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To hasten the launch of new medicines in India, the Organisation of Pharmaceutical Producers of India (OPPI), which represents key multinational pharmaceutical companies, has urged the drug controller to enable parallel approval of drugs in sync with global markets, reported The Economic Times (ET).
According to the OPPI, launching a new drug in India takes up to four years longer than in markets such as the United States and the European Union (EU). This has an impact on the introduction of innovative and significant products in India, it said.
The lobby represents pharmaceutical titans such as Novartis, Roche, AstraZeneca, Sanofi, and Merck.
The group attributes the delay to strict clinical trial regulations.
“OPPI envisions a transformative approach to drug approval processes, advocating for regulations that enable parallel filing of marketing approval applications in sync with major global markets,” the pharma lobby group said in a statement to ET.
Last month, the Drug Controller General of India (DCGI) met domestic pharma lobby groups and foreign players to address the problems of global clinical trials.
“Our dialogue with regulatory agencies emphasises the importance of a predictable regulatory pathway with minimal ambiguity and enabling early access of innovative therapies to patients in India,” a statement from the OPPI stated.
According to the OPPI, by actively participating in global studies and pursuing parallel Marketing Authorisation filings, the companies hope to drastically reduce the time lag of approximately 18 months, which can sometimes extend to three or four years, for bringing innovative therapies to Indian patients, when compared to the launch date in the US or the EU.
“Not only will our recommendations help to speed up patient access to innovative medicines, but they will also position India as a proactive player in global clinical trials. We strive to catalyse a paradigm shift, making India a preferred destination for phase-III studies/global clinical trials and paving the way for a more agile and patient-centric healthcare landscape,” it stated.
The organisation had given a presentation to the DCGI, in which it said timelines can be easily reduced to less than two years if India participates in global trials for early access to innovation in India.
This can be further shortened if the overall review timeline is reduced to 12 months or the review is done parallel to the US and the EU, it added.
First Published: Dec 29 2023 | 12:21 PM IST
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