The government broadened the five-year exemption from price control
for new foreign drugs patented in India through an amendment in
January 2019. The amendment removed a requirement that the drugs
should have been developed through indigenous R&D. This included
orphan drugs used to treat rare medical conditions.
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/centre-plans-on-tweaking-drug-policy-that-exempts-foreign-medicines-from-price-control/articleshow/77379786.cms
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