With govt aid, stem cell banks seek to strike the right chord

Written by Shreya Roy | Shreya Roy | Updated: Oct 31 2011, 09:05am hrs
Indian stem cell banking, which has thus far failed to strike a chord with the public, is seeking the governments help in getting its message across. With penetration languishing at 0.01% of the newborn population, stem cell banks that have come up over the past few years are hoping that the state will introduce Acts for mandatory education on cord blood banking for expecting parents, and help bring stem cell therapies under health insurance. The Association of Biotech Enabled Enterprises (ABLE), a lobby group for the biotech industry, is planning to create a formal focus group to boost the sector by the year end.

These banks store stem cells of individuals for future regenerative therapies. India is lagging in the penetration of stem cell storage, at one out of every 1,000 newborns against 20 out of 1,000 newborns in Europe. In the US, 4% of all newborns have stem cells stored. Cumulatively, India saves close to 35,000 samples a year, while other Asian countries, such as China, save close to 1,00,000 samples every year.

Companies believe that though they spend anywhere close to 20% of revenues on awareness, there has to be a policy-level intervention for the word to really spread in India.

Majority of the states in the US have adopted the law of mandatory information about stem cell banking. A gynecologist has to educate expecting parents of all options available in this field, after which, they can take an informed decision about storing the newborns chord blood cells. We are hoping that the government will introduce something similar here, said Rajesh Sharma, CEO of Netherlands-headquartered Cryo-Save India. Awareness at the moment, even among the medical fraternity, is very low, he adds. A study conducted by the company earlier this month showed that 61% of expecting parents surveyed across eight major cities in India were unaware of stem cell banking.

There is also a belief that the sector will benefit from government's help in building awareness through campaigns and in increasing the number of chord blood units available. In 2005, the US government had spent close to $80 million to increase the number of cord blood units. Besides education, the industry is looking at the possibility of having stem cell therapies treated as a medical expenditure, which will allow people to get tax benefits out of it. Individual companies are also in talks with insurance providers to have it covered under the ambit of health insurance.

We are looking for more support from the government, more perspective on insurance, the possibility of having stem cell therapies treated as a medical expense and consequently a tax benefit, says Mayur Abhaya, executive director of LifeCell International. The Chennai-based bank currently has 40,000 samples.

The industry, currently estimated at R175-200 crore and growing at the rate of 30-40%, has seen a lot of interest from international stem cell companies, such as Cryo-Save, and Singapore-based CordLife Sciences. While Cryo-Save has invested close to 2 million euros in its India operations, Cordlife had earmarked an investment of close to R17 crore in India last year for expansion in metros and Tier-I cities. Domestic majors, such as Reliance Life ScienceRelicord and LifeCell International, have also made investments. However, over the past six months, says Sharma from Cryo-Save, banking has remained almost stagnant.

Stem cell research in the country has also been taking a beating due to regulatory issues. Those that are done with grants from the government, in particular, are suffering as a result of the lengthy processing period and intellectual property issues.

If you are waiting for a DBI grant, it is a 12-18 month process, with facility approvals, technical audit, financial audits and various other such procedures. In other countries, Malaysia for instance, it is a 2-3-month process. Here, the government also either wants to own or co-own IP. None of this is good for the industry, says BN Manohar, CEO of Stempeutics Research, a stem cell research organisation.The government is looking into these aspects, he adds.

In June last year, the health ministry had put up draft rules for umbilical cord blood banking for public consultation. It had also approved an 11-member committee to look at therapies related to stem cells and genes as well. However, the guideline draft on stem cell banking tabled in 2007 is yet to take the shape of a law. Forming the ABLE focus group may be a way to push for faster implementations.

Despite the challenge of convincing people about the viability of spending anywhere between R60,000 and R1,50,000 cumulatively to store stem cells for a period of 21 years, companies believe that Indias growth story will apply just as well to this industry as it has to others. An estimate says that with its current growth rate and a birth rate of 26 million a year, companies operating in India will store over 100,000 cord samples by 2012.

At the moment, 2,000-2,500 samples are being collected in India every month, which is nowhere by international standards. However, considering the population growth rate, we do believe the potential is enormous, says CordLife Sciences India MD Megnath Roy Chowdhury.