Drugs From India - Regulatory Affairs Associates

One of the major concerns for people getting cancer treatment is the cost of medications. While the cost to develop drugs is quite high (and getting higher) because of all the tests needed to ensure that they're safe and provide the stated benefit, the cost to manufacture approved drugs can be very low - there are markups in the drug trade of several thousand-fold, and this is why generic drugs are cheaper (and can be cheap enough that Wal-Mart can sell $4 generics and still stay in business.)

These drugs or part of the drug (the active ingredient) are outsourced to places where the labor costs are lower; like much of American technical manufacturing, The vast majority of American generic drugs are manufactured in India and China, and both India and China took different turns on patent law to keep their export drug industry strong.

In the US, drug patents are on the specific product. In India, the patent is deemed to be on the process that makes the drug, not the drug itself. According to the process patent system, if the same product comes out of a different manufacturing method, it can be sold without paying patent royalties to the developer. Because of this, India led the world in creating active ingredients, many of which are shipped overseas and turned into final drug products in the US; most countries with substantially cheaper drugs get them by the same process.

Unfortunately, there's a risk in this process. US drugs (and European drugs from Western Europe, and most drugs from Israel) are made in plants that have agreements to let FDA inspectors (or their local inspectors, who work to FDA standards) make surprise visits to make sure that everything is being run to the quality assurance standards specified.

In India, that isn't always the case, and most plant inspections have to be scheduled weeks or months in advance. Even worse, from the perspective of the FDA, is that a lot of Indian drugs are released early - they release drugs that are still going through FDA clinical tests, hoping to get an earlier entry point to the market. This isn't to say that India drugs aren't quality checked; they're checked by the somewhat looser standards of the World Health Organization…and for some drugs (such as ibuprofen), that's probably enough regulatory oversight.

However, for drugs that can be dangerous if the dosage is input incorrectly, that may not be enough oversight. Some drugs have complicated manufacturing processes or need extra purification to be effective, and those are the expensive, labor intensive steps that might be the first corners cut.

From the perspective of the business making the drugs, the aim is to sell the highest volume of product possible at the best price possible…and sometimes that can result in cutting corners or releasing drugs to the market before they're fully approved. (In most cases, to be fair, this means drugs that have been approved elsewhere but are still going through FDA clinical tests in the United States).

As India's drug market expands, it's moving up the production chain. Indian drugs are now being sold as finished product to the US, rather than delivering ingredients for US manufacturers to combine, and India is starting to import active ingredients from other countries, such as Pakistan and China, both of which have even laxer quality control standards than India does.

What this means, as a consumer, is that you shouldn't try to buy drugs from India directly. While saving money (especially on a chronic disease like cancer) is important, getting the right drugs to do the job is more so. You, as a private individual, have no access to the records needed to verify the contents of the drugs you're taking. Your pharmacist or oncologist does, though you may have to talk to them about the options—and they know how to get FDA involved if they suspect there is a problem.

Drugs produced in India are controlled by the World Health Organization (WHO) and in many cases these drugs are FDA approved ! They are NOT counterfeited as can be the case in China or other countries. Read on for more info. As an example we suggest you check out just one Indian drug manufacturer at http://www.cipla.com. You will find a company that has been in business for over 7 decades producing only the highest quality drugs, many of which are exported to the USA.

Compare different Country Prices :

First, is it legal to import generic equivalents of brand name drugs currently under patent from an overseas pharmacy ?

The World Trade Organization (WTO) treaties between nations protect patents and trademarks. India is one of the few nations that selected a protection scheme based upon protection of the manufacturing process (Process Patents) rather than using the more common scheme of protecting the actual product (Product Patents).

As a result, Indian pharmaceutical chemists can legally create, and sell worldwide, drugs that are still patent protected elsewhere if they do so using a process that creates the identical drug through the use of a different process. Therefore, these drugs can be marketed at prices that reflect their real manufacturing cost, rather than a price that is set without regard to competition.

But, still...
Even considering the foregoing, how can the drugs available through online prescription pharmacies be at such a discount ?

Well, the real question is 'Why are pharmaceutical companies allowed to charge so much when their cost of ingredients is so low ?'

What most people are not aware of is the actual cost of the ingredients that make up these pharmaceuticals. For example, 100 Celebrex 100 mg pills costs the consumer $130.27, but the cost of the ingredients is a mere $0.60! That is a markup of 21,712%! Or, how about 100 Prozac 20 mg pills? Consumer cost is $247.47. However, the cost of the actual ingredients is just $0.11! That is a 224,973% markup !

Certainly the pharmaceutical industry is a profitable industry in the US. The profit margin of the drug companies, which takes into consideration the substantial costs for research and development of new drugs, is a source of much discussion. Regardless of a person’s personal thoughts on this topic, the fact of the matter is that nearly all the new medical innovations are developed in the USA, even if they are testing in other countries. Perhaps this is just an example of letting great scientists follow their hearts and minds, or maybe it is an example of the free-market at work ?

World Health Organization (WHO)
Food and Drug Administration (FDA), USA.
Medicines Control Agency (MCA), UK.
Therapeutic Goods Administration (TGA), Australia. Medicines Control Council (MCC), South Africa.
National Institute of Pharmacy (NIP), Hungary.
Pharmaceutical Inspection Convention (PIC), Germany.
Food and Drug Administration (FDA), India.

Indian Manufacturers

Given below is a list of some of the Indian manufacturers from whom these overseas pharmacies source the drugs for you. All these are well known in North American & European markets.

GlaxoSmithKline (GSK), India.
Novartis India Limited.
Wyeth India Limited.
AVENTIS PHARMA INDIA.
PFIZER INDIA LIMITED
UCB Pharma Ltd
E Merck India Ltd
ELI Lilly and Company (India)
AstraZeneca Pharma India Ltd.
JOHNSON & JOHNSON (ETHNOR DIVISION)
Cipla Limited.
Ranbaxy India Limited.
Dr.Reddy Laboratories.
Nicholas Piramal India Limited.
SUN PHARMA LIMITED.
RPG LIFESCIENCES LTD.

Some of these plants pass regular inspections by visiting regulators from the government regulators in the United States, Britain, Canada, Germany, France, Spain, and other countries. Ranbaxy has U.S. F.D.A. approval for 20 of its generic products and it owns a factory in New Brunswick, N.J.

You can use the web links listed above to learn more about these companies, their quality standards and their credentials.

Indian Online Prescription Pharmacies

Your orders are processed at specially created export facilities of overseas pharmacies and these Licensed Pharmacies are manned by licensed pharmacists who verify the prescription, if needed, and then dispense the drugs exactly as you ordered.

Your order is filled with drugs drawn from the same immense inventory pool as that used to fill bulk orders from the chain's retail stores, which dispense thousands of prescriptions daily. This assures you that your drugs are factory fresh, genuine, and of the highest quality.

All of the drugs that are offered are in the form of pills, capsules, or tablets and are machine sealed at the factory in tamper-proof packs.

HIV Drugs

In the USA it cost about $12,000.00 per year for the three drugs that are commonly used to control the HIV virus. These 3 drugs are from 3 different companies and their profits from these drugs are enormous. In India these same 3 individual drugs are manufactured as one drug, in one pill, and sell for about $300.00 per year.