Drug regulator to include outside experts in review panels for complex therapies

CDSCO

India's drug regulator plans to bring in specialists from the private sector and even abroad in its expert review committees to evaluate complex modern therapies, a marked departure from its long-standing reliance on government-only experts.

Central Drugs Standard Control Organisation (CDSCO) chief Dr Rajeev Singh Raghuvanshi described the move as a "very important milestone" necessary to keep pace with innovation.

"The ministry has agreed that we will now bring in experts from non-government system also for our subject expertise," the Drug Controller General of India (DCGI) said at the first Annual CAR-T Cell Therapy Summit in Mumbai.

The DCGI leads CDSCO, which is India's primary drug regulatory body.

"Till now, ... all our experts because of conflict of interest or whatever historical or defensive thinking we can say... had to be from government setup,” he said.

While acknowledging the capability within government institutions, the official admitted limitations in dealing with novel treatments.

"In the modern therapy areas, there is some limitation. We don't find many people who understand this domain.”

"To solve that problem, we have, we are now moving beyond the government setup," the regulator said.

The search for expertise will widen considerably and "maybe we'll come to the private industry also, retired people who have developed these products”.

The change will initially focus on the rapidly evolving the Cell and Gene Therapy (CGT) field, which would be used as a pilot for broader application,  the DCGI said.

"My expectation [is] that we will be able to do that maybe next one year for every subject expert committee, wherever there is a need, we will be allowed to bring people from outside,” Raghuvanshi said.

Cell and gene therapy are used to treat diseases such as genetic disorders spinal muscular atrophy, hemophilia, and sickle cell disease., cancer and the so-called acquired illnesses by modifying cells and genes. In cell therapy, healthy or modified cells are used to treat or prevent disease. Gene therapy focuses on fixing or replacing faulty to cure or help the body fight a disease. Some therapies are a combination of cell and gene approaches.

The reform is part of a larger effort to streamline regulation and foster innovation.

"We are now working with a motto of reduction in regulation," the official said. "Lighter in regulation and heavier on execution. That's basically the slogan which we are working with". This includes potentially eliminating up to 50 percent of certain test licences (T licences) and export No Objection Certificates (NOCs) to free up resources for complex reviews," he added.

CDSCO has approved two CAR-T therapies of ImmunoAct and Immuneel, and nine CAR-T therapies were are at different stages of clinical trials, Raghuvanshi said.

There were 59 active applications within the CGT domain.

The regulator is separating CGT review from traditional pathways, reducing review layers and internal timelines, with most active CGT applications addressed within 15 days, he said.

The regulator will also be moving the CGT application process online likely by the end of the month.  The regulator will also unveil new CGT guidelines with industry input, which is expected by June.

Cell and gene therapy are used to treat diseases such as genetic disorders, cancer and the so-called acquired illnesses like diabetes by modifying cells and genes.

Cell therapy involves transferring whole, live cells into a patient to help treat or cure a disease. In CAR-T therapy, the immune T-cells are modified in a lab before being put into the patient. The modified CAR-T cells identify and destroy cancer cells.  Cell therapies are used in treatment of various blood cancers.

Gene therapy aims to treat or prevent diseases by modifying a person's genes. It works by correcting the underlying genetic disorders such as spinal muscular atrophy, hemophilia and sickle cell disease. These therapies are highly complex and expensive.

Some treatments are also a combination of cell and gene therapies.