The drugs,
registered in the country so far under the Drug Act, 1976, total around
66,000 with 55,000 of them active drugs, says Pakistan Pharmaceutical
Manufacturers’ Association (PPMA) Chairman Haroon Qasim.
Drugs are registered by the Health Ministry’s Drug Registration Board after examination of their safety, efficacy, quality and economy. The board consists of 21 pharmaceutical and health experts.
Haroon said that the number of registered drugs was around 27,000 two or three years ago. He said of the registered drugs, around 10,000 were imported drugs.
He also said around 1,000 drugs had been de-registered over the last many years for reasons, especially international withdrawals and safety recalls.
The PPMA chairman said registered drugs included medical disposable devices such as disposable syringes, catheters and bandages. He said the Drug Registration Board had six meetings in 2010.
According to him, the process of drug registration takes eight to 12 months during which the Health Ministry evaluates submitted dossiers to ensure that nothing is missing and all rules have been complied before sending the selected ones to the Board for registration.
“In many instances, the facility inspections are done, stability studies are taken and compliance of the rules and regulations by the applicants are examined,” he said.
Haroon said the Drug Registration Board was a very competent board, having experts from all the fields, including officials from the Health Ministry and provincial health officials, professors from academic institutions, medical doctors, representatives of consumer organisations and other stakeholders, to ensure that the registration process was fully complied.
He said though PPMA had its representation in the board as an observer, not a member. In this light, he said, the claim that PPMA pressurise the ministry for drug registration is baseless.
The PPMA chairman said the Drug Registration Board had its own mechanism of checking quality and safety of the products, be these were locally manufactured or imported through registration and plant inspections.
Also, he said all pharmaceutical companies had their own internal audit system and subsidiaries/third parties of international companies were periodically audited by their overseas experts. “Local companies are marketing novel generic products, competing in the market place and surpassed their share with these international companies,” he said.
Haroon said Pakistani pharmaceutical industry exported products to more than 60 countries, including Sri Lanka, Vietnam, Philippines, Cambodia, Myanmar, all Commonwealth Independent States, Russia and many African countries.
He said many of these countries had their own rules and regulations to check standards of imported pharmaceutical goods. “This automatically gives a quality seal to our manufacturers,” he said.
Drugs are registered by the Health Ministry’s Drug Registration Board after examination of their safety, efficacy, quality and economy. The board consists of 21 pharmaceutical and health experts.
Haroon said that the number of registered drugs was around 27,000 two or three years ago. He said of the registered drugs, around 10,000 were imported drugs.
He also said around 1,000 drugs had been de-registered over the last many years for reasons, especially international withdrawals and safety recalls.
The PPMA chairman said registered drugs included medical disposable devices such as disposable syringes, catheters and bandages. He said the Drug Registration Board had six meetings in 2010.
According to him, the process of drug registration takes eight to 12 months during which the Health Ministry evaluates submitted dossiers to ensure that nothing is missing and all rules have been complied before sending the selected ones to the Board for registration.
“In many instances, the facility inspections are done, stability studies are taken and compliance of the rules and regulations by the applicants are examined,” he said.
Haroon said the Drug Registration Board was a very competent board, having experts from all the fields, including officials from the Health Ministry and provincial health officials, professors from academic institutions, medical doctors, representatives of consumer organisations and other stakeholders, to ensure that the registration process was fully complied.
He said though PPMA had its representation in the board as an observer, not a member. In this light, he said, the claim that PPMA pressurise the ministry for drug registration is baseless.
The PPMA chairman said the Drug Registration Board had its own mechanism of checking quality and safety of the products, be these were locally manufactured or imported through registration and plant inspections.
Also, he said all pharmaceutical companies had their own internal audit system and subsidiaries/third parties of international companies were periodically audited by their overseas experts. “Local companies are marketing novel generic products, competing in the market place and surpassed their share with these international companies,” he said.
Haroon said Pakistani pharmaceutical industry exported products to more than 60 countries, including Sri Lanka, Vietnam, Philippines, Cambodia, Myanmar, all Commonwealth Independent States, Russia and many African countries.
He said many of these countries had their own rules and regulations to check standards of imported pharmaceutical goods. “This automatically gives a quality seal to our manufacturers,” he said.
