Recent controversy on Shantha Biotechnics case whether drug firms need to get GEAC permission to conduct clinical trials for biopharmaceuticals has once again brought the long standing plea for an integrated regulatory mechanism for the recombinant drugs produced in India to the spot light.
Various bodies representing the biotech sector and certain individual companies themselves have been repeatedly urging for a harmonised regulatory set-up for the speedy and smooth approval for pharmaceuticals of recombinant origin, for some time now.
Currently, the Institutional Bio-safety Committee (IBSC) with Department of Biotech (DBT) nominee approves project (category I and II) and recommends to Review Committee on Genetic Manipulation (RCGM). Then comes the RCGM approval for Category III followed by approval for toxicity study by RCGM subject to animal ethics committee clearance. Animal ethics committee approval is obtained followed by the toxicology studies. ISBC reviews toxicity studies and clinical trial protocols and recommends to RCGM. RCGM approves toxicity reports and recommends to DCGI and Genetic Engineering Approval Committee (GEAC) for human trials. DCGI permission is required for human trials in addition to GEAC permission. ISBC reviews human clinical trial data and recommends to RCGM.
Most of the leading players in the industry feels this as cumbersome and empahsise the urgency for a single window where decisions can be taken at one-go. They agree that the regulatory policies per se are not hostile to the industry. However, the flawed implementation processes add to the delay in approvals and cost overruns, besides increasing the uncertainty over the final decision.
"The inadequate regulatory infrastructure and more importantly the cumbersome approval protocols being adopted by the present regulatory process are delaying product approval timelines inordinately," they maintain. Moreover, whilst GEAC has a vital role in GM crop approval, they do not understand its relevance in the approval of recombinant drugs.
However, the experts from the regulatory side was not in full favour of such` single window clearance'. Upholding India's is one of best biosafety regulations existing anywhere else in the world, they argue since the biotech products cut across all disciplines of science and fall into various categories of industry involving a number of Administrative Ministries (AMs), it is not possible to have a single window clearance mechanism for all biotech products, they argue.
The recommendations in Export Trade Policy 2004-'09 unveiled by the union minister of Commerce, of late, can be taken is an example. Realising the need to establish Biotechnology Parks in the country, the government has announced that Biotech Parks will enjoy all facilities that are applicable to 100 per cent Export-Oriented Units.
The announcement made recently by Kapil Sibal,Minister for Science and Technology at a conference organised by the Federation of Indian Chambers of Commerce and Industry (FICCI), that India is planning to put in place a single-window system by January to handle all clearances for biotechnology, whether for farm or medical products, further underscores the sentiment that things are changing in a positive direction.
The regulatory mechanism, which should be in place by January 2005, would ensure single window clearance to technologies, whether for farm or medical products. Sibal reportedly stated. The biotech industry is pinning much hope on the recommendations of the committee for an umbrella law to cover the entire approval process of r-drugs.