President likely to sign drug authority law on November 12

07 Nov, 2012

The president is likely to sign the Drug Regulatory Authority of Pakistan Bill of 2012, converting the Drug Regulatory Agency into Drug Regulatory Authority on November 12. The Bill has been passed by the National Assembly and the Senate and now it had to be approved by President Asif Ali Zardari.
There were as many as 14,000 cases of drugs registration pending for the past two years after the devolution of the Ministry of Health. "Some issues relating to the import and export of medicines and raw material need to be solved. After the establishment of the Drug Regulatory Authority, these issues are likely to be solved on an immediate basis, as foreign investment in pharmaceutical sector in Pakistan is declining with each passing year,"sources said.
A recent decision of the Drug Pricing Committee (DPC) regarding an increase in prices of only 18 drugs out of 140 requests for price hike "is likely to result in shortage of life saving medicines in the domestic market".
"For the past 10-12 years, prices of medicines have not been increased while because the gradually increasing price of the imported raw materials, it has become very difficult for the pharmaceutical industry to manufacture these drugs. The government's recent decision to increase prices of 18 drugs from Re1 to Rs17 per tablet out of 140 medicines would obviously lead to a severe shortage of life saving drugs in the local market because of a considerable reduction in their manufacturing," sources added.
"Out of 140 hardship cases of medicines, 122 cases are still pending with the Ministry of National Regulations and Services. The government has stalled issuing quota to the medicine companies for import or locally manufacturing ephedrine, which may result in shortage of some life saving drugs in the country; while four renowned medicine companies have taken stay orders from the Lahore High Court with respect to the decision of the government to considerably reduce prices of 92 medicines, while the other companies have stopped manufacturing these medicines creating severe shortage of these drugs in the domestic market", sources added.
Betnesol N drops, Betnesol tablet, Polyfax eye ointment, Thyroxine tablet, Vancocin injection, Cardarone tablet, Inderal tablet, Benadryl syrup, Xanax tablet, Lexotanil tablet, Ativan tablet, Hydryllin DM syrup and Arinac tablet, Actifed (including Actifed DM syrup, Actifed cold, Actifed P tablet), Sancos cough syrup, and Erythrocin (used for throat infection) are among those medicines that are facing a severe shortage in domestic market.
Sources said: "It is a fact that despite the energy crisis, the pharmaceutical sector is growing at 20 percent per annum, but there are some foreign multinational pharmaceutical brands that cannot be introduced in Pakistan because of intellectual property rights and pricing issues."

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