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Pharma Lobby Urges Parallel Drug Approvals in India to Align with Global Markets

Written by : Varsha Sharma

December 29, 2023

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The OPPI urges parallel drug approvals in India, envisioning a transformative approach to streamline processes. Major pharmaceutical companies advocate for early access to innovative therapies and position India as a proactive player in global clinical trials.

In a bid to expedite the introduction of new medicines in India, the Organization of Pharmaceutical Producers of India (OPPI), urges the drug controller to enable parallel approval of drugs in sync with global markets. The group attributes delay to strict clinical trial regulations.

The pharma lobby, OPPI, representing major multinational pharmaceutical companies including Novartis, Roche, AstraZeneca, Sanofi, and Merck, seeks to expedite the drug approval processes, along with pushing for regulations that facilitate the simultaneous filing of marketing approval applications aligned with major global markets.

Last month, the Drug Controller General of India (DCGI) engaged with domestic pharma lobby groups and foreign players to address issues in global clinical trials. In their discussion, they underscored the significance of a clear regulatory pathway, minimizing ambiguity and ensuring early access to innovative therapies for patients in India.

According to OPPI, active participation in global studies and pursuing parallel marketing authorization filings can significantly reduce the current 18-month lag, sometimes extending to three or four years, for bringing innovative therapies to Indian patients compared to launch dates in the US or the EU.

"Our recommendations aim to expedite patient access to innovative medicines and position India as a proactive global player in clinical trials. We aspire to drive a paradigm shift, making India a preferred destination for phase-III studies, thus creating a more agile and patient-centric healthcare landscape," stated the organization.

In a presentation to the DCGI, OPPI suggests that timelines can be reduced to less than two years with India's participation in global trials for early access to innovation. This timeline can be further shortened by reducing the overall review time to 12 months or by conducting the review in parallel with the US and the EU.


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