The Indian Council of Medical Research has objected to amendments proposed by the Ministry of Health and Family Welfare to the Drugs and Cosmetics Rules, 1945 on the regulation of stem cells procedures.

The amendments seek to exclude certain kinds of processed stem cells, called minimally manipulated stem cells, from being defined as new drugs. Such an exclusion will man that these cells will not have to be tested in clinical trials for efficacy and safety before they receive market approval. If passed, these amendments may legitimize the use of unproven stem cell therapies in India. 

Stem cells are cells that are derived from organs of the body like the embryo and umbilical cord that can grow into different kinds of specialized cells in the body, like nerve cells or blood cells. Stem cells derived from bone marrow have been successfully used for treating blood cancers including leukemia.

Donation may be autologous, in which a patient is treated with his or her own stem cells, or allogenic, in which a patient gets stem cells from another donor. Many other stem cell therapies are still in clinical trials and their efficacy and safety are yet to be proven.

In India, there is no law to regulate the use of stem cells. The Indian Council of Medical Research has issued guidelines that recognize stem cell therapies only for certain treatments and say that other types of treatments are unproven and should not be offered as therapy.

If the amendments are accepted, stem cells will be classified as drugs and will come under the jurisdiction of the Drugs Controller General of India. Crucially, however, the proposed amendment excludes stem cells that are “minimally manipulated” from the definition of a new drug.

Stem cells are described as being minimally manipulated when they are retrieved from an individual, subject to minor procedures like rinsing, cleaning and resizing and do not undergo any other processing steps that may alter their function before being re-implanted into the same individual.

The amendment contradicts the guidelines issued by the ICMR. On April 29, ICMR submitted its objections, suggesting that minimally manipulated stem cells should also fall under the definition of a drug. By excluding “minimally manipulated” stem cells, the proposed amendment may allow doctors to offer many unproven and unregulated stem cell therapies.

“Even if minimally manipulated stem cells are to be used for clinical application, our guidelines mandate that necessary permissions from the Central Drugs Standard Control Organisation and the Institutional Committee for Stem Cell Research need to be taken,” said Dr Geeta Jotwani, deputy director general, Indian Council of Medical Research.

A senior official from the office of the DCGI said that guidelines are “not mandatory”. The same official added that the guidelines were not being followed. “The only way we can regulate the industry is by having a legislation which clarifies what is and what is not allowed,” added the official who did not want to be named.

The health ministry notification says that only those stem cells that undergo “substantial or more than minimal” manipulation need to be regulated. But the ICMR wants the use of minimally manipulated stem cells also to require approval before they are offered as clinical therapy.

Capacity of the regulator

Health activists and researchers said that the regulatory difficulties cannot be an excuse to not regulate the industry. Dr Anant Bhan, a researcher of bioethics and global health and policy, pointed out that patients will be more vulnerable to exploitation in the absence of a regulatory authority.

Speaking to Economic Times, Stem Cell Society of India president Dr. Alok Sharma called the changes progressive and in line with developments in countries like Japan, Korea and the US.

“This amendment will facilitate the growth of cell therapies in India and will also make these therapies available to lakhs of patients who are currently suffering with incurable diseases,” he said.