Tamil Nadu Medical Services Corporation (TNMSC), the drug procurement agency for the Tamil Nadu Government, has appointed a fresh committee to review the tender document submitted by Human Biological Institute, a division of Indian Immunologicals Limited (IIL) for the supply of its anti-rabies vaccine Abhayrab for the year 2004-05.
The Corporation had last month rejected the company's offer following an adverse inspection report. The enquiry report as part of the tender process for supply of human anti-rabies vaccine to the TNMSC was learnt to have indicted Human Biologicals Institute for serious irregularities in production and supplies to Tamil Nadu hospitals during the last three years.
However, the sources from the TNMSC has informed that following an appeal from the company, the Corporation has now appointed a new internal committee to reassess the offer document by conducting a fresh inspection.
According to the earlier inspection report of TNMSC, it had mentioned that while the batch size as per the batch manufacturing records was about 9950 vials, which corresponds to the freeze drier capacity of 10,000 vials at its Ooty manufacturing plant, IIL has supplied more than its capacity during the supply period from 2001 to 2003 to TNMSC.
The report had also noted that the irregularities have been found out following inspections done by the officials at the IIL premises in Chennai and Hyderabad, confirming more vaccines were released from Hyderabad than its actual capacity informed to the TNMSC. Further, the company also supplied quality-failed product of batch numbers 85, 86 and 91 to TNMSC in the previous years.
As per the WHO guidelines, it is mandatory that each and every batch manufactured need to be tested and released by CDL, Kasauli. Report cites the company sends the batches to Kassauli for tests, and based on the test reports, the product is transferred to Hyderabad by stock transfer notes. However, the firm failed to maintain a separate raw material register to show the issue of different raw materials used in the manufacturing of vaccines, registers to show the receipt, issue of labels, packing materials used in primary packing etc. and lacks records for labels given to Ooty for the excess quantity manufactured than the batch size. The report also cites the raw material human albumin is not tested for HIV, HbsAg, HCV etc, and it failed to maintain proper data on in process manufacturing methods.
The report says the company sources had maintained that it did not release any batch in 2002, as quality problems caused to reject the product in tests at CDL Kassauli, and the products were destroyed. However, no records were produced to ascertain the claim of destruction.
The report also indirectly indicates the company was suspected of manufacturing human vaccines at its two veterinary vaccine plants in Hyderabad. It notes the officials had seized documents of stock transfer of Abhayarab human vaccine from Jubilee Hills and Rakshapuram plants at Hyderabad, despite official confirmation that the company was manufacturing only anti rabies vaccine (veterinary) in liquid form at Hyderabad. Further, the distribution manager could not give a comprehensive answer or documents for the supply of 50, 000 to 60, 000 vials per batch against the batch size of 9,600 manufactured at Ooty.
When contacted, K.V.Blasubramaniam, managing director, IIL, said that the report was unfortunate and claimed that his firm was not excluded from the tender process. "The Tamil Nadu Government is in the process of reassessing our plant capacity, quality aspects etc. and we have not been officially communicated about the exclusion. A clear picture will emerge only after one or two weeks" maintained the MD. He said some agencies have been consciously trying to tarnish the reputation of the institute and to kill its products, and he would prefer to view the allegations as part of this agenda. "Abhayarab is a high quality product of reputation in the market. The allegations pertaining to our manufacturing capacity of the lypholyzer plant is a highly technical issue and I prefer it to be considered by the experts and judge it" maintained Subramaniam. However he refrained from divulging the production capacity and sales of IIL.