Norris Medicines recalls toxic syrups, says only sold in India

Norris Medicines

06/10/2023 14:30

By Krishna N. Das
       NEW DELHI, Oct 6 (Reuters) - India's Norris Medicines
 NORI.BO  has recalled a cough syrup and an allergy syrup that
the country's federal drugs regulator had found to be toxic, its
managing director said on Friday, adding that the products had
only been sold in India.
    Tests by India's Central Drugs Standard Control Organisation
(CDSCO) showed the medicines were contaminated either with
diethylene glycol (DEG) or ethylene glycol (EG).
    The same toxins found in other Indian-made cough syrups have
been linked by the World Health Organization (WHO) and other
health agencies to the deaths of more than 140 children in
Gambia, Uzbekistan and Cameroon since the middle of last year.
    Regulators have not suggested any harm has been caused by
the products which Norris is recalling.
    "All stocks have been recalled and data has been submitted
to the CDSCO," Norris Managing Director Vimal Shah told Reuters.
    "We have never exported these products. We are investigating
the issue at our end with toxicology studies. We have
investigated (and) no harm has been reported," Shah added.
    The company's Trimax Expectorant, made in January, contained
0.118% of EG, while allergy drug Sylpro Plus Syrup, made in May,
had 0.171% of EG and 0.243% of DEG, according to CDSCO
laboratory tests, Reuters reported last week, citing a monthly
report from the regulator for August.
    The WHO says the safe limit is no more than 0.10%. The WHO,
which has issued several alerts about Indian medicines since
last year, told Reuters the CDSCO had informed it about the
Norris products.
    Shah declined to say how many bottles of the two syrups
Norris made in total and how many had been recalled.
    "We have been manufacturing these syrups for the last 10
years without any complaint," he said. "Of late, diethylene
glycol and ethylene glycol have been brought to the list of
watch by the CDSCO due to the incidents abroad."
    The drug regulator of Gujarat state, where Norris is based
and has two factories near to each other, has shut all its
production, citing violations of good manufacturing practices
after an inspection last month, Reuters reported last week
citing H.G. Koshia, commissioner of Gujarat state's Food and
Drug Control Administration. Koshia did not cite any evidence.
    Shah did not respond to a request for comment on Koshia's
allegation. The cough syrup was made in one factory and the
other product in another, according to the CDSCO.
    The CDSCO list also named a glycerine batch it said was made
by Adani Wilmar  ADAW.NS  in October 2021, despite it containing
0.025% EG, which is within the WHO safety limit.
    An Adani Wilmar spokesperson told Reuters in an email it
believed "that the product in question (that tested by the
CDSCO) is counterfeit and communicated the same to the
department with a request to drop the recall notice".
    The CDSCO did not immediately respond to a request for
comment on Adani Wilmar's suspicion that the product tested was
a fake and was not manufactured by the company itself. 

 (Reporting by Krishna N. Das; Editing by Alexander Smith)
 ((Krishna.Das@tr.com; https://twitter.com/krishnadas56 ;))