India's producers accused of selling low quality generic drugs to Kenya

 

Kenya: Generic drug manufacturers from India  have been accused of deliberately exporting poor quality medicines to Kenya and other African countries while reserving better products for richer nations.

A report appearing in the prestigious British Medical Journal said several antibiotics and tuberculosis drugs sold in Nairobi and eleven other African cities were of poor quality compared to similar products from the same manufacturers sold in other parts of the world.

For example, the study said, almost nine per cent of samples of the widely used antibiotic Ciprofloxacin sold in Africa tested substandard, compared to 3.3 per cent in India and none in the richer countries.

Study authors said this was the first time market segmentation, where different quality products are deliberately made and distributed to particular markets on the capacity to pay, has been identified with medicines.

“If true, this is a very serious allegation, and we will swiftly and aggressively move to authenticate the claims and identify the perpetrators. This would be a callous and inhuman act,” Dr Kipkerich Koskei, the chief government pharmacist, told The Standard on Sunday yesterday when told of the report.

Generics are copies of brand-name drugs in terms of characteristics such as strength, dosage form, quality and intended use. However, they are usually sold at a substantially lower price than their branded counterparts.

The use of generics has been on the rise in Kenya, with the National Drug Policy requiring that all prescriptions and advertisements for drug supplies in public hospitals quote for generics whenever possible.

The controversial report by a US private company, the National Bureau of Economic Research, University of Ottawa, Canada and University of Maryland, US, was published last week.

Nairobi was one of 12 cities in Africa where samples were collected from pharmacies and tested. According to the report, some were found to contain only baby powder, or to contain glass and other potentially dangerous substances.

The other African cities in the study were Accra, Addis Ababa, Cairo, Dar es Salaam, Kampala, Kigali, Lagos, Luanda, Lubumbashi, Lusaka and Maputo. These cities, say the study authors, had the highest number of substandard or falsified medicines, compared to those sold in India or to other richer countries.

A news flash by the British Medical Journal says the India  generic industry has reacted sharply to the study, questioning its motive and seeing a deliberate campaign to malign the manufacturers.

But the authors counter this, and say the industry in India is capable of producing high quality generics, but these are targeted at richer markets. Richer cities sampled in the study included Bangkok, Beijing, Istanbul, Moscow and Sao Paolo.

“We’re seeing drug companies sending poor-quality drugs to certain pre-identified countries,” said lead author Roger Bate of the American Enterprise Institute at a briefing in Washington. “This is legal producers working out where they’re going to send low-quality drugs,” Bate had told the media.

This is the second time in as many years that Bate is claiming that some first line TB drugs in Kenya have been found to be substandard. In 2012, the team, following laboratory tests, found one in ten TB pills to fail basic quality assessments, half to be poorly manufactured and the other half to be fake.

The Ministry of Health has, however, downplayed the possibility of high volumes of fake TB drugs in Kenya, and maintains that these are centrally purchased through its systems and given free in all hospitals.

“Maybe only a few private institutions stock TB drugs for people who feel they don’t want to queue at public hospitals,” says Dr Koskei.

But this begs the question whether the fakes could have penetrated the government procurement system for lack of competent regulatory systems.

In 2011, Bate presented evidence indicating that highly subsidised malaria drugs meant for the Kenyan market were being smuggled into neighbouring countries and being sold at a much higher price than the recommended one. That initiative, The Affordable Medicines Facility-malaria (AMFm), which had seen the cost of malaria drugs drop from Sh400 to Sh40 in Kenya, has since been shelved.

The researchers, without naming the manufacturers, said the distribution of the poor quality products was not accidental or a random happening but a well and deliberately planned activity.

“These findings support what has been known anecdotally for years, that some Indian drug companies segment the global medicine market into portions that are served by different quality medicines,” said the researchers.

But Dr Dominic Ngugi, a former national chairman of the Pharmaceutical Society of Kenya, strongly disagreed with the possibility of market segmentation as a policy sanctioned by the pharmaceutical sector in India.

“This is grave as it appears to be a case of greedy traders in India, Kenyan importers and weak regulatory agencies conniving to make the biggest possible profits from poor, sick Africans,” said Dr Ngugi, a lecturer at the University of Nairobi.

Why you find better quality medicine in Beijing, China, Dr Ngugi said, is simply because the laws demand so, and the law breakers are swiftly punished, unlike in Kenya and elsewhere in Africa.

Bate and his team said the marketing of poor quality drugs to Africa is a double burden. One, they said, sick patients will not be cured, while under-dosing could lead to the development of hard-to-treat disease-causing organisms.

“As proven with Ebola, this will swiftly travel to other parts of the world,” said Prof Julius Wanjohi Mwangi of the Department of Pharmacology and Pharmacognosy at the University of Nairobi.

The authors of the report said Africa is targeted with these kind of drugs because traders know the risk of being caught is low. This is because “countries are typically poorer, have a less educated population and do not function well in regulating drug quality”.

A recent study by the Kenya Medical Research Institute (Kemri) told of how drug inspectors and pharmacies are running a highly sophisticated corruption network, putting the lives of millions of Kenyans in danger.

The network, Dr Francis Wafula of Kemri explained, is organised in such a way that it allows dispensers to pay a bribe, either on demand or after a fault has been identified, or send money periodically through M-Pesa to keep inspectors away.

But Dr Koskei said they had been made aware of those weaknesses and have almost eliminated the networks. He said they will soon establish if there is a deliberate effort to export low quality drugs from India into the country.

Our email enquiries to the Indian High Commission in Nairobi went unanswered.