Pharmaceutical Manufacturing

Making a pill is technically easy, but manufacturing a medicine that delivers an active compound in a narrowly defined dose range and within a time that ensures clinical efficiency is much more difficult. Setting up a manufacturing plant that produces drugs according to international quality standards requires significant investment and a highly skilled and specialized workforce.  Given the fact that current global manufacturing capacity for drugs is under-utilized and practically all medicines that are easy to make can be purchased at fairly low prices in reasonable quality, local manufacturing should not necessarily be a priority from a drug policy perspective unless there is a solid analysis showing that it makes economic sense.

Factors to be considered in such an analysis are:

• Size of domestic market
• Availability and price of imported generic drugs
• Availability of skilled managers and workers
• Functioning regulatory framework to ensure market access and quality control
• Costs of inputs (building, equipment, training, labor, utilities, raw materials, taxes etc.)

For further study:

US Good Manufacturing Practice regulations – showing the complexity of the issue:
http://www.fda.gov/cder/dmpq/index.htm

WHO guide on GMP:
http://www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpcover.html