To expedite the process of establishing a strong regulatory environment for similar biologics in the country, the Department of Biotechnology (DBT) will soon begin work on framing the draft guidelines for individual products of the similar biologics. Dr K K Tripathi, advisor, DBT informed that his office will be getting on this task at the earliest, after receiving suggestions from the stakeholders on the draft guidelines on similar biologics issued in September last year.

Currently, manufacturing and marketing of similar biologics in India are governed by the Environment Protection Act of 1970 and the Drugs and Cosmetic Act (D&C Act). Even though similar biologics is regulated under the provisions of these Acts, there is no specific set of rules for this sector in the country today.

According to sources, the draft guidelines on similar biologics which was framed with an aim to address the problem of lack of regulation in the field of similar biologics in the country is in its final stage of approval. The Confederation of Indian Industry (CII) is organising a meeting for the stakeholders on February 2 in New Delhi to get their suggestions on the draft guidelines containing requirements of data for both pre-clinical trials and clinical trails which is a compilation of research work done by the DBT and CDSCO.

Dr Tripathi informed that the proceedings of this meeting is of high importance as many key decisions pertaining to similar biologics will be taken during its progress since the stakeholders are directly involved in it. The DBT's office had submitted the draft guidelines to CII on December 27 after reviewing and approving the draft notes on clinical trials that was submitted by the Drug Controller General of India's (DCGI's) office to the DBT.

He added, “The draft has been prepared for the benefit of the industry keeping their progress in mind, thus getting their suggestion is the most important factor in the whole process. Right now our aim is to complete the procedure and start the finalisation of it so that we can hasten the process of bringing in strong guidelines which will bring better credibility to the Indian industry in the world.”

Dr Tripathi further informed that after getting the stakeholders' view, they will be sending the draft copy of the Similar Biologics India September 2011 for wider consultation to the director-general Indian Council of Medical Research (ICMR) to get their expertise on the clinical trails before sending it for final approval to the secretary DBT.

It is expected that the main guideline will be ready to be issued by the end of February this year. Dr Tripathi informed that soon the DBT will try to complete its work on framing the draft guidelines for individual products of the similar biologics which is not expected to take as much time as the main guidelines.