The Department of Biotechnology (DBT) and the Central Drugs Standard Control Organisation (CDSCO) may release the final draft guidelines for similar biologics by December end. To discuss the guidelines and finalise it, the DBT is going to meet the CDSCO officials by end of November, so that they can proceed with the formalities of getting stakeholders view on the same.

The Drug Controller General of India's (DCGI's) office recently submitted the draft notes on clinical trials for these products  titled Similar Biologics India September 2011, to the DBT for its review and approval. The draft guidelines contains requirements of data for both pre-clinical trial (which was done by the DBT earlier) as well as clinical trail data done by the CDSCO.

Dr K K Tripathi, advisor, DBT, informed that they have already started their work on reviewing the draft which was sent to them by the DCGI's office and are planning to have high level meeting with them on the same. Following that, DBT is also planing to have meeting with the stake holders to discuss and get their suggestions on the guidelines so that it can be effectively implemented.

“We want to ensure that all the stakeholders are informed of the same so that even their comments and suggestions can be included in it. Ultimately, these guidelines are being made for their benefit so it is essential to take them into consideration while drafting it. Our main aim is to ensure that the guidelines are well accepted by all and if things go as planned, we are hopeful that the final draft guidelines will be ready by end of this year,” Dr Tripathi informed.

The 23 page draft guidelines submitted by the DCGI 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.

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.

Dr Tripathi states, “This guideline will help in addressing the problem of lack of regulation in similar biologics in the country by giving better credibility to the Indian industry in the world.”

Manufacture 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 this sector in the country today.