New Delhi: India’s drugs regulator has decided to abandon his own proposal to link marketing approvals for non-patented versions of a drug to its patent status, called patent linkage, dropping a plan that led to heated debate and intense lobbying from industry factions and public health advocates.
Indian drug makers, which had opposed the proposal and dubbed it “patent policing” by the office of the Drug Controller General of India (DCGI), hailed the new stance.
“In the light of renewed effort by brand name drug industry to obstruct entry of generics, it is a welcome change. This will let the regulator focus on evaluating safety, efficacy and quality of drugs as well as the capacity-building of his own agency”, which are the controller’s primary responsibilities anyway, said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), which represents large Indian generic drug manufacturers.
DCGI’s proposal, made in the wake of a controversy over the cancer drug Tarceva, had the potential to hurt sales of generic or non-patented drug makers and potentially could have delayed introduction of cheaper drug copies in the market.
“We will not base our regulatory approvals to the patent status of a drug,” said DCGI Surinder Singh.
At an industry seminar in April, Singh had mooted the idea of rejecting applications of generic drug makers for making copies of patent protected drugs in India.
Roche’s office in Basel, Switzerland. DCGI’s original plan came after F Hoffman-La Roche sued Mumbai-based Cipla over generic copies of Roche’s Tarceva, alleging patent infringement (Photo by: Christophe Bosset/Bloomberg )
“There will be no policy on this either. It is not in our purview to stop a drug’s marketing approval because of its patent status,” he said. Patent infringement issues typically end up in Indian courts.
Singh’s original plan came soon after Swiss drug maker F Hoffman-La Roche Ltd sued Mumbai-based drug maker Cipla Ltd over generic copies of Roche’s Tarceva, alleging patent infringement.
The case is still in the Delhi high court.
Ranga Iyer, president of the Organisation of Pharmaceutical Producers of India, an industry lobby of multinational drug makers in India and convenor of the seminar in which the patent linkage announcement was first made, declined to comment on Singh’s change of mind, saying he had not officially heard it from the regulator’s office.
While patents are granted by the Indian Patent Office, marketing approvals are sought from DCGI, who independently looks into the safety and quality of drugs.
If the proposal were to become a reality, the controller’s office would have needed to track all listed, delisted, relisted, challenged or revoked patents, something that fell outside the jurisdiction of the Drugs and Cosmetics Act, 1940, which governed that office, said some critics of the idea.
Singh said he is now considering putting the regulatory stance of not denying marketing approval to generic versions of patented drugs on DCGI’s website so that all global drug makers are aware of the way the system worked, and also informing them if a generic version was going to be approved.
Then “let the companies slug it out between themselves”, he said.
Drug access agency Medecins Sans Frontieres’ campaigner in India, Leena Menghaney, has expressed concern about DCGI’s plan to inform the patent holder if a generic version is being approved, which is similar to what the US food and drug administration does, saying that it will block the early entry of generic medicines in the market.
The controller “should focus on ensuring provision of safer drugs for the people rather than acting as de facto patent police”, she said.
IPA’s Shah, however, welcomed the sharing of such approval information.
The controller “should put up a list or notify all new drugs approved for marketing on its website, whether or not they are patented.
Thereafter, companies can keep tracking them” and deal within themselves, he added.