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Novartis seeks regulatory consistency in India

Swiss multinational drug giant Novartis, which was among a few firms that suffered setbacks in the Indian market pertaining to patents protection and clinical trials, wants India to ensure consistency in the regulatory environment to retain and attract global investors.

Referring to episodes like overnight changes in key regulations governing clinical trials a few years back that destabilised investments of MNC pharma firms, Novartis global drug development head Vas Narasimhan said such inconsistencies send out wrong signals to investors. 

Narasimhan, who was in India to participate in Bio Asia 2017 conclave at Hyderabad, said sudden regulatory shifts will affect MNC drug companies, who make long-term investments in innovation. 

"We (multinationals) cannot simply keep adjusting. That sends a signal that maybe, we shouldn't invest as much," he told ET. 

Admitting that things have improved in consistency with rest of the world and the regulatory environment has got better now from both intellectual property and clinical trials' perspective, he said, such environment enables MNCs "invest with certainty over longer periods of time." 

However, he said "the key is it stays this way and keeps improving. Then, I think you will have more (clinical) trials coming in". 

Novartis currently conducts more than 50 clinical trials in India across all its therapeutic segments. 

Apart from ensuring consistency in regulatory policy environment, India should also allay the apprehensions of global investors at the earliest "so that it gives confidence to the principles all over the world because these clinical trials have been planned for long-term investments and they will have implications on global (drug) filings," Novartis India president Jawed Zia said.

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