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Letters to the Editor

Indian Pediatrics 2004; 41:1185-1186

Tuberculin in India


This is with reference to the Letter to the Editor, regarding the shortage of Tuberculin PPD and concern for the lack of indigenous manufacture of the same by Dr. T. Jacob John(1).

In this context we would like to draw your attention to the fact that Span Diagnostics Ltd. has been indigenously manufacturing and marketing Tuberculin PPD in three strengths of 2TU, 5TU and 10TU since 1973. Production and quality control protocols were based on those developed at the Staten Serum Institute, Copenhagen by Magnusson, et al.(2). Each batch of Tuberculin has been calibrated, against WHO’s standard preparation of PPD RT23. For several years, 2TU-dosage form was discontinued because of lack of demand in Indian market. Subsequently, however, in the year 2001, SPAN has relaunched Tuberculin 1TU/2TU, at the behest of several leading Pediatricians, mainly for the screening in the high prevalence areas.

SPAN’s Tuberculin Purified Protein Derivative is manufactured at its Surat based plant, which complies with the WHO-cGMP guidelines and is accredited with ISO 9001-2000 Quality Management System.

Further, please note that SPAN has been continuously producing all the different strengths of Tuberculin PPD and so far millions of vials have already been sold in India. We also hold substantial stock of bulk material that can last for several years. The product is quite economically priced and made available through a distribution network of more than 250 stockists in the country. Moreover, SPAN’s technical competence and manufacturing infrastructure is capable of meeting with any demand, nationally or internationally. Incidentally, in the past one-year, we have supplied more than 3000 vials of Tuberculin 1TU to TNMSC, Chennai.

Although, we appreciate your concern and interest regarding the availability of Tuberculin PPD, we would like to assure you about its perpetual supply, now and in future. We also take this opportunity to stress upon the fact, that India’s dependency on procurement of PPD from outside sources is not truly justified when the product with equivalent quality is being indigenously manufactured and made available in the country itself.

Tushar Jani,
Product Development Manager,
Span Diagnostics Ltd.,
173 B, New Industrial Estate,
Udhna-394210, Surat, India.
E-mail: [email protected]

References

 

1. John TJ. Shortage of Tuberculin in India: Reasons and Remedy, Indian Pediatr 2004: 41; 293-294.

2. Magnusson M, Bentzone MW. Preparation of Purified Tuberculin RT23, Bull WHO 1958: 19; 829-843.

 

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