India has seen tremendous growth in stem cell business in the recent past. Stem cell therapies hold a great promise for improving human health by supporting and curing several ailments. However the industry is still at a nascent stage in India when compared to the west.
ICMR and the Department of Biotechnology (DBT) had laid down the fundamental guidelines for stem cell research and therapy way back in 2007. However in the absence of laws specific to the issue, the guidelines was set aside. Apparently we are yet to formulate norms for stem cell banking and storage procedures. Stem cell banking in India is yet to come under a regulatory framework where government bodies need to spell out clear cut procedures for storing stem cells. As a first step, senior officials at the ministry of health and family welfare need to lay the process together with the help of an expert committee for stem cell banks and therapy.
As of today there are no checks on the conditions and temperature in 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 the same. It’s imperative for any government to form a body with an expert committee to study the application of stem cell banking as also their characterization and indication and recommend suitable parameters based on which the regulator would give their guidelines.
Awareness on the stem cell banking and therapy in our country has been relatively low when compared to the west. Although this industry is about six years old in India, we are yet to put the regulation in place. Initially the government with the help of ICMR set the procedure for stem cell banking in accordance with the blood bank norms and all stem cell companies were actually laid under the broad spectrum of blood bank category. Many of the European countries do follow the same category. The government formulated the draft norms about three years ago and this is still in the draft condition. In the current scenario, the government will need to take initiative to redraft the norms to suit the requirements of the stem cell storage system as per the global standards. This draft should cover all important areas in the stem cell industry such as the collection of cord blood, processing and storage. It is important that the regulation is implemented and rigorously followed to suit the Indian medical norms.
Most of the European countries have stringent norms and procedures. In Europe, the stem cell regulations are made in the lines of a blood bank and in few other countries they are made in the lines of sterile drug manufacturing following cGMP practices. Indian Government should create regulations as per cGMP requirements. This will enable the government to standardize regulations across the board. More than regulations, it’s imperative to have regular inspections by external sources to monitor the quality of the stem cell banking companies and their storage facilities.
There should also be a higher body above the licensing authority who will then offer the accreditations to all facilities. We need to integrate a clause where without this accreditation, companies cannot execute their functions. This makes it easy for licensing authorities to monitor the quality of the company.
The training of the licensing authority should be in accordance with international standards. This should be done in line with American association of blood bank. This US body recruits and trains assessors from all over the world to evaluate the storage facilities and procedures followed in the lab. The same methodology requires to be followed as it ensures that we have a good team of external and as well as internal assessors.
Government participation is vital for a country like ours for creating awareness about the stem cell banking in India. It is crucial in this case as a country we have close to 25 million births every year. If we can get our act together and create a regulation with active Government participation along with the private companies, we can actually have several samples in our registry (created for public banking) and can outsource stem cells for curing several diseases.
Government has been successful in creating awareness on eradicating or controlling chronic ailments like polio, HIV, TB and several other ailments in the past. Similar exercise should be done by the government to create awareness for stem cells banking and the benefits that one could obtain in the long run.
Government can actually think of creating a public bank in each state with the help of the existing infrastructure of private companies and make samples available for own public and the world consumption from these public banks. If this can be achieved over the years, what we see in IT industry can be replicated in the medical world as this could also become a source for generating revenue for the Government. This will also help in the growth of medical tourism in the next few years. Research in stem cells will be the key area of focus for our drug manufacturing companies.
US has now made it mandatory in three of its states that storage of stem cells is a must. In the Indian context, government participation holds the key for creating greater awareness about the stem cell industry.
- The author is MD of Cryo Save India