The working paper entitled ‘Poor Quality Drugs and Global Trade: A Pilot Study,’ published earlier this month in the National Bureau of Economic Research (NBER), is based on an assessment of 1470 antibiotic and tuberculosis drug samples that claim to be made in India and were sold in Africa, India, and five mid-income non-African countries between 2009-12.
The authors, from the conservative US think tank and lobbying group the American Enterprise Institute (AEI), said the prevalence of substandard drugs in Africa was partly due to Indian manufacturers’ practice of differentiating quality by final destination.
This accusation was not well received in India with the India Brand Equity Foundation (IBEF) – on behalf of the Indian Government – accusing the AEI researchers of being part of a “smear campaign” against the Indian drug industry.
IBEF picked apart the paper in a press release Friday, attacking the “methodology and ethics” as well as “the poor treatment of data sampling used.”
Despite the study’s acknowledgement that some products may falsely claim to be made in India and transportation and storage may also have played a part, secretary general of Indian Pharmaceutical Alliance (IPA) D G Shah said.
“It still attributes poor quality (of drugs at the consumer end) to manufacturers and the Indian pharma regulator.”
He continued saying the report is “designed to pass off pre-conceived notions and a hidden agenda in the garb of a scientific study.”
Pharmexcil India Director General, PV Appaji said: “They [the AEI] have published this report to damage the image of India in the international market.”
Shooting the messenger and corruption allegations
One of the authors of the paper, economist Roger Bate - a visiting scholar at the AEI – told in-Pharmatechnologist.com the press release is “all rather ridiculous.”
“We never targeted India we just bought and tested products and it became obvious that Indian products were worse in Africa,” he said. “There are numerous caveats written in the paper and possible other causes, but statistically there seems little doubt that exports from India to Africa are worse.”
Furthermore, he accused IBEF of “shooting the messenger.”
“They seem to have the Indian government in their pocket and believe any criticism is some kind of conspiracy to undermine them, rather than an alert they should respond to.”
“Increasing concern about drug quality means India should do far more to tighten up quality control. I have no doubt Indian companies can make good products,” he said, but questioned “just whether they always do, given their regulators are both incompetent and corrupt.”
In a direct response to these accusations IBEF, on behalf of all the stakeholders of the Brand India Campaign, told in-Pharmatechnologist.com: “Whilst we welcome an open and frank discussion on issues, Mr Bate seems more intent on pushing his own agenda through unsupported and defamatory statements.”
“Having raised our objections, supported by the evidence (or lack there of), rather than engage in debate, Mr Bate has instead chosen to make sweeping statements and libellous accusations, which we will be dealing with firmly.”
Noting Indian facilities were under regular local and international audit and the number of approved units is increasing, IBEF added: “It’s unfortunate that we have to give comment and time to this issue when we should be debating the amazing strides made by Indian pharma in the last 30-years.”
In related news, India’s new Prime Minister Narendra Modi is visiting the US this week to discuss trade and defence, though talk of pharma quality issues appears not to be on his formal agenda for now.