The Department of Biotechnology (DBT) recently submitted the draft guidelines of Similar Biologics India September 2011 to the Confederation of Indian Industry (CII) to get their consultation and suggestions on the same. DBT is hopeful that after getting stakeholders view on the draft guidelines they will be able to hasten the process to implement the guidelines at the latest for the benefit of the industry.

The DBT's office 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. It is reported that CII has already submitted the copy among its members in the industry to get their inputs on the guidelines.

According to Dr K K Tripathi, advisor, DBT, “The draft that we have submitted to the CII, is a compilation of research work done by the DBT and the CDSCO, and contains requirements of data for both pre-clinical trials and clinical trails. We have prepared these guidelines with an aim regulate the growing similar biologics market with proper guidelines so that our industry gets more credibility and respect in the international market for the products that are manufactured in the country.”

DBT has been working on this guidelines from some time now so as to provide the industry with a unique set of rules that will help them in their growth. As of now, manufacturing and marketing of similar biologics in India are currently 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.

The 23 page draft guidelines submitted by the DBT contains introduction, background, objective, scope of the guidelines along with requirements for pre marketing and post marketing data. It states requirements for conducting clinical studies for phase I and phase II trials; extrapolation of efficacy and safety data to other indication etc. It also gives in detail, the applicable regulations, principles of developing similar biologics in the country.

He added that the Department is expecting the inputs from the stakeholders soon so that they can proceed further on this matter. “This guidelines have been specifically designed to benefit the industry, after conducting extensive research on similar biologics and its market requirements. In the mean time, we have also ensured that we leave no page unturned to meet the demands and needs of the industry while drafting it.”

He added that the Government is positive that the guidelines will be well accepted by all the stakeholders and if things go as planned, DBT is hopeful to get ready with the final draft guidelines by end of January. It is believed that the market for similar biologics will change significantly by 2015, as many well known biologic drugs are on the verge of patent expiration.