THIS refers to the report ‘Drug-makers plan 10 FDA-certified laboratories’ (May 17). The stance of the Pakistan Pharmaceutical Manufacturers’ Association (PPMA) and its chairman’s approach to increase export looks impressive.

The facts and figures shared clearly show that aggressive planning with prompt implementation is mandatory and there is certainly ample scope in the field for investors and businessmen as well as the government to generate revenue if the government takes the initiative and devises plans and policies with the consent of all stakeholders.

The strategy of the PPMA chairman sounds good, but there are a few things I reckon would have been overlooked, such as expertise of the technical staff required for FDA audit preparation, the approval of a trained team for the creation and implementation of a modern quality system, previous experience of handling FDA audits and the role of international consultants and local experts.

Planning for a target international market with selection of the product range, as specialised plants are designed for specific products, and FDA requirements are not same for every part of the world.

Investing money in marketing professionals and paying high salaries to medical representatives is good but it is not the solution. Investment in research and development is mandatory but in the later phases after getting FDA approval for established drug products.

The investment in acquiring required technical professional skills for modern quality system is the top priority.

A citizen

Karachi

Published in Dawn, May 25th, 2015

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