In a bid to expedite the introduction of new medicines in India, the Organisation of Pharmaceutical Producers of India (OPPI), representing major multinational pharmaceutical companies, has called upon the drug controller to facilitate concurrent approval of drugs aligned with international markets.
The OPPI highlights that the launch of a novel drug in India takes nearly four years longer than in the United States and the European Union (EU), adversely affecting the timely introduction of ground-breaking products in the country. The Drug Controller General of India (DCGI) recently engaged with both domestic pharmaceutical lobby groups and foreign stakeholders to address issues related to global clinical trials.
As reported by Business Standard, the OPPI asserts that through active involvement in global studies and the pursuit of parallel marketing authorisation filings, companies can significantly reduce the time gap of approximately eighteen months, at times extending to three or four years, for the introduction of innovative therapies to Indian patients compared to the launch timelines in the US or the EU.
