Ranbaxy debacle: Big Pharma's target is Indian drug industry

It’s abundantly clear that the Ranbaxy fiasco in the US, in which the company has to pay $500 million for allegedly selling adulterated drugs, is the big opportunity that the multinational drug companies have been waiting for to malign India.

Grabbing Ranbaxy by the scruff of its neck, the propaganda machines of the Big Pharma have unleashed a campaign against Indian generic manufacturers: if India’s $2 billion dollar Ranbaxy is bad, the rest of the industry should be bad as well. Their medicines are dirty and they are really bad not just for the North Americans and Europeans, but for Africans and Latin Americans as well.

The glee of Fortune magazine, which has been editorially campaigning for quite a while against the generic drugs and Indian patent regime alleging that they compromise on quality and safety of people, was effusive. The title of its widely circulated story on the Ranbaxy case was the message by itself: Dirty Medicine.

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It was not just about Ranbaxy, but also about India and its “dirty” generics.

The Fortune story leads with an Indian protagonist, Dinesh Thakur, a former Bristol-Myers Squibb employee who joined Ranbaxy only to turn a whistleblower. Over a few years, he successfully got Ranbaxy penalised and pocketed a neat $49 million for his inside job. Along with the MNC propagandists, Thakur also continues his anti-generics campaign which is willy-nilly aimed at the Indian generic industry.

Thakur’s role in exposing the “fraud” and the Ranbaxy story are now public knowledge, but the Fortune article has an innocuous mention of how his three-year-old son’s ear infection that a Ranbaxy antibiotic didn’t cure was cleared only by a GlaxoSmithKline drug. “Now he took the boy in his arms and resolved not to give his family any more Ranbaxy drugs until he knew the truth,” the article says to drive home the fear factor on Indian drugs.

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For Big Pharma propaganda, Ranbaxy is just the symbol. The rest of the story is about what is projected as the big, dark, deceitful and dirty world of the Indian drug industry. They repeat the same message over and over again: generics, particularly made in dirty Indian labs through deceitful ways, are not as good as the original branded drugs; and they compromise Americans’ health and safety.

[caption id=“attachment_827093” align=“alignleft” width=“380”] Grabbing Ranbaxy by the scruff of its neck, the propaganda machines of the Big Pharma have unleashed a campaign against Indian generic manufacturers. Getty Images[/caption]

It reinforces the public perception that the Big Pharma media campaigns have been able to sustain: a Pew survey in 2010 showed that 50 percent of Americans distrusted Indian drugs and 70 percent, Chinese drugs.

The language is in fact lethal, and the purpose sinister.

“Pharmaceutical companies in developing countries such as India are increasingly exporting potentially dangerous low-cost, off-patent drugs overseas. Some of these lethal products have even slipped past US Food and Drug Administration regulations,” said an American Enterprise Institute article early this year. In January, the Fortune magazine asked: Are generics really the same as branded drugs?

What is the real truth?

Let’s pose the same questions to the US Food and Drug Administration (FDA).

It has a diametrically opposite view.

“Yes. A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used.”

Are they safe?

“Health care professionals and consumers can be assured that FDA approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.”

This is exactly the reason for the heartburn of the multinational drug companies that are looking for opportunities such as the Ranbaxy debacle for their propaganda. America cannot survive without the generic drugs. In fact, 80 percent of the prescriptions in the US are met by generics, a lot of them Indian. Doctors and hospitals have been using them for several decades.

It saves the country and its people lot of money too. As the FDA itself notes, “according to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.”

While the Big Pharma raise the bogey of dirty drugs and lack of safety, FDA has engaged its own staff and resources to tell people that the stories of lack of safety they hear are wrong. It quotes one of its senior pharmacists: “every day without fail we educate consumers and health care professionals about the safety and efficacy of generic drugs. It even released PSAs to tell people the same.

Now, let’s briefly look at the Ranbaxy case itself.

By volunteering to pay a hefty amount, the company would have had some reason to feel vulnerable and guilty. They wouldn’t have wanted to jeopardise their chances in the US because US generic market is lucrative, particularly in the first six months after the expiry of a patent when a drug company with a first-mover advantage can make a lot of money before others also get an opportunity.

However, the only FDA-charge against the company was that it “falsified drug data and systemically violated current good manufacturing practices and good laboratory practices.”

Isn’t that serious enough?

Yes, indeed.

But it doesn’t tell the complete story.

This is only the last of the seven conditions that the FDA has laid down for allowing generics into the US market. The federal agency or the anti-generic campaigners haven’t said that Ranbaxy has failed the most important conditions such as the same active ingredients as the innovator drug, being identical in strength, same dosage form and route of administration; same use indications; same bioequivalence; and same batch requirements for identity, strength, purity and quality.

DG Shah, Secretary General of the Indian Pharmaceutical Alliance (IPA), has no doubts that the efforts are to malign Indian pharmaceutical industry. Both the big pharma companies as well as the western generic manufacturers are behind this campaign.

Will it impact Indian exports?

Shah feels that there would be no immediate impact because Indian generic drugs have been in use in the US for years. India’s record with the FDA has been consistently good and they have been very appreciative of the Indian drugs. The Ranbaxy episode might lead to sharper probing and scrutiny, which will anyway be good for the Indian industry.

According to the IPA, almost 55 percent of the revenue of the Indian generics - which is about $13 billion - comes from overseas markets. Of this, 50 percent are from regulated markets of North America, Japan and Europe and the rest are from 225 middle and low-income countries. In other words, if exports are hit, the industry will be seriously hurt.

Given the low awareness and educational levels, the campaign against India, however, might have some impact in Latin America and Africa, which accounts for about 21 percent of the export earnings. As was seen in the AIDS-epidemic, India is the pharmacy of the poor countries of the world, a fact that peeves both the Big Pharma and western generic manufacturers.

While resisting its intent, the Ranbaxy case and the campaign to discredit India should be turned into an opportunity. It should be treated as a wake-up call to ensure complete adherence to manufacturing and certification of best practices and total quality. The Big Pharma is out to get the generic industry, particularly in India.

They use every opportunity to conflate lower standards and denial of patents with counterfeit drugs. The Americans are also trying to use the UN agency for drug and crime (UNODC) to take up the issue of counterfeits in its multipronged strategy to discredit drug industries in countries such as India.

Indian drug industry should mend its ways, not just for the overseas market, but also for its own citizens because generics are the only lifeline for millions of Indians. For the Americans, they have an extremely meticulous FDA; but for Indians?

Any behavior that endangers their lives should be considered criminal.