The central government has decided to waive the requirement for clinical trials in India if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and European Union.
Although the permission doesn’t extend to all drugs, it primarily applies to five categories. These categories are 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.
According to the order issued by the drug regulatory agency of India, CDSCO, on Wednesday, the central government has permitted the waiver of “local clinical trials” for approval of new drugs.
‘Under Rule 101’
“In exercise of the powers conferred under Rule 101 of the said rules with the approval of the Central Government, the countries namely; USA, UK, Japan, Australia, Canada and EU are hereby specified for following categories of new drugs…,” said the order issued on August 7.
India previously permitted waivers for local clinical trials. However, in 2012, a parliamentary standing committee expressed concerns in its 59th report about approving certain new drugs in the country without conducting local clinical trials. The committee had raised several red flags regarding how the drug controller general of India was approving new drugs without adequate clinical trials.
Good move but requires scrutiny of each application: Experts
On one hand, pharma companies would celebrate this development, as they have been pushing for it for a long time. On the other hand, public health advocates have called for strict scrutiny before every waiver.
“The move will benefit both domestic and foreign drug makers in India. Moreover, it will also help Indian patients. For instance: Indian drugmakers can manufacture orphan drugs and make them affordable for patients here,” said an industry official, requesting anonymity.
According to T Prashant Reddy, co-author of The Truth Pill (a book on drug regulation in India and the gaps in the regulatory process), “The move is good, overall.”
But, he added, there may be certain medicines that require local clinical trials due to Indian conditions and genetic factors. “Therefore, a blanket waiver might not be the best idea—instead, each proposal should be scrutinised individually and the science behind the waiver should be confirmed by people with expertise in the subject. The general opinion is that it is unethical to repeat clinical trials of a drug that has already been validated.”
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