The Central Drugs Standard Control Organisation (CDSCO) has recently made a forward-looking decision to waive local clinical trials for several categories of new drugs approved in the US, UK, Japan, Australia, Canada and the EU. This policy shift promises faster access to advanced therapies, offering a ray of hope to millions of Indian patients, particularly those in urgent need of lifesaving treatment, said Kiran Mazumdar-Shaw, chairperson, Biocon and Biocon Biologics.
Rigorous regulatory oversight is paramount to ensure the policy change does not compromise patient safety. Countries from which these drugs will be imported are known for their stringent regulatory processes. Moreover, existing Indian clinical trial rules state that a waiver is contingent on specific conditions: new drug must have no major adverse events; there is no evidence of differences in the Indian population related to enzymes, genes, or other factors affecting the drug’s pharmacokinetics, pharmacodynamics, safety, and efficacy; and the applicant must commit to a phase 4 clinical trial on the design approved by the Central Licensing Authority (CLA) to establish the drug’s safety and effectiveness, she added.
Eliminating repeating local trials, the CDSCO aims to ensure that Indian patients can benefit from the latest medical advancements without unnecessary delays. Historically, requirement for local clinical trials has delayed introduction of breakthrough treatments in India by several years. This often left patients, especially with rare diseases and conditions with unmet medical needs, at a disadvantage, Shaw told Pharmabiz in an email.
We got a glimpse of what such a waiver could achieve during the peak of Covid-19 pandemic where drugs like Favipiravir and Paxlovid were approved under the emergency use authorization (EUA) route without requiring standard phase-wise clinical trials. The rapid availability of these treatments and Covid-19 vaccines were crucial to combat the pandemic in India, she said.
While CDSCO's move is welcome, the clinical trials waiver should also be extended to globally-approved biosimilars, because they are cost-effective, high-quality alternatives to expensive biologics, making advanced treatments for cancer, autoimmune diseases, and diabetes more accessible to patients. Enabling launch of biosimilars already approved in any ICH country without a repeat clinical study in India can significantly enhance affordability and accessibility of these lifesaving therapies, she said.
This waiver is in line with best practices adopted in several countries. For example, a Brazilian Health Regulatory Agency, ANVISA, resolution in 2022 facilitates innovative product introduction in Brazil with fewer obstacles. It accelerates product approval, for drugs that received marketing authorization from regulators like US FDA, EMA, Health Canada, SwissMedic, WHO and MHRA, UK. In 2018, UAE fast-tracked registration for innovative drugs and orphan drugs having regulatory approvals in 21 countries, including Australia, Canada, US, UK, Germany, France and Japan. This global trend underscores the importance of timely access to lifesaving treatments and advantages of regulatory flexibility, she noted.
Conducting local clinical trials is both time-consuming and expensive. With this policy, CDSCO is aiming to reduce the development cost and launch these therapies in India. This financial relief can make it more feasible to introduce orphan drugs and advanced gene and cell therapies in India, said Shaw.
For globally approved drugs, phase 4 study, as recommended by CDSCO, will bring necessary checks and balances. This study collects real-world data after a drug is available in the market. To ensure its benefits, CDSCO should oversee the real-world data from phase 4 trials and in case the drug does not deliver the expected medical or financial benefits to patients, it can intervene, she said.
On a concluding note Shaw said, “The policy shift marks a significant milestone in India’s healthcare landscape and is a forward-thinking move balancing patient safety with the imperative of timely access to advanced lifesaving treatments.”
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