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India tightens regulations on stem cell research

Wednesday, March 3, 2010, 9:13 This news item was posted in Biotech category and has 0 Comments so far.

Government of India has drawn up a plan to effectively review and monitor the way stem cell research being conducted in the country, according to reports.

An effective surveillance on the highly complex stem cell research is yet to be in practice in India even though the country has already worked out the fundamental guidelines for stem cell research more than two years ago.

Indian Council for Medical Research (ICMR) – the apex body regulating medical research in India –and the Department of Biotechnology (DBT) under the ministry of science and technology, government of India announced the guidelines for stem cell research  and therapy way back in 2007.

These guidelines were set aside due to the absence of laws specific to the issue. Government bodies need to spell out clear cut procedures for storing stem cells.

India is yet to formulate norms for stem cell banking and storage procedures.Stem cell banking in India is yet to come under a regulatory framework.

Though the ministry has initialized the process, certain technical hitches the occurred midway made it lag for long, sources said.

Now that the health ministry has come forth with a renewed vigour, a National Apex Committee for Stem Cell Research to prescribe stringent procedures for souring and use of stem cells by research institutions in the country could soon be reality.

NAC, comprised of experts from various fields, will be responsible for examining the scientific, technical, ethical, legal and social issues in the area of stem cell based research and therapy.

The NAC will have around 10 members.A chairman, a deputy chairman, member secretary and nominees from DBT, DST, CSIR, ICMR, DCGI, DAE, and biomedical experts from pharmacology, immunology, cell biology, haematology, genetics, developmental biology, clinical medicine and nursing.

Legal expert, social scientist, and a women’s representative will also be part of NAC.NAC could also  consult outside experts on a case to case basis.

Institutions involved in stem cell research and therapy will have to be registered with the NAC through Institutional Committee for Stem Cell Research and Therapy (IC-SCRT).

NAC will set standards for procedures for collection, processing, differentiation, preservation and storage of human tissues to their assure quality and sterility.

There are over three dozen research institutes, hospitals, and firms involved in stem cell research in India.

These sites include large public hospitals such as the All India Institute of Medical Sciences (AIIMS) and private firms such as LifeCell in Chennai, and research institutes such as the National Centre for Cell Sciences (NCCS) in Pune.

Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Bangalore studies the fundamental issues in stem cell applications into cardiovascular cells.

NCCS has conducted animal and preclinical analyses of bone marrow stem cell injections for pancreatic regeneration.

Christian Medical College and Hospital (CMC) in Vellore has a centre for stem cell research in collaboration with DBT.

Sankara Nethralaya also has a facility for stem cell research which focuses on corneal stem cells, cancer stem cells, and the use of stem cells in tissue engineering.

Stempeutics Research, a biotechnology company developing stem cell based medicinal products, is reportedly in the process launch its investigational new drug (IND) for acute myocardial infarction and critical limb ischemia in India by 2012.

Drug Controller General of India and ICMR have given approvals for Stempeutics to conduct  clinical trials using allogenic mesenchymal stem cells from the bone marrow.

Stempeutics’ is considered the first DCGI and ICMR approved clinical trial using adult allogenic mesenchymal stem cells from the bone marrow.

Most stem cell research companies in India depend on umbilical cord blood banking as their primary source.

LifeCell of Chennai, CryoStemCell of Bangalore, and Reliance Life Sciences of Mumbai have umbilical cord blood banking facilities.

Reliance Life Sciences is also learnt to be engaged in developing cell-based therapies to address neural, cardiac and metabolic disorders.

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