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The Centre has decided to waive clinical trial requirements in India if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and the European Union. The move is expected to make drugs manufactured outside India more accessible and affordable in the local market.
Five category of drugs will be waived off from the clinical trial requirements. These include orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in case of a pandemic, new drugs used for special defence purpose, and those having therapeutic advance over the current standard care.
Sources said , more country names may be added to the list or existing ones taken-off the list, if required.
The order was issued on August 7 by the Drugs Controller General of India under Rule 101 of New Drugs and Clinical Trial Rules, 2019 related to new drug approvals.
“In exercise of the powers conferred under Rule 101 of the said rules with the approval of the Central Government, the countries namely: (the) USA, UK, Japan, Australia, Canada, and the EU...” the order read.
Clinical trials, a safety prerequisite
At present, several medicines, already approved by other regulatory authorities in some of the countries like UK or the USA or even the UK are not readily available in India. Certain regulatory requirements mandate clinical trials be carried out first here. Clinical trials are processes where humans are designated recipients of such medicines. These trials ensure that any medicine, surgical method, or, more broadly, an intervention is safe.
A Health Ministry official said, some drugs used for treatment of rare diseases, such as cancer, among others, could now become readily available.
Generally, some of these medicines are available in India – post their introduction in other countries – after a gap of many years.
Innovative therapies
In a statement, Anil Matai, Director General, Organisation of Pharmaceutical Producers of India (OPPI) said, the organisation has been advocating for this. Inclusion of specific categories like orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, among others “is particularly crucial for accelerating access to innovative therapies to the patients in India”.
“Extending these waivers to a broader range of therapeutic categories will further enhance access to cutting-edge treatments,” Matai said
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