Reuters/London/Mumbai
A major Indian supplier of tuberculosis drugs to developing countries has been severely criticised by the World Health Organisation for inadequate manufacturing standards and poor testing procedures.
The United Nations agency issued a warning letter to Mumbai-based Svizera Labs, part of Maneesh Pharmaceuticals, stating that the approval and use of its products would be suspended if “critical and major observations are not corrected within a reasonable time frame”.
The move is the latest setback for India’s drugs industry, a vital source of cheap generic medicines to countries worldwide which has been tarnished by a series of quality problems.
Svizera is important well beyond India because it is one of four manufacturers with a long-term contract to supply medicines to the Stop TB Partnership, a WHO-backed organisation set up in 2001 to fight tuberculosis in more than 100 countries.
The WHO, which checks on medicines used by UN agencies, issued the “notice of concern” letter to Svizera on September 2 setting out 10 shortcomings.
Svizera managing director Vinay Sapte said he disagreed strongly with the content of the report, adding that independent consultants who had visited the factory since the WHO inspection in June had found it to be up to standard.
“We are convinced that ... we can resolve this issue in short time,” Sapte said in an e-mailed statement.
The lengthy list of deficiencies identified by the WHO team included rusty and unclean surfaces on drug packaging lines, defective seals and black mould in a cleaning area, generally low hygiene standards, and inadequate factory record-keeping.
The inspectors also criticised the quality of drug testing and said some of the results may have been manipulated.
