WHO has approved the anti-tuberculosis formulation plant of Cadila Pharmaceuticals at Dholka near Ahmedabad, under its Global TB Drug Facility (GDF) programme. The GDF ‘Stop TB’ Programme of the World Health Organisation is planned for ensuring quality production of tuberculosis drugs globally especially in the developing countries where the disease is more prevalent.

In the case of GDF quality approval, the inspection team of WHO as per the specific quality standards recommended by the organization, examines the manufacturing facility. This Programme meant for expanding accessibility of drugs for quality treatment for TB patients. GDF quality certification is more relevant now as there are increased instances of poor quality drugs supplied by formulation companies to government institutions and hospitals involved in the tuberculosis treatment worldwide even through WHO procurement.

The poor quality drugs in case of tuberculosis treatment would extensively lead to multi-drug resistant TB, a serious health threat to the world, for which at present there is no treatment available. The certification is now mandatory for international tenders of anti-TB drugs especially for the US sponsored WHO procurement programmes.

The Geneva team inspected the Cadila facility in August 2003. The Rs. 4 crore new anti-TB formulation plant is a separate unit in the huge manufacturing complex of Cadila Pharma at Dholka. The plant formulates both mono and combination dosage forms of all TB drugs like rifampicin, isoniazid, pyridoxine, ethambutol and pyrazinamide. The per-shift capacity available at this plant is one lakh capsules and 3 lakh tablets and would have a per-shift packing capacity of 18000 kits.

In India, there are currently six facilities approved by WHO, Geneva for anti-TB formulations manufacturing. The major amongst them are Lupin, Cadila Pharma and Stride. The other three are in the small-scale sector. There are around 33 pharmaceutical companies manufacturing and marketing anti-TB drug formulations in the country at present.