KARACHI, Jan 7: Scientists and researchers associated with drug development have underscored the need for establishment of a "compliance agency" at the federal level to develop , monitor and approve new medicines as per practices in the developed world and to control the sale of substandard and counterfeit drugs in the local market.

According to them, the local market is flooded with counterfeit and substandard Chinese and Indian drugs, including weight-loss supplements and aphrodisiacs which are highly toxic and hazardous.

Prof Dr Aquilur Rehman - associated with the Georgetown University Medical Centre of the United States, who is currently visiting Pakistan - told PPI here on Wednesday that instead of the ministry of Health, which allows or disallows marketing of new drugs in the country, the government should establish a separate compliance agency to monitor the process of medicine development.

"Pharmaceutical companies take years in the United States and other developed countries to introduce a new medicine for general prescription by the physicians," he said, adding that unfortunately the Pakistanis were compelled to buy and use counterfeit and hazardous drugs.

He opined that with the establishment of such an agency, it would be very difficult for quacks and untrained people associated with "herbal" medicines to introduce their products in the local market. Lack of awareness among the people and policy-makers was the major reason behind the mass marketing of substandard and counterfeit drugs by some pharmaceutical companies who were minting millions, possibly billions.

Another researcher, Dr Mansoor Ahmed, who is associated with the Research Institute of Pharmaceutical Sciences, University of Karachi, said the local market was full of counterfeit medicines, which were often hazardous. "Recently, a person came to us with a known sex-stimulant for its testing and upon analysis it was revealed that the chemical kills human sperms and makes its users impotent," he said, adding that a majority of such medicines contained steroids.

Excessive use of steroids was destructive for the human body as they affected the bone marrow, red blood cells, bones, liver and hair, he added. "Majority of drugs being sold in the name of Indian and Chinese herbal medicines are actually local drugs, manufactured by Pakistani companies that introduce such drugs without conducting clinical trials or approval from the competent authority," he maintained.

Another researcher working for a multinational said pharmaceutical companies should conduct tests in the laboratory and on animals to show the biological activity of the compound against the targeted disease. The compound should also be evaluated for safety. These tests take approximately three-and-a-half years to complete.

After completing pre-clinical testing, pharmaceutical companies in the developed world file an Investigational New Drug (IND) application with the FDA to begin trials on people, he said.

The IND became ineffective if FDA does not disapprove it within 30 days. Clinical trials take about a year and involve about 20 to 80 normal, healthy volunteers. The tests study a drug's safety profile, including the safe dosage range.

The studies also determine how a drug is absorbed, distributed, metabolized and excreted by a human body, besides the duration of its action. Unfortunately, In Pakistan the practice is reverse and counterfeit medicine and drug developers are thriving owing to the apathy of the authorities. - PPI