The Department of Biotechnology (DBT) informed that it is in the last stage of releasing the final guidelines for similar biologics 2011, which was drafted with a view to benefit the industry at large. The draft is at present lying at the Drug Controller General of India's (DCGI's) office to get its comments on clinical trials so that it can also be incorporated in the final guidelines before its release.

The DBT has already included the stakeholders views and suggestions in the guidelines as and when possible to make it more industry friendly before sending it to the DCGI's office. A senior official from the Department informed that, DBT has been very thorough with the whole procedure and have already submitted the much awaited guidelines to the DCGI's office in the first week of February from whom they are yet to get a status update on the same.

According to Dr K K Tripathi, advisor, DBT, “The entire guidelines have been painstakingly drafted with a view to establish a strong regulatory environment for similar biologics in the country, which is absent today. Thus, we hope that the release of the guidelines is not delayed any further due to the instability at the DCGI's office, as the industry is desperately waiting for it to come into effect.”

He further added that to speed up the matter, the department is working towards getting comments on the clinical trials at the earliest from the drug controllers office so that they can start the printing and circulation of the guidelines among the industry members.

Highlighting the reasons for the delay from the DCGI's office, Dr Tripathi stressed, “Constant change in the role of the leadership at the DCGI's office is the main reason that is delaying the decisions or approvals from the office. Since the DCGI's position is fluid at present there is a problem for them in taking long lasting and strong decisions. The time bound DCGI should also be given power to take decisive decisions, so as to ensure proper functioning of the office and to see to it that the responsibility rendered to the position is delivered justifiably.”

Once the DBT receives the comment from the DCGI's office, the final copy of the guidelines will be sent for printing so that it can circulated among the stake holders for reference. It is expected that the final guidelines will be available for the stakeholder by March this year.

On the sidelines of this, DBT has already started its work on framing the draft guidelines for individual products of the similar biologics as well which is progressing at a faster pace.