Taken remedial actions at two plants in Maharashtra: Drug firm Novartis

NEW DELHI: Drug firm Novartis today said it has taken remedial action at its two plants in Western India which had received a warning letter from the US health regulator and expects the manufacturing facility to returm to normal functioning soon.

Sandoz, the generic drug arm of Swiss drug major Novartis, had received a warning letter from the US health regulator for violations of current good manufacturing practice (cGMP) norms at its two plants in Maharashtra.

"Two Sandoz plants have received a warning letter from US Food and Drug Administration (USFDA). We have already taken remedial action at these plants and these units would be soon back to normal," Novartis India Managing Director and Vice Chairman, Ranjit Shahani told PTI on the sidelines of an event here.

On October 22, 2015, the USFDA had issued a warning letter to the company's Sandoz Division concerning Indian sites in Kalwe and Turbhe.

Both Turbhe and Kalwe fall in Maharashtra.

The warning letter observations followed USFDA inspection at both sites in August 2014 and are related to deficiencies in current good manufacturing practice (cGMP) for finished pharmaceuticals.

At Turbhe, Sandoz mainly produces active pharmaceutical ingredients. In Kalwe oral solid dosages or tablets are produced.

Novartis India shares today ended at Rs 848 a piece on the BSE, down 1.62 per cent from previous close.

Well developed infrastructure and strong intellectual property rights in Switzerland provide an incentive for companies to invest in innovation, Swiss Ambassador Linus von Castelmur said at an event here.

Citing data from the European Patent Office (EPO), he said Switzerland filed 848 patents per one million inhabitants, the most patents per capita, in 2014.

He was speaking at a conference here on 'Innovate or copy paste? A debate on innovation and intellectual property in the health sector'.

"Switzerland's well developed infrastructure and strong intellectual property rights, which provide an important incentive to invest in innovation by enabling firms to recover their investment costs," Castelmur said.

Hegemann said there should be predictable laws and regulations that reward innovations by way of IPR protection.

Soumya Swaminathan, Director General of the Indian Council of Medical Research, emphasised the importance of traditional medicine and traditional knowledge in the context of drug discovery.

"I think we still have a vast knowledge in the ancient systems of medicine both in Indian and Chinese medicines...," she said, adding that it was an area being looked at.