I refer to Prof Carlo Fonseka’s reply to my article under the title "Consciousness raising about generic drugs".

I do not wish to comment on several economic matters most of which arise from the economic theory of Principal/Agent and the Asymmetric Information theory, subjects for which Nobel prizes in Economics were awarded. I will confine myself to the central issue of the bio-equivalence and therapeutic value of the generic versus the branded drug.

Prof Carlo’s apt title reflects the fact that doctors and patients don't seem to trust generic medications, preferring the brand name drugs. Is this mistrust justified? No says Prof Carlo. He quotes from "Clinical Medicine by Kumar and Clark that "generic drugs are required to go through the same stringent regulatory processes as the branded counterparts". In USA a generic drug must contain the same active ingredients in the same dosage form as a brand name drug. The strength and purity of generic medications are strictly regulated. The FDA requires all generic manufacturers to demonstrate that a generic drug will have the same medical effect as its Name-Brand equivalent by measuring the rate and extent of drug absorption. The generic drug should treat your illness or condition with the same effectiveness and safety as its brand name equivalent. Generics have to meet the same rigorous requirements as Name-Brand drugs".

Fine, but can we apply this same standard to generic drugs manufactured in India or Pakistan. In my last article I referred to the fact that even the FDA has been slack owing to lack of resources and the eagerness to put out the generic.

Do the Drug Approval authorities in the Indian subcontinent apply the same rigorous standards? Would Prof Carlo enlighten the public on this issue of bio-equivalence, which I think is the critical issue?

I understand that there are fake drugs manufactured on the Indian sub-continent and I would think our own Health Authority should carry out tests before approving the import of generic drugs. I have heard that the Japanese donated a Quality control Laboratory to us some time back. They even trained a person to be in charge. He happened to be the son-in-law of a friend of mine. He left in disgust because his services were not being utilized due to the usual maladies in the public service on which Prof Carlo places his confidence. As Prof Carlo has pointed out the Health Department should be able to persuade the doctors at least that generic drugs are bio-equivalent to their branded counterparts. I would certainly prefer to buy the cheaper generic drug if it is bio-equivalent and has the same therapeutic value. Who will prove this to patients like me?

I checked on the Internet and came across this description from a website Neurological and Psychiatric Department, University of Padua, and Casa di Cura Parco dei Tigli, Padua, Italy. g.borgherini@gpnet.it

BACKGROUND: For the purposes of drug approval, the interchangeability of a generic drug and the corresponding brand-name drug is based on the criterion of "essential similarity," which requires that the generic drug have the same amount and type of active principle, the same route of administration, and the same therapeutic effectiveness as the original drug, as demonstrated by a bioequivalence study. However, bioequivalence and therapeutic effectiveness are not necessarily the same. OBJECTIVE: This review summarizes available data comparing the bioequivalence and therapeutic efficacy of brand-name psychoactive drugs with those of the corresponding generic products. METHODS: Relevant information was identified through searches of MEDLINE, Current Contents/Clinical Medicine, and EMBASE for English-language articles and English abstracts of articles in other languages published between 1975 and the present. The search terms used were generic drug, branded drug, safety, toxicity, adverse events, clinical efficacy, bioequivalence, bioavailability, psychoactive drugs, and excipients. RESULTS: Few publications compared the bioequivalence and efficacy of brand-name and generic psychoactive drugs. Those that were identified revealed differences in the efficacy and tolerability of brand-name and generic psychoactive drugs that had not been noted in the original bioequivalence studies. Specifically, l study found that plasma levels of phenytoin were 31% lower after a switch from a brand-name to a generic product. Several controlled studies of carbamazepine showed a recurrence of convulsions after the shift to a generic formulation. After a sudden recurrence of seizures when generic valproic acid was substituted for the brand-name product, an investigation by the US Food and Drug Administration found a difference in bioavailability between the 2 formulations. Statistically significant differences in pharmacokinetic variables have been reported in favor of brand-name versus generic diazepam (P < 0.001). Finally, a case report involving paroxetine mesylate cast doubt on the tolerability and efficacy of the generic formulation. CONCLUSION: The essential-similarity requirement should be extended to include more rigorous analyses of tolerability and efficacy in actual patients as well as in healthy subjects.

PMID: 12860486 [PubMed - indexed for MEDLINE] www.pubmed .org

I am afraid I can’t judge these statements myself lacking knowledge of pharmacology and what not in medicine. So I would prefer to go by my doctor’s advice. I do not believe that all well-known doctors are in the pay of drug companies and recommend branded drugs because of base motivations.

I like to quote from another website "So there are true differences between generic and brand name drugs, though most of the time these differences are not clinically important. But in those special circumstances where people are allergic to fillers, or need a constant or regular concentration of their drug in the bloodstream, generic vs. brand name really does matter"

"Just recently, an article in the LA Times has shed more light on the debate about drug equivalency, and my fellow bloggers Abel Pharmboy and Joseph (at Corpus Callosum) have summarized the issues very well. As it turns out, the FDA allows for a fairly broad interpretation of equivalency when it comes to the rate at which the bioactive ingredients are released into the bloodstream"