In the second week of April, a clutch of Asian countries met in Japan to discuss regenerative medicine or the use of stem cell-based products for treatment. The meeting saw regulatory as well as industry participation from Japan, China, Taiwan, Singapore and India, with the objective of harmonising the regulatory framework between countries to facilitate quicker access to breakthrough drugs for patients.

Closer home, April also saw the Union Health Ministry come out with a draft notification clarifying the definition of stem cells or cell-based products as drugs. It would be classified a drug if the cells were processed, altered or put through “more than minimum manipulation” to make it a product for treatment, the note said. Though stem cell-based products are already under the Indian drug regulator’s watch, the recent draft was to bring in greater clarity, explains the Drug Controller General of India (DCGI), S Eswara Reddy, hoping that more companies develop such products as the regulatory pathway becomes well defined.

And the clarity has come not a day too soon. Ambiguity of any sort needs to be plugged, as stem cells are seen as a “miracle” treatment of sorts. And there are people who operate in the regulatory grey zone to exploit desperate patients seeking treatment where all others have failed.

Spell it out clearly

Dr Vasantha Muthuswamy, Chairperson with the Ethics Advisory Committee of the Indian Council of Medical Research’s Bioethics Cell, agrees on the need to clearly define that stem cell-based new drugs require DCGI approval. But it is also necessary to state explicitly that all other research using stem cells needs to abide by the ICMR’s existing national guidelines, she says, adding that any room for interpretation could be exploited.

The reference here is to the draft notification’s exclusion of human cells taken from a patient and used in the same person in a surgical procedure in a hospital. If these cells were used without processing of any kind, it did not require a drug regulator’s approval, the draft indicates, without stating that the process still needed to adhere to ICMR guidelines, she observes.

Stem cells are unique “unspecified” cells sourced from the body and coaxed into a non-functioning part of the body to help regenerate fresh cells. Once stem cells are introduced into a damaged organ, for instance, they play the part or start behaving like cells in the organ, thereby helping with the repair. “Doctors routinely use stem cells that come from bone marrow or blood in transplant procedures to treat patients with cancer and disorders of the blood and immune system,” the United States Food and Drug Administration had said last year, cautioning patients from taking unregulated “miracle therapies” hawked by “unscrupulous” providers.

BN Manohar, Chief Executive of Stempeutics, understands the importance of having clear regulations, in line with globally accepted practices. Having ventured into this space almost 10 years ago in India, Stempeutics is now in the advanced stages of clinical trials on two prospective products to treat Osteoarthritis and Critical Limb Ischemia (a progressive disease that affects blood flow in the lower extremities, feet and toes), respectively.

Recalling the early struggle when rules were still being formulated in this segment, he says the challenge now is in making these products more affordable.

No more tall claims

Stem cell banking company LifeCell recently forayed into stem cell-based products. As the regulatory pathway becomes clear, Managing Director and Chief Executive Mayur Abhaya says the company has invested in a new facility to make Mesenchymal stem cells that have the potential to make bone cartilage, muscle and adipose tissue, etc. And these could one day be off-the-shelf products.

Patients have, in the past, spent lakhs of rupees on stem cell therapies and products without being sure if it worked or without knowing if the product sourcing was authentic, he says.

Last year, the USFDA cracked down on illegal clinics. And now the DCGI’s notification will ensure that products cannot make unsubstantiated claims, he says, urging patients to always check if the stem cell-based miracle cure being hard-sold to them is approved by regulatory authorities or not.