“We don’t do clinical trials, we provide commercial stem-cell therapy,” says an executive of a Pune-based company on the phone when we inquire about participating in one to avail the treatment that its website boldly speaks of. “If you can’t come in person, send us your case study in email and we’ll advise you how many infusions of stem cells your patient would require,” he suggests.
The company’s website says it has provided 1,000 infusions to patients and is a ‘leader’ in stem-cells ‘therapy’. The so-called therapy costs upwards of Rs 2-3 lakh, the executive discloses on persuasion.
This Pune clinic is only one among the many that peddle the unproven stem-cell therapy. They are supposed to enrol patients under a proper clinical trial; instead they get by with merely adding the word ‘experimental’ to their offerings. You won’t find these clinics on the clinical trial registry of the Indian Council of Medical Research (ICMR), where they must enlist.
Now, contrast this liberally-delivered, unregulated treatment with what Stempeutics Research in Bangalore is trying to do. For seven years, the startup, promoted by the Manipal Group and led by chief executive BN Manohar, has been at the bench studying stem cells in its labs in India and Malaysia. With a series of clinical trials, government approvals, 24 patents, 41 journal publications and Rs 125 crore in investment, the company is finally close to launching one of its three—the least regulated one at that—stem cells-based products in 2013.
These two starkly opposite sides of how this new field of regenerative medicine is developing in India point to two problems that could derail the entire thing:
1. Regulatory hurdles that hit the growth of a nascent industry: The science behind it is advancing rapidly and the medical and commercial prospects are so promising that experts fear the regulatory gaps and delays are hurting the level playing field for entrepreneurs and investors who are fleeing to countries like Malaysia and Singapore. (While it takes just 60-90 days to get regulatory clearances in Malaysia, it may take 12-18 months in India.)
Of these, the CLI study is under fast track as the government is also keen to bring such a product to the market. “It’s an open label study so we can see the outcome; I can tell you that we have terrific results,” says Manohar. The final phase of most of these studies will be completed in 2013 and by end 2014 or early 2015, Stempeutics plans to roll out its products.
Srivastava says the question to ask is: Have these claimed successes been medically tested by independent physicians? “Personal testimonies are not scientific data and this distinction needs to be made when reporting these stories,” he says. (Some clinics, like Geeta Shroff’s NuTech Mediworld in Delhi, are beginning to understand this read end part of the story.
“To provide a path for progress with clinical stem-cells research in India during this period when the regulatory agency develops expertise and capacity and single path gets established, the ICMR and DBT, which have funded most of the academic clinical studies, have developed alternate paths for their review and approval based on the existing guidelines,” says Srivastava. The privately sponsored studies also follow a similar path through the DCGI and ICMR.
(This story appears in the 22 February, 2013 issue of Forbes India. To visit our Archives, click here.)
Dear Yogesh, Even blood has cells, why don\'t we ban that as well ? Manohar i liked your article but sale of stem cell is unfortunately not illegal. Check with your lawyers its not unconstitutional. I totally agree that it should be controlled. People without the right background shouldn\'t be permitted. A lot of patients come looking for it.
on Mar 19, 2014Lets wake up from sleep! Guys Mesenchymal stem cells has already got approval in two countries for GVHD and there are hundreds of peer reviewed publications of clinical application of these in prestigious journals. I don\'t know why some people are propagating a lie that there is no evidence at all. Research by Pharma company is focused on only those areas where IPR are available however clinics perform research in all useful areas there by widening the scope of research and clinical application. Its the role of regulators to fine tune regulations in such a way that research happens in both the places in a ethical manner. There is more science behind pharmaceutical products because they pass through a long process of R/D however more variety may be seen at clinic level which may be further leveraged by Pharma companies to make superior quality products
on Nov 6, 2013Due to lack of regulatory framework, there are many clinics and nursing homes mushrooming in our country claiming success in stem cell treatment. This is leading to misconception on stem cell as a subject, its ongoing research and trials. Stem cell products should not be marketed until the results are proved.
on Jul 26, 2013Medical practice is regulated by MCI and there is no need for new regulatory system to be created just for stem cells. At present mass production of stem cell as marketable products are not allowed and only medical practice on case to case basis(individualized to one patient) as per deceleration of Helsinki is allowed. Therefore government should directly regulate stem cell clinics and SHOULD not divert regulation through the route of DCGI making it mandatory for stem cell clinics to develop marketable products. These marketable products will benefit only one company/Clinic and limit participation of medical professionals in diversity thereby preventing innovation on large scale. Product patenting is not allowed for human cells therefore if one company/clinic gets product license from DCGI then other clinics will also manufacture the same product and the company which has invested time and money in new product development will be in losses and all its investors will not get returns. There fore government should directly regulate stem cell clinics and not promote marketable product development as a tool to prevent unethical practices. Direct regulation of stem cell clinics by MCI will be more fruitful in developing countries like India
on Apr 18, 2013A proper regulation of health sector is essential today. Private sector and other private practitioners have the potential to contribute to health sector. They should follow the rules and do what is needed.
on Feb 28, 2013If it is all about making money, then why choose healthcare. we cannot allow a treatment to become a practice just because a person or a firm has invested so much and would loose a lot of money if a product is not taken to the clinic soon. proper compliance of regulations is very important as far as healthcare is concerned. And if there is no regulation then one should WAIT until a regulation is framed and then abide by it. DO NOT POLLUTE HEALTHCARE INDUSTRY....
on Feb 16, 2013What ever the cureent situation, if you have an opportunity to store the Stemcells of your kids.. please do so.. This is the best Lifteime gift ever can be given before the opportunity ceases. Stemcells from a 6 to 7year old\'s milk tooth Dental pulp can be stored for lifetiem... Kudos to the reserchers........
on Feb 15, 2013Stempeutics Research is most awaited treatment for those with degenerating disorders.Already unscrupulous practice is prevailing in many centers. I called up many centres for my son\'s muscular dystrophy clinical trial but all claimed of proven laureate results but none had published literature for back up or personal experience reports of treated patients under the plea of confidentiality. On the contrary I met patients who had undergone the trial claimed of no positive results instead fleeced of the little finances they had accumulated over years. So we need some controlling and regulation for faith to be established.
on Feb 15, 2013Superb article. Kudos for the depth and breadth of issues you\'ve covered. Somebody should send a copy to the health ministry. Ministers come and go but nobody talks about regulating this sector, it\'s going to be $100 billion in two years! As someone who\'s experienced this treatment (in family) I appreciate the concern you are raising. It\'s hit and miss situation today.
on Feb 12, 2013