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.
The Organisation of
Pharmaceutical Producers of India(OPPI), which represents prominentmultinational 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.
The lobby represents pharma giants
includingNovartis,Roche,AstraZeneca, Sanofi and Merck.
"OPPI
envisions a transformative approach todrug 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.