Launch of Breakthrough Drugs in India Without Local Clinical Trials

Highlights:

India waives local clinical trials for breakthrough drugs from select developed countries
Rule 101 targets critical therapies like cancer, rare diseases, and pandemic treatments
This move aims to reduce drug launch delays and costs, benefiting Indian patients

The Indian government has introduced a new rule that allows the rapid launch of breakthrough drugs without the need for local clinical trials. This development, notified through an executive order by the Drugs Controller General of India (DCGI), promises to transform the landscape of drug approval in the country, particularly for therapies targeting conditions such as cancer, rare diseases, and other critical health challenges ().

The foundation of this decision lies in the New Drugs and Clinical Trials Rules (NDCT), which were established to streamline the process of drug approval in India. Rule 101 provides the legal framework for exempting certain drugs from undergoing local clinical trials if they have already been approved in specified developed countries. Despite the introduction of this rule five years ago, the government had not yet listed the countries eligible for this exemption, leading to delays in the availability of critical medications in India.

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Breakthrough in Drug Approval

Recently, the DCGI issued an executive order specifying the list of countries under Rule 101, paving the way for faster approval and launch of breakthrough therapies in India. The countries identified include the United States, the United Kingdom, Japan, Canada, the European Union, and Australia.

The waiver of local clinical trials is applicable to specific categories of drugs, including:

Orphan drugs for rare diseases
Gene and cellular therapy products
New drugs used in pandemic situations
New drugs used for special defense purposes
New drugs offering significant therapeutic advances over current standard care

These categories have been carefully chosen to address critical and unmet medical needs in the country, ensuring that Indian patients gain timely access to the latest advancements in medical science.

India’s Push for Faster Access to Breakthrough Drugs

India has historically faced significant delays, often 5-20 years, in launching crucial drugs due to the requirement for local clinical trials, which, while ensuring safety, also prolonged access to vital medications. The new rule aims to eliminate these delays for specific drug categories, enabling faster access to essential treatments and reducing costs associated with importing drugs.

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Despite waiving local trials, the approval process will remain rigorous, with each application vetted by the Drugs Controller General of India (DCGI) or a subject expert committee under the Central Drugs Standard Control Organisation (CDSCO). The inclusion of countries with stringent regulatory regimes like the US, UK, and EU underscores India’s commitment to maintaining high safety standards while expediting drug availability.

This decision also has the potential to boost research and collaboration between Indian and global pharmaceutical companies, fostering a more robust pharmaceutical ecosystem. The Organisation of Pharmaceutical Producers in India (OPPI) supports the move, seeing it as beneficial for both domestic and foreign manufacturers. However, industry leaders suggest extending waivers to more therapeutic categories and call for clear criteria for defining "significant therapeutic advances."

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Overall, this progressive policy promises to improve healthcare access in India by reducing time and costs for bringing new therapies to market, potentially enhancing patient outcomes and addressing unmet medical needs.

Reference:

Govt notifies rule for rapid launch of breakthrough drugs in India, bypassing local clinical trials - (https://theprint.in/health/govt-notifies-rule-for-rapid-launch-of-breakthrough-drugs-in-india-bypassing-local-clinical-trials/2214197/)

Source-Medindia

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