The Drug Regulatory Authority of Pakistan has set up a committee to resolve registration and licensing issues with local contract manufacturers.
Thousands of contract drugmakers have been awaiting license renewals following the regulator’s (DRAP) latest plans to introduce a uniform drug pricing policy in the country – held up because of restructuring. As many as 14,000 registration applications are also still pending.
However through the new committee – a joint provision between DRAP and the Pakistan Pharmaceutical Manufacturers Association (PPMA) – the Government hopes to speed up the process, as well as discussing issues such as the including the proposed hike in fees for services offered by the authority.
In a speech at the Lahore Chamber of Commerce and Industry (LCCI), DRAP CEO Arshad Farooq Faheem also said contract manufacturing organisations (CMOs) will be given additional protection until the official announcement is made.
He said: “All the contract manufacturers in the pharmaceutical industry have been given legal cover besides extending their validity till the announcement of the new policy due on December 31, 2012.”
He added that raised fees for new registration, import license and contract manufacturing will been postponed until a “mutual understanding” between the stakeholders and DRAP is struck.