The purpose of this article is to generate confidence in Indian suppliers that serve Canadian and online pharmacies. India commands the dominant world market share as exporter of generic product.
Indian suppliers are the generic sourcing choice for Canadian and online pharmacies because globalization is driving them toward U.S. FDA compliance in the move to more collaborative relationships with the US, EU and Japan. Learn more.
Be sure that your online vendor uses FDA compliant suppliers. This page represents proper disclosure that would be reassuring for a consumer.
Evolution of the Indian pharmaceutical industry:
In the 50’s and 60’s India had minimal internal pharmaceutical production. They were dependent on western sources for medicines which they could ill afford. The Indian government instituted tariffs and liberalized patent laws to nurture a domestic pharmaceutical industry. The patent laws allowed protection of the process of manufacturing vs. the product as well as process. This had the effect of allowing Indian manufactures to duplicate western formulations before the expiration of the patent in the country of origin, typically the US. This environment caused western pharmaceutical companies to withdraw from India.
From the 70’s to 2005 the Indian pharmaceutical industry experienced double digit growth. They became expert at producing western preparations using a slightly modified process to stay within Indian patent law. They became known as the “Pharmacy of the poor”. Low wages and high educational standards lent it self well to super charging the growth of the pharmaceutical industry. Focusing on generic production eliminated developmental risk as well as prohibitivly expensive research dollars. India holds 20% of the world generic market but 2% of the pharmaceutical world market. 22% of total generic production is exported and of that 80% goes to US and the EU.
After the 2005 patent law reform through the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights the industry entered a more collaborative environment with western pharmaceutical industry than during the earlier developmental period. This reorientation of the industry resulted in these important changes.
1. A segment still focuses on generic as its prime business. In this segment 80% of generic production is targeted for US, EU and Japan.
2. A major segment is focusing on development of new medicines. This has spawned new research relationships between Indian firms and western giants like Ely Lily.
3. Contract manufacturing for western giants is the last segment of the reorientation.
The most significant change resulting from patent reform is movement of the entire Indian pharmaceutical industry toward US FDA compliance due to the new western focus on so many touch points. The US, EU and Japan are the most lucrative world markets. Since the US FDA governs the major segment of export target market the move to FDA standards serves the reorientation of the Indian pharmaceutical industry.
Here are some relevant excerpts and website links.
The Indian pharmaceutical industry is also getting increasingly U.S. FDA compliant to harness the growth opportunities in areas of contract manufacturing and research. Indian companies such as Ranbaxy, Sun Pharma, and Dr. Reddy’s are increasingly focusing on tapping the U.S. generic market. Recently, Ranbaxy Laboratories Ltd has received a tentative approval from the US Food and Drug Administration to manufacture and market Lamivudine tablets (150 mg), a medicine used in treating HIV infection. This tentative approval has been granted under the US President’s Emergency Plan for AIDS Relief Initiative (PEPFAR).
Wage costs in the Indian drugs industry come to only about 30% of the European level or 20% of the US level. Overall drugs manufacturing in India is up to 50% cheaper than in western industrial countries.
Here is an overview of the Indian pharmaceutical regulatory structure. Click on full screen and use finger to advance through slides.
These circumstances generated the investigation which produced this information.
The event:
In November of 2006 I had a second heart attack. This event was in addition to the first heart attack and stent in 2002 and a 2005 a bad stress test report led to two more stents. This second heart attack was the first event which resulted in heart tissue loss. This loss was due to blockage from clotting in the LAD diagonal artery.
In August 2006 we moved from NJ to GA. I had no contact with a Cardiologist at this point. I was at the mercy of the ER to produce a qualified Intervention Cardiologist. The surgery was to no avail. The artery was too firmly blocked to get a stent implanted. The LAD diagonal was lost. I was put on a Coreg a beta blocker designed for post heart attack patients. Here is the difference between domestic brand and Canadian generic sourced from India.
| Product | Wal-Mart | Canada Rx | Canada Rx | ||
| Per Pill | Per Pill | % Savings | |||
| Coreg | $2.25 | $0.50 | 78% |
Validate per pill pricing Carvedilol (Generic Coreg)
The story:
My plan was to get the med from Canadian online to save money. At this point I was three years short of being eligible for Medicare. I had no insurance. Investigation into private coverage produced the same answer from several insurers. I was uninsurable because of my cardio history. They said they could do something with corporate coverage but not private. Ultimately the whole 2006 event cost me around $10,000 cash. The hospital gave a 40% discount and the doctor around 30% for a lump sum cash payment. The alternative to cash would have been a pay schedule with interest.
In the follow up visit I asked the doc for a one month brand prescription which was called into a local pharmacy as well as a hand written script to fax to Canada. The reason for the one month local prescription was to accommodate the two to three week delivery time for Canadian generic product that would come from an Indian supplier. I found that local pharmacies will only give you a thirty day supply but Canadian or online pharmacies will fill a ninety or one hundred eighty day order.
When I went to pick up the prescription the local pharmacist frightened me. He was very adamant that the non-domestic suppliers universally produced unsafe, impure and ineffective products. After this unsettling experience I was determined to get to the bottom of this quality issue. So took the one month order of the brand from him and went home to investigate. Obviously I was very interested in getting proper effectiveness from this med.
I went on the computer and searched the word Coreg. This produced some Canadian pharmacies which had a generic. I looked up the generic name a Cardivas. This was very comforting. The word Cardivas let me to Intas Pharmaceutical a manufacturer in India. The above link shows that Intas is FDA approved and inspected.
These images show the 2005 and 2006 stent procedure. I had bypass surgery in 2008. I asked the 2006 surgeon “you think I would be better served with a bypass?” He said “no”. The bypass was done at the Atlanta VA by Dr. David Vega and the Emory University heart transplant team which does heart procedures at the VA twice per week. I felt very blessed to have that world class team do the procedure.
Heart images 2005-2006
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