As the scheme to make India self-reliant in bulk drug supply gets underway, the Department of Pharmaceuticals (DoP) is to shift its focus to encourage research and development of novel drugs in the country. While a new policy is in the works, the government has announced a $1.33 billion booster for ramping up domestic production of raw materials for producing drugs, reports The Pharma Letter’s India correspondent.
Looking to boost manufacturing in India, the DoP outlined guidelines for four schemes on July 27. The scheme opens the door for critical API production and manufacturing of high-end medical devices in the country.
"We are seeking to ensure India's pharma sector becomes completely independent. The country's dependence on imports for certain critical active pharmaceutical ingredients (APIs) is huge. We want to increase manufacturing of these API in India," said an official privy to the interactions.
At one time, India was considered a top player in API manufacturing. The aim now is to bring those faltering industries back on track.
Against this play out in the background, the government is also planning a major overhaul of the country’s drug authority, with a high-level committee proposing a single-window approval system to speed up availability of new drugs in the country.
Four schemes planned
Minister for Chemicals and Fertilizers D V Sadananda Gowda launched the four schemes on July 27 from the DoP for promoting domestic manufacturing of bulk drugs and medical devices parks in the country.
Mr Gowda said the schemes are in line with the vision of Prime Minister Narendra Modi and follows his clarion call to make India completely independent in the pharma sector. He exhorted the industry and states to come forward and participate in these schemes.
While the Production Linked Incentive Scheme (PLI) for APIs consists of an outlay of $867 million, another $400 million has been set aside for three bulk drug parks. Another scheme has an outlay of $457 million for PLI scheme for medical devices, and a grant-in-aid of $53 million for four medical device parks.
Noting that India is often referred to as 'the pharmacy of the world', Mr Gowda said it is a matter of concern that the country is critically dependent on imports for basic raw materials, viz bulk drugs Key Starting Materials (KSMs)/Drug Intermediates and APIs.
India has almost been self-reliant in the case of 700 APIs, the official said, adding it is only in the case of 53 critical APIs that India tends to depend on imports. "We want to reduce this dependence. API manufacturing requires a gestation period of two years. These manufacturing facilities will be up and running within the next two years," added the official.
The DoP’s P D Vaghela noted the fruits of labor would be visible over the next two years. Stating that the schemes would make India self-reliant, Mr Vaghela said it would also help the country cater to the global demand for select bulk drugs and medical devices.
"This is a golden opportunity for investors. Incentivization to the industry coupled with world-class infrastructure support will help in bringing down the cost of production significantly. These schemes, along with the liberal Foreign Direct Investment (FDI) policy in these sectors and an effective corporate tax rate of about 17% (including surcharge and cess). will give a competitive edge to India in the selected products vis-a-vis other economies," Mr Vaghela added.
The initiative, including incentives, is set to bring an expected investment of around $10.41 billion and generate employment for 255,500 people.
Applicants are to be selected on the basis of capacity of their proposed plant and the sale price of the APIs they would offer. The government is keen to take on companies that can offer APIs at the cheapest price.
Single-window clearance scheme
The Indian government is simultaneously aggressively working on creating a single-window clearance scheme to expedite FDI and domestic investment in the pharma sector. The government has already categorized pharma as a 'priority sector' in terms of FDI.
Following concerns raised at the highest levels of government over the ability of the regulatory framework to keep up with the demands of industry and scientists, a cabinet secretary panel committee has been formed to reform the drug regulatory system.
The committee was set up after Prime Minister Modi sought overhauling of the country’s drug regulatory system. Among other suggestions was restructuring the approval process for new drugs by allowing parallel submission of applications.
Under the present system of sequential processing, gaining an import license for a new drug can take about a year. While it takes 90 days to get permission to import and market a new drug, the company then has to apply for an import registration certificate. The process could take another 270 days. A month later, the manufacturer can get the import license.
An official said the committee deliberated on the different measures that could be undertaken by the Central Drugs Standards Control Organization (CDSCO) to make the whole system speedier and enable faster clearances.
The issue of reforms in the Drug Regulatory System has been engaging the attention of the Indian government for quite some time. Although requisite procedural changes have been carried out and has worked quite well during the current COVID-19 pandemic, it was felt that comprehensive changes in the drug regulatory regime needed to be carried out to reflect global best practices as well as ensure domestic requirements. The aim is also to streamline the CDSCO to make it more effective.
Committee suggestions
As per the interim report submitted by the committee to the Prime Minister’s Office, the parallel application system for new drug approval and grant of manufacturing and import license will be able to reduce the processing duration by about 3-6 months.
The committee has also recommended market authorization to be submitted simultaneously which will reduce the time by 2-3 months.
Among other suggestions are that companies be allowed to manufacture unapproved new drugs that are still under clinical development, currently in the case of the novel coronavirus pandemic, to enable faster access.
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The Link LonkJuly 28, 2020 at 10:39PM
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India gets $1.33 billion booster to ramp up domestic drug production - The Pharma Letter
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