The move is important as it allows multinational drug firms to launch their patent-protected medicines without fear of infringement by domestic drug makers.
Leading drug firm Cipla had recently launched a low-cost version of cancer drug erlotinib, challenging the patent enjoyed by Swiss drug firm Roche on the medicine in India. The matter is under litigation after Roche dragged Cipla to the Delhi High Court alleging "patent infringement".
Multinational drug firms have welcomed the DCGI move. However, domestic players termed it "unwarranted" and without a legal basis.
"The laws governing drug regulation (Drugs and Cosmetics Act, 1940) do not provide for any linkage between patent status and regulatory approvals," they claimed.
"Patent linkage is the practice that creates a link between the patent status of a product and the application for a marketing authorisation. It prevents registration and authorisation of generic medicines until the expiry of the patent and considerably delays generic market entry," said DG Shah, secretary general, Indian Pharmaceutical Alliance.
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"The decision was taken at my level as we need to reassure the industry that patents are honoured in India. I have asked drug companies to provide the details of the patents granted for their new medicines. Whenever a second application seeking marketing approval for the same medicine comes, we will pass on the details to the patent office for an expert opinion," DCGI Surinder Singh said.
Singh added that the authority would initiate formal discussions will all stakeholders, including the domestic pharma industry, before finalising the formal guidelines.