The revised Schedule Y of Drugs and Cosmetics Act is expected to be ready for notification in two weeks time. A committee of experts dealing with the revision of Schedule Y is known to have fine tuned the final draft a couple of days ago. There are no "major changes" in the final document from that of the final draft, a committee member informed Pharmabiz.

The final draft has been circulated for expert comments for the last several months now. According to sources, the office of the Drugs Controller General of India (DCGI) compiled 61 pages of such comments that came from clinical trial experts from within government institutions and private organizations. The meeting held here last week went through all the comments and has incorporated all valid suggestions, it is learnt.

Sources were non committal when quizzed about the possibilities of the incorporation of a new clause for DNA mapping of human volunteers involved in drug trials. Pharmabiz had earlier reported the possibilities of such a change in the revised Schedule-Y. The move was expected to be in line with the need for upgrading the clinical research regulations to global standards as pharmacogenetics is gaining importance in the accuracy of drug research.

With the final notification of revised Schedule Y round the corner, the drug regulatory authorities would now have to think of facing fresh challenges posed by the new clauses in the law. With limited resources at their disposal, the authorities would have to work hard to ensure sufficient trained and competent staff needed to handle any possible spurt of clinical trial activities in the country.

It is known that the new rules would allow outsourcing of trained evaluators. The authorities would now have to find ways and means to remunerate them. While the rules call for setting up of ethical committees, the regulatory system to monitor the committees is yet to emerge clearly. The Indian Council of Medical Research (ICMR) has already taken some lead in this regard, with a WHO sponsored national survey to assess the actual standards and status of institutional ethics committees already underway. It has also prepared standard operating procedures for IECs.

There are also concerns over the regulation of trials on medical devices/diagnostics, novel drug delivery systems, pharmacogenetics, as in these cases, regulatory protocols are yet to be evolved completely.