Liberalise regulatory system, particularly for drug approvals: Zydus Group Chairman to Govt

Addressing the inaugural session of ''The India Pharma 2021 & India Medical Device 2021'' event here, the minister also emphasised that the domestic pharma industry has the capability to achieve the target of USD 130 billion turnover by 2030.

"Under the leadership of Prime Minister Narendra Modi, the government continues to strive to improve the ease of doing business in the country. Vigorous effort is on to reduce the regulatory compliance burden on the (pharma) industry," Gowda said.

Minister of State for Chemicals and Fertilisers Mansukh Mandaviya said that reforms are being undertaken by the government especially in the pharmaceutical sector.

"In ease of doing business, we have reached 79th position now from the earlier 145. In the pharma sector our ranking has improved to 63. So, it tells that reforms are indeed taking place in the vertical," he noted.

Speaking at the event, FICCI Pharma Committee Mentor and Zydus Group Chairman Pankaj R Patel urged the government to further liberalise the regulatory system, particularly for drug approvals.

Gowda said the country has been serving more than 200 plus countries and territories with its pharma products and it will continue to grow in value terms.

"Indian pharma industry can achieve the ambitious target which it has set for itself, reaching an annual turnover of USD 130 billion by 2030. Similarly, the medical device industry in the country has the potential to grow to about USD 50 billion by 2025," he noted.

He further said: "Along with this growth I am sure the industry will stay committed to the noble cause of providing drugs at an affordable price to the common man."

The minister said the COVID-19 pandemic has exposed vulnerabilities of the global supply chain in the pharma sector.

In order to take care of that, the Department of Pharmaceuticals (DoP) has launched a production-linked incentive (PLI) scheme for bulk drugs and medical devices with an outlay of Rs 6,940 crore and Rs 3,420 crore respectively.

"We have been able to approve applications of incentives worth Rs 6,564 crore already. Besides, the Cabinet has also approved another PLI scheme for the pharma sector with an outlay of Rs 15,000 crore. We want to support manufacturing units to become global champions, and penetrate the global value chain," Gowda said.

The government wants to build domestic capabilities in high-end specialised products such as biopharmaceuticals, complex generic drugs and gene therapy drugs, he added.

"We want to see India emerge as a global supplier of Active pharmaceutical ingredients (API) and intermediates in the future," he added. Gowda said that bulk drug and medical device parks were being set with an outlay of around Rs 3,400 crore which would help in realising the vision Aatmanirbhar Bharat.

The Minister also sought industry participation in government schemes like Ayushman Bharat Yojana and Pradhan Mantri Bhartiya Janaushadhi Pariyojana.

Lauding the role played by the pharma industry during the COVID-19 pandemic, Gowda said the initiatives have brought laurels to the country and has helped generate goodwill and respect throughout the world.

Zydus Group Chairman Pankaj R Patel said the pharma industry can grow to USD 80-90 billion in turnover with normal growth rate but with new initiatives from the government the industry can grow to USD 120-130 billion.

To achieve that, higher allocation to healthcare is an important step, he noted.

"Encouraging investment is necessary therefore we need a policy that is clear, coherent and definite and there should not be much tinkering with the policy. It will ensure sustainable growth for the industry," Patel said.

Besides, one of the important steps would be to make a pharma sector regulatory system of global standards, he added.

"If we want to become a world supplier on a constant basis, Indian regulatory system should be in line with the global regulatory system," Patel said. He also sought a new tax refund scheme in place of the export incentives which are no longer there.

"The API and pharma industry faces a lot of challenges with the Pollution Control Board. We believe in a healthy environment and pollution control system, but I think expedited approval and removal of unwanted hindrances in approvals would help in the growth of the industry," Patel said.

He also urged for a rethinking on important issues like pricing mechanism, support to innovation etc. Patel also sought one ministry and one department for the pharma sector.

FICCI Co-Chair Medical Devices Committee and GE Healthcare South Asia President & CEO Shravan Subramanyam said that in order to achieve the universal goals and make India self-reliant, the first step is to build mutual trust and develop innovative partnership models and Integrate digital technology and tools which can bring in the needed transparency and accountability.

Department of Pharmaceuticals (DoP) Secretary S Aparna termed the PLI scheme for pharmaceuticals as a game changer.