DCGI rules out low-cost version of patented drugs

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.

Shah added a patent linkage created an impossible situation for the regulatory authorities who lack resources and legal expertise to assess the validity of patents.

"If we take into account that any single product is usually protected by many patents whose status is subject to change (additional patents granted, invalidation of patents etc), this linkage should not be provided," he added.

"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," Surinder Singh, DCGI, said.

He added that the authority would initiate formal discussions with all stakeholders, including the domestic pharma industry, before formal guidelines are finalised.