Streamlining Regulations

11 May 2004 | News

N.Suresh

Good news is trickling in for the biotechnology sector. First, the country's first biotechnology IPO has made Biocon founder and industry icon, Kiran Mazumdar-Shaw, the richest woman in India and has given many budding entrepreneurs a hope to create their own sunshine in the sector. Second, the much-awaited Dr MS Swaminathan Task Force on Application of Biotechnology in Agriculture has submitted its recommendations, which when accepted, will pave the way for a smooth and sensible regulatory process for the bio agriculture sector.

The third significant event concerning the sector is the setting up of a Task Force chaired by CSIR director-general Dr RA Mashelkar to streamline the regulatory process for the recombinant DNA products. The biotech industry could not have asked for a better person than Dr Mashelkar to clean up the regulatory mess that faces this sector. Dr Mashelkar's contributions to the toning up of the governance process are legendary. Starting with his stint as a member of the Prime Minister's Technology Task Force appointed by Rajiv Gandhi,
Dr Mashelkar's recommendations on a range of issues, including the introduction of Compressed Natural Gas as a clean auto fuel, or the ways to fight the scourge of spurious drugs have had a seminal impact on progressive policy making in our country. We could certainly expect an equally monumental effort from him, which will play a big role in transforming the way we deal with the approval of biotech-based drugs.

Our national election process is usually accompanied by a paralysis of the business of governance. In the past decade, the Election Commission has more or less taken over the role of the final arbiter of government policy in the months preceding elections. And governments have usually tried to keep on the right side of the Election Commission in recent years, due to the fear induced by the Seshan effect, kept up by his successors too without any let up. So all credit should go to the Environment Secretary Prodipto Ghosh for the bold decision to set up the Mashelkar Task Force amidst the election process. It is a sign of the responsiveness of the Environment Ministry, which oversees the key biotech regulator, the Genetic Engineering Approval Committee (GEAC), listening to the repeated requests from the biotechnology sector to cut the red tape associated with the clearance of the recombinant DNA products. It also shows that our bureaucracy is not a heartless, mechanical system that thwarts the progress of the nation, as is the general impression. Of course, the problem is that only crying baby gets the food and so one has to cry from public forums to get the attention of the policy makers.

Since its launch in March 2003, BioSpectrum has worked closely with the biotech industry to provide a forum for the sector to discuss critical issues, which hamper its growth and reach out to the policy makers so that these cries are heard and acted upon. The MashelkarTask Force provides the right forum and industry leaders have already proposed part of the agenda for the task force, which have been featured elsewhere in the current issue. In the weeks ahead, there will be more interactions with the task force and this opportunity to be heard by the cream of the nation's policy makers related to biotechnology should not be missed.

 

sureshn@cmil.com

 

 

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