To: The Ministry of Health & Family Welfare, Government of India and all relevant stakeholders.

 

We, the undersigned citizens of India, hereby raise an urgent appeal regarding the ongoing efforts by the Department of Health & Family Welfare (DoHFW), Directorate General of Health Services (DGHS), and Department of Health Research (DHR) to formulate new guidelines for stem cell therapy and regenerative medicine.

 

While we commend the initiative to formalize a well-defined policy for stem cell therapy, significant concerns have arisen regarding the transparency, impartiality, and potential implications of the proposed guidelines. These concerns, if unaddressed, could severely impede access to life-changing therapies for millions of patients and stifle medical innovation in India.

 

Our Key Concerns and Calls to Action: -

 

1.  Lack of Transparency in Committee Constitution and Selection Process:

    The process for constituting the "Steering Group," "Guideline Development Group," and "Systematic Review Teams" remains unclear.

    Details regarding selection process and members of these crucial committees are not publicly available

    The method for including patient group representatives and their selection procedure is opaque.

    Crucially, no public notice was issued for the constitution of these committees, preventing concerned citizens, medical professionals, and experts from participating in this vital policy-making process.

    We demand complete transparency in the constitution and selection of all committees involved in developing these guidelines. All related information and processes must be made public and accessible to every citizen of the nation

 

2.  Unclear Scope and Inappropriate Application of Guidelines:

    The specific purpose of the proposed guidelines is unclear.

    Existing legal and regulatory authorities for Stem Cell Derived Products (SCDP) explicitly exclude therapies (procedures performed by doctors in clinics). The applicability of new guidelines to therapies, given this exclusion, is questionable.

    Applying clinical trial procedures designed for drugs to stem cell therapies and surgical procedures appears impractical and inappropriate. This approach risks creating uneven standards and demanding an impossibly high level of research from individual doctors.

    It appears these guidelines may be selectively applied only to stem cell surgical procedures, while other surgical procedures like bypass surgeries, bone grafts, and skin grafts are exempt.

    We urge the authorities to clarify the scope and applicability of the proposed guidelines, ensuring they are practical, evidence-based, and do not inappropriately apply drug-centric regulatory frameworks to clinical therapies.

 

3.  Apparent Bias and Potential Harm to Patients:

     The opaque manner in which these guidelines are being framed suggests pre-determined conclusions and potential bias.

     There is a strong perception that these guidelines, if enacted, will lead to doctors being forced to stop offering beneficial cell therapies, thereby pushing patients towards expensive Stem Cell Derived Products (SCDPs) manufactured by large pharmaceutical companies.

     This could result in patients suffering without treatment, paying exorbitant amounts for potentially inferior products, or being denied safer procedures using their own cells, effectively stifling medical innovation by Indian doctors.

     It raises concerns that regulatory bodies may be prioritizing pharmaceutical profits over patient interests, even when scientific evidence supports safer and more accessible alternatives.

     We call for an unbiased approach to policy development that prioritizes patient well-being, accessibility to care, and the advancement of medical innovation by Indian doctors. The use of a patient's own cells in an operative setting is often safer and less prone to contamination compared to commercially developed products.

 

 

Our Demands: -

 

In the public interest, we sincerely request that the Directorate Health Research (DHR) and Ministry of Health & Family Welfare to: -

 

1.  ‘Provide clear responses’ to all outstanding questions regarding the proposed guidelines, as previously communicated.

2.  ‘Immediately make public’ all details and activities related to the drafting and preparation of any proposed guidelines, allowing for public input and suggestions.

3.  ‘Grant a comprehensive opportunity for all stakeholders, including real patients and medical professionals, to be heard’ before any further work on the proposed guidelines commences or progresses.

 

We believe that India has the potential to become a "Vishwaguru" (world leader) in stem cell therapy, provided that the right policies are made transparently and impartially. This issue affects the common person and their health problems, and therefore, all related decisions must be made public and accessible.

Kindly Sign this petition to support an impartial, transparent, and patient-centric approach to stem cell therapy regulation in India!

My email ID is "drrajeshjauhri@gmail.com"