New Delhi: Domestic drug companies are strongly objecting to the Indian drug quality regulator’s plans to link marketing approval for a drug with its patent status in the country, citing resources required and fears it could block access to affordable medicines by suppressing competitive forces.

Bitter taste: A chemist shop in New Delhi. The drug controller has proposed a new plan to avoid ticklish cases where a generics firm gets the marketing go-ahead for a drug patented by another company. (Photo: Rajeev Dabral / Mint)

Cancer drug Tarceva is a case in point where Mumbai-based Cipla Ltd secured approval from the regulator, decided to launch the drug at risk in India when it was patented by Swiss drug maker F Hoffmann-La Roche Ltd. A related lawsuit is being heard in the Delhi high court.

The implementation of India’s relatively new product patent law, which came into force from 2005, is putting a lot of Indian systems and processes under stress. While the Delhi high court is seemingly trying to balance the rights of the patent holder in the Tarceva case with providing affordable medicines for all, the Union ministry of chemicals and fertilizers is grappling with a formula for negotiating the prices of patented drugs while the DCGI is considering linking patents to marketing approvals for generics.

Meanwhile, Indian drug companies note that companies choosing to launch copies of a patented drug anyway run the risk of being sued for patent infringement by the innovator and courts should remain the forum to deal with such disputes rather than involve the DCGI.

Makers of patented drugs, on the other hand, have welcomed the efforts by DCGI to link the regulatory and intellectual property aspects of medicines. The rules of the Drugs and Cosmetics Act, 1940, will have to be changed as no provision currently bars the DCGI from approving a generic version of a patented drug.

The office of DCGI is gearing up to introduce this change.

“We will have to amend the rules in the Act. We have to put it before the Drugs Consultative Committee first and this could be around the end of this year," said a senior official in DCGI office, reaffirming the government agency’s intent of establishing the linkage so that no slips happen in the future. Singh was travelling overseas and couldn’t immediately be reached for commens.

Indian Pharmaceutical Alliance’s secretary general D.G. Shah claims that “efficient and effective" patent and regulatory linkage “will need enormous resources in the Office of the DCG(I)" and will run into several glitches.

“We need not put this onerous responsibility on the DCGI," he said. “It is up to the generic manufacturer to launch its version of a patent protected drug and face the consequences."

In a letter to Naresh Dayal, secretary of ministry of health and family welfare which oversees the office of DCGI, Shah wrote: "Data base of patents granted in India is not readily available. How will the DCG(I) obtain this information? Even if it is compiled by third party, how will the Office of the DCG(I) ensure its accuracy?"

The Association, which represent big Indian pharmaceutical manufacturers, has urged the health ministry to abstain from passing any such orders.

Typically, a drug molecule is typically guarded by more than 20 patents—called a patent estate—that cover its manufacturing processes, salts and intermediate raw materials.

"How would DCG(I) decide that the second applicant’s product corresponds to the patent quoted by the right holder?," Shah wrote, especially when "patents are routinely challenged and successfully invalidated". Industry estimates peg the number of patented drugs in India by global drug makers, such as Pfizer Inc., Roche and GlaxoSmithKline Plc, to about a dozen medicines. But, there are no official estimates on the exact number or the size of this segment.

Ranga Iyer, president of the lobby of global drug makers, Organization of Pharmaceutical Producers of India, welcomed the proposed change by the regulator and wants “something similar to the US Orange Book" in India. The Orange Book lists patent information on the approved drugs.

“If a patent has been issued under the laws of the land, it should be respected," he said. “At this point of time, no alternate system exists (of ensuring generic versions are blocked if patented drug in market) and DCGI is the link that gives marketing nod to a drug. If he wants to check it at that point, it is excellent."

Iyer agrees that the new system was “bound to have problems initially" but, brushed them away as “minor" issues.