Private stem cell majors like Reliance Life Sciences, Tata Institute of Fundamental Research (TIFR), LifeCell and Cryostem Karnataka Pvt Ltd will soon have to apply for licences under the Drugs and Cosmetics Act as India plans to join a handful of countries regulating stem cells.
Currently only the US, Israel, UK, Belgium, Singapore and China have regulations for stem cell research and development. India plans to regulate the umbilical cord blood collection and harvesting centres across the country.
Reliance Life and TIFR are among the dozen-odd global organisations recognised by the National Institute of Health (NIH) of the US which are eligible for federal government funding on embryonic stem cell research.
The ministry has proposed an amendment in the Drugs and Cosmetics rules to introduce standards for collection of such samples. Sources in Reliance Life Sciences and LifeCell said the move would help the sector grow both within and outside the country. Even as the two companies are approved by the USFDA, the licence from the Central government here would help them apply for Netcord (an international association active in stem cell research) membership.
The three companies have about 5,000 cord blood samples. LifeCell has about 4,000 samples and the rest 1,000 are shared between Reliance Life Sciences and Cryostem Karnataka separately.