Drug quality assurance: New inspection mechanism to be devised
Drug regulatory authority board to consider increase in prices of medicines today
Drug regulatory authority board to consider increase in prices of medicines today. PHOTO: FILE
ISLAMABAD:
The drug manufacturers and the government on Monday decided to devise a new mechanism in a week for the inspection of industrial units in consultation with all stakeholders.
The decision was taken after a series of meetings of drug manufacturers with Prime Minister Nawaz Sharif and health officials.
The Punjab government’s recommendation to cancel licences of 14 local companies for selling substandard medicines had infuriated the manufacturers.
They threatened to launch a protest against the recommendation.
The representatives of Pakistan Pharmaceutical Manufacturers Association (PPMA) met with the premier and health officials to discuss the issue and review its the decision.
The PM asked the health officials to address grievances of the manufacturers.
The Drug Regulatory Authority of Pakistan, however, did not take any decision on the licence issue.
Ministry of National Health Services Secretary Ayub Sheikh assured the drug manufacturers that the decision would be taken according to the law.
The manufacturers said the Punjab government task force recommendation was unlawful and the relevant forum to decide the cases was the regulatory authority.
Addressing a press conference earlier in the day they said the authority should differentiate between substandard and spurious drugs and decide punishment according to the international and national laws.
The substandard drugs were genuine medicines which may not meet quality specifications set by national standards due to human error and poor storage facilities in hospitals and medical stores, claimed Chaudhry Ansar, who chairs PPMA pricing committee.
Spurious drugs are those which do not contain any active ingredient mentioned on the packaging, he added.
According to international practices, drugs of such companies are recalled from the market and an investigation is initiated against the makers, he said. Licences are not cancelled nor cases registered against the manufacturers, Ansar contended.
Manufacturers are not responsible if the medicine was stored at hospitals and drugstores at higher temperatures, he maintained. This ultimately affects the quality of the medicine, said Ansar.
He said that the drug firms’ body had been providing employment and sustenance to over 2.5 million people of Punjab and any wrong decision will affect lives of thousands of people associated with the industry.
Regarding the pricing issue, he said multinational companies had raised prices taking stay orders from courts. On the other hand prices of locally manufactured drugs have not been increased since 2001 while prices of every product have increased manifold in 15 years and inflation rate had also gone high.
Due to less profit and high losses, many companies have stopped production of drugs for tuberculosis, causing a shortage of the drug in the market, he said.
“Manufacturers stop manufacturing medicines that do not give profit,” he remarked.
Meanwhile, the pricing board will consider an increase in prices of 228 medicines requested by 52 pharmaceutical companies on Tuesday.
The companies had requested the board to raise the prices as the manufacturing cost had increased.
Published in The Express Tribune, August 30th, 2016.
The drug manufacturers and the government on Monday decided to devise a new mechanism in a week for the inspection of industrial units in consultation with all stakeholders.
The decision was taken after a series of meetings of drug manufacturers with Prime Minister Nawaz Sharif and health officials.
The Punjab government’s recommendation to cancel licences of 14 local companies for selling substandard medicines had infuriated the manufacturers.
They threatened to launch a protest against the recommendation.
The representatives of Pakistan Pharmaceutical Manufacturers Association (PPMA) met with the premier and health officials to discuss the issue and review its the decision.
The PM asked the health officials to address grievances of the manufacturers.
The Drug Regulatory Authority of Pakistan, however, did not take any decision on the licence issue.
Ministry of National Health Services Secretary Ayub Sheikh assured the drug manufacturers that the decision would be taken according to the law.
The manufacturers said the Punjab government task force recommendation was unlawful and the relevant forum to decide the cases was the regulatory authority.
Addressing a press conference earlier in the day they said the authority should differentiate between substandard and spurious drugs and decide punishment according to the international and national laws.
The substandard drugs were genuine medicines which may not meet quality specifications set by national standards due to human error and poor storage facilities in hospitals and medical stores, claimed Chaudhry Ansar, who chairs PPMA pricing committee.
Spurious drugs are those which do not contain any active ingredient mentioned on the packaging, he added.
According to international practices, drugs of such companies are recalled from the market and an investigation is initiated against the makers, he said. Licences are not cancelled nor cases registered against the manufacturers, Ansar contended.
Manufacturers are not responsible if the medicine was stored at hospitals and drugstores at higher temperatures, he maintained. This ultimately affects the quality of the medicine, said Ansar.
He said that the drug firms’ body had been providing employment and sustenance to over 2.5 million people of Punjab and any wrong decision will affect lives of thousands of people associated with the industry.
Regarding the pricing issue, he said multinational companies had raised prices taking stay orders from courts. On the other hand prices of locally manufactured drugs have not been increased since 2001 while prices of every product have increased manifold in 15 years and inflation rate had also gone high.
Due to less profit and high losses, many companies have stopped production of drugs for tuberculosis, causing a shortage of the drug in the market, he said.
“Manufacturers stop manufacturing medicines that do not give profit,” he remarked.
Meanwhile, the pricing board will consider an increase in prices of 228 medicines requested by 52 pharmaceutical companies on Tuesday.
The companies had requested the board to raise the prices as the manufacturing cost had increased.
Published in The Express Tribune, August 30th, 2016.