Under the microscope: Drug regulator criticised for non-utilisation of funds
Asked to hire more drug inspectors; not a single lab prequalified by WHO in Pakistan, NA committee told
Aslam said the government had decided to sue the companies to recover the amount the companies earned by raising the price in violation of the drug policy. PHOTO: FILE
ISLAMABAD:
The national drug regulatory body came under criticism for non-utilisation of funds at a parliamentary committee meeting, and was also asked to hire more inspectors.
The shortage of drug inspectors in the country came to light during a Tuesday briefing given by the Drug Regulatory Authority of Pakistan (Drap) CEO Dr Muhammad Aslam to the National Assembly Standing Committee on National Health Services, Regulations and Coordination.
There are about 14 drug inspectors for the federal areas, and across the rest of the country one drug inspector has to inspect nearly 40 industries.
The members of the NA committee objected to non-utilisation of resources by the Drap and directed the regulatory body to hire more inspectors.
MNA Dr Zulfiqar Bhatti said the Drap had surplus financial resources and instead of utilising them, it gave surplus Rs600 million to a public investment fund.
Aslam informed the committee that there were no drug labs pre-qualified by the World Health Organisation right now except a private lab in Pakistan.
But the WHO has conducted initial assessment of the Drap, and in 2017, the Central Drugs Testing Laboratory, Karachi will be the first WHO pre-qualified and accredited laboratory in the public sector, he said.
The CEO said there were five drug labs in Punjab and one in Islamabad functioning under the Drap.
Another Federal Drug Surveillance Laboratory was supposed to start functioning in Chak Shehzad but the previous Pakistan People’s Party (PPP) government allocated the premises to a medical and dental college.
The issue was taken up with the president and prime minister and the college is trying to get its own land, he said.
The CEO told the committee that the total drugs produced in Pakistan amount to about $3 billion and of them only 2 per cent were substandard and less than 0.1 per cent were spurious.
Aslam said at an international forum recently Pakistan was blamed for having the largest share in spurious market. But India and China are biggest players in spurious drug market as 70 per cent of spurious drugs produced in the world come from the two countries.
Even in Pakistan spurious drugs are smuggled from China and India, he said.
The CEO said recently a sample of about 35,000 drugs was tested in Islamabad and Punjab drug testing labs that found two to three per cent drugs substandard. But the spurious drugs produced in Pakistani market amount to just 0.01 to 0.02 per cent, he added.
In order to curb the menace of spurious drugs, the Drap has decided to introduce bar coding system for the first time in Pakistan and legislation for this purpose will be finalised soon, Aslam said.
By this system a customer would be able to check through one’s mobile phone whether the drug is genuine or fake at the time of purchase, the CEO said.
Regarding the drug pricing issue, the CEO said, some pharmaceutical companies had increased the prices of their drugs on their own and then got stay orders from Sind High Court.
The Drap is vigorously following multiple cases in various high courts and has requested early fixation of dates for disposal of the cases.
About 117 cases regarding pricing, registration and quality assurances have been pending in various courts in the country, he said.
Aslam said the government had decided to sue the companies to recover the amount the companies earned by raising the price in violation of the drug policy.
Published in The Express Tribune, August 10th, 2016.
The national drug regulatory body came under criticism for non-utilisation of funds at a parliamentary committee meeting, and was also asked to hire more inspectors.
The shortage of drug inspectors in the country came to light during a Tuesday briefing given by the Drug Regulatory Authority of Pakistan (Drap) CEO Dr Muhammad Aslam to the National Assembly Standing Committee on National Health Services, Regulations and Coordination.
There are about 14 drug inspectors for the federal areas, and across the rest of the country one drug inspector has to inspect nearly 40 industries.
The members of the NA committee objected to non-utilisation of resources by the Drap and directed the regulatory body to hire more inspectors.
MNA Dr Zulfiqar Bhatti said the Drap had surplus financial resources and instead of utilising them, it gave surplus Rs600 million to a public investment fund.
Aslam informed the committee that there were no drug labs pre-qualified by the World Health Organisation right now except a private lab in Pakistan.
But the WHO has conducted initial assessment of the Drap, and in 2017, the Central Drugs Testing Laboratory, Karachi will be the first WHO pre-qualified and accredited laboratory in the public sector, he said.
The CEO said there were five drug labs in Punjab and one in Islamabad functioning under the Drap.
Another Federal Drug Surveillance Laboratory was supposed to start functioning in Chak Shehzad but the previous Pakistan People’s Party (PPP) government allocated the premises to a medical and dental college.
The issue was taken up with the president and prime minister and the college is trying to get its own land, he said.
The CEO told the committee that the total drugs produced in Pakistan amount to about $3 billion and of them only 2 per cent were substandard and less than 0.1 per cent were spurious.
Aslam said at an international forum recently Pakistan was blamed for having the largest share in spurious market. But India and China are biggest players in spurious drug market as 70 per cent of spurious drugs produced in the world come from the two countries.
Even in Pakistan spurious drugs are smuggled from China and India, he said.
The CEO said recently a sample of about 35,000 drugs was tested in Islamabad and Punjab drug testing labs that found two to three per cent drugs substandard. But the spurious drugs produced in Pakistani market amount to just 0.01 to 0.02 per cent, he added.
In order to curb the menace of spurious drugs, the Drap has decided to introduce bar coding system for the first time in Pakistan and legislation for this purpose will be finalised soon, Aslam said.
By this system a customer would be able to check through one’s mobile phone whether the drug is genuine or fake at the time of purchase, the CEO said.
Regarding the drug pricing issue, the CEO said, some pharmaceutical companies had increased the prices of their drugs on their own and then got stay orders from Sind High Court.
The Drap is vigorously following multiple cases in various high courts and has requested early fixation of dates for disposal of the cases.
About 117 cases regarding pricing, registration and quality assurances have been pending in various courts in the country, he said.
Aslam said the government had decided to sue the companies to recover the amount the companies earned by raising the price in violation of the drug policy.
Published in The Express Tribune, August 10th, 2016.