Stem Cells Industry: The Battle Within

Fearing that unscrupulous use may hijack this promising field, stakeholders are racing to regulate its applications. Are they swift enough?

Image: Mallikarjun Katakol for Forbes India

Stempeutics Researchs CEO BN Manohar: While we work till science matures, others [stem -cells clinics] are making money from day one

We dont 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 cant come in person, send us your case study in email and well advise you how many infusions of stem cells your patient would require, he suggests.

The companys 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 wont 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 threethe least regulated one at thatstem 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.)

Says Nitin Deshmukh, chief executive of Kotak Private Equity and an executive member of the biotech industry body, ABLE (Association of Biotechnology Led Enterprises) council: Many of our companies are shifting their research and development and IP registration to Malaysia and Singapore. They even want to license outside India. Visibly angry and disappointed, he says he has stopped investing in life sciences companies as they have no future in India. Clinical trial is the bedrock of this industry; if that is not streamlined how will companies progress?

The regulatory gaps and delays in life sciences have come to such a frustrating state that ABLE has sent a representation, rather an SOS, to the government in the new year.

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Stem Cells Industry: The Battle Within