Many of the advertisements are fraudulent and exaggerated claims

Several companies are taking advantage of the lack of laws governing the stem cell segment and advertising their therapies and clinical trials as approved by the Indian Council of Medical Research (ICMR).

White paper

This was stated in a white paper on “Stem Cells: Transforming Global Medicine and Healthcare Industry”, brought out by Yes Bank and the Federation of Asian Biotech Associations (FABA). It was released by former President A.P.J. Abdul Kalam at the inaugural function of a three-day international conference on “Stem Cell and Regenerative Medicine: Research to Business” here on Thursday.

While mentioning about the challenges faced by the stem cell sector, the white paper said “however, given the multi-tiered system of registration and approvals recommended in ICMR's guidelines, some of these are based on fraudulent and exaggerated claims. Further, there are also ethical worries on the side-effect of such treatment,” it noted.

Pointing out that the legislation for this sector was in the draft stage, it said that a regulatory framework governing the sector, instead of guidelines existing at present, is essential for the proper growth of stem cell research and applications in India. There are also no guidelines regarding pricing, which results in certain unproven injections being sold for around Rs.80,000.

It said that with pro-active governmental support and policies, private and public investments and public advocacy, the stem cell industry is poised to grow by leaps and bounds.

Road map

Dr. Kalam, said that an experts group on stem cell area would submit a road map in a month's time for development, production and clinical application of stem cells in the country. “A mission mode operation on stem cell research has been prepared”. He urged the researchers to draw a road map for enhancing the use of cord blood stem cells for treating difficult diseases.

Prof. Stephen Minger, Global Head (R&D) at GE Health Care, expressed concern that world-wide certain unapproved treatments were being offered using stem cells and wanted Indian government to enforce rigorous norms to prevent such practices.

Prof. Mahendra Rao, Head of Centre for Regenerative Medicine at NIH, Bethesda, USA gave the key-note address.

  • The companies are advertising their therapies and clinical trials as approved by ICMR

  • A regulatory framework instead of guidelines is essential for growth of stem cell research