MANILA, Philippines?For a generic drug to be safe, effective and approved for marketing, its manufacturer must be able to prove that its product has the same chemical structure or the same active ingredient as that of the original, patented drug it copies.

The generic drug must be able to show that even its inactive ingredients such as coatings, stabilizers, fillers, binders, flavorings and diluents are the same.

?This is what we call as bioequivalence. This is important because the generic drug must be able to release its active ingredient into the individual?s bloodstream at virtually the same speed and in virtually the same amounts as the original drug,? explained Mito Raagas, business development director of Winthrop Pharmaceuticals Philippines, during the launch of the company?s generic version of Clopidogrel, an anti-platelet drug (helps prevent stroke or heart attack) and Amlodipine, an antihypertension drug.

Winthrop Pharmaceuticals is the generic arm of sanofi-aventis.

Address health needs

Present in 22 countries throughout Europe, Asia, South America and Africa, the company is set to address major health needs in therapeutic areas such as metabolic, cardiology, thrombosis and pain.

?Since the company develops, manufactures and markets generic drugs following the Sanofi-Aventis Group?s world-class standards, its products are assured of its high quality in terms of product efficacy and safety,? Raagas explained.

Raagas also explained that the entry of companies like Winthrop in the local market would improve the image of generic drugs that are often perceived as cheap but unreliable.

Fundamental

?Access to medicines is fundamental for all individuals to achieve their right to health. And we should ensure that poor people have access to quality medicines. This is why the Generic Drug Act of 1988 was passed and why the Universally Accessible Cheaper and Quality Medicine Act of 2008 will be signed into law,? Sen. Pia Cayetano said during Winthrop?s launch.

She added that the proposed measure while not perfect should be strong enough to bring down prices of medicine through free competition and better access to affordable brands.

The Quality Medicines Act of 2008 is also set to amend the Intellectual Property Code to allow, among others, parallel importation of patented medicine from other countries where these are more affordable.

Allowed

Once signed, local generics firms will soon be allowed to test, produce and register their generic versions of patented drugs, so these could immediately sell them once the patent expires.

The forthcoming law, which was originally filed three years ago, will also allow the government to use patented drugs when the public interest is at stake.

?We are indeed at a defining moment in history of healthcare in the Philippines and our company is proud to play its part in this development,? said Carlito Realuyo, general manager and president of sanofi-aventis.