Medindia LOGIN REGISTER
Medindia

Proper Validation of Generic Drugs Could Save Millions of AIDS Patients

by Medindia Content Team on Sep 14 2005 12:24 PM

Increasing criticism is faced by AIDS generic drugs usage to treat HIV infections, due to non-compliance with clinical and laboratory procedures and data handling. Recently, the use of Anti-HIV single dose drug Nevirapine which is used for the prevention of mother to child transmission is very much questioned of its effect.

Though Generic drugs is used by the large population of people during epidemics, due to its low cost formulations, which is useful for the treatment of millions of people as a life saving drug, there are evidence that generic drugs are as safe and as effective as branded drugs. In Brazil massive use of generic drug treatment as reduced HIV mortality.

Some critics point out that generic drugs are not monitored and tested properly as branded drugs produced by global pharmaceutical companies and comment generic drugs as “dubious”, “cheap”, and “deadly”, though it is commented by some critics in reality generic drugs offer the most affordable and best treatment for infected people in developing countries.

It is the fundamental right of the patient to know what drug they are taking and how effective and safe the drug is, and the patient should be aware that unsafe drugs could cause drug resistance and new strains of virus could emerge. Generic drug manufacturers are mostly from the Asian countries, there are 27 manufacturers in Asian countries, mostly they are produced for domestic uses and some drugs are exported, the countries mostly manufacturing generic drugs are China, India, and Thailand. The manufacturing companies are wholly or partly owned by the government enterprises, and these companies can simply sell drugs to their own government, fostering an intimacy between manufacturers and governments.

A system of drug monitoring of generic drugs is required, by which a network of clinical laboratory is to be linked to the generic drugs for its testing and validation before marketing of the product similar to the FDA or WHO and the monitoring should be a continuous process so that he quality of the drug produced should be monitored to find if there is fluctuation over time without vigilant testing. By this way if the generic drug produced is maintained in a standard to that of branded drugs, the amount of investment which is spent on the branded drugs would be saved enormously, and if proper system is maintained in monitoring and validation of generic drugs it would be very much useful for patients in developing and underdeveloped countries as it would offer an affordable and effective treatment to the affected patients, as the HIV-infected population is continuously climbing and it is estimated that 6 million HIV patients will die without immediate access to antiretroviral drugs.

Source: The Lancet.


Advertisement