The abrupt suspension of the sale of Abhayrab, the anti rabies vaccine manufactured by Indian Immunologicals Ltd (IIL) on October 29 by the Drug Controller of Kerala may disqualify IIL from bidding for supply of this product in Kerala. With this move, the multinational, Aventis Pharma, which has been the sole supplier of this vaccine to the Kerala government for many years until IIL came into the picture in 2001, would become the only bidder to supply the vaccine to the state government.

The Central Purchase Committee of the state government is likely to ask IIL to hold the scheduled supply of 50,000 doses of Abhayrab to be delivered this month. As per the contract, IIL had already supplied one lakh doses during last 12 months. The vaccine, which is priced at Rs 146 per dose, is indigenously manufactured and is the lowest priced vaccine in the anti-rabies biologicals segment in India.

As far as this new generation anti-rabies vaccine market in Kerala is concerned, there exists a very unhealthy competition between the two brands namely 'Abahyrab' and 'Rabipur'. Rabipur, which is manufactured and marketed by Aventis is currently the market leader in the segment in the country with almost 80 per cent share.

However, since the state government decision is to buy the low cost vaccine for the use in government hospitals, the Central Purchasing Committee has already given the order for two lakh doses of the vaccine to IIL after completing the due tender invitation procedure last year. Since then, IIL has been supplying the vaccine to CPC Kerala at a price of Rs 146 per dose. Aventis participated in the tender an year ago and has been trying hard to persuade the government officials to shift the order to them from IIL.

In August 2002, there was a single case of adverse drug reaction reported after administration of 'Abhayrab' in a district hospital in Kerala. It is yet to be established this was on account of poor quality of the vaccine or due to the poor storage condition in the hospital. However, the product was suspended from the market by the Drug Controller on October 12, 2002. Interestingly, this is the first-ever adverse reaction case reported with Abhayrab in the country.

There are reports from the state that the abrupt decision to suspend the sales of Abhayrab was unfair on the part of Central Purchasing Committee and the Drug Controller's department.

According to Dinar Kumar, product manager, IIL, it is very clear from the reports of the concerned authorities that no defects have been found in the quality of the vaccine. The primary investigation report by the state Drug Controller also states that the vaccine was stored at the room temperature instead of the recommended temperature of 2 to 8 degree C. Interestingly, the company sources wondered that it had not supplied the batch of the vaccine, AYB 90/2001, which is mentioned in the adverse reaction report.

However, reacting to the Pharmabiz query about the alleged favors done by Aventis to the concerned authorities in the State, the Aventis spoke person said "We deeply resent and strongly refute the statement that Aventis Pharma is involved in providing favors to government officials to kill the competitor brand."

The company sources added that Aventis has been the market leader in the rabies vaccine segment for over a decade. Rabipur has proven efficacy, having saved millions of lives. This vaccine has earned the respect of doctors and patients all over the country, not only for its effective and life-saving properties but also because of the Company's relentless public awareness campaign against rabies. Aventis is strongly committed to ethical business practices and has no need to resort to any unethical means for gaining business, they added with no specific mention about its market strategy in Kerala.

While commenting about the sales suspension of the vaccine, D. Gopinathan, drug controller, Kerala, said that the department is waiting for the report from Central Research Institute (RRI), Kasouli. He said that as it is a controversial issue, it is not appropriate to talk about it at this juncture. He, however admitted that in the primary investigation it was found that storage facility at the hospital was poor so that they were keeping the product at the room temperature only. He added that since all the biological products are coming to the market only after the quality clearance from the national testing laboratory, there is hardly any chance for inferior quality vaccines coming into the hospitals.

According to industry sources, the facts like reporting of an adverse reaction of a vaccine after about two months of the incident, the hasty decision to suspend the use of the product and the wide media coverage to the action against the product encouraged by the CPC officials have again raised serious doubts about the intentions of the CPC.