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EDITORIAL

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 Kathmandu Monday September 18, 2000 Aswin 02,  2057.


Regulate quality of drugs

The other day, Nepali drug manufacturers welcomed the government’s move to levy registration
charge for foreign drug suppliers to Nepal. Obviously, this benefits them more than the health
sector of the country since foreign drug suppliers will have to register individual brands before
they enter the Nepali drug market. However, it must be cautioned that the regulation to protect
domestic industries could result in the entry of cheap and low quality drugs into the domestic
market. The government has to introduce some mechanism that will prevent substandard drugs
from being sold in the market before it makes it difficult for foreign drug suppliers to sell their
products in Nepal.

The new provision on the import of foreign drugs states that a pharmaceutical company of
SAARC countries will have to pay 50,000 rupees to supply their products to Nepal. For
non-SAARC drug manufacturers or suppliers, the charge will be US 1000 dollars. For individual
brand registration, the companies of SAARC region having export recommendation letter will be
levied a fee of one thousand rupees every year. Companies from outside SAARC will have to pay
US 30 dollars. Similarly, drugs categorized under life saving will have to pay 500 rupees for
registration and 50 rupees for annual renewal. For non-SAARC countries, every company will
have to pay US 15 dollars for registration and 10 dollars in annual renewal fees.

Nepali drug manufacturers have so far managed to capture less than 30 percent of the domestic
drug market. Nepal imports over four hundred thousand brands from India. It is a sad fact that in
South Asia, Nepal is the only country that imports maximum number of brands without
monitoring the quality of drugs. Have all these companies met the criteria set by World Health
Organisation (WHO) ? How many of them have acquired good manufacturing practice certification
from WHO? If these drug companies have been violating international norms, then what are the
steps the government has introduced against such practices? These are a few questions the
government has failed to answer.

The new measure to restrict the import of foreign drugs will no doubt boost the domestic drug
industry. This apart, the measure will generate additional millions of rupees in revenue every year.
But, how many domestic drug companies have met WHO’s criteria so far? In a recent WHO
survey, there were hardly a few Nepali companies that conformed to good manufacturing practice.
Under such circumstances, how can the government ensure that the health sector will improve if
it introduces such measures? The government must realise that while it is a good idea to
encourage domestic manufacturers, the health of the people is even more important. The
government must ensure that the quality of drugs dispensed at retail outlets, whether locally
manufactured or imported, meet the minimum quality set by organisations like WHO. The
government surely owes at least this much to its citizens.


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