18 Dec 2012
There was much talk of'generic drugs' after actor Aamir Khan broached the topic on histelevision show, 'Satyamev Jayate.'
However, the Indian PharmaceuticalAssociation (IPA) has pointed out that the definition of genericdrugs in India is incomplete and misleading. There is a pressing needfor generic drugs to be tested and their efficacy checked against theoriginal drug formulations.
"Generic drugs are often wronglyinterpreted as a cheaper alternative to branded medicines. They havethe same chemical composition as branded drugs but are sold undertheir chemical name. However, this definition is not sufficient,"said IPA Pune president Dr Atmaram Pawar.
According to him, the lack of awarenessof quality medicines and the prevailing poverty in the country hasled to a mindset which drives people to buy cheap medicines.
"The concept of bio-equivalence isignored in India. Even though many brands of the same drug have thesame chemical composition, the physical forms of the drug, additivesused in the formula or method of production may be different, whichalters the amount drug entering the bloodstream, and thus, itsefficacy. Hence, every brand of the drug needs to be checked forblood levels. For generic drugs, it requires testing on 25 healthyindividuals," he explains.
"The common man often goes by theamount of drug in a tablet, which is not important. Thebio-availability of the drug, that is, how much drug reaches thebloodstream, is important," he added. Bio-equivalence is a termused to rate generic drugs. It refers to identical blood levels ofdrug products having the same composition, once it is ingested. Suchbrands of a drug are said to be bio-equivalent. Then their efficacyand safety is the same.
Dr Pawar also claimed that India hasmore than 1,000 manufacturing units approved by the World HealthOrganisation which exports 'therapeutically equivalent' genericmedicines worth US $ 20 billion, but immorally promotes their'pharmaceutical equivalent' brands as generic drugs, withoutsufficient biological studies for domestic use.
He felt the need to create awarenessabout generic drugs to pressurise the government to enact stringentlaws requiring clinical trials to demonstrate the bio-equivalence ofgeneric drugs.EFFICACY MATTERS
- If you were to buy different brandsof a drug, their effectiveness would not be the same as theirefficacy depends on their levels in the blood stream, which isdifferent for each brand. Their efficacy varies from brand to brand.
- India lags behind in research at amolecular level. Only formulations of available drugs are currentlybeing researched.