Tuesday, September 15, 2015

Dinesh Thakur - The Commerce Ministry Should Not Act as Spokesperson for Indian Pharma

The [Modi government] appears to rely heavily on the bureaucracy for policy guidance, rather than demanding that civil servants put the political leaders’ ideas into effect. This was a conclusion drawn by a report published in July this year by the Hudson Institute, titled “Modi one year on”.

A case in point is the way the Ministry of Commerce has dealt with the fallout from the European Union action against an Indian company, GVK Biosciences. As reported widely in the press, the EU regulators had accused the company, a clinical research organization (CRO), of manipulating data from clinical trials conducted for approval of generic drugs. As a result, the EU cancelled the marketing authorisations it granted to several drug manufacturers, which included both Indian and foreign pharmaceutical companies.

The observations of data manipulation against this company are not unique; over the last two years, as many as 39 manufacturers in India have been banned from selling their products in the United States.

In many cases, regulators from the US, UK, European Medicines Agency (EMA) and most recently, the World Health Organisation caught these companies red-handed, either fabricating data or flouting good manufacturing practices. This all began with the prosecution of Ranbaxy, once India’s largest pharmaceutical company for selling adulterated drugs in the US for which it paid $500 million in criminal and civil penalties.

Clearly, a section of the Indian pharma industry is on its back foot. Rather than acknowledging its shortcomings and taking proactive measures to correct them, it continues to blame “western interests” for its woes. On the one hand, the Modi government is aggressively promoting India through its “Make in India” campaign, while on the other hand, with each such instance, the campaign is loosing its credibility. Large buyers today look at generic drugs made in India with great suspicion.

What baffles logic and common sense, however, is the response from the Indian government. First, it retaliated by calling off trade talks with the EU – accusing it of using the ban against GVK as a trade weapon of protectionism. This, despite the fact that the EU ban equally affects European companies which secured approvals based on data provided by GVK Biosciences. The script has now become even more bizarre with the Minister of Commerce, Nirmala Sitharaman, claiming that the EU did not even disclose the reasons behind the ban.

A few days ago, Sitharaman was quoted by the press as saying, “What prompts the ban without telling us the reason?”. This is a surprising claim because the EMA published its findings and the reasons for its action on its website way back in January of this year.
In particular, the EMA notes,

“The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site generally and on the reliability of data generated.”

This is an extract from the summary; detailed reports are available publicly that provide precise details of the data manipulation. All of these documents have been made available on the internet by the EMA. Why then is Sitharaman asking for the reasons behind the ban?

She then goes on to say, “Further two independent doctors — one from Germany and the other, I think from the Netherlands — went through the paper work, and they too were under the impression that the French inspector’s findings were not relevant”

Is the commerce minister speaking on behalf of the government or GVK Biosciences? There is no public record of either the government or any of its agencies, e.g., the Central Drugs Standard Control Organization, ever having conducted an investigation into this affair. An investigation was announced in the press but if such an investigation was indeed undertaken, shouldn’t the Indian government make its findings public? The EMA went to great lengths to explain that their action was based on scientific rationale, why they believe that the suspect ECGs submitted by GVK Biosciences were considered fraudulent. Shouldn’t our government also go to the same lengths?

Now, as far as the argument that the drugs that were banned by the European Union had no “negative impact on patients” as the minister says, I wonder how many people have we found in India who got sick after eating what the government called “tainted Maggi”? Yet the government rightly took action because the threshold for enforcement of safety standards is not necessarily linked to people actually falling ill. The mere possibility of people falling ill because of the violation of safety norms is enough to trigger enforcement action. Why are we then following a different standard when it comes to GVK?

While it is unreasonable to expect the minister to know the scientific details of such regulatory actions, it certainly begs the question, is she being given all the facts? Credibility, especially of someone who makes representations on behalf of the Indian government should be considered sacrosanct. Unfortunately, the credibility of the Ministry of Commerce, especially when it acts as the de facto spokesperson for the Indian pharmaceutical industry, is slowly but surely eroding.