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‘Work hard to acquire WHO-GMP certificate’
KATHMANDU, OCT 25 - The Department of Drugs Administration (DDA) has underlined the need to put more efforts for Nepali drugs companies on upgrading their manufacturing practice to acquire globally recognized Good Manufacturing Practice (GMP) certificate.
Talking to The Kathmandu Post after completion of first ever intensive inspection over the domestic drugs companies under the GMP guidelines, a senior inspection team-member, said that manufacturing process of most Nepali drugs companies have failed to meet the standard set by the World Health Organization (WHO).
The DDA, the regulatory authority that oversees the operation of domestic drugs companies along with supply of foreign drugs within the country, recently concluded its WHO-GMP inspection on six Nepali companies that have applied for the WHO-GMP certificate.
Experts believe that one major factor behind the failure of Nepali drugs to penetrate the international market is lack of global recognition for its quality. None of the Nepali companies till date, has acquired WHO-GMP certificate, which the DDA has proposed to make mandatory from 2007, with a view to encouraging domestic industrialists to produce quality products that eventually could penetrate the international market.
The source also informed that the DDA would be carrying out the second round of inspection within the next two months. "The second round of inspection will be initiated soon," said he, adding that a foreign WHO-GMP expert will also be included in the team for the upcoming inspection.
The source, however, hinted that despite some weakness, the DDA would award at least two companies out of six after the completion of second round inspection. The six companies that were inspected during that first phase were Nepali Pharmaceutical Lab, Quest, National Health Care, Deurali Janata, Omnica and Hukam Pharmaceuticals.
"During the first round of inspection, only minor weakness were identified in the manufacturing process of two companies. Our team is considering to award these two companies with WHO-GMP certificate if they succeed to improve while inspecting during the second round," he added.
However, he declined to name the probable companies that would bag the award within the next six months.
Such WHO-GMP inspection from the DDA comes after the government drew strong criticism for its laxity on regularly monitoring the domestic drugs market, which is flooded with the inferior drugs lately.
The DDA had recently proposed the government to make WHO-GMP guidelines mandatory to all domestic drugs companies, so that the export base of Nepali drugs would get a boost, which is just around 3 percent of the total output.
"Acquiring WHO-GMP certificate would definitely boost the exports of Nepali drugs in future," says Pradeep Man Vaidya, President of Association of Pharmaceutical Producers of Nepal (APPON). He said that international recognition would be very supportive to the domestic manufacturers to penetrate the global market, which has always been tough for them.
However, Hari Bhakta Sharma, owner of the Deurali Janta Pharmaceuticals, one of the companies that was inspected by the DDA under the WHO-GMP guidelines, said that WHO-GMP award alone cannot help the domestic companies to penetrate the international market.
"When many countries, especially that of Europe, allowed only ISO certified drugs to enter in their market, it is hard for Nepali drugs to make their presence in markets other than Indian, " he added.
But India, where most of the Nepali drugs are exported, is not an easy market, complained drugs producers. "India imposes unnecessary hurdles and it takes almost around nine months for Nepali drugs to reach the Indian market," said Vaidya.
There are 39 pharmaceuticals in Nepal that meet 27 percent of the total domestic drugs market, which has an annual turnover of over Rs 6 billion.Posted on: 2003-10-25 12:22
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