The Drug Controller General of India (DCGI) and the Department of Biotechnology (DBT) are believed to have completed its work on the draft of the Similar Biologics 2011 guidelines. Dr G N Singh, DCGI informed that the guidance document, which was drafted to bring in proper regulation in this field, will be released at the earliest in the public domain.

Both the bodies have already consulted the stakeholders in this matter by conducting meetings and having repeated discussions with them on the same.  The draft guidance has been prepared after duly addressing their doubts and after taking into consideration their views and suggestions.

Dr Singh, pointed out, “The country needs a guidance document that can specifically cater to the domestic industry's requirements, and which are tailor made after considering their demands and needs within the country. We have prepared this draft after considering all these factors so that it will help in creating and maintaining the goodwill of the industry even at the international level.”

The 23 page draft guidelines contains introduction, background, objective, and scope of the guidelines along with requirements for pre marketing and post marketing data. It contains requirements of data for both pre-clinical trial which was done by the DBT as well as clinical trial data done by the CDSCO; 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.

Dr Singh further stressed that these guidelines are essential as it will help the Indian regulators to meet the industries expectation by asserting the industry to follow these guidelines for maintaining and upgrading the quality of the similar biologic products that are manufactured within the country.

“Our main aim is to harmonise the industry and to ensure that we can stand at par with other international players as well when it comes to delivery of quality healthcare services. Through this guidelines we want to stress on need to maintain quality, efficacy and safety of the biosimilar products that are made in India,” he added.

Dr Singh said that they have full confidence that this guidelines will be accepted across the country as it was drafted with a view to recognise and raise the standards of the industry. He expressed that if all the things go as planned, then based on the guidelines' efficiency and impact, the government may think of adopting it as an Act.

Manufacture and marketing of similar biologics in India are currently governed by the Environment Protection Act of 1970 and the Drugs & 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.