MNC drugmakers push for 10-year exclusivity period for trial data

First entities' data filed for novel drugs needs protection: OPPI

The Organisation of Pharmaceutical Producers of India (OPPI), which represents research-based global pharmaceutical companies in the country, is seeking an exclusivity period of ten years after market authorisation for protection of regulatory data of first entities who have filed for novel drugs.

 

This comes after the Central Drug Standards Control Organisation (CDSCO) sought comments from pharma industry stakeholders on rules that require the first applicant to conduct clinical trials and bioequivalence studies, while the subsequent filers could skip the trials and have an easier path to obtaining approvals for a product launch.

 

A note circulated by India’s regulatory agency had highlighted a lack of level playing field between the first company that obtains a new drug for the first time in the country based on clinical trial and bioequivalence study data and the subsequent applicants that obtain approval of the same new drug based on bioequivalence study data.

 

Saying that India is in a better place in terms of pharma investments than before, OPPI Director General Anil Matai told reporters at the sidelines of the industry body’s annual conference that why would a global company launch a new molecule if a second applicant is asked to do a small bioequivalence or a bioavailability study and then it gets referenced to the originator’s regulatory documents.

 

He added that India needs to step up investments for new innovation in pharma, as it cannot remain only a generic supplier to the world. 

 

“That is what we are advocating with the government, that we need to have policies and guidelines, which encourage innovation,” he added.

 

For this, he said that the government would need to set up an enabling environment.

 

This includes regulatory data protection, apart from improvement in the functioning of the State Expert Committee (SEC) of the CDSCO which advises on the safety and efficacy of new drugs and clinical trials in India.

 

“The third improvement could be in the speed at which our clinical trial applications get processed,” he said.

 

Another executive said that drug makers are also talking of better linkage between the Centre and states.

 

In India, drugs lose their status as a “new drug” four years after the initial grant of a patent by Centre, and the authority to grant manufacturing permissions shifts from the central licensing authority (CLA) to state licensing authorities.

 

“In many cases, the state approves manufacturing authorisation to other players, years after the Centre has already given a patent. This can cause generic companies to seek manufacturing authorisation for a patent or proprietary medicine (PPM) and lead to availability of a mixture that was different from the one which the initial nod,” he added.