Although the license does not apply to all drugs, it mainly applies to five categories of drugs. These categories are orphan drugs for rare diseases, gene and cell therapy products, new drugs for use in pandemic situations, new drugs for special defense purposes, and new drugs that represent significant therapeutic advances over current standard treatments. (Representative image)
While drug companies will celebrate the development, as they have long been pushing for it, public health advocates are calling for rigorous scrutiny before each exemption
The central government has decided to waive the requirement to conduct clinical trials in India if these drugs are approved in the US, UK, Japan, Australia, Canada and the EU.
Although the license does not apply to all drugs, it mainly applies to five categories of drugs. These categories are orphan drugs for rare diseases, gene and cell therapy products, new drugs for use in pandemic situations, new drugs for special defense purposes, and new drugs that represent significant therapeutic advances over current standard treatments.
According to an order issued by India's drug regulator CDSCO on Wednesday, the central government has allowed “local clinical trials” to be exempted from the approval of new drugs.
“Under Rule 101”
“Subject to the approval of the Central Government, in exercise of the powers conferred by Rule 101 of the above rules, namely: The United States, the United Kingdom, Japan, Australia, Canada and the European Union hereby designate the following categories of new drugs…” the order issued on August 7 read.
India previously allowed exemptions from local clinical trials. However, in 2012, the Parliamentary Standing Committee in its 59th report expressed concern over the approval of certain new drugs in the country without conducting local clinical trials. The committee raised several red flags about how India's Drug Regulatory General approves new drugs without adequate clinical trials.
Good move, but every application needs to be carefully scrutinized: Experts
On the one hand, pharmaceutical companies will celebrate this development because they have been pushing for it for so long. Public health advocates, on the other hand, are calling for rigorous vetting before each exemption.
“This move will benefit domestic and foreign drug manufacturers in India. And, it will also help Indian patients. For example: Indian drug manufacturers can produce orphan drugs and make them affordable for patients here.
“Overall, the move is a good one,” said T Prashant Reddy, co-author of The Truth Pill, a book about the flaws in India's drug regulation and regulatory process.
But he added that some drugs may require local clinical trials due to conditions and genetic factors in India. “Thus, blanket exemptions may not be the best idea. Instead, each proposal should be reviewed individually and the science behind the exemption should be confirmed by professionals in the field. It is generally accepted that repeated clinical trials of already proven drugs should Experimenting is unethical.
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