The Department of Biotechnology (DBT) has started the process of framing a set of guidelines for the biologicals upto the clinical stage so that the process of approvals could be simplified and made more transparent.

"We have been working on the guidelines internally for the last few months. A committee within the department has met several times and has taken the views of the industry also as there are no practical regulatory mechanism existing now to govern the emerging biological sector," a senior official with the DBT said.

The guidelines will be issued on all aspects like toxicology studies and other pre-clinical stages upto forwarding the applications to the DCGI. The drug controller will then take care of clinical trial stages and final approvals. As of now, the pre-clinical approvals and studies were based on the Schedule Y norms. "Biologicals are totally different from the chemical-based drugs and hence we don't believe in applying Schedule Y guidelines on them. That is why we are planning separate guidelines," he said.

"We are hoping to issue the guidelines in a few months time as it is very important. Right now at least six statutory bodies are involved in clearing the applications and studies. Once the National Biotechnology Regulatory Board is in place, the process can be streamlined through a single window, and the companies need not to go to different bodies for clearance," the official said. He said even the very definition of biologicals needs attention as United States was using the term 'biogenerics' while the Europe was using 'biosimilars.'

India has a huge potential in the sector and so far the DBT has forwarded 20 biologicals to the DCGI for clearance. More and more companies are working on developing more biosimilars now. Meanwhile, the DCGI office is also actively considering of framing guidelines for biologicals to treat them as new products.

The Organisation of Pharmaceutical Producers of India (OPPI), sometime back, had submitted a detailed representation to DCGI to consider classifying all biosimilar products as new products enforcing all the procedures needed for the approval of a new product in the market. The biosimilars vary from the innovators due to their nature and complexity of manufacturing process, though the sameness of molecular structure in chemistry based generic medicines is very much defined.

Any alteration to the manufacturing process of biological drugs may result in a completely different product and it should not be considered as a similar product to the original biopharmaceutical product from the innovator company, according to OPPI.

Following the success of its generic pharmaceutical industry, Indian policy makers plan to repeat this in the biogeneric sector. Indian biotech revenues, currently at about $2 billion, are projected to reach $5 billion by 2010. Already, nearly 60 per cent of these revenues are from exports, according to various estimates. The DBT now spends close to $200 million annually to develop biotech resources in the country, including the expansion and improvement of academic programmes.