Generic medicines flooding market sans tests, research

ISLAMABAD: The Pakistan government and pharmaceutical companies are playing with the lives of people as contrary to the common practice of registering the generic medicines after proper research, medicines are being registered even without the bio-equivalence test and clinical trials.
Thus the generic medicines produced by the local companies are not as effective as the original medicines, an investigation by The News has revealed.
“Whichever molecule hits market as a medicine is registered after proper research by any pharmaceutical company and this research process is very difficult, complex and laborious,” said Dr Mushtaq Mangrio, an American doctor of Pakistani origin, when contacted for comments. “This research is a lengthy process and usually it takes at least 12 years,” he elaborated.
Dr Mushtaq Mangrio said that the patent of the medicine produced after proper research is reserved and when the patent expires, any company could produce this medicine but with the condition that the product is effective equivalent to the original medicine called generic medicine.
According to the Draft Drugs (Bio-Study) Rules 2011, bio-equivalence means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
Two products are bioequivalent when they produce such similar plasma concentrations of the active ingredient that their clinical effects can be expected to be the same. In a standard bio-equivalence test both products are administered on separate occasions to healthy volunteers.
Bio-equivalence is then determined by comparing the peak plasma concentration, time to achieve a maximal concentration and the extent of absorption.
These studies are well suited to identifying potentially significant differences in the delivery characteristics of the active substance of different products. The same bioequivalence principles apply to new drugs when different formulations of an active ingredient are compared.
“In Pakistan, the generic medicines are registered on the basis of formula only and that too even without the bioequivalence test and clinical trial as no government laboratory in Pakistan has the facility of bioequivalence test,” Dr Mushtaq Mangrio said.
“Because of this, there is a common complaint in Pakistan that the generic medicines of Pakistani companies are not as effective as the original medicines and thus the locally produced medicines are called counterfeit medicines,” he added.
When contacted for comments, another health expert endorsed the views of Dr Mushtaq Mangrio and said on condition of anonymity that both the Pakistan government and local pharmaceutical companies are playing with the lives and hard-earned money of the people.
The health expert remarked that like other sectors, corruption is rampant in vital pharmaceutical sector too and almost everybody having knowledge about the pharmaceutical production and healthcare system is aware of the problem but nobody is ready to heed to the genuine problem of Pakistani people.
Since the federal ministry of health has been abolished as part of the implementation of the 18th constitutional amendment, the Cabinet Division now looks after the important issues related with the health sector. When the relevant officials in the Cabinet Division were approached, they asked this correspondent to contact the Drug Controller Department, where an official who identified himself as Mr Tanvir told The News that nearly 1,100 original molecules are currently registered in Pakistan as compared to around 50,000-60,000 registered generic medicines.
The official also confirmed the absence of bio-equivalence test facility at the government level, saying that every country does not have this facility officially, the major universities and laboratories are benefited from and the same is happing in Pakistan.