Indian Council of Medical Research

Ministry of Health & Family Welfare

Department of Health Research

Minutes of the 2nd Inter-Ministerial / Inter-Agency Meeting to Discuss the Strategy to Regulate the Rampant Practices of Banking and Use of Stem Cells for Therapeutic Purposes

At

ICMR Hqrs, New Delhi on 5th September, 2016 at 2:30 PM

Members:

Dr. Soumya Swaminathan, Secretary DHR and DG, ICMR                      Chairperson

Dr. G.N. Singh, DCGI, CDSCO

Dr. Anil Kumar, DG, RHS

Dr. K.K. Agarwal, General Secretary and President Elect, IMA

Dr. V.G. Somani, Joint DCGI, CDSCO

Dr. A. Ramkishan, DDC, CDSCO

Mr. Shiv Kumar, ADC, CDSCO

ICMR Secretariat

Dr. Vijay Kumar, Scientist G and Head, Division of BMS

Dr. Geeta Jotwani, Scientist E

President MCI, DGHS and Secretary, Health MoHFW could not attend due to prior commitments.

Welcome and Introductory Session

The meeting started with a warm welcome by Dr. Soumya Swaminathan, Secretary, DHR & Director General, ICMR to all members. She apprised the members regarding the alarming commercialisation of unproven treatments using stem cells and cell based products. A strategy to curb such practices was stressed upon. It was further informed that, based on the recommendation of the 1st meeting,  the present meeting was being organised to have one –to-one dialogue with the concerned agencies so as to take urgent steps to stop the indiscriminate transplantation of stem cells.

With these remarks, Dr. Swaminathan invited Dr. Geeta Jotwani to present the overview of the issues and concerns in the field. The presentation showcased the screen shots of the websites of various clinics/ hospitals/ stem cell banks openly advertising and luring patient into unproven stem cell therapies. The plights of the patients who had availed such treatments but failed to see any improvement was also displayed through their blogs which highlighted the exploitation of patients. The possible solutions for the concerns and issues were also presented. The agenda of the meeting was discussed item wise and discussion is summarised below.

Discussion:

1. The role of MCI in prevention of abuse of stem cells and promotion of ethical clinical research was discussed. It was informed that despite several invitations, MCI President or its representative fail to attend the meeting making it difficult to strategies the actions that can be taken against erring clinicians. Dr. Agarwal thoughtfully took upon himself that the task of requesting the MCI to nominate a member to be present in future meetings.
2. Dr. Singh stressed upon clear definitions of all the terms including stem cells, stem cell research, therapy, products, academic trial vs regulatory trial, trial requirements etc. which can then be incorporated into the proposed new bill on Drug and Cosmetic Act.  This will help to completely demarcate the areas that fall under the purview of ICMR and CDSCO. Moreover as the definitions will be framed by the expert groups in the field, the government agencies will not be questioned on the legitimacy of incorporating them in the proposed bill. Dr.  Agarwal opined to include MCI recognised medical colleges amongst those institutions that can do academic trials.
3. Dr. Agarwal proposed to create a white paper on the prevalent practices in the field that can be jointly prepared by ICMR and IMA in view of the Hon’ble Supreme Court’s ruling on prevalent practices in medicine.
4. It was also suggested to create a mapping network of all those involved in stem cell transplant. In addition, registry of all stem cell transplants was also proposed in order to monitor the clinical use of stem cells across the country.
5. Creating awareness amongst all the stakeholders and especially the general public was considered as important aspect by Dr. Swaminatahn. It was suggested to write articles in press and e-media for lay man. For making clinicians aware on the rightful use of innovative technologies and the relevant government policies, Dr. Swaminnathan further suggested creating awareness modules and using the IMA webcast platform which has an outreach to almost 5,000 doctors per session, to further the cause.
6. The procedure to file complaint against the doctors offering unproven stem cell therapies was discussed. Dr. Agarwal informed that only written complaints, and not emails are accepted and they have to be filed with the state MCI. He also recommended copying the complaints to the IMA grievance cell. He stated that self regulation in the medical practices is IMA’s mandate and necessary action will be taken by IMA in coordination with MCI.
7. Regarding banking of tissues other than umbilical cord blood (UCB), Dr. Somani referred to the National Guidelines for Stem Cell Research -2013 and stated that the various tissues as sources of stem cells other than UCB have been mentioned in these guidelines. Thus banking of these tissues other than UCB cannot be prevented. The matter of several cord blood banks operating without the license of the CDSCO, as indicated from the website of these banks on the internet, was also discussed.
8. The harmonization of all the existing guidelines, rules and acts were discussed. It was informed that a new bill on Drug and Cosmetic Act is being drafted and the suggestions/ recommendations made in the meeting can be incorporated in the proposed document.

Based on the discussions above, following recommendations were made:  

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