Pharmabiz.com carried a news-story "TNMSC appoints committee to reassess IIL tender for anti-rabies vaccine" May 28, 2004. In this connection Dinar A Kumar, Marketing Manager, For Human Biologicals Institute wrote to us. We carry here his letter and also our correspondent's response:
We would like to bring the following facts for your kind notice.
1. We are supplying anti rabies vaccine to the Tamil Nadu Govt. through TNMSC for the past 2 years. Till date, we have successfully participated in three tenders based on our price being L1 and on the merits of our bids and supplied the vaccine without any complaints from TNMSC.
2. Our low prices and consistent quality have made the switch over from the unsafe sheep brain vaccine possible by the Govt. of Tamil Nadu.
3. This prompted them to float a large tender in Jan 2004, the one presently in question, for supply of 2 million doses of the tissue culture vaccine. This is the largest such tender floated so far in India by any organisation and is valued approximately at Rs 40 Cr.
4. There were only two bidders, viz Aventis Ltd and Human Biologicals Institute (HBI) who were being technically evaluated.
5. Meanwhile, a fictitious company - Biome Science Company purportedly in Hyderabad - addressed a letter dt. 27 Feb 04 to the TN Drug authorities making allegations of technical nature questioning HBI's production capacity and manufacturing methods.
6. Inspectors of Drug control dept. of Tamil Nadu, carried out investigation at Ooty and Hyderabad plant on 24th and 29th March. Several documents were not seen by them and they thus came to wrong conclusions.
7. Based on such preliminary investigation a report was prepared by them and submitted to TNMSC. Based on this report TNMSC rejected our bid vide letter dt April 2, 2004. It is this letter and its contents, which are being referred to by your correspondent in his article.
8. We wish to present that this letter carries improper information such as that we supplied failed batches nos 85, 86 and 91; that we do not test human albumin for HIV, HbSAg, HCV; that we do not have records of materials used and destruction records; that we manufactured the vaccine in Hyderabad etc., All this is false and we deny the same.
9. In our view, this letter has been released by interested parties in TNMSC, in connivance with our competitors, to tarnish our image due to the subsequent developments presented below.
10. We represented our case to the Govt of Tamil Nadu ( Health Secretary) on 4th April 2004 on the grave injustice done to us by this report.
11. After convening a meeting on 26.04.2004 to hear us along with officials from TNMSC, Drugs Controller of Tamil Nadu and Drugs Controller of Andhra Pradesh, the Health Secretary directed the TNMSC to constitute an 11-member high-level committee comprising of all the concerned authorities and experts in vaccine production, to visit our plant in Ooty and re-assess the case.
12. Accordingly, the committee visited the plant in Ooty on May 26, 2004. We understand that the committee has absolved us of all the negative findings of the earlier report.
Your correspondent has published contents of a biased report leaked by interested parties in TNMSC and without verifying the facts. In fact in his brief telephonic talk with our Managing Director on May 26, your correspondent was told that the contents referred to were misplaced and he was requested to wait till the findings of the Govt Committee are known so that a balanced and fair report can be presented.
This report has done tremendous damage to our reputation and has only furthered the cause of the interested parties in this case.
We wish to also submit that IIL has several firsts to its credit in indigenous development of vaccines required by Indian farmers for animal diseases unique to the country. IIL has an unblemished record of producing quality veterinary vaccines and also due to their affordability, has made the country less dependent on imported vaccines from MNC companies.
Since IIL had expertise in tissue culture vaccines manufactured for the veterinary market, the Govt of India requested IIL to develop a cost effective tissue culture human rabies vaccine in order to help State Governments to phase out the nerve tissue vaccine made from sheep brain and administered to dog bite victims. For this purpose, IIL established Human Biologicals Institute (HBI) in Udhagamandalam (Ooty) in 1998 to manufacture tissue culture rabies vaccine.
HBI is the second institute in the world to develop this vaccine for which technology is difficult to develop. HBI is also planning to introduce other vaccines at affordable prices to the Indian consumer. You are possibly aware that we have developed the world's first DNA rabies vaccine.
This human rabies vaccine made by HBI is sold in the market under the brand name Abhayrab at a price, which is 40% lower, compared to multinational brands. HBI has been supplying this vaccine for over four years now, mainly to Govt establishments .Due to its low price, the state of Tamilnadu has been able to introduce this modern vaccine about two years ago in its hospitals to replace the older sheep brain vaccine.
HBI's entry has challenged the monopoly of its MNCs and HBI did constantly face campaign against its capabilities to displace it from the institutional market. Such campaign has been carried out continuously since the MNC companies did not want to reduce prices to the level of HBI's prices in line with their profit maximization objective.
"Story based on inspection report by officials"
Our Correspondent PB Jayakumar responds:
From the clarification of Human Biologicals Institute (HBI), it is clear that the Institute never contradicted the factual information conveyed by the article. As mentioned in the letter, the story was primarily based on the information related to the inspection report, carried out by the official agencies in Tamil Nadu.
We would like to state that at the time of filing the story, Pharmabiz was in possession of numerous 'documents', which directly accused IIL of manufacturing human vaccines at its veterinary plant. Further, these documents include five to six pages of records on the vaccine manufactured at Ooty since 1999 with details of batch number, CDL clearance number, date, batch size, and quantity released, besides copies of your production certificate and Annexure VI form you had submitted to the officials of TNMSC in your earlier supplies. These are good enough to substantiate the argument.
The documents also include two letters with relevant supporting documents written by one Sanjiv Pal Singh, General Secretary of the All India Vaccine Dealers Association, of Jawahar Nagar, Delhi, to the Drug Controller General of India (DCGI) with the subject 'complaints about Human Biologicals Ltd., dated 12./04/2004, and 1/03/2004, along with the letter from one Biovet and Sciences Company (address: Registered office no: 2-88-109, Daulatabad, Hyderabad, A.P) addressed to the Intelligence wing of the Drug Control Administration, Tamil Nadu, with copies of this letter marked to the Chief Ministers Cell, the Health secretary, Health Minister, Director of Medical Education, Director of Public Health & Preventive Medicine, Dy. Drugs Controller General of India, Drugs Controller General of India, Director General- Drugs Control Administration, A.P. and the Managing Director, TNMSC
We would like to bring to your notice that we are also in possession of another letter from one VAC Point Distributors (address: No.I-5-780, Second Street, Sanath Nagar, Hyderabad - 500 033) demanding a CBI enquiry against IIL based on the above report, and addressed to the Tamilnadu Chief Minister's Cell, Health Minister, State Vigilance Commissioner, DCGI, Director, CDL, Kasauli and Director, CRI, Kasauli.
However, Pharmabiz decided not to mention any details on the information provided by these sources, as our extensive enquiries in Hyderabad, New Delhi and Lucknow had proved these companies could be 'fictitious' as doubted by the HBI letter.
However, we do not find the logic behind IIL never coming forward to neither clarify its stand nor demand legal remedies, despite 'official' letters with 'support documents' (whether fictitious or not) being written regularly for the last few months to all the top level drug control officials in India and decision makers in Tamil Nadu. As per the HBI letter and based on the conversation with the Managing Director, we conclude that IIL was also aware of the happenings.
It may be noted that a PIL petitioner seeking to ban Abhayarab in Kerala, had informed even the High Court of Kerala about banning 'Abhayarab in Tamil Nadu' while the TN Government is yet to pronounce such announcements, according to our knowledge.
Before we carried the story, all these factors were considered and details were discussed with the IIL Managing director during the so-called 'brief telephonic conversations'.
Pharmabiz wishes our story and subsequent clarifications by various involved parties could prompt the authorities and other concerned agencies to probe and expose the ways of unethical competition and marketing methods, if they exist. If it was for other reasons, we hope the story could unearth the interest of the quarters, which consciously try to sabotage the reputation of our leading pharma companies.
We appreciate the move of IIL to clarify its stand to the public, though only after offended by the Pharmabiz story.