Confusion and international debate over evolving a definition for biosimilars have delayed the process of framing separate regulatory guidelines for biosimilars by the Department of Biotechnology (DBT). Bio-pharma industry has been calling for a transparent and simplified regulations for the sector for some time.

Though the DBT launched the process of drafting the guidelines in 2008, the deadlines have been postponed several times. A core committee has been formed within the DBT many months back with a deadline of three months, but the process is stuck as it could not finalise on the very definition of biosimilars, it is learnt.

The US was using the term 'biogenerics' while the Europe was using 'biosimilars' whereas the senior officials in the Department do not subscribe to both the terms. Now the panel is also looking at the US model of Hutch-Waxman Act which was recently announced, sources said.

“Though the initial deadlines could not be met, we are still hoping to come out with some guidelines by December. The committee has been told to work it out,” DBT advisor Dr K K Tripathi told Pharmabiz. He said the DBT was looking to coin some other Indian term like 'geneticeuticals’ for the biosimilars.

Presently, the biosimilars in India are governed under the Environment Protection Act of 1970, Order 1989 and the Drugs and Cosmetic Act. The industry, on the other hand, has been pressing for separate and simplified regulatory mechanism and single window clearance as, at present, the process of getting approvals biologicals was so cumbersome. Only if the regulatory guidelines are set, it could be further streamlined.

In view of the growing potential of the sector, the DBT launched steps to frame guidelines as early as in 2008 by setting up a 33-member panel which held consultations within and outside the department. Later, a core committee was set up within the department for finalizing the draft.

The guidelines will be issued on all aspects like toxicology studies and other pre-clinical stages upto forwarding the applications to the DCGI. The drug controller will then take care of clinical trial stages and final approvals. As of now, the pre-clinical approvals and studies were based on the Schedule Y norms. "Biologicals are totally different from the chemical-based drugs and hence we don't believe in applying Schedule Y guidelines on them. That is why we are planning separate guidelines," Dr Tripathi said.