Disputes conclusions of NBER study not only for its methodology and ethics but also for poor treatment of data sampling used
The India Brand Equity Foundation (IBEF), on behalf of the Government of India, has strongly objected to a study published by the Washington-based American Enterprise Institute (AEI), which it considers to be a ‘smear campaign against the whole Indian pharmaceutical industry’ and an effort to ‘tarnish the image of the Indian pharma industry’.
On 17 September, the AEI published the findings of ‘a working paper’ in the National Bureau of Economic Research (NBER) Working Paper series, which detailed the results of an ‘extensive investigation into Indian pharmaceutical quality’, in which almost 1,500 India-made drug samples were collected from 22 cities throughout Africa.
According to the AEI, 10% of the antibiotic and anti-tuberculosis samples contained insufficient levels of the key active ingredients.
The AEI said this new research complemented the ‘growing body of anecdotes indicating that India’s generic drug industry routinely violates basic quality control standards and knowingly ships sub-par medicines to foreign patients’.
It added that International regulators had found more than 1,600 errors in 15 drug applications submitted by the Indian generic giant Ranbaxy, with officials noting that these drugs were ‘potentially unsafe and illegal to sell’.
Ranbaxy later pleaded guilty to seven felonies in a US court in May 2013 and paid out ‘more than half a billion dollars in fines and settlements’.
There seems to be a deliberate campaign to malign the Indian pharma industry
It also reported that Ranbaxy had to recall ‘millions of dollars’ worth of drugs in 2012 after investigators found glass particles mixed in with the raw ingredients used for its generic version of Lipitor. Safety officials found widespread failure to follow basic safety protocols and reporting requirements in several of the company’s manufacturing facilities.
In addition, the AEI cited examples of drug recalls by Dr. Reddy’s Laboratories and Wockhardt.
The AEI urged newly elected Indian Prime Minister Narendra Modi, who is making an official tour of the US, to ‘make it a national priority to crack down on poor drug manufacturing practices and ensure that medicines coming out of India cease threatening public health’.
The IBEF said the study ‘cites anecdotal evidence and hearsay’ and disputed the conclusions ‘not only for its methodology and ethics, but also for the poor treatment of data sampling used’.
Pharmexcil India Director General, Dr PV Appaji protested about the lack of ethics in the study.
‘There seems to be a deliberate campaign to malign the Indian pharma industry,’ he said.
‘The minimum requirement would be to give an opportunity to the labelled manufacturers to give their comments against their test observations.’
Appaji pointed out at least eight technical issues with the sampling and data techniques, including the fact that samples were not authenticated either from the source or from the regulators of the local country; samples were not referred to manufacturers to ascertain their genuineness; Minilab protocols were used to analyse the drugs, which is not taken as conclusive analysis; the authors did not record the storage conditions at which samples were stored and collected; samples drawn from Africa were not registered in their country; the authors did not ascertain the source of supply of the drug, nor was it indicated in the report; and the names of the manufacturing firms were also not disclosed.
The minimum requirement would be to give an opportunity to the labelled manufacturers to give their comments
‘They have published this report to damage the image of India in the international market,’ he said.
IBEF added: ‘Without regards to ethics, data collection and sampling techniques or even the primary protocols involved in publishing such research, the authors have made several allegations, passing them off as statistical conclusions from the so-called study.
‘It is not known whether they have selected the test sample on a rational basis keeping in view the huge volumes of generics shipped from India or from a select few companies.
‘In all fairness, when such results are found, they should have also contacted Pharmexcil or the Indian drug regulator in advance and ascertained the facts.’
Realising the ‘serious damage that such an irresponsible report is trying to make’, IBEF said it has asked the Government of India to initiate legal proceedings against all concerned.