Who regulates research in biotechnology in India? Who takes care of discrepancies in drug pricing, genetic engineering in plants, or the safety of clinical trials? The answer, at present, is: Nobody. Different ministries at the Centre have still not arrived at a consensus on the nature of regulations needed in the area, and the functions that will fall within the jurisdiction of the proposed National Biotech Regulatory Authority (NBRA). A draft bill on the regulatory body lies in cold storage.
The delay affects bio-safety and a slew of other issues, many too complicated for a lay person to even understand. At the Bangalore India Bio-2010, discussions occurred around, significantly, the need for a fool-proof regulation of the emerging industry of ‘biosimilars’.
The biosimilar is a term used to describe officially-approved new versions of innovator biopharmaceutical products after the patent of a similar older product has expired. Simply put, these are pharma products developed using the latest technology, including gene therapy. They speed up and mimic a drug discovery method, to faster achieve a better, but similar, drug.
“There have been differences between various union ministries and agencies concerned with health, science and technology, food and agriculture,” an expert privy to the government’s efforts to set up the authority, who also participated in the session, told DNA on condition of anonymity.
KK Tripathi, adviser and member-secretary of the review committee on genetic manipulation, union department of biotechnology, under the ministry of science and technology, admitted to DNA that fast-progressing technology had remained outside regulatory cover. The sheer pace of developments made legislation quickly obsolete, leaving it in a constant state of contention between different players.
The pace of technological advancement in the field also comes as a stumbling block in the formulation of guidelines for the regulatory authority. The absence of a regulatory authority, however, could pose problems that cannot even be properly anticipated, as legal loopholes could be abused and new and insufficiently researched pharma products could be introduced in the market.
