The Ministry of Environment and Forests has come out with "Good Regulatory Practices" for all regulatory agencies that come under its administrative control. The Genetic Engineering Approval Committee (GEAC) and the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) will now have to follow these "Good Practices" as long as they are consistent with the existing systems, and do not involve any amendments to the relevant statutes or regulations.
Taking note of the guidelines for "Good Practices in Environmental Regulations," the GEAC has already decided not to postpone any items that are included in the agenda of a particular meeting. The Committee would consider all the items listed in the agenda and if required the meeting would continue the following day, GEAC has decided. GEAC has also started giving opportunity for personal hearing for the applicants after the recommendations in the "Good Practices.”
The Ministry of environment is in the process of updating and revamping all regulatory procedures undertaken by these agencies and intends to have the guideline as an interim remedy to the clearly perceived problems with such procedures.
Apart from scheduling of meetings of regulator / expert committee, the guideline also insists that the regulatory agencies should not ask any information which is not in the public domain, except that which is specific to the proposal and necessarily available with the applicant.
Acknowledging that the current practice of holding up consideration of applicants till other regulators have given clearance is a catch-22 situation for applicants, the ministry has suggested that neither ministry staff, nor the regulator / expert committee may hold up consideration of applicants while other regulators are undertaking their own due diligence. "In case the award of another regulator is materially relevant to the application, the final decision of the regulator / expert committee may caveat the requirement of award by the other regulator, before the regulator / expert committee's decision can be acted upon by the applicant," the guideline suggests.
Giving opportunity to the applicant to present the proposal, the guideline says that unless there are good reasons to suppose that the application has deliberately not followed the prescribed procedure in order to realize some unwarranted benefit, which must be recorded in the grounds for rejection, applications should not be rejected on procedural grounds alone.