The World Health Organization has suspended the approval of tuberculosis drugs made by India’s Svizera Labs, a major supplier to developing countries, following an investigation into standards.

• The United Nations agency, which acts as a drug watchdog in markets lacking robust local regulation, said it had suspended all TB products made at Svizera’s Mumbai site because manufacturing standards and quality management were unreliable.
• It also said independent experts should retest batches of medicine already on the market and it might be necessary to recall supplies, depending on the outcome of those tests.
• The move is a fresh blow for India’s pharmaceuticals industry, which supplies cheap generic medicines to countries worldwide.
• The WHO had previously issued a warning letter to Mumbai-based Svizera Labs, part of Maneesh Pharmaceuticals, in September 2015, after finding dirty surfaces, black mould in a cleaning area, low hygiene standards and inadequate record-keeping.

The WHO plays a critical role in monitoring drug quality in poorer countries through its Pre-qualification of Medicines Programme, which ensures that treatments supplied by UN agencies such as UNICEF are of acceptable quality.

Did You Know?

• About one third of the world’s population is infected with tuberculosis (TB) bacteria. Only a small proportion of those infected will become sick with TB.
• People with weakened immune systems have a much greater risk of falling ill from TB. A person living with HIV is about 26 to 31 times more likely to develop active TB.