Mwita, a resident of Manzese commended TFDA for speedy technical investigations that uncovered a local drug company (TPI Ltd) involved in the manufacturing of fake drugs, which endangers lives of millions of Tanzanians.

He challenged TFDA to conduct extensive inspections countrywide in order to unearth other local drug companies involved in the malpractices, expressing optimism that "they (TFDA may find many local companies doing the same thing which is being done by TPI Ltd." "Besides, as public members, we want to see police investigation is completed soon and legal actions are taken promptly against this company. That's the only way to win public trust and confidence in the conduct of security organs," said Mwita.

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