Last Updated on December 31, 2023 by The Health Master
Pharma industry has urged the Department of Pharmaceuticals (DoP) to include Chile amongst the countries for Abbreviated New Drug Application (ANDA) / New Drug Application (NDA) approval under Clause 4.1 of the operational guidelines for the Rs. 15,000 crore production linked incentive (PLI) scheme for pharmaceuticals.
The DoP on August 13, 2021 issued corrigendum amending clause 4.1 of the operational guidelines to include ANDA / NDA approvals from countries like Australia, Switzerland, Japan, Brazil and other member countries of PIC/S, such as Vietnam, South Africa, Iran, Cyprus, Israel, Ukraine and the like, the industry’s request to include Chile remains unaddressed.
Besides this, the DoP has included EMA, BfArM and ANVISA in the list of overseas regulators covered under the scheme.
The latest corrigendum issued by the DoP on August 13 has enhanced the list of countries for ANDA / NDA purposes. While the extension of timelines will allow the industry to better prepare for filing purposes, the selective inclusion of some countries has left the industry confused, said Alkem Laboratories.
AlKem has requested for inclusion of Chile under the list of countries for ANDA/NDA to be eligible under the PLI 2.0 application.
The company is in the process of making an application under the PLI 2.0 scheme released by the DoP. In this regard, the drug company has also been interacting with the department in the recent past to showcase and enable a fair chance for maximum participation.
Alkem has a strong presence in Chile which has a highly regulated pharma sector with a government health expense of US$ 14,900 million in 2020. Alkem holds more than 200 registrations with the Public Institute of Chile for its products.
The average healthcare expense by Chile amounts to around 5 per cent of their GDP on an average as compared to 2-3 per cent in countries like Vietnam and South Africa. Chile also ranks higher on the list of best healthcare systems in the world and stands at 33 as compared to some of the PIC/S countries which have been included in the PLI scheme (for instance, Iran stands at 93). This is also reinforced by the confidence that a lot of US based pharma companies are showing in Chile.
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“India itself not being a PIC/S member country, has quality standards as the backbone of its pharmaceutical sector and DoP along with CDSCO is constantly improving such standards for the country which are being accepted and appreciated globally. Concomitantly, we believe that department also views countries like Chile which are not PIC/S members, as countries having robust healthcare system and regulation in place,” said Alkem in representation to DoP.
The pharma company hopes that DoP would consider such countries having an established healthcare system and framework, on a similar footing as some of the member countries of PIC/S. Accordingly, the drugmaker requested inclusion of Chile amongst the list of the countries for acceptable ANDA/NDA approvals under the PLI 2.0 guidelines.
Given that ANVISA has now been included, we believe that the department is more open to accepting regulatory approvals from other developed nations as well, said Indian Drug Manufacturers’ Association (IDMA) in a representation to DoP secretary S Aparna.
IDMA has made representation to DoP in this regard following an appeal from Alkem Laboratories.
In June the DoP has issued operational guidelines for PLI scheme for promotion of domestic manufacturing of critical key starting materials (KSMs), drug intermediates (DIs) and active pharmaceutical ingredients (APIs) in India under the newly approved Rs. 15,000 crore PLI scheme to boost existing brownfield API units in the country.
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