Mumbai-based Svizera Labs has been suspended as a supplier of TB drugs to a World Health Organization-sponsored program, Reuters reported, as manufacturing quality standards remain unreliable following a September notice on operations.
The move hits the prequalification status of the company owned by Mumbai-based Maneesh Pharmaceuticals, a highly sought-after designation by vaccines and medicine makers to be able to sell into global health programs.
India is at the center of a storm of TB cases domestically, including multidrug-resistant forms that will see the launch this week domestically of a closely watched effort between the government and Johnson & Johnson ($JNJ) unit Janssen for a pilot of Sirturo (bedaquiline) that has the potential to dramatically improve treatment outcomes, the Economic Times reported in a separate story.
The rollout coincides with World TB Day on March 24, a WHO initiative.
The country has the highest number of TB patients in the world with over 2.3 million new cases every year and more than 70,000 suffering from multidrug-resistant strains.
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| Indian Council of Medical Research director general Sowmya Swaminathan |
In February, the Indian Council of Medical Research director general Sowmya Swaminathan said patients with multidrug-resistant tuberculosis in government-run hospitals in four cities will get bedaquiline in a controlled release.
At the same time, Indian companies are at the forefront of many global campaigns with Svizera one of four manufacturers with a long-term contract to supply medicines to the Stop TB Partnership that includes the World Health Organization.
Boudewijn Ploos van Amstel, managing director of Svizera Europe, told Reuters by telephone from the Netherlands that the company disagreed with the assessment: "The letter of suspension is very misleading."
- here's the Reuters story on the Svizera suspension carried in the Economic Times
- a copy of the WHO September 2015 notice to Svizera
- and an Economic Times story on a Sirturo program in India