Drugs from India not that safe, says expert

Philippine Daily Inquirer

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

Food supplements.............

Philippine Daily Inquirer
First Posted 02:16:00 09/29/2009

Why would the Department of Health and the Food and Drug Administration (FDA) go after the Filipino makers of herb supplements when they’re just trying to sell their products? People are familiar with herbal drugs, especially those that have been around for generations. Our country is gifted with abundant sources of herbal medicine. These herbs are common, cheap and free of side effects, unlike chemical medicines.

What the DoH and FDA officials won’t admit is that they are yielding to pressure from greedy multinationals whose share of the market for expensive drugs is being eaten up by these very common herbs. Unlike former Health Secretary Juan Flavier who encouraged the use of alternative cures, the present DoH and FDA officials are anti-Filipino and pro-greedy multinationals. Multinational drug makers always raise the issue that herbal supplements didn’t go through years of laboratory research. Well, they have gone through generations of common-sense, valid observation by herbalists and users; they are known to be safe and without side effects. So why go suddenly strict about the use of herbal medicines? Because multinational drug makers are telling them to do so? Allow me to remind the DoH and FDA that Filipino farmers and growers are going to lose their jobs if they clamp on the local herbal drugs industry.

There is a potential export market for Filipino herbs, especially in the West, because herbs are becoming popular and chemical drugs are suddenly be unpopular because of their price and side-effects. In the United States and Europe, herbal makers are generally left alone and are making a serious dent on the sales of chemical drug makers. In Switzerland and Germany, herbs and supplements are a multi-billion dollar industry.

Combined with generics and the Minimum Retail Price, our thriving herbal industry can counter the multinational drug maker’s greed. We should encourage the Filipino herbal industry so it will thrive even more. Look at TCM (traditional Chinese medicine) and Ayurveda medicine. They have become multibillion-dollar industries in their own right. Sure, sometimes unsafe ingredients are found in them but they are quickly removed. The more than 1.3 billion Chinese people can’t be wrong about their TCM; neither can the 1 billion Indians be wrong with their Ayurveda medicine.

The health secretary and FDA director must be reminded that they are employees of the Filipino people and work for the Filipino people, not for the multinational drug makers.

—RICHARD YU,
richyu1980@yahoo.com