DCGI Rules Out Low-Cost Version of Patented Drugs

Joe C Mathew, writing today, May 1, 2008, for the Business Standard, India’s leading business daily states:

The Drugs Controller General of India (DCGI) has decided to reject applications seeking marketing approvals for copycat versions of medicines that have product patents in the country.

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 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 currently under litigation after Roche dragged Cipla to the Delhi High Court alleging "patent infringement". DCGI's latest move will prevent a repeat of such cases as the authority will not give marketing approval for low-cost version of patented medicines.

Multinational drug firms have welcomed the DCGI move while domestic players have termed it "unwarranted" saying it doesn't have any legal basis. The law governing drug regulation (Drugs and Cosmetics Act, 1940) does not provide for any linkage between patent status and regulatory approvals, they say.

"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," says D G Shah, secretary general, Indian Pharmaceutical Alliance, the representative body of leading Indian drug makers.

Read the full article here.