KATHMANDU, NOVEMBER 13

The Department of Drug Administration has ordered the recall of two types of medicines manufactured by Nepali pharmaceutical companies after they were found to be substandard.

Issuing a public notice today, the department directed to immediately recall vitamin supplements produced by two Nepali manufacturing companies - Biogain Remedies Pvt Ltd of Rupandehi and Lomus Pharmaceuticals Pvt Ltd of Kathmandu.

BIOCAL-D (Calcium Carbonate and Vitamin D3 Tablets BP) produced by Biogain with batch number 'BD2104' failed the assay test (a laboratory test to find and measure the amount of a specific substance) for Vitamin D3 while Asvit (Vitamin-C Tablets IP) produced by Lomus with batch number 'AS2121' failed the friability test (used to test the durability of tablets during packing processes and transit), as per the notice.

'During the examination of the drug samples collected by the department while market monitoring, it was found that the drugs produced by the listed manufacturers were of low quality,' the notice read.

'The distribution of these drugs should be stopped, they be recalled from the market immediately, and the details should be submitted to this department.'

According to the notice, the department has instructed all against purchase, sale, and use of medicines under Section 14 of the Medicines Act, 1978.

Santosh Baral, vice-president of the Association of Pharmaceutical Producers of Nepal, said that it was always possible that two per cent of the total medicines supplied in the market underwent deterioration due to several reasons and were unable to meet the medical parameters during random sampling.

'As per the World Health Organisation guidelines, if such a technical problem is detected, all products from that batch should be recalled from the market,' he said.

'I think these two factories have started to inform all distributors and dealers to recall the products from the mentioned batch numbers. After collecting all products, they will again examine drugs at their respective labs.

'If they detect any problem again, they will fix them and manufacture them,' he added.

The two supplements were widely prescribed for, and used by, patients of novel coronavirus.

Officials of DDA and Lomus Pharmaceuticals did not respond to repeated calls seeking their comments.

Supplements made by Biogain Remedies and Lomus Pharmaceuticals found substandard

A version of this article appears in the print on November 13, 2022 of The Himalayan Times.