Health Ministry de-lists 45 drugs: Government silent spectator to sale
of hazardous medicines
By Waqar Gillani

Many medical and drug stores including those operating near Lahore’s hospitals are selling banned medicines like Vioxx, which was internationally withdrawn by its manufacturer on September 30 because it had severe side affects and caused heart disease.

The federal, provincial and local governments are still hush on the issue and have not taken any measures to ensure the withdrawal of the banned medicines. Government drugs inspectors haven’t even bothered to inform the drug stores properly about the banned medicines. The stores continue to sell their existing stocks of 45 different drugs, which were de-listed by the Federal Health Ministry in the first week of October. These drugs are still available in pharmacies, most of which were willing to sell Vioxx to a Daily Times correspondent without
asking for a prescription. At present, pharmacies near hospitals such as Mayo, Services, Ganga Ram and the drugs market in Lohari Gate (Walled City) are selling the banned Vioxx.

Merck and Co, a large multinational, announced a global withdrawal of Vioxx (generic name: rofecoxib), its largest selling product, on September 30. The withdrawal was announced after the company obtained evidence of increased health risk on the usage of Vioxx, which was
proved to cause cardiovascular problems such as heart attacks and strokes.The Network, a Pakistani non-government organisation (NGO) protecting consumer rights, had been raising concerns about the safety of Vioxx with the Ministry of Health since 2002, however the government never took these concerns seriously. After Merck and Co announced to withdraw
the product; the Federal Ministry of Health banned Vioxx and 44 other generic equivalents. All the 45 drugs contained “rofecoxib” as a basic ingredient, the use or sale of which was a crime punishable under the Drugs Act of 1976. However, the government never implemented the ban properly.

All the pharmacies’ salesmen offered Vioxx to the Daily Times correspondent but when he sought the drugs expiry date or showed surprise on its availability, the salesmen referred with the purchaser managers and then denied the store had the drug. “The company has
withdrawn this drug,” a salesmen quoted the purchaser manager as saying, adding, “But we do not know that it has been banned.”

Even a reputed pharmacy outside Mayo Hospital offered Vioxx and its substitutes and admitted that they were still selling it. Asked about the ban on the drug, a salesman said that he had no knowledge of it. Later, he asked the purchase manager and confirmed that Vioxx had been banned. Distributors have started withdrawing Vioxx from the market, he added. However the stores were not aware of the ban on the 45 drugs and were openly selling it to customers.

However, most salesmen and mangers said that the government was responsible because drug inspectors had not informed the pharmacies about the ban on these drugs. “The drug inspectors occasionally come for ‘routine’ surveys,” they said. When contacted, various doctors confirmed that information about the ban had not been disseminated effectively and this had caused problems to many customers and patients. Federal, provincial and local government authorities were not available for comment.

Health Ministry sources told Daily Times that the government would not take action unless the dealers and stores sold their entire stock of the banned drugs.

Ayyaz Kiani, a representative of The Network, told Daily Times that the study which led to Vioxx’s withdrawal included an analysis of a 1.4 million people database and found that those who took Vioxx were two times more likely to suffer a heart attack or a cardiac arrest compared to those who did not take it. Based on their findings, investigators linked Vioxx to more than 27,000 heart attacks and cardiac arrests in the US from the time it came on the market in 1999 till 2003. The report estimated that more than 100,000 people could have died
worldwide from the consumption of Vioxx.

“The Health Ministry and other departments have no effective mechanism for monitoring the market or taking remedial action once an emergency regulatory measure like this becomes necessary in public interest,” said the NGO representative. “The provincial government shall take all such steps as may be necessary to ensure compliance with the conditions subject to which the drug is registered and to prevent the manufacture or sale of a drug; which has not been registered (or); the registration of which has been cancelled or stands suspended,” he read clause 7 (12) of the Drugs Act of 1976 as stating.

There is still around one year’s stock of these drugs in the market and many doctors contacted were unaware of the product’s withdrawal and said they were still prescribing it to patients.

The Network and Punjab Lok Sujag has demanded the companies concerned withdraw these stocks immediately and destroy them according to the World Health Organisation (WHO) guidelines. “These drugs have fatal affects and this liability will lie entirely with manufacturers,
retailers and ministry officials.” He said, adding, “ The companies should launch a campaign to warn doctors, pharmacists and the general public of this threat.” The government must make regulatory authorities more efficient to pre-empt and counteract such potentially catastrophic
events now and in the future, he demanded.

 

 


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