Drug Act 1978 of Nepal: A Critical Analysis

Background: With the enactment of the Drug Act in 1978, through the establishment of different bodies under the act, drug-related activities have been regulated and controlled in Nepal so as to provide safe and efficacious drugs of standard quality to the general public.  However, with the overgrowing use of drugs, cosmetics, biotechnological products, nutraceuticals, and veterinary products in the present market and the present act failing to include these aspects, this paper tries to critically analyze the Drug Act 1978 of Nepal which will comprise strengths, weaknesses, opportunities, and threats faced in current scenario regarding the act. The regulation of drugs in Nepal was started with the enactment of the Drugs Act in 1978 AD, which is being carried out by the Department of Drug Administration as provisioned in the section 5 of the act. To facilitate the proper implementation of the act, various rules, regulations and guidelines are framed. The objective of this study was to explore the areas to improve in the Drugs Act and help foster the use of safe, efficacious and quality drugs. Method: The Drugs Act 1978 was critically analyzed focusing on the strengths, weaknesses, opportunities, and threats of the act as of current scenario. Result: After critically analyzing the drugs act 1978 we found out that there is lack in regulations of use of cosmetics, newer biotechnology products, nutraceuticals, veterinary product, innovative pharmaceutical products as well as the online pharmacy services. Conclusion: A major amendment and periodic revision is required with the consequence of meeting timely needs and promoting the idea of safety and efficacy in drug related activities

Conducting a phase III clinical trial in children during the COVID- 19 pandemic: Experience and lessons learnt from a clinical research facility of Nepal

Clinical trials in humans are vital to test safety and efficacy of new interventions and are accompanied with the complexity of related regulatory guidelines, stringent time frame and financial burden particularly when participants are children. Conducting clinical trials in low and middle income countries, where 90% of global diseases occur, increases the complexity as resources, infrastructures, and experience related to clinical trials may be limited in some countries. During the COVID-19 pandemic, due to multiple infection control measures such as social distancing, lock-down of the societies, and increased work load of hospital workers, conducting clinical trials seemed very challenging. Related guidelines and recommendations on clinical trials required updates to adapt the situation for ongoing clinical trials to be continued and new clinical trials to be initiated. In this review report, we described the lessons learnt through our experiences, challenges we faced, and the mitigation measures implemented as a response while conducting a phase III clinical trial on a non-COVID-19 vaccine at a government children’s hospital during the COVID-19 pandemic. We hope this report will contribute in lowering the obstacles to allow the successful completion of future studies, in countries where people live with the burden of vaccine-preventable diseases