Pharmaceutical Regulatory Affairs: Open Access

The cellular mechanisms of AMP-Activated Protein Kinase (AMPK) activators in the treatment and prevention of diabetes, cancer, and cardiovascular disease (Graphical abstract).

Among the developing nations of the world, India has already carved out a special niche for itself in many business verticals of the pharmaceutical industry and is currently being recognized as the ‘pharmacy of the world’ for the generic drug products. The Indian generics market is growing day by day with Indian pharmaceutical companies seeking more Abbreviated New Drug Application approvals (ANDAs) in US. Generic medicines are formulated when patent and other exclusivity rights expire. To ensure the therapeutic efficacy of generic products, it must be pharmaceutically interchangeable and bioequivalent to the originator product. The contribution of the Indian pharmaceutical industry for the growth of generic drugs in the world is very high i.e. about to 35%. To sustain competition from developed world Indian generic manufacturer should plan the market strategy and regulatory requirement needed, very quickly because for generics production large number of application will be filed and competition from domestic market will also be there. This review enlists the validated regulations for manufacturing of generic drugs in India and US. Implementation and regulation, of the pharmaceutical sector at the state level, rather than on simply introducing new regulations is call of the hour. Henceforth, the use of drugs needs to be emphasized significantly for cost savings to the government and customers, in addition to its optimistic impact on health.

Background: Essential anti-malarial drugs are often not available in healthcare facilities when patients need them.

Objective: The study aimed to assess role of essential drug list in drug management including availability and stock outs of anti-malarial drugs among public and private primary, secondary and tertiary healthcare facilities in two cities of Pakistan; Islamabad (Federal capital) and Rawalpindi (twin city).

Methods: A comparative, cross-sectional study was designed to evaluate the availability, stock outs and management of anti-malarial drugs records in fifty public and private primary, secondary and tertiary healthcare facilities in the twin cities, namely Islamabad (Federal capital) and Rawalpindi. Pre-validated tools i.e. WHO facility indicator form and USAID inventory indicator and drug stock outs form were used to collect data. A structured questionnaire was designed for data collection on drug management from the personnel involved in drug management among both public and private primary, secondary and tertiary healthcare facilities. After the data collection, data was coded and analyzed by using SPSS version 16.

Results: Essential drug list was not available in any of the healthcare facility. Chloroquine and sulfadoxine/ pyrimethamine tablets were the most commonly available anti-malarial drugs in most of the public and private tertiary, secondary and primary healthcare facilities. On the other hand chloroquine injections were not available in any of the public or private tertiary, secondary and primary healthcare facility. Major stock-outs of anti-malarial drugs were seen in both healthcare facilities but the situation was more prevalent in the public healthcare facilities.

Conclusion: The results of the present study conclude that drug management follows different methods in both public and private healthcare facilities in the twin cities. Gaps in drug management including procurement, quantification, inventory control and drug stock outs must be addressed to improve the availability of drugs in healthcare system of Pakistan.

The performance of any enterprise is influenced by the environment in which it is located. The last two decades has witnessed the pre and post democratic governance in Nigeria as well as a number of government initiatives aimed at addressing some challenges facing the health delivery system of the country. The purpose of this paper was to study the capacity utilization of the pharmaceutical industry in the last twenty years to understand the association or otherwise with some government initiatives. A survey of the scientific work force and the capacity utilization in the industry was carried out. Interviews were held with individual to gain more insight in the activities of the industry during the period. The study showed that the capacity utilization of the pharmaceutical industry increased steadily but marginally. There was reason to believe that the marginal increment in the capacity utilization was influenced by the government policies and initiatives but the local industry is yet to be able to meet substantial essential drug needs of the country. Improvement in the internal controls and management by the industry along with sustained support and provision of infrastructures by the government would help to improve the capacity utilization in the pharmaceutical industry.