Why More Indian Generic Drugs Will Make Their Way to the U.S. ?

Never mind the FDA crackdown on Indian drug makers for quality control problems. Sales of prescription drugs to the U.S. by the Indian pharmaceutical industry likely won’t take a huge hit, at least according to a new report.

Why? India’s generic drug makers remain large suppliers to American consumers, writes India Research & Ratings. The FDA may have banned imports from 21 Indian manufacturing plants last year – more than in any other year – but Indian drug makers accounted for 40 percent of U.S. generic drug imports, based on volume, and 39 percent of total generic drug approvals by the agency.

Moreover, the ratings firm believes that the Affordable Care Act will further expand the U.S. market for lower-cost generics. Already, 86% of prescriptions filled in the U.S. last year were for generics, according to the IMS Institute for Healthcare Informatics. And so, the firm forecasts the Indian pharmaceutical industry should experience compounded annual growth of 20% for the next five years.

Despite numerous FDA import bans and warning letters issued, Avinash Lodha, an associate director at the firm, contends the U.S. “will not discourage the largest source of generic drugs” from supplying its biggest market. In short, Indian drug makers and the U.S. need one another. And that calculus is not expected to change, even as the FDA voices concern over abject quality control.

He also notes that much of the negative publicity over FDA actions centered onRanbaxy Laboratories , which has the dubious distinction of owning four plants where shipments have been banned by the FDA. But most bans were issued to plants run by small makers of pharmaceutical ingredients. As a result, the firm says the regulatory moves will not have a material impact on overall industry export revenue.

The well-publicized travails of a few suppliers “served as a wake-up call, but we believe industry exports will continue to grow,” says Lodha. “These companies know that compliance is an imperative. The attraction of the U.S. market is simply too hard for them to ignore.” For this reason he believes Indian drug makers, by and large, will take the steps necessary to improve procedures and pass muster with the FDA.

Indeed, industry growth is dependent on the U.S. market. Last year, 26% of Indian pharmaceutical exports were to the U.S., which made this the largest export market for the industry. Lodha argues that Indian drug makers, collectively, have too much at stake to risk – 523 manufacturing plants are registered with the FDA, which is the largest number outside the U.S.

This is not to say that FDA scrutiny will not have any effect. Lodha acknowledges the agency crackdown is an “important and urgent matter,” and points to the recent increase in the number of FDA inspectors working in India. Should a worst-case scenario develop, he foresees export revenue to the U.S. declining by 7% to 8% this year and next, which would trim his projected five-year compounded annual revenue growth to 16%.

Among those expected to take a hit are a few large suppliers, such as Wockhardt, which also suffered an FDA import ban. Ranbaxy, meanwhile, is expected to suffer delayed product launches and ongoing outlays to correct manufacturing problems.

Of course, Lodha is correct that Indian drug makers can ill afford to alienate the FDA. But the agency is also under pressure to ensure the veracity of the pharmaceutical supply chain and there is divided opinion about the extent to which the Indian pharmaceutical industry can sufficiently adhere to FDA standards. A few more slip ups might easily alter the calculus.

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Generic Drugs versus Brand

What is the Difference?

Quality

Health Canada reviews and approves all drugs (brand-name and generic) before they can be sold in Canada.

Health Canada mandates that a generic drug is designed to work the same way in the body as the original brand-name drug.

Further, Health Canada requires that both brandname and generic drug companies follow the same rules for the manufacturing process and for ensuring the quality of their ingredients.

Ingredients

Health Canada also mandates that generic drugs have the same active ingredient (the chemical that makes the drug work) and that they work the same way in the body as the brand-name drug. Generic drugs must also have the same amount of active ingredient in the prescription.

Health Canada even regulates the non-medicinal ingredients, such as fillers and preservatives, for both brand-name and generic drugs and they are subject to the same approval process.

Results

When a generic drug is approved by Health Canada that means the medicine is as safe and as effective as the original brand-name drug and they will work the same way.

1 Million Everyday – Everyday in Canada, approximately one-million prescriptions are filled using generic drugs.2/3 – Two thirds of all prescriptions in Canada are filled with generic drugs.

The only difference is price

The only difference between a generic and a brand-name drug is the price. Generic drugs are used to fill more than 66% of all prescriptions in Canada, but they account for only 23.5% of the $22.2-billion dollars Canadians spend annually on prescription drugs.

Why should I care about cost? I’m covered by my drug plan.

It is important to remember that you and your employer pay for the cost of your prescription drug benefits. Your employer is not required to offer you a health benefit plan. They do so in order to attract and retain the best employees and to keep you and your family healthy and at work. Rising drug costs are putting pressure on all employers’ ability to continue to offer these important drug benefit programs.

Generic drugs cost much less than brand-name drugs and will lead to an affordable and sustainable drug plan for you and your family. Ask your doctor or pharmacist if there is a generic equivalent available for your prescription needs.

What are generic drugs?

A generic drug is a chemically equivalent, lower-cost version of a brand-name drug, costing 30-80% less! A brand-name drug and its generic version must have the same active ingredient, dosage, safety, strength, usage directions, quality, performance and intended use.

Are generic drugs as safe as brand-name drugs?

Yes. Generic and brand-name drugs must meet the exact same standards for effectiveness, safety and quality.

Are generic drugs as strong as brand-name drugs?

Yes. The Food and Drug Administration (FDA) requires generic drugs to have the same quality, strength, purity and stability as their brand-name versions. Generic drugs are thoroughly tested to make sure their performance and ingredients meet the FDA’s standards for equivalency.

Do generics take longer to work?

No. Generic drugs work in your body in the same way and in the same amount of time as brand-name drugs

Are brand-name drugs manufactured in better facilities than generic drugs?

No. Both brand-name and generic drug facilities must meet the same standards; the FDA won’t permit drugs to be made in substandard facilities. The FDA conducts about 3,500 inspections a year to ensure standards are met. In fact, brand-name firms are linked to an estimated 50% of generic drug production. They frequently make generic copies of their own or other brand-name drugs, then sell them with a generic name.

What is the price difference between generic and brand-name drugs?

In 2008, the average price of a brand-name drug was $137.90, while the average generic prescription cost $35.22, according to the National Association of Chain Drug Stores. In addition to the savings on the price difference, there is also a savings on your copayment for using a generic drug over a brand-name drug.

If generic drugs are just as good as brand-name drugs, why do generics cost less?

When a company develops a new drug and submits it for FDA approval, a 20-year patent is issued, preventing other companies from selling the drug during the life of the patent. As a drug patent nears expiration, any drug manufacturer can apply to the FDA to sell its generic version. Because these manufacturers didn’t have the same development costs (such as years of expensive research), they can sell the drug at a discount. Once generics are allowed, the competition keeps the price down. Today, almost half of all prescriptions are filled with generics.

Why do some generic drugs look different from their brand-name versions?

All drugs have inactive ingredients such as dyes, fillers and preservatives. These ingredients often determine the size, shape and color of the drug. Trademark laws do not allow a generic drug to look exactly like its brand-name version. A generic drug must duplicate the active ingredient and it must be equally effective, but the color, shape, and other inactive ingredients may be different.

How do I get generic drugs?

Talk with your doctor and pharmacist. Explain that you want the most effective drug at the best price. Ask your doctor to write prescriptions for generic drugs whenever possible.

What’s the bottom line on generics?

You can use generics with confidence. Although they may look different from their brand-name versions, generics are safe and effective. As always, any medication changes must be discussed with your physician and pharmacist.

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Generic Keep Growing

Nobody wants to have their medicine made in factories that swarm with flies or are awash in urine or where safety tests are faked. That’s why the U.S. Food and Drug Administration in the last year banned imports of generic drugs from at least five Indian factories that failed FDA inspections. In December 2014, some European countries banned the marketing of some drugs that had been approved on the basis of clinical trials conducted by a lab in India after a a French review found that data there was being falsified. Generic drugs now account for 80 percent of U.S. prescriptions. India is the second-largest exporter of drugs to the U.S., and almost half of active pharmaceutical ingredients used in the U.S. come from India or China, which has had its own scandals involving tainted drugs.  This trend poses challenges similar to those from the rise in imported foods: A global supply chain that delivers low-cost products but sprawls outside regulators’ traditional geographic orbit. With only a handful of inspectors in those two giant countries, the agency is focusing its efforts on improving the quality of work done by its Indian and Chinese counterparts. At stake is whether the pill a patient takes halfway across the world will do its job or not, something an increasing number of doctors and researchers question.

The Situation

Last year, one of India’s biggest makers of generic drugs, Ranbaxy, paid a fine of $500 million to settle charges that it sold adulterated drugs and lied to the FDA. Later, the agency banned imports from a Ranbaxy factory where workers hid failures on quality tests by repeating them until they got acceptable results. In factories run by another drugmaker, Wockhardt, inspectors found urine spilling over open drains and mold growing in storage areas for raw materials. The FDA’s director, Margaret Hamburg, spent a week in India hammering home the message delivered by the factory bans.  The FDA will expand its offices in India, train regulatory officials and strengthen inspections of overseas plants, she said. The push for improvement is funded by new fees collected from the generics industry that were approved by Congress in 2012.  The FDA is also using $20 million of the money for the first widespread evaluation of the safety and quality of generics, whether made abroad or at home.

The Background

Generic drugs took off in the U.S. during the 1980s with the passage of the Hatch-Waxman Act, which made it easier and cheaper to bring a drug to market. In the 90s, generic production proliferated in India and China, where manufacturing can cost half as much as in Europe or the U.S. But regulation and oversight didn’t keep up. In the face of the rapid rise of generic-drug exports, regulators have adopted different approaches. The European Union mandates batch testing, where a sample from each shipment is tested before it can be released for sale; the FDA focuses on inspections and doesn’t do spot tests, although the FDA and the European Medicines Agency in December agreed to share information on inspections and safety studies.  Some Indian manufacturers are considered to have stringent safety standards, but independent estimates of the extent of counterfeit medicines sold in the country range from 12 percent to 25 percent. Concerns with generics aren’t limited to India and China: in 2012, Teva Pharmaceuticals of Israel pulled one version of Wellbutrin after regulators said it wasn’t the same as the brand-name medicine.

The Argument

At a Washington hearing in February, researchers reported finding signs of contamination in imported drugs and doctors spoke of their need to have patients try different versions of generics until they find one that performs as promised. While the FDA’s critics are pleased by its plans to add staff and step up overseas inspections, they think more needs to be done. In April, the chairman of a U.S.-Chinese safety commission, Dennis Shea, called the FDA “woefully, inadequately staffed” in China. Some experts would like doctors and patients to be given more information on where drugs come from. Hamburg said the key to safer generics is for overseas drugmakers to take responsibility for implementing the necessary quality-control procedures and local regulators to develop the expertise needed to enforce them. That may improve India’s U.S. exports but not benefit all patients. G.N. Singh, India’s top drug regulator, told India’s Business Standard in January that if he had to impose U.S. standards on factories making drugs for the Indian market, “we will have to shut almost all of those.”

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Pharmaceutical Exports from India

India is among the fastest-growing pharmaceutical markets in the world and has established itself as a global manufacturing and research hub. A large raw material base and the availability of a skilled workforce gives the industry a definite competitive advantage. The Indian pharmaceutical industry is estimated to be worth US$ 26 billion. The industry is expected to reach US$ 45 billion by 2020 to become the sixth largest globally. India ranks third in production volume (10 per cent share) and fourteenth by value (1.4 per cent share) worldwide.

EXPORTS AND ADVANTAGE INDIA

India exports to over 200 countries. Pharmaceutical exports clocked a CAGR of 10.3 per cent to US$ 15.5 billion during 2014–15 from US$ 10.4 billion during 2010–11. The US is the largest importer of Indian products. Exports to the UK grew at 11.9 per cent between 2009 and 2010, and 2013 and 2014.

India has the highest number of plants approved by the United States Food and Drug Administration (USFDA) outside the US. Around 584 Indian companies/sites are registered with the USFDA. Several plants have also obtained regulatory approvals from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; the Medicines Control Council (MCC) in South Africa; and the Therapeutic Goods Administration (TGA) in Australia.

India has one of the lowest manufacturing cost in the world. Manufacturing cost in India is approximately 35–40 per cent of that in the US as installation and workforce costs are low.

PHARMACEUTICAL EXPORT PROMOTION COUNCIL

The Pharmaceutical Export Promotion Council (PHARMEXCIL) was established in 2004 by the Ministry of Commerce and Industry, Government of India, to promote pharma exports.

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Why India’s Generic Medicines Industry is So Important

Janice Lee is a pharmacist who worked with medical teams in Doctors Without Borders/Médecins Sans Frontières (MSF) projects in Liberia and Zimbabwe before starting work with MSF’s Access Campaign. Her job is, among many other things, to identify potential new sources of drugs that could be of use to MSF’s work treating patients in developing countries.  She also works closely with both originator and generic drug companies to feedback on the medical needs that MSF sees in its work in the field. Here, she talks about why generic medicines are so important to our medical teams working in some of the poorest places on earth.

You worked as a pharmacist in Liberia and Zimbabwe, dealing with the drugs for our projects, how dependent are MSF medical teams on generic drugs from India to carry out their work ?

Our reliance on Indian generic drugs for treating patients with HIV/AIDS across all our programmes in MSF is particularly acute—around 80 percent of the AIDS medicines we use are generic drugs made by Indian companies. But it’s not just AIDS. In other projects too, we also routinely use Indian generic drugs to treat other diseases, such as TB, malaria, and a wide range of infectious diseases.

And it’s not just MSF that relies on the flow of generic drugs; all the major donors and leading international treatment providers, like the Global Fund, PEPFAR, UNITAID, and UNICEF, are all rely on quality affordable generic drugs for the programs they support. Right now, at a time when funding for global health programs is shrinking, it’s more important than ever to keep the flow of these affordable drugs going.

Why are so many of these generic medicines made by companies in India ?

There are several reasons. Most importantly, many of the AIDS drugs we use right now to treat people with HIV are patented in many countries. But international trade rules required India to start granting patents on pharmaceutical products only after 2005. Until that time, Indian companies were able to manufacture generic versions that competed in price not only with brand name companies but also amongst themselves to bring down the prices of AIDS drugs drastically. This is what allowed the price of treatment to drop from over US$10,000 ten years ago to less than US$80 today.

What’s more, it has been possible for them to create fixed-dose combination pills of these generic antiretrovirals—essentially two or three pills in one—that have been hugely influential in simplifying AIDS treatment and making treatment more practical in developing countries where we work. Imagine, we can offer a patient one pill once a day rather than a handful to be taken at different times of day.  Some of these fixed-dose combinations don’t even exist in rich countries precisely because of the patent barriers that exist there.

In 2005, India put in place a patent law—fortunately it’s a law that supports public health objectives, so the result has been that India’s generic manufacturers have had some space to continue producing affordable and effective medicines. But the problem ahead of us is that many of the newer AIDS drugs are now patented in India and so cannot be produced by the generic manufacturers, so they will remain out of reach.

How will the current trade talks between the European Union and India make this situation worse ?

The trade talks could be another tightening of the screw. One of the main provisions that Europe wants to include in the trade deal is data exclusivity, which means more affordable generic medicines can’t be registered on the basis of data for safety and efficacy that is already out there, the generic companies will have to run their own clinical trials. If India accepts this then two options open up: generic companies will either have to wait longer (anywhere from five to ten years) before they can market their own versions of an expensive originator drug. This means it will be longer before patients can benefit from the development of an affordable generic version of the medicine. Or, in order to register their medicines, the companies will have to conduct their own clinical trials on their products, which is not only unnecessary but will also be very expensive, time-consuming and unethical. Data exclusivity won’t affect drugs that are already registered and on the market in India but would impact on the promising newest antiretroviral drugs coming along in the drug pipeline that could be our new essential treatment for AIDS patients. And what’s particularly dangerous is that it applies even where drugs are not under patent, so it acts like an alternative patent that blocks generic production.

So how much more expensive could AIDS treatment be for patients if we had to use branded or originator drugs rather than generic drugs ?

We know in the lowest income countries, a year’s treatment using the latest recommended World Health Organization recommendations containing tenofovir from an originator company costs US$613. And in some middle-income countries that price rises to over US$1000. Compare that to the price of the generic version of US$176 in a fixed dose combination pill and you can see why generics are so important, allowing us to treat many more people.

Patients who have been on antiretroviral treatment for some time develop resistance to their treatment and may have to move to newer AIDS treatments. How do branded drugs compare in price to generic drugs in that case ?

For what is called a second-line treatment, the cost of a year’s treatment using a generic combination of second-line antiretrovirals (containing boosted atazanavir) would be US$465. A branded product can cost two to three hundred dollars more.

And once a patient develops resistance to that second set of drugs, there are really no affordable options since the generic production of the newest AIDS drugs has already been stopped in India because the drugs are patented. The lowest branded product can cost over US$3,200 for a year’s treatment, which is completely out of reach for most people in developing countries.

Do generic medicines also make the treatment of children with AIDS more affordable ?

It’s a different story for children because the originator companies don’t see any commercial gain in developing and marketing fixed-dose combination treatments for children.  This is essentially because in their main markets, rich countries, pediatric AIDS has almost been wiped out. So most AIDS medicine formulations for children only come from generic manufacturers in the first place. Currently the most commonly used generic fixed-dose combination for treatment of HIV/AIDS in children costs US$55 to treat a child for one year.

We also need to expand the range of options for treatment of children with HIV/AIDS and ensure that they are developed with the needs of developing countries in mind both in terms of research and development but also the formulation. For instance, most of our patients do not have a refrigerator and some remote places where we work don’t have a power supply, so drugs cannot be refrigerated. Formulations adapted for use in developing world are more likely to be developed by generic manufacturers than the big name pharmaceutical companies based in Europe and the United States.

You’ve been working for MSF in AIDS programs alongside the medical teams, what would it mean if we couldn’t get our hands on these generic drugs any more ?

Patients would die! And we would go back ten years to where we started, when treatment was too expensive to give to patients and all we could do was basically just treating the opportunistic infections that accompany HIV infection without being able to suppress the virus at all. When you remember that there is already a funding crisis today that threatens countries’ ability to put more patients on treatment, then having medicines become more expensive in the future is a very a frightening prospect.

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How faster USFDA nods will help Indian generic drug makers

MUMBAI: A long spell of sluggish approvals for generic drugs in the US may be nearing an end with early signs of a rebound. A backlog of as many as 4,000 pending applications at the US Food and Drug Administration(USFDA), of which a fourth is estimated to have been filed by Indian firms, is awaiting clearance. Fortunes of generic drug makers to a great extent hinges on their approval timelines. Experts say going by the current run rate, theFDA may clear at least 470 such products this year, a sharp uptick from 409 approvals in 2014.

The number may even cross 500 if the FDA does not seek additional details via complete response letters. Some of these products may mark the entry of new companies in areas that have so far seen limited competition, implying a cut in profit margins. As part of a fixed five-year plan, the Generic Drug User Fee Amendments were initiated in 2012 in the US to facilitate a speedy approval process, with industry players paying a fee to supplement costs of reviewing the applications and inspecting facilities.

While the first two years of the plan did not show a perceptible change in terms of faster approvals, the FDA had shared details on industry forums about additional hiring for review processes and investments made to accelerate the pace of approvals. Some of the Indian drug makers have already seen faster approvals this year. A recent report by HSBC analyst Girish Bakhru named Aurobindo Pharma as a company that has witnessed a higher number of approvals.

It indicated the company has a better approvals outlook and can be expected to see growing sales of its injectables towards the end of 2015-16. Aurobindo has gained 17 FDA approvals so far this year, second in the chart among Indian firms.

Lupin has emerged as the biggest beneficiary of the GDUFA process as the company gained approvals for 19 products in 2015. Last week, the company disclosed of an approval, its third in five days, for a delayed release version of gastric ulcer and heartburn drug omeprazole.

A few big companies, however, are lagging in terms of approvals like Dr. Reddy’s, Sun and Cadila. Applications from these companies are mostly held back due to their internal manufacturing related issues rather than the FDA’s application review process.

Over the last 12 months, Sun has undertaken a corrective action plan at its crucial site at Halol in Gujarat. Dr Reddy’s, similarly, is seeing a delay in approvals of big-ticket drugs owing to observations cited by the FDA at its Srikakulam site in Andhra Pradesh. Cadila’s Moraiya facility in Gujarat is also expected to gain clearance for over a dozen products, once those pass through the FDA’s checks. Analysts also note that the volume of filings for generic products by Indian companies has surged, adding to the existing logjam.

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India Must Resist US Pressure on Generic Drugs, African Leaders to Tell Modi

So far, the NDA government has been a mute spectator to the US pharma strategy of forcing Indian generics manufacturers to produce only what is required for Indian consumers and abandon the export of cheap drugs to Africa

Anti-retrovirals from Indian in the customs warehouse at the airport in Accra, Ghana. Credit: David Baron/PRIs World

In his ‘Mann ki baat‘ radio show on Sunday, Prime Minister Narendra Modi proudly spoke about how India will host 54 heads of state from Africa for the first time to reinforce “our nation’s historical and cultural links’ with African countries.

However, invoking this very spirit, the visiting African leaders will place before the Prime Minister an issue of life and death for their peoples in which India can play a critical role – the export of cheap and affordable generic medicines for the cure of AIDS and other deadly diseases. The African heads of state will urge Modi to resist growing pressure from the United States government and Western drug multinationals on India to stop exporting cheap generics to Africa.

Kenya’s ambassador in India, Florence Imisa Weche told this writer in an interview for RSTV that the issue of affordable medicine imports from India – especially for treating AIDS – is a matter of great concern for African nations. Weche indicated that the visiting African leaders will urge Modi not to dilute India’s current status as the “Pharmacy of the Third World”. This comes after the South African health minister expressed similar apprehensions a few months ago. The India-Africa summit will provide an opportunity to address this question.

The US pharma lobby wants India to limit the production of affordable generics to only what is required for Indian consumers under a “voluntary licensing scheme” and not produce drugs for third country patients. Some Indian companies, lured by higher profits, are already striking cosy deals with US pharma giants. The NDA government has shown a tendency to assist this collaboration through the back door, by signalling its willingness to dilute India’s pro-public health intellectual property policy which has been widely hailed in the developing world. India’s existing policy has enabled the price of HIV drugs to fall 99% – from $10,000 per person per year in 2000 to $100 per year today. Other diseases like tuberculosis, hepatitis and malaria which afflict millions of people in Africa also need affordable generic medicines exported from India.

The Modi government has publicly said that it is not willing to dilute India’s IPR law – whose provisions on compulsory licensing and the ‘evergreening’ of patents make it difficult for Western pharma companies to earn super-profits from essential formulations – but at the same time it has made some non-transparent moves like setting up a committee to look at the implementation of the IPR guidelines, especially in the pharma sector. Prime Minister Modi had publicly assured American CEOs in President Obama’s presence in India last January that he would “address all their concerns on Intellectual Property Rights”.

This assurance had caused apprehension about the NDA’s continued commitment to the current IPR policy. There is a fear that the law may remain the same but cumbersome procedural guidelines could make it costlier for domestic pharma companies to export cheap drugs to other developing countries.

Inspite of the big boost for a pro-public health policy which the Supreme Court delivered through its judgement against the US MNC Novartis some years ago, it appears American and other Western pharma companies have mounted a massive offensive against their Indian rivals through clever, procedural tweaking. So far, the NDA government has been a mute spectator.

For instance, a US multinational company, Gilead, launched an anti-Hepatitis C drug and entered into a deal with seven Indian companies to make the drug cheaper, but still unaffordable, thus offering higher profits to the Indian counterparts. The Indian pharma companies agreed to be co-opted because the alternative would be to get into long drawn and costly litigation against Gilead in order the make the same drug much cheaper in India – both for Indian patients and for export to developing regions like Africa. Given the critical importance of affordable drugs, it could be argued that a pro-active government ought to help its domestic pharma industry in the litigation process and even put price caps on such life saving drugs to ensure that public health objectives are met. This is precisely what the African heads of State will be urging Modi to do.

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