- “Our company is GMP, CE and ISO 13485-2016 certified, with exports to more than 40 countries,” Adeshwar stated in its separate letter to Honey Bee.
By AARON CHIYANZO
THE Indian manufacturers of the controversial gloves and condoms which Honey Bee Pharmacy supplied to the Ministry of Health have disputed the laboratory tests conducted by Zambia Bureau of Standards (ZABS).
The manufacturers said ZABS’ results were faulty because the institution did not follow required test procedures as specified by the World Health Organisation.
Both firms indicated that they had state of the art in-house laboratory that conduct pre-delivery quality control while other samples were sent to independent tests from other reputable laboratories to ascertain ZABS’ claims.
They have now demanded for an independent evaluation of the ZABS test.
Universal Prophylactic PVT Limited of India, the manufacturer of the condoms and Adeshwar Meditex Limited which manufactured the gloves have all discredited the results from ZABS.
“We have found some discrepancies in their report. It has mentioned length of condom as 195mm as not being acceptable but it is acceptable as per ISO 4075: 2015 and WHO specifications. The ISO 4074: 2015 standard says that minimum length required is 180mm and both standard and specification have not mentioned maximum limits of length,” Universal Prophylactic said in a letter to Honey Bee dated January 12, 2021.
Universal Prophylactic indicated the burst volume, hang and roll, and package integrity of the condoms conformed to the required standards and specifications after further tests.
“We do not agree with the report, we are not aware of procedure and parameters used during testing and no representatives of manufacturer and supplier were invited or present at the time when tests were conducted,” the company lamented.
And Adeshwar stated that it seriously doubted if sampling standards and inspection protocols provided under ISO 11193: 2008 were followed by ZABS when conducting tests.
“Our company is GMP, CE and ISO 13485-2016 certified, with exports to more than 40 countries,” Adeshwar stated in its separate letter to Honey Bee.
Honey Bee Pharmacy is accused of supplying defective condoms and gloves to the Ministry of Health but has rubbished claims.
And when contacted for a comment, ZABS executive director, Manuel Mutale said he was constrained to comment on the matter as he has to respect confidentiality for the client’s results.
“I have no authority to comment on the matter. ZABS is just a laboratory, and as a laboratory, we can just be contracted to do the test and give the results to the client but I cannot start commenting on the results in public,” Mr Mutale said.