The latest report of the Comptroller and Auditor General (CAG) of India has found fault with the Department of Biotechnology for completely failing to develop vaccines for Contraception. The apex body observed that the multi-centric study failed to achieve the ultimate objectives of developing female and male vaccines (âhCG, oFSH & Anti-VCP/RCP) even after incurring an expenditure of Rs 13.78 crore during 1987-2001.

Since April 1987, DBT had been supporting the project "Immunological Approaches to Fertility control in Mission Mode". The project aimed at development of an anti-fertility vaccine for females based on Beta Human Chorionic Gonadotrophin (âhCG), development of an anti-fertility vaccine for males based on Ovine Folllicle Stimulating Harmone (oFSH) and development of an anti-fertility vaccine for females based on Anti-Vitamin Carrier Proteins & Anti-Riboflavin Carrier Protein (Anti-VCP & Anti-RCP).

In its previous report (Paragraph 3.1 of Report No.6 of 1994) CAG had mentioned about the non-achievement of the project objectives within the stipulated date. The DBT in reply to the Public Accounts Committee in 1994-95, stated that âhCG (Female anti-fertility vaccine) would be ready for large scale clinical trials (Phase III) by the end of the Eighth Plan period. It also stated that the position regarding oFSH (Male vaccine) would be clear after the Sub Committee Report and that human trials for Anti Vitamin Carrier Protein Vaccine, might begin by the end of the Eighth Plan period.

In December 1997, DBT sanctioned the Second Phase of the project "Development of Vaccines for contraception", a multi centric study at a cost of Rs 230.74 lakh for a period of 3 years. The project was extended upto June 2002 at three centres at the Indian Institute of Science, Bangalore, the Institute for Research in Reproduction, Mumbai, the Post Graduate Institute of Medical Education and Research, Chandigarh and upto December 2002 at the National Institute of Immunology, New Delhi. An amount of Rs 147.86 lakh was spent till March 2001 (UC for 2001-02 awaited) under the second Phase, in addition to Rs 1230.50 lakh spent under the first Phase.

DBT stated in November 2002, that (i) âhCG had completed Phase II human clinical trials but without enhanced and sustained immune response, the candidate vaccine cannot be tried further on humans, (ii) oFSH had completed Phase I human clinical trials, but the vaccine was found to interfere with the hormonal parameters of men and could cause mutagenic changes. It was, therefore, discontinued for its probable social unacceptability and (iii) anti-RCP vaccine would have to adopt all newer molecular approaches to take care of all basic queries that emerged and were experienced with âhCG and oFSH.

"In November 2002, DBT stated that while the three vaccines could not be successfully delivered, the Indian efforts were recognised to be the most advanced contraceptive efforts in the world" CAG has observed.

The report also revealed several instances of non-achievement of objectives, overlapping of project sanctions and non-utilisation of technologies in many of DBT sponsored projects over the years. According to the report, eight out of the ten technologies developed from DBT supported projects are currently not in commercial use while the status of one technology was not available with DBT.

Though DBT transferred 24 technologies through Implementing Agencies NRDC/BCIL between 1996 and 2001, it could make available the information only for 18 technologies. It was seen that none of these technologies except two had reached the commercial stage as yet, the report noted.

The Review 2003 focuses on the funding of projects under DBTs various Task Forces including planning, monitoring, implementation, achievements and end use of technologies developed during the period 1996-2002.