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Drugs from India not that safe, says expert


Philippine Daily Inquirer
First Posted 04:03:00 08/26/2010

Filed Under: Pharmaceuticals, Medicines, Safety of Citizens

MANILA, Philippines?An infectious disease expert has warned against using pharmaceutical drugs from India, whether generic or branded, because their formulations may not be safe.

?Generic drugs are really cheap but we?ve been telling our patients to make sure that the generic drugs they?re taking are not from India because the add-ons or substances of these drugs are not stable,? said Dr. Mario Panaligan, secretary of the Philippine Society of Microbiology and Infectious Diseases, and a consultant at the University of the East-Ramon Magsaysay Medical Center (UERMMC).

Speaking at a forum on ?Fever: The Multi-faceted Ally and Foe,? Panaligan said that paracetamol, antibiotics and other medicines from India are not 100 percent effective compared to those manufactured by ?innovator? companies.

There are more than a hundred generic companies in India, he said, and even those drugs manufactured by its top 10 companies are not guaranteed to be 100-percent safe.

Add-ons

According to Panaligan, a drug?s efficacy depends on its add-ons during its formulation.

?They have to add more substances to make that particular drug stable,? he explained.

A substance in a particular generic drug could become unstable, meaning they can cause side effects.

?The joke among us is, it?s gawa sa gawgaw (made from cornstarch),? he said.

Told that such a statement could spark a protest from the Indian government, Panaligan said he was a member of a hospital?s therapeutic committee and knew what he was talking about.

He said the committee was shown drugs made by the top 10 pharmaceutical companies of India and told that the products? efficacy and capability were guaranteed.

Guaranteed, but ?

?The problem is, if you say they?re guaranteed, then you have to perform a bio-equivalent study to prove that when compared to the original (drugs made by innovator companies), it will have the same effect on humans. So even if they say that the drugs are made by a top 10 company, it?s hard to believe because there is no bio-equivalent study. Whereas the innovator companies who made the original drugs have done a cycle of studies,? Panaligan said.

Panaligan said he did not want to be accused of promoting branded drugs but stressed that paracetamol under the brand names Tempra and Biogesic have actually been proven to be effective as first-line treatment for fever. Both brands are known to be equivalent in terms of efficacy and capability, he said.

He said the health department?s Food and Drug Administration does not have the infrastructure to evaluate drugs for approval, and merely relies on the reports being submitted by the manufacturers which are usually self-serving. Cynthia D. Balana



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