9 pc of drugs in the market are estimated to be substandard: DDA
Paracetamol 500mg BP (Cetophen) is one of nine substandard drugs subjected to in-vitro analysis in two labs
46 pc total drugs are domestic production while 54 pc are imported
Govt purchases essential drugs worth Rs 1.5 billion annually to distribute free of cost from its health facilities
KATHMANDU, Dec 26: Life-saving drugs supplied to the health facilities and to the market by both the government and the private sector have been found substandard and a danger to public health.
Nepal Health Research Council (NHRC) sent 214 samples of the drugs for in-vitro analysis at two different laboratories in order to examine them for quality. Out of the 214 samples, 26 were supplied by the government and 188 by the private sector. Among these, nine drugs were found to be substandard.
According to research published recently by NHRC, three essential drugs supplied by the Government of Nepal were found to be substandard, including Paracetamol 500mg BP (Cetophen).
“Six non-essential drugs supplied by the private sector also failed to meet the required standards in one laboratory test,” says the NHRC research report.
According to the Department of Drug Administration (DDA), drugs worth Rs 16.5 billion (46 percent) constitute the annual domestic production while drugs worth Rs 19.45 billion (54 percent) annually are imported. Of the 54 percent imported medicines, 52 percent is purchased from India and two percent from other countries.
The government purchases 72 kinds of essential drugs for distribution to the public free of cost through government health facilities. According to the Primary Health Care Revitalization Division (PHCRD) under the Department of Public Health Services, the government has allocated a total of Rs 1.5 billion in the current fiscal year for the purchase of essential medicines that are to be distributed free of cost.
Out of this total amount, Rs 362.6 million (24.27 percent) is allocated for local bodies, Rs 19.5 million (1.03 percent) for upgraded hospitals, Rs 57.87 million (3.86 percent) for district health/public health offices, Rs 10 million (0.67 percent) for the five regional hospitals and Rs 1.05 billion (nearly 70 percent) for the center.
Similarly, the government allocated Rs 1.49 billion for the procurement of essential medicines last fiscal year and Rs 1.5 billion the previous fiscal year. Out of the annual allocations, 70 percent is allocated for the center and 30 percent for the local levels.
Nine percent of the drugs available in the market are estimated to be substandard, said Santosh KC, senior drug administrator at the Department of Drug Administration (DDA). “A larger number of drugs produced by domestic manufacturers are also substandard,” he added.
KC further said the low quality of raw materials and inadequate level of ingredients compromise the quality of the drugs, and there are also problems of storage and transportation.
“We are the monitoring authority but checking the market has not been so effective,” KC said, “There is also lack of a comprehensive law on drug procurement. We still purchase medicines under laws meant for construction materials,” he added. “The technical specialty of medicines should be evaluated differently while budgeting for medicines, but the present practice is to reward tenders to the lowest bidder.”
Bhogendra Raj Dotel, director at PHCRD, admitted the lack of specific procurement laws in the country. “However, the substandard medicines mentioned by NHRC were not purchased by the central government,” he claimed. “Medicines purchased at local, district and regional levels might be substandard.”
The NHRC carried out a cross-sectional study of 90 health facilities in the five development regions, including one district hospital, one primary health care center and four health posts from one district each representing the mountain, hill and tarai regions. It also collected 10 generic medicines each of five brands.
Among the total prescribed drugs from all the health facilities, 60.71 percent were found to have been prescribed with generic names instead of brand names and the highest percentage were from district hospitals, according to NHRC. A total of 68.91 percent was found to be essential medicines while 23.74 percent was antibiotics. There was an almost 400 percent variations in price among the different brands of medicines, including Tamsulosin 0.4mg capsules, Cefixime 200mg tablets and Amlodipine 5mg tablets.
Furthermore, 26 percent of the health facilities were found to be not storing vaccines in cold chain, which is mandatory, says the report.
There are more than 4,000 government health facilities across the country, including primary health centers, health posts and district hospitals, with about 35,000 health workers including 1,500 doctors, according to the Ministry of Health (MoH). There are 109 government hospitals while the private sector owns 154 hospitals. Besides these, dozens of private clinics and nursing homes are also operating in the country.