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Drug Regulatory Authority of Pakistan says manufacturers in pharmaceutical industry given legal cover

Lahore, October 18, 2012 (PPI-OT): The Chief Executive Officer of Drug Regulatory Authority of Pakistan (DRAP) Arshad Farooq Fahim has said that all contract manufacturers in pharmaceutical industry has been given legal cover besides extending their validity till the announcement of new policy due on December 31, 2012.

Arshad Farooq Fahim was addressing pharmaceutical manufacturers here at a Lahore Chamber of Commerce and Industry on Thursday. LCCI President Farooq Iftikhar, Vice President Mian Abuzar Shad, Chairman PPMA Pakistan Javaid Akhai, Chairman PPMA North Zone Saleem Iqbal, Vice Chairman PPMA Nasir Qureshi and Former Chairman PPMA Amjad Ali Jawa also spoke on the occasion.

He said that the government is considering to introduce a uniform drug pricing policy in country to bring at par the prices of same products being manufactured by different companies.

Arshad Farooq Fahim said that as many as 14000 application for registration are pending with the Authority and the process has be expedited to resolve the issues of registration of products and renewal of licenses of pharmaceutical manufacturers.

The CEO said that new fee structure revision for fresh registration (for local manufacturing), import license and contract manufacturing on contract manufacturing for export purpose has been put off till mutual understanding between stakeholders and DRAP.
He assured the pharmaceutical manufacturers of his full cooperation on all issues being faced by Pharmaceutical industry.

Speaking on the occasion, the LCCI President Farooq Iftikhar invited the attention of the CEO of Drug Regulatory Authority towards the shortage of medicines and stressed the need for accelerating the process of registration of new medicines.

The LCCI President also urged the DRAP CEO to take practical measures for removing the reservations of the pharmaceutical sector before granting MFN status to India.

The Chairman PPMA Pakistan Javaid Akhai said that in order to ensure swift disposal of pending registration applications, it is proposed that a committee be set up which should be empowered to hold frequent meetings to discuss and approve the applications and registration letters of approved products be issued immediately.

“If required, post facto approval of Drug Registration Board can be sought for the applications approved by the committee. if the proposal is accepted, backlog of pending registration applications can be cleared within a span of 3-4 months and the credit of this achievement will not doubt go to DRAP.

He said that it has been the long outstanding demand of our local industry to devise and implement one molecule – one price policy. However no concrete step could be taken till to-date towards this direction despite the genuine and basic demand of industry in the prevailing scenario of unprecedented increase in the cost of utilities, power shortages, increase in minimum wages, law and order situation, depreciation of rupee value etc. due to these factors, cost of production has registered a sharp increase adding to the financial woes of pharma industry. It is therefore requested that one molecule – one price policy may kindly be formulated in close coordination with PPMA at the earliest.

He also urged the DRAP CEO to frame vitamin policy at the earliest as registration of multivitamins is not being granted to applicant companies which is against their constitutional rights. Due to the vacuum so created, market is flooded with herbal and so called nutritional products of suspect quality which are playing havoc with the health of general public.

He said that one window operation should immediately be setup to address export related issues like product registration.

For more information, contact:
Shahid Khalil
Information Department
Lahore Chamber of Commerce and Industry (LCCI)
11-Shahrah-e-Aiwan-e-Tijarat,
Lahore -54000, Pakistan
Tel: +9242 111 222 499
Fax: +92 42 636 8854

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