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Awaiting approval: Pradeep Seth waited formore than two years for the go-ahead from thegovernment for phase I trials of his HIV vaccine.P

radeep Seth has given up. For nearlytwo years, Seth, a microbiologist atthe prestigious All India Institute ofMedical Sciences (AIIMS) in New

Delhi, has been awaiting word on his HIVvaccine candidate from the health ministry.

Seth’s vaccine research was funded by theDepartment of Biotechnology (DBT), part ofthe science ministry. He published his work inpeer-reviewed journals and received positivefeedback from several evaluation committees.In March 2003, the DBT gave him the greenlight to form a partnership with an Indiancompany and manufacture the vaccine forphase I human trials.

Everything went according to plan. A com-mittee at the AIIMS helped Seth select anindustrial partner and write a licence agree-ment. The institute’s legal and financial depart-ments approved the agreement. Then, inDecember 2003, an over-cautious AIIMSdirector sought additional approval for theagreement from the health ministry. Seth hasbeen waiting for that approval ever since.

The quality of the potential vaccine does notseem to be the problem. The healthy ministryformed a committee to review the vaccine inDecember 2003. But before it made a decision,India headed for national polls, and a new government took charge in May 2004. “It was

back to square one,” says Seth. A new commit-tee then recommended in November 2004that trials on the vaccine should proceed with-out further delay. Then the health secretary,who had to okay the licence agreement,retired. “Again back to square one,” says Seth.Finally, a third committee reviewed the vac-cine in February 2005. This committee, led byNirmal Kumar Ganguly, director-general ofthe Indian Council of Medical Research(ICMR) — the research arm of the health min-istry — recommended on 29 March 2005 thatthe trials should proceed. By then Seth hadalmost retired.

Lack of coordinationSeth’s story is well-known in Indian academiccircles. Some say the story is a tragicomic caseof classic Indian bureaucracy. But others saythe events are no accident. Seth’s vaccine didnot fare well because of a deep-seated rivalrybetween the DBT, which funded his research,and the ICMR, they say. “Most DBT-fundedprojects in the AIIMS have met a similar fate,”says Seth.

There are several branches of governmentthat fund biomedical research, but moneycomes primarily from the health ministry,which finances research through the ICMR,and the science ministry, which oversees the

DBT, the Department ofScience and Technologyand the Council of Sci-entific and IndustrialResearch (see graph).

Each agency has — oris at least supposed tohave — a well definedrole. For example, theDepartment of Scienceand Technology looksafter basic research; theDBT focuses on thedevelopment of biotech-nology products andprocesses; and the

ICMR funds projects in epidemiology andclinical research.

In theory, the health and science ministrieswould coordinate research. “In practice, how-ever, overlaps do take place,” says MartandaSankaran Valiathan, former president of theIndian National Science Academy.

These glitches occur despite representativesfrom funding agencies sitting on each other’scommittees and asking applicants to notewhether they receive funds from elsewhere.

Some projects can be neatly classified asbasic or clinical, but increasingly there aremany projects that are ‘applied’. Stem-cellresearch falls squarely into this hazy overlap.

No single government agency in India hasbeen assigned responsibility to licence ormonitor stem-cell work. As a result, the DBTand the ICMR each issued guidelines — theDBT in 2001 and the ICMR in 2002 — with-out consulting each other. The result was aplethora of public- and private-funded insti-tutes that joined the stem-cell bandwagon.

Researchers at Nutech Mediworld, a privateclinic in Delhi, say they have used stem cells tosuccessfully treat paralysis in 24 patients sinceMay 2003; their work is as yet unpublished. P. Venugopal, a surgeon at the All India Insti-tute of Medical Sciences in Delhi has usedbone-marrow derived stem cells to repair dam-aged heart muscles (see Nature 434, 259; 2005).And the L. V. Prasad Eye Institute in Hyder-abad has since 2001 used limbal stem cells torepair damaged corneas in 260 patients (V. S.Sangwan et al. Biosci. Rep. 23, 169–174; 2005).

The competition between the DBT and theICMR in particular has been the focus ofmuch discussion among researchers. “Greatercollaboration between agencies is a criticalissue,” says secretary of the DBT Maharaj Kishan Bhan. “Our research efforts are gettingfragmented because of this lack of coordina-

Rivalry andred tapeResearchers are suffering as a resultof the conflicts between fundingagencies. T. V. Padma uncoversplans to heal the rift.

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To outsiders, VijaylakshmiRavindranath’s story might seema resounding success. In 2000,she was appointed director of thenascent National Brain ResearchCentre in Manesar, on theoutskirts of New Delhi.

But her achievement did notcome easily. When Ravindranathwas a postdoc at the US NationalInstitutes of Health, her husband,also a scientist, remained in India.She initially took her two-year-oldson with her, but, unable to arrangefor his care when she was in thelab, she sent him to be looked afterby her parents. “I had to be awayduring two critical years of myson’s childhood,” she recalls.

Twenty years later, she was onceagain faced with a difficult choice.The offer to head the new centrewas a rare opportunity, but itmeant a five-year separation fromher husband and son. “Had myhusband and son not cooperated,it would have been impossible,”she says.

Ravindranath is one of the lucky few. Unable to juggleprofessional and domesticdemands, and sometimes copingwith nepotism and sexualharassment, most Indian womenscientists give up early in theircareers. According to a 2004report of the Indian NationalScience Academy (INSA), only

nine of 398 Shanti SwarupBhatnagar awards, India’s highesthonour for science, went towomen.Within the INSA, womenhave won only 14 of theacademy’s 502 awards andmedals, and no woman has everled the academy.

Like their counterpartsworldwide, Indian womenscientists fare better in biologythan in engineering or physics. In2000, women accounted for 32%of medical students, comparedwith 16% in engineering. But, aselsewhere, there is a steep drop-offin women at graduate level. Manyof those who continue opt for acareer in medicine or teaching,rather than research, says ManjuSharma, former secretary of theDepartment of Biotechnology

and co-chair of an internationaladvisory panel on womenscientists.

Apart from the usual factors,such as marriage and lack ofadequate childcare, Indian womenalso have to endure the country’sstaunch patriarchal culture. Manycomplain that male colleagues do not treat them as peers andoften assign them to receptioncommittees or to choosing menusfor conferences.

Women also face considerablebias in the interview process, saysSharma, who has served on theinterview committees of severalnational institutes. “I have noticeda tendency to ignore the excellentcareer records of womenscientists when it comes toselecting top positions,” she says.

The government is beginning to take action. In 2003, theDepartment of Science andTechnology initiated a scheme tooffer fellowships to women whosecareers were interrupted by theirhusbands’ geographical moves.More than half of the 2,000applicants were from life sciences.

Women scientists particularlyneed assistance when they arestruggling to balance their earlycareer with a growing family, saysRavindranath. “If the woman cantide over the period of marriageand child rearing, a critical mass ofwomen scientists can develop inbiology,” she says. “Today, my son and husband are among theproudest and happiest about my success.”T. V. Padma

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tion.” If the different departments workedtogether, they could avoid duplication andsave enormous resources, Bhan says. “Rightnow all agencies work subcritically.”

Bhan, who has led the DBT since 2004, andGanguly both say they are taking steps to putan end to the famous rivalry.After much dis-cussion, the two agencies have agreed to meetin June 2005 to combine the two sets of guide-lines. They are also jointly drafting a nationalstem-cell initiative and plan to work togetheron HIV vaccines and microbicides.

A waiting gameAnother area of researchers’ lives that couldbe improved is that of paperwork. For exam-ple, to get a grant approved, Indian scientistshave to be prepared to wait for more than a

Vijaylakshmi Ravindranath is one of the very few high-achieving women scientists in India. She is thedirector of the National Brain Research Centre, near New Delhi, but she could not have reached this positionwithout the support of her husband and son.

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year while their application is processed, andmonths more to get the money after approval.The funds go to the institution and not to theinvestigator, so additional delays occur duringthe transfer of money to the researcher.

Researchers have to submit nearly 30copies of their proposal to funding agenciessuch as the ICMR. So cumbersome is the redtape that in January 2005, at the opening ofthe science congress in Ahmedabad, primeminister Manmohan Singh lamented the“tyranny of bureaucracy” in Indian agencies.He went on to ask whether India has “allowedbureaucratic systems and patron–client rela-tionships to stifle creativity” and “scare away”young researchers.

“Most of the red tape is due to the fact thatthere are no serious consequences for incom-

petence,” says Sandip Basu, director ofNational Institute of Immunology in Delhi. “Itis not easy to take severe disciplinary action,and all jobs are until retirement,” he says.

Some delays are entirely avoidable, Basuadds. These are the ones agency chiefs arecommitted to cutting down. Some researchersare reporting that recently submitted proposalsto the Department of Science and Technologyand the Council of Scientific and IndustrialResearch cleared in six months. What’s more,the process required only two hard copies: therest was handled through e-mail.

But this may have all come too late for Sethwhose last working day was 30 April. “I amthrough with it,” Seth says. ■

T. V. Padma is a freelance writer based in New Delhi.

A TOUGHJOURNEY

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