The Department of Drug Administration´s (DDA) deadline for the companies to comply with its directives is ending in mid-April 2012. [break]
Although the instructions were issued in 2003, only 20 out of 40 drug manufacturing companies operating in the country have complied with the instruction so far.
But with the deadline approaching near, 10 pharmaceutical companies have approached DDA for the certification. Those seeking certification from DDA include GD Pharmaceuticals, Unique Pharma, Florid Laboratory, Manoj Pharmaceuticals, Chemi Drug Industry, Siddhartha Pharmaceuticals, Shiva Pharma, Alliance Pharmaceuticals and Everest Pharmaceuticals.
“These companies have approached for GMP recognition and after going through some of the documents, we will soon issue them WHO-GMP certification,” said Bal Krishna Khakurel, senior drugs administrator at DDA.
Likewise, five other companies have informed the DDA that they have started restructuring their infrastructures and conducting research to get GMP certification. However, five others have simply turned deaf ear to the DDA instruction.
GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. DDA had urged the companies to operate with WHO-GMP mainly to assure quality in manufacturing process as well as final products.
Countries across the globe have adopted this certification as benchmark of the quality output, and in many countries, companies are not allowed to undertake productions without such certification. However, efforts of the authority to compel similar quality assurance in Nepali products had faced a road block as half of the companies dragged feet on getting the certification.
Officials at the Association of Pharmaceutical Producers´ of Nepal (APPON), meanwhile, opined that the acquisition of WHO-GMP by half of the manufacturers in the market was an achievement in itself.
“We anticipate all the producers to comply with the DDA directives within the set deadline,” said Mahesh Gorkhali, president of APPON, referring that acquisition of GMP certification was important for the companies themselves as it will enable them win consumers´ confidence and compete with foreign manufacturers both in terms of price and quality.
With the compliance, APPON believes Nepali drug makers will be able to sharply expand their business in the domestic market. Currently, Nepali manufacturers occupy 42 percent of the total drug market share in the country.
“It would also open doors for Nepali manufacturers to export their products,” said Ravi Bhakta Sharma, deputy director of Deurali Janta Pharmaceuticals Ltd (DJPL), a GMP certified company.
However, as manufacturers have been acting slowly to comply with the directive, DDA has presently stopped issuing operating licenses to new companies, unless investors agree to start operations with GMP certification.
“GMP certification is a precondition now for entering into drug manufacturing business,” said Head of DDA, Radha Raman Prasad.
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