Hedman commented that although it is important to foster long-term initiatives of national QA regulation such as those discussed here, in the short term there is an “immediate need to make sure that we reduce the risk of non-QA drugs that are going into high-burden countries.”
QA Regulation in India
As described in Chapter 1 (Box 1-4), the World Bank provides loans to the Indian government to cofinance its NTP, with the objective of building and strengthening India’s overall health system. According to Seiter, part of that system strengthening, particularly with respect to the NTP, should also include development of India’s own voluntary stringent regulatory pathway. This would enable the development of a recognized “seal of approval,” both for the purpose of exporting SLDs to other countries and to allow domestic procurement financed by external donors. At present, the Indian government employs a procurement agent, with an independent QA process in place, to procure SLDs directly from manufacturers. Seiter reported that it would cost the government three times as much to purchase a PQ product from the same company.
Brazil’s National QA Model
Brazil’s model for QA and management of SLDs can be characterized as a “rationally established environment,” whereby the NTP is responsible for maintaining and assuring the quality of its TB drugs. The majority of SLDs are produced in-country in the public and private sectors. Keravec explained how, in Brazil, product quality is assured through a national regulatory system of registration, documentation, monitoring, onsite inspections, testing, and enforcement that is specifically designed for TB drugs. Production consistency in terms of batch sizing is analyzed, postmarketing surveillance is performed, and inspections are carried out at non-domestic manufacturing sites that respond to international tenders.
In terms of capacity, Brazil has a National System for Sanitary Surveillance based on the model of an independent NRA, Anvisa. The system in Brazil includes a national laboratory institute, the National Institute for Quality and Control, responsible for quality and control testing, developing reference materials, and administering proficiency-testing programs to accredit labs in the 27 states that meet the appropriate technical standards. A specific TB Drug Quality Testing Program has tested all FLDs and SLDs in use since 2004, according to national regulation policies for sanitary surveillance.