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| Kathmandu, Friday February 21, 2003 Falgun 09, 2059. |
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Amendment to Indian Drug Act
may squeeze Nepali exports
By Sameer Ghimire
KATHMAND, Feb 20 : With the Indian government
planning to enforce an amendment to its Drug Act, Nepali drug manufacturers are likely to
face yet another blow while exporting their products to the Indian market. The Nepali drug
exporters are already feeling the heat to export domestic products to India due mainly to
complicated export procedures.
The new amendment to the Indian Drugs and
Cosmetics Act 2001, which will come into effect from March 1st, 2003, has introduced a
robust surge of various fees, making the exports of Nepali drug products to India
well-nigh impossible.
As per the amendment to the Act, the
registration charge for any drug company intending to export their products to India has
been raised 30 times higher than the previous charge, fixing it at US $1500, says Pradeep
Jung Pandey, former president of the Association of Pharmaceutical Producers of Nepal.
Along with the high registration charge, the
amended Act has also imposed different new fees including factory inspection charge
amounting to US $ 5,000 and quality examination fee of US $ 1,000 to each new brand of the
foreign drug that are exported to India. Until now, Nepali drug exporters are not required
to pay such heavy fees.
"The already nominal drug export to India
would surely be badly affected by the new amendment to the Act as it intends to restrict
drug imports to India through the imposition of various new charges," said Pandey.
Nepali drug manufacturers are worried that the
imposition of additional charges would greatly erode already fragile competitiveness of
domestic drug products in the Indian market, he added.
While the Indian drugs can enter Nepali market
quite easily, the Nepali drugs have to pass through a longer and difficult route to
penetrate into the lucrative Indian market. Due to the various complications, Nepali drugs
generally take six months to enter Indian market, concerned entrepreneurs say.
The undue lingering is mainly made by Central
Drug Lab of India in examining the quality of foreign drugs. "Such undue delay owing
to lengthy batch-wise examination has been discouraging to Nepali drug exporters,"
added Pandey.
Along with the drug industrialists, the senior
government officials also flay the delay. "The lengthy quality checking of our drugs
by Indian Central Lab has been sending wrong signal to our exports," said Bhupendra
Bahadur Thapa, chief of Department of Drugs Adminstration (DDA).
With the new amendment coming in effect soon,
the DDA, which is entrusted with ensuring the flow of quality drugs into Nepal, is also
planning to enact similar provision for foreign drug companies while entering into Nepal.
"We have already proposed the government to
enact some provisions that would check the quality of foreign drugs while entering into
Nepal for domestic consumption," said Thapa.
As of now, foreign drug companies are required
to deposit only NRs 50,000 as registration fee to acquire the licence, which allows them
to enter Nepali market. Along with the licence, foreign companies need to produce WHO-GMP
(World Health Organisation- Good Manufacturing Practice) licence to the DDA of Nepal to
penetrate Nepali market.
Nepali drug companies only contribute 27 per
cent of total drug demand to Nepal, which is a market of annual turnover of around seven
billion rupees, and employ over 25,000 people.
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