Indian Pharmaceutical Suppliers and the US FDA

The purpose of this article is to generate confidenceAspects of Intellectual Property Rights, the industry
in Indian suppliers that serve Canadian and onlineentered a more collaborative environment with
pharmacies. India commands the dominant worldwestern pharmaceutical industry than during the
market share as manufacturer and exporter ofearlier developmental period. This reorientation of the
generic product.industry resulted in these important changes.
Indian suppliers are the generic sourcing choice for1. A segment still focuses on generic as its prime
Canadian and online pharmacies because globalizationbusiness. In this segment 80% of generic production
is driving them toward U.S. FDA compliance in theis targeted for US, EU and Japan.
move to more collaborative relationships with the US,2. A major segment is focusing on development of
EU and Japan. Learn more.new medicines. This has spawned new research
Evolution of the Indian pharmaceutical industry:relationships between Indian firms and western giants
In the 50's and 60's India had minimal domesticlike Ely Lily.
pharmaceutical production. They were dependent on3. Contract manufacturing for western giants is the
western sources for medicines which they could illlast segment of the reorientation.
afford. The Indian government instituted tariffs andThe most significant change resulting from patent
liberalized patent laws to nurture a domesticreform is movement of the entire Indian
pharmaceutical industry. The patent laws allowedpharmaceutical industry toward US FDA compliance
Indian companies to copy expensive originaldue to the new western focus on so many touch
preparations by foreign firms and produced these bypoints. The US, EU and Japan are the most lucrative
means of alternative production procedures. This hadworld markets. Since the US FDA governs the major
the effect of allowing Indian manufactures tosegment of export target market the move to FDA
duplicate western formulations before the expirationstandards serves the reorientation of the Indian
of the patent in the country of origin, typically thepharmaceutical industry.
US. This environment caused western pharmaceuticalHere are some relevant excerpts and website links.
companies to withdraw from India.The Indian pharmaceutical industry is also getting
From the 70's to 2005 the Indian pharmaceuticalincreasingly U.S. FDA compliant to harness the growth
industry experienced double digit growth. Theyopportunities in areas of contract manufacturing and
became expert at producing western preparationsresearch. Indian companies such as Ranbaxy, Sun
using a slightly modified process to stay within IndianPharma, and Dr. Reddy's are increasingly focusing on
patent law. They became known as the "Pharmacytapping the U.S. generic market. Recently, Ranbaxy
of the poor". Low wages and high educationalLaboratories Ltd has received a tentative approval
standards lent it self well to super charging thefrom the US Food and Drug Administration to
growth of the pharmaceutical industry. Focusing onmanufacture and market Lamivudine tablets (150
generic production eliminated developmental risk asmg), a medicine used in treating HIV infection. This
well as prohibitively expensive research dollars. Indiatentative approval has been granted under the US
holds 20% of the world generic market but 2% ofPresident's Emergency Plan for AIDS Relief Initiative
the pharmaceutical world market. 22% of total(PEPFAR).
generic production is exported and of that 80% goesWage costs in the Indian drugs industry come to only
to US and the EU.about 30% of the European level or 20% of the US
After the 2005 patent law reform, which resulted inlevel. Overall drugs manufacturing in India is up to
the adoption of the Agreement on Trade-Related50% cheaper than in western industrial countries.