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C.R. Sukumar

HYDERABAD, Nov. 11

INTERVENING in the `unhealthy' corporate war between the two Andhra Pradesh-based Hepatitis-B vaccine manufacturers, triggered by the tenders floated by the AP Government for the $25-million vaccination project being funded by the Bill & Melinda Gates Foundation, the AP High Court has directed the State Government to alter the conditions stipulated for the tenders.

The issue assumes significance in view of visit of Mr Bill Gates, Chief of the Bill & Melinda Gates Foundation, to Hyderabad on Thursday and participate in the immunisation programme for the 1.6-million children born in the State.

The court was moved by one of the Hepatitis-B manufacturers - Bharat Biotech International Ltd (BBIL), which alleged that the conditions specified for the tenders announced by the AP Health & Medical Housing & Infrastructure Development Corporation for procuring the vaccine supplies were `arbitrary and whimsical'.

In its advertisement in a local daily here on October 30 for procuring the supplies of Hepatitis-B vaccine, the Corporation invited tenders from primary manufacturers in the country with "WHO (World Health Organisation) pre-qualification only."

Alleging that the condition specified for participating in the tenders were tailor-made to suit only one primary manufacturer of Hepatitis-B vaccine in the entire country, BBIL submitted to the court that the Hyderabad-based Shanta Biotechnics was the only company with WHO pre-qualification out of five primary manufacturers of the vaccine in the country, besides six Indian companies with multinational parentage that import and market the vaccine with necessary statutory approvals. The primary manufacturers include Wockhardt, Panacea Biotec, Serum Institute of India, Shanta Biotechnics and Bharat Biotech. The companies that are importing the vaccine and marketing them locally include Glaxo, Cadila, Vh Bhagath and LG. For releasing a vaccine into the Indian market, a company is required to get each batch of its product tested and approved by the Central Research Institute located at Kasauli in Himachal Pradesh. Interestingly, while none of the Indian players mentioned had the WHO pre-qualification for Hepatitis-B vaccine till last year, Shanta Biotechnics received the WHO pre-qualification recently. BBIL has its manufacturing and research facilities in the Genome Valley here, which were recognised by various institutions both within the country and overseas. The company holds Good Manufacturing Practices (GMP) certificate issued by the National Regulatory Authority as per the guidelines issued by the WHO.

Bharat Biotech submitted to the court that WHO pre-qualification certificate was specifically intended for the supplies to be made to UNICEF requirements and that the certificate was meant essentially for the countries where there were no manufacturing and testing facilities. The company also brought to the notice of the court that even UNICEF did not ask for WHO pre-qualification in its tenders for Hepatitis-B last year. The UNICEF tender had asked for certification of Indian Pharmacopoeia (IP) and GMP, it contended. Arguing that the WHO pre-qualification condition had no rationale and was imposed arbitrarily only to suit and benefit the chosen bidder of the Corporation, BBIL urged the court to pass suitable orders.Responding to this, the AP High Court directed the Corporation to process the tender schedule of the petitioner (BBIL) without insisting for the WHO pre-qualification certificate.

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