Drug Management Department to Implement Minimum Stock System to Address Shortages

Kathmandu. The Drug Management Department is preparing to implement a minimum stock system to solve the problem of drug shortages that are occasionally seen in the market.

The department has put forward this new plan after shortages appeared in the market due to various reasons related to drug production, import, and pricing.

According to Shivani Khadgi, the acting director general of the department, shortages are sometimes created because all registered drugs are not regularly produced or imported. She informed that due to pricing, there was an extreme shortage of cancer treatment drugs some time ago, and there is still a shortage of cancer drugs. She stated that the shortage of paracetamol and life-saving drugs during the COVID period was also related to the primary pricing.

Shortages also occur because producers or importers are not interested in 'orphan drugs' used for some rare diseases, as they are commercially less profitable. While such drugs are not needed regularly, if they are not available when needed, patients' lives are at risk. Targeting such drugs, the department has planned to maintain a minimum stock in coordination with the Department of Health Services, hospitals, and other concerned bodies.

Acting Director General Khadgi said, 'We are currently registering all producer companies whose processes are correct when they come to register any drug. Shortages are occasionally caused by importers; we have licenses, but some do not produce. There are also situations where there is a shortage in the market because some do not import.' She clarified that preparations are underway to maintain a minimum stock of drugs that will be in shortage in the coming days.

There is also a plan to prepare a list of life-saving drugs that are imported through the department's special recommendation or are registered in very small quantities in Nepal, and to ensure their domestic production or regular import. The department has stated that the government aims to achieve at least 80 percent self-sufficiency in essential medicines and will encourage domestic industries towards the production of essential medicines.

Meanwhile, acting Director General Khadgi stated that the department has not received any official information regarding the alleged shortage of rabies vaccine in the country. While mentioning that the delay in the government's procurement process might have affected the vaccine supply, she informed that the procurement process is now in its final stages. All vaccines for human use in Nepal are dependent on imports, while only veterinary vaccines are produced domestically.

She said, 'The issue of rabies vaccine shortage is being raised a bit. There is no information about a shortage in the department. This is due to a slight delay in the government procurement process, but it seems almost complete now.'

On the other hand, the department is also aware of the issue of unregistered, substandard, and counterfeit drugs and vaccines entering Nepal due to the open border with India. Recently, a counterfeit drug named 'Seroflo' was found in the market. It is difficult to regulate effectively due to the lack of permanent presence of the Department and the National Drug Laboratory at border customs points and a shortage of manpower. Khadgi said, 'Due to the open border, we are facing difficulties in regulation because the Department of Drug Management and the National Drug Laboratory do not have a permanent presence at the customs points.'

The department has not been able to conduct foreign drug industry inspections (GMP inspections) required for new drug registration for the past three years. Although files recommended by the GMP committee have been sent to the ministry, a decision is pending. However, the department plans to resume foreign industry inspections regularly according to the annual program from this year and prioritize new drug registration.