Experts Call on Paktistan to Reform Pharma Regulatory Framework

| By | Pakistan, Regulatory

Pakistan needs to urgently reform its existing regulatory framework, to unlock the potential of “scale” within the local pharmaceutical manufacturing sector of Pakistan and secure access to global markets for products manufactured locally, if it is to compete for a share of the global contract manufacturing market.

Unfortunately, the existing regulatory mechanism governing the use of contract manufacturing organization’s (CMO’s) in Pakistan does not take into account the vast opportunities available to local manufacturers and is in fact constraining the local industry from benefiting from partnerships with global players, pharma industry sources said.

The sources maintained that Pakistan faces serious challenges on the economic front; however, the difficult situation always presents opportunities one of these is in the pharma sector where with right policy exports can be increased thousands of job created and increases FDI without the government having to make any investment. All this can be achieved through reforms in the existing contract manufacturing policy, the sources claimed.

It may be noted that the current legislation governing Contract Manufacturing-SRO 152(I)/2014 dated March 05, 2014, restricts contract manufacturing for export purposes only thereby limiting multinational companies from providing access to the same medicines to the local population. In addition, it also limits the number of products a CMO can manufacture to 05 per section only up to a maximum of 30 products.

The sources added that Pakistan should allow contract manufacturing to help local manufacturing operations to reach efficient scale and become competitive in the global market. Further, traceability of drugs can be enhanced by assigning dual responsibilities on both the CMO as well as its MNC client. By fostering and encouraging active partnerships between local manufacturers and global players, Pakistan can improve quality standards in local manufacturing, facilitate the transfer of technology and best practices and provide global reach and access to local manufacturers, the industry sources said.

As per report published by the Asian Development Bank (ADB), over 450 local licensed manufacturing operations in Pakistan have less than $1m of annual sales or are operating on less than the minimum critical mass required for an efficient and cGMP compliant manufacturing facility.

This situation has been aggravated over the years as a result of the licensing authorities awarding drug manufacturing licenses without taking into consideration the long term commercial viability of each facility and the ability of the local manufacturer to continue to reinvest in regularly upgrading its facility to changing global cGMP requirements.

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