Health Talk | Why India waiving off local clinical trials for globally approved new drugs is good news
The CDSCO's decision is aimed at speeding up the introduction of advanced drugs in India, particularly benefiting patients who would otherwise face delays
On August 7, India’s drugs regulatory agency, Central Drugs Standard Control Organisation (CDSCO), issued an order that allowed waiving off local clinical trials for approval of certain categories of new and novel drugs in the Indian market that have already been approved for use globally by regulators of countries that follow strict quality control.
It can be argued that this was a move that should have been made years ago as it would have meant getting novel or advanced drugs that are already in use in western countries to India at relatively faster and cheaper rates.
Local clinical trials or bridging studies as these are called are designed to demonstrate equivalent immunogenicity meaning to exclude a clinically significant difference in the immune response between the population in whom efficacy was shown and the population to whom those efficacy results are extrapolated. The studies provide clinical data on the efficacy, safety, dosage, and dose regimen of a drug in the new region.
The national regulator has identified six countries for considering a waiver. If the new molecule is approved to be marketed by the regulators in the United States, the United Kingdom, Japan, Australia, Canada, and the European Union, then the pharmaceutical companies can apply for a trial waiver to CDSCO in India.
These countries have been selected as these are a part of Stringent Regulatory Authorities, which are national drugs regulatory authorities that the World Health Organisation considers to have strict standards for the quality, safety, and effectiveness of drugs and vaccines.
The waiver, however, is meant specifically for five drug categories — orphan drugs for rare diseases; gene and cellular therapy products; new drugs used in pandemic situations; new drugs used for special defence purposes; and new drugs having significant therapeutic advances over the current standard care.
India finally acted on the long-standing demand from patient groups, the medical fraternity, and industry bodies who were lobbying for it in the interest of patients. On the face of it, it may seem that the move will benefit multi-national pharmaceutical companies as they won’t have to go through the hassle of generating data locally and getting it assessed separately, but on a closer look, it becomes clear that the patients are set to be the bigger gainers if unnecessary processes are cut in introducing new drugs.
Mrinal Gounder, a sarcoma oncologist and early drug development specialist at the Memorial Sloan Kettering Cancer Center in New York, sums it up well. “The Japanese have the same policy as they say they are a very unique population and their genome is different so you have to come and repeat studies in Japan. I actually published a paper while looking at the last 20 years and it showed that of the drugs that were approved in the US, Europe, and Japan, the dose of the drug, and the way it’s given is about 98% the same. The only difference is that the drugs in Japan get approved three years later after they have been approved in the US/UK, etc. There is a delay in Japan because they insist on local trials. So, you gain nothing but lose time," Gounder said.
Rhythma Kaul, national editor, health, analyses the impact of the most significant piece of news this week in the health sector
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