KATHMANDU, Jan 2: Twenty-five domestic drugs manufacturers have been operating illegally. However, the Department of Drug Administration (DDA) has not taken any action.
There are 55 drugs manufacturers in the country and they produce different types of medicines, according to DDA. Nine more drug companies are awaiting DDA approval to come into operation.
According to DDA, drugs worth Rs 16.5 billion are produced domestically every year ( 46 percent of the total supply) while drugs worth Rs 19.45 billion (54 percent) are imported, including 52 percent imported from India and two percent from other countries.
Nepal Health Research Council (NHRC), the apex scientific body in the health sector, recently found that nine substandard drugs were supplied by the government and the private sector to government-run health facilities, including seven drugs produced domestically.
About a decade ago, the government mandated the Who Health Organization Good Manufacturing Practices (WHO GMP) for all manufacturers of pharmaceuticals. “Several domestic pharmaceuticals producers have not applied the WHO GMP,” said Bhogendra Raj Dotel, executive director at the Primary Health Care Revitalization Division (PHCRD) under the Department of Public Health Services.
However, according to DDA officials, 25 domestic manufacturers have not adhered to WHO GMP to date. “Some of them have not applied WHO GMP at all while others have not renewed their GMP certification,” said Santosh KC, senior drug administrator at DDA, which certifies manufacturers for WHO GMP compliance. He said WHO GMP certification is mandatory when importing medicines. “We are working for effective implementation of WHO GMP and have warned or suspended a few manufacturers for non-compliance.”
According to WHO, GMP ensures that products are consistently produced and controlled by the quality standards appropriate to their intended use and as required by marketing authorization. GMP is aimed primarily at diminishing the risks inherent in pharmaceutical production, which may broadly be categorized into two groups: cross contamination/mix-ups and false labeling.
The substandard drugs supplied at government health facilities are produced by Lomus Pharmaceuticals Pvt Ltd, Alive Pharmaceuticals Pvt Ltd, Vijaydeep Laboratories Ltd, Ind-Swift Limited, Nova Genetica Pvt Ltd, Arya Pharma Lab Pvt Ltd, Omnica Laboratories Pvt Ltd and Leben Laboratories Pvt Ltd, according to an NHRC report.
And according to the Ministry of Health, there is no bio-availability test system in use in the country. The system tests for the level of drug intake needed for results. Medicines are labeled standard while they do not meet minimum required standards for composition, storage and manufacturing practice.
Deepak Prasad Dahal, president of the Association of Pharmaceutical Producers of Nepal (APPON), claimed that the domestic production of drugs has met international standards. “Each pharmaceutical firm has its own laboratory and we check the quality of our products as well as do bio-availability testing,” he said. “So far as the government report is concerned, we have to investigate further to establish the causes behind storage, composition and other problems.
“We should apply WHO GMP but the government is responsible for the monitoring and certification ,” he added, claiming that Nepal Aushadhi Ltd., the only state-owned only drugs manufacturer, also does not follow WHO GMP.
DDA forced Nepal Aushadhi (formerly Royal Drugs Limited) about 10 years ago to shut production for failing to maintain WHO GMP standards while manufacturing 120 kinds of medicines. DDA did not issue its permission for importing raw materials for medicines or renew its production license because of the WHO GMP issue.
The government issued Rs 64.8 million to Nepal Aushadhi to revive production. “With this budget, we have applied WHO GMP for ORL, tablet units and the quality assurance lab as well as research and development,” said Gyani Bahadur Rayamajhi, chief of the administration division at the drug manufacturer. “We have already started producing ORL and paracetamol tablets from this month,” he said. “We plan to produce 35 kinds of medicines including essential drugs,” he added.