New Delhi: The health ministry has prepared draft rules for umbilical cord blood banking and put them up for public consultation, in India’s first move to regulate the growing business of stem cell banking.
Umbilical cord blood is an important source of stem cells, which have the ability to renew themselves and develop into a range of specialized cell types. Stem cell banks store blood and frozen tissue samples for research and surgery.
A number of domestic and foreign firms have entered stem cell banking in recent years. Stem cells could hold the key to as-yet undiscovered therapies for diseases that are currently incurable. The market size is estimated to be Rs100 crore, growing at 30-40% annually.
“Cord blood stem cell banking was allowed a few years ago. They currently fall under the rules of blood banks, but we needed guidelines separately for them,” a health ministry official said.
“The new rules will be an extension of the existing blood banking rules, but will govern cord blood stem cells,” added the official, who didn’t want to be named.
Currently, India has no laws governing stem cell banking once a laboratory is approved. There are no checks on the condition and temperature at which the cells are stored or transported. If a consumer has a complaint against a stem cell bank, the government has no power to act on it.
The new rules for cord cell banking have been drafted under the Drugs and Cosmetics Act, 1940. They set out to define both cord blood bank as well as umbilical cord blood.
They lay out the requirements for collection, processing, testing, storage and banking and release of stem cells derived from umbilical cord blood. They also specify the norms for transportation of these cells and the requirements for their release.
Another bureaucrat from the ministry said the temperature and longevity of storage of stem cells are quite different from those of blood, making new rules necessary.
“We had tried to regulate cord blood stem cell banking by giving a definition for it. However, we realized that it would not help in regulating it. So, for that purpose we have given out requirements and rules now,” he said. The official also spoke on condition of anonymity.
The move is part of a number of steps the ministry is considering to regulate stem cell banking and research. Its health research department is preparing a biomedical authority Bill to govern issues such as stem cell research, genetic engineering and clinical trials.
The Central Drugs Standard Control Organization and the Indian Council of Medical Research have requested the formation of a panel to study the proposals submitted by firms looking?to set up stem cells banks and conduct stem cell research.
Mint had reported in November that the Drug Controller General of India (DCGI) has proposed to set up an expert committee to study the applications of stem cell banking as well as their characterization, and submit a recommendation to DCGI, based on which the regulator would give approval or a no-objection certificate.
At the moment, only stem cell research that aims to create a drug requires prior approval from DCGI for conducting human clinical trials.
The Indian Council of Medical Research and the department of biotechnology had laid down guidelines for stem cell research and therapy in 2007. But these remain guidelines and not mandatory procedures.