Pharmaceuticals

Strengthening the pharmaceutical sector including drug regulatory capacity and trade and health for it to play a special role in India’s future is a key objective in the Country Cooperation Strategy (CCS) (particularly in the context of enhanced access to generic drugs, vaccines and medical products). Increased access to drugs (including patent issues and Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPS); continued advocacy for reducing prices as well as improvements in procurement and supply chain management) should be fostered, especially for quality essential products for managing NCDs, TB, HIV/AIDS, malaria and neglected tropical diseases (NTDs), among others.

The number of “stock-outs” of medicines in public centres will also need to be reduced. Promising market niches (e.g. generics for NCDs) should be explored with a view to both identifying business opportunities and serving the needs of low income countries and emerging world markets. WHO will support the development of platforms and networks for horizontal collaboration, and transfer of technology between the international community, industry federations and relevant players, and generation of knowledge on international trade and health. This will help in building enhanced capacities for trade negotiations in cognizance of intellectual property rights issues and international covenants which have bearing on public health. Due consideration should be given to their implications for Indian industry and access to affordable quality pharmaceuticals locally and globally.

Drug regulatory work by the relevant authorities including the Indian Pharmacopoeia Commission and other stakeholders should be strengthened in line with the emphasis on “trade and health” and access to medicines. The number of trained Institutional Ethics Committees as per standard operating procedures or guidelines should be increased to improve standards of clinical trials and research. Research and development (for example, the creation of drug testing laboratories) should be expanded and all trade legislation should strictly adhere to the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property(GSPOA).

Quality assurance and safety policies and, in general, good manufacturing practices (GMP) should be reaffirmed by consolidating the technical expertise developed in recent years while supporting the National PharmacovigilanceProgramme and integrating reports of adverse drug reactions (ADRs) under national programmes on HIV/AIDS, tuberculosis, malaria and vaccines. Rational drug use initiatives and sector inspections (e.g. distribution, prescription, and delivery over the counter) should be scaled up in order to protect customers and contain antimicrobial resistance.