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Govt. strives to delineate stem cells as drug, regulate use in treatments

  • An amendment proposed by the Centre might ultimately bring stem cells and cell-based products under the range of the law
  • The health ministry stated that stem cells and their derivatives will have to follow protocols that are delegated for any new drug development

MUMBAI: An amendment has been proposed by the Union health ministry to the Drugs and Cosmetics Act that might ultimately bring stem cells and cell-based products under the range of the law. Fascinatingly, the Indian Council of Medical Research (ICMR) — a division of the health ministry that has been to the lead of demanding stringent rules for stem cell usage and even formulated strategies last year — was actually not consulted.

In a statement issued on April 4, the ministry demarcated the grouping of stem cells and their derivatives that would be labeled a drug, and would thus have to follow the protocols authorized for any drug development. It said stem cells and products which are markedly altered, amounting to an alteration in biological features or those subjected to gene editing or amendment will be treated as a drug and will have to seek the regulator’s sanction before coming to the marketplace. Presently, no such permission is needed.

The notification though has practically left the usage of autologous stem cells — where the person’s own stem cells are gathered and minimally treated before instilling it back into the patient — unchecked. Such therapies intended to overhaul or regenerate impaired cells; tissues and organs are more unrestrainedly used in centers across the nation. The proposed amendment to the Drugs and Cosmetics Act articulates that these would be considered “minimal manipulation”. Henceforth, doctors could continue to offer them without necessitating permission from the drug regulatory body.

Stem cells reaped from the umbilical cord and bone marrows have been scientifically verified to treat cancers, immunological diseases, etc. But, over the years, a lot of doctors have begun offering stem cell treatment for sicknesses where effectiveness and safety are yet to be proven.

“It is a draft and certainly necessitates more clarity. We are discussing the contents and will submit our suggestions to the health ministry,” said Dr. Geeta Jotwani from the ICMR, who was at the helm of framing the 2017 stem cell strategies. “In a nation where stem cell therapy is already exploited, there has to be complete clarity in outlining it. Stem cells are presently being used for hereditary disorders, dementia, autism, etc., without clarifying to patients or relatives that autologous mono nuclear cells transplant is not going to be beneficial to them in any way,” she said. “The health ministry has to outline immune therapy, gene therapy and stem cells separately in the Drugs and Cosmetics Act; else the risk of misusing the science will continue.

Stem cell doctors though have termed it as the first large step by the government to legitimize the usage of such therapies in the nation. An orthopedic surgeon Dr. Bhagat Singh Rajput, who consistently uses stem cell therapy to treat muscular dystrophy and spinal cord injuries states that here is an enormous uproar about the legitimacy of using stem cells to treat patients when they are being used worldwide. Doctors fear losing their registration. The autologous therapies call for an operation theatre setting as cells are taken out from bone marrow but most reputable hospitals refuse permission, the doctor remarked. He claimed that there are 500-odd doctors in India using stem cells and merchandises and the health ministry has concreted the way for them to do the job in a reputable manner.

“It will transform the market owing to the clarity that comes with the law. Now there will be an enforcing agency that will control and leave the unscrupulous players out of the market,” said Dr Rohit Kulkarni, vice-president, Stem Cell Society of India. Asked why the industry was not creating sufficient data to authenticate their claim, Dr. Rajput said there are sufficient case studies to show its success.

“Globally, only hematologists can call themselves stem cell therapists, but here doctors and surgeons have given up their specializations and began using stem cells on patients,” said a senior high-ranking doctor.