Dec. 18 (NBD) -- A famous Chinese eye drops company that was accused of deceiving consumers about its product's impact on cataracts made a 20,000-character statement Saturday defending that its ads had been approved by authorities.

Zhejiang Shapuaisi Pharmaceutical Co (hereafter referred to as "Shapuaisi"), manufacturer of Shapuaisi Bendazac Lysine Eye Drops, claimed that as of December 7, the company has gained approval for 74 ads relating to the product - 40 commercials, 27 photo ads, and 7 audio ads.  

According to the scripts of commercials and audio ads listed by Shapuaisi in the statement, the ads indeed contain characters "for treatment of early stage of senile cataract", which are placed in an inconspicuous position. 

In this regard, the pharmaceutical company underscored that the Zhejiang Food and Drug Administration has reviewed the company's ads for Shapuaisi Bendazac Lysine Eye Drops in terms of the advertising contents, expressive form, and actual audio-visual effects, and compared ads being broadcast recently with those already approved in a random inspection, but no inconsistency was found. 

However, the company's ads that have been approved and are still within the validity don't comply with the newest requirements concerning advertising contents listed in the newest notice of the China Food and Drug Administration and Zhejiang Food and Drug Administration. 

The company, therefore, has proactively offered to suspend broadcasting the approved ads as of December 12. 

In order to get more specific information about the noncompliance with the new requirements, NBD tried to reach out to Shapuaisi's board secretary Wu Jianguo, but Wu didn't answer the phone. 

In the statement, the eye drops maker said that given its social responsibilities as a listed company, it will reduce the volume of ads while enhancing publicity concerning cataract prevention.  

The company also acknowledged that despite certain impact of the accusation, the production and sale of Shapuaisi Bendazac Lysine Eye Drops and other products almost remain the same. 

NBD reporter was also told the same story in a recent ground visit to Shapuaisi's headquarters, where is also the location of its production plant. 

In addition, the eye drops manufacturer detailed the R&D and clinical test results of the controversial product in the statement, noting that the product has certain effects in delaying the development of senile cataract and maintaining or even improving eyesight. 

According to the results of two phases of multicenter clinical trial, which were completed in December 1995 and July 1998, respectively, the product's curative efficiency in this respect was 71.13 percent and 73.73 percent, respectively. 

Ordered by the China Food and Drug Administration, Shapuaisi should run new clinical tests against Shapuaisi Bendazac Lysine Eye Drops to complete consistency evaluation in three years. If failed, the company could not be able to register, produce and sell the product.

This means the product will still be available on the market for at least three years. 

Moreover, the company reminded investors in the statement of risks in four counts: first, the failure to pass the consistency evaluation, second, dropping sales of Shapuaisi Bendazac Lysine Eye Drops and declining business performance, third, penalties caused by related ads, and fourth, claims for compensation lodged by product users.  

Email: lansuying@nbd.com.cn