A Pakistani federal minister complained to authorities about the quality of medicines and drug regulations when she noticed “a pill she had ingested came out intact in her stool”,according to a media report today.
“For this to happen,right under her (the minister’s) nose,was unacceptable since drug regulation comes under her own ministry,” The Express Tribune quoted its sources as saying. The daily did not identify the minister.
After the minister sent her complaint,the chairman of quality control,Abdul Rashid,sent drug inspectors to pick up samples of the medicine from Karachi and Islamabad.
The tablet is “light brown and film coated,and marked with ‘Adalat 30’ on one side,” according to a copy of a test report accessed by The Express Tribune.
The pill is made by a German company,Bayer Healthcare AG,and is prescribed for high blood pressure and angina. It reached the Central Drug Laboratory in Karachi on June 6.
However,the then federal government analyst,Obaid Ali,was “appalled by the situation and the fuss being created” as the minister had missed an important fact about the medicine — the pill is manufactured in a way that allows its active ingredient,Nifedipine,to be released from a laser hole in
its shell which is then expelled intact.
According to the test report,”Coming out of the shell via faeces in its original shape is the beauty of formulation and does not mean that the active ingredient responsible for therapeutic effect — Nifedipine — is not released in the body.”
Ali told the daily the medicine was an innovative formulation that has been available for about 10 years.
“This particular situation was a prime example of the incompetence of the entire system How else would such a small detail which was even mentioned on the tablet go undetected by the minister concerned,the chairman of quality control,the federal drug inspectors and the top tier of mangers?” he said.
At the same time,Ali said manufacturing practices in Pakistan are “so pathetic” that not a single product,even those made by pharmaceutical giants and multinational companies,are approved in the developed world.
“This is because the manufacturing companies do not comply with the regulations,” he explained.
An unnamed pharmaceutical company owner said there are 475 licensed drug manufacturers,of whom about 50 do not follow Good Manufacturing Practices for making medicines.