The program is conducted with the support of a working group that carries out its activities and monitors results and regulatory measures. The initial findings of the program revealed quality and labeling defects in 32 percent of the 70 samples analyzed,6 which were linked primarily to API quality and discrepancies among the analytical methods used by the NRA and the public manufacturers. The NRA notified manufacturers of products that failed to meet adequate quality standards, and the products were recalled.

Keravec maintained that the “working group” model has facilitated improved interactions between producers and regulatory authorities as they have undertaken efforts to improve drug quality and harmonize analytical methods by decentralizing quality testing to the state level. Transparency for stakeholders is ensured because reports on product quality are publicly and freely accessible. The implementation of the e-TB Manager database (described in Chapter 1, Box 1-4) has also enhanced the NTP’s capacity for pharmacovigilance.

“Vicious Cycle” of QA SLD Supply

Patrick Lukulay, USP, depicted SLD supply as being plagued by a “vicious cycle” in which there is a limited supply of QA API and QA FPP, while QA FPP volumes are also affected by the limited demand for QA drugs, including the poor diagnosis of MDR.

Lukulay differentiated between two components of QA: QC and quality of the manufacturing process (Good Manufacturing Practices). The former encompasses the quality of the attributes of the product, that is, presence of impurities, dissolution profile, ingredient identification, and microbial content (for injectables). Manufacturing process control helps ensure that drugs that meet QC standards are also produced in an environment appropriate for drug manufacturing. A facility could, for example, be prone to contamination or a product might not have been provided with sufficient documentation to be tracked if problems arise. QA medicines satisfy both components.

Limited supply of QA API is a serious barrier that affects lead times, price, quality, and prequalification of FPPs. Lukulay suggested there is an urgent need for more API suppliers to voluntarily seek WHO PQ in spite of the capital and human resources investment that the process entails. Entry into the API manufacturing industry is severely restricted by the complexity and cost of production. Lukulay’s analysis revealed that in terms of cost/reactor volume, China (followed by India) has the lowest current Good Manufacturing Practices (cGMP) and operating costs in the

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6 Thirteen percent failed due to labeling and 19 percent failed due to tests.



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