Emergency registration of critical medicines okayed

Emergency registration of critical medicines okayed

ISLAMABAD: As med­ici­nes for the treatment of can­cer, epilepsy, diabetes, hype­r­tension, etc are either scarce or unavailable in the cou­n­try, the Min­istry of National Health Services (NHS) has decided to allow emergency registration of medicines on emergency basis.

Former member of the Cen­tral Executive Commi­ttee (CEC) of Pakistan Phar­ma­ceutical Manufac­turers Association (PPMA) Usman Shaukat said that the emergency registration of essential life saving drugs was a positive step.

Ministry’s Spokesperson Sajid Shah said that the decision has been made on the direction of acting health minister Dr Nadeem Jan, hoping that the decision will incite an increase in supply of the life saving medicines in the market.

He said that the Drug Regulatory Authority of Pakistan (Drap) has also registered anaesthesia, influenza, heparin (used to treat blood clotting) and enoxaparin (to prevent deep venous thrombosis) injections and even allowed the importers to import medicines so that the availability of the medicines would be ensured.

Drap ‘suspends’ six pharma firms, cancels licences of three companies

“Similarly a new anti-diabetes medicine semaglutide injection has been also registered,” Mr Shah said.

Dr Jan has reassured that there would be no shortage of live-saving medicines in the market.

“All possible steps will be taken in that regard. A pharma park will also be established in Islamabad so that the local production of medicines and active pharmaceutical ingredients (APIs) would be started. We are also taking steps to address the capacity issues of pharma companies,” he said.

Reacting over the development, Mr Shaukat said that the emergency registrations of essential life saving drugs was a positive step by Drap but shortages were persisting due to various challenges.

“The mechanism of pricing and inability to manufacture products at the fixed maximum retail prices (MRPs), due to costing challenge, is a major hurdle in the availability of medicines and should be addressed to ensure uninterrupted supply of life saving drugs to patients,” he said.

Meanwhile, taking action over the quality of medicines, Drap has cancelled licenses of three pharma companies and suspended licenses of other six companies. Show cause notices have been issued to seven manufacturers.

The action has been taken by the Drap Licensing Board over the violation of good manufacturing practices.

“Sub-standard medicines will not be allowed in Pakistan,” Dr Jan said.

“We have cancelled licences of three pharma companies, six licenses have been suspended and show cause notices have been issued to seven companies. Moreover a veterinary vaccine for the lumpy skin disease has been registered,” he said.

Published in Dawn, December 6th, 2023



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