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India’s pharma lobby bats for drug approvals in line with global markets


New Delhi: The Organisation of Pharmaceutical Producers of India (OPPI), which represents prominent multinational pharma companies, has urged the drug controller to enable parallel approval of drugs in sync with global markets, to expedite the launch of new medicines in India.

According to the OPPI, launching a new drug in India is delayed by up to four years, compared to markets like the US and the European Union. This affects the launch of innovative and significant products in India.

The lobby represents pharma giants including Novartis, Roche, AstraZeneca, Sanofi and Merck.

The group blames the delay on complex 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 told ET in a statement.

Last month, the Drug Controller General of India (DCGI) met domestic pharma lobby groups and the foreign players to discuss the challenges around 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,” the OPPI said.According to the OPPI, by actively participating in global studies and pursuing parallel Marketing Authorisation filings, the companies aim to drastically reduce the time lag of about 18 months that, at times, extends to even 3-4 years for bringing innovative therapies to Indian patients when compared to the launch date in the US or the EU.

“Our recommendations will not only (help) expedite patient access to innovative medicines but 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 said.

The organisation had given a presentation to the DCGI, in which it said timelines can easily be shortened into less than two years if India participates in global trials for an early access to innovation in India.

This can be further shortened if the overall review timelines is reduced to 12 months or the review is done parallel to the US and the EU, it said.


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