Transparency, accountability and proper coordination between state drug control departments are of paramount importance  for the effective functioning of regulatory authorities in the country, according to Dr BR Jagashetty, Karnataka drugs controller.

Establishment of an efficient national regulatory system is viewed as an integral component of an effective public health programme. This would help lead to a better patient protection through provision of medicines which are safe, efficacious and good quality. Regulatory authorities need to carry out their functions effectively and efficiently within a set of principles based on transparency and good governance,  stated to Dr Jagashetty while speaking on Pharmaceutical Opportunities and Challenges of Regulatory Agencies in the New Decade at the annual conference of  India Pharmacy Graduates Association at New Delhi recently.

He said that the role of the regulatory authority is to promote and protect public health. The lack of access to drugs remains a huge concern whether these are essential medicines, vaccines, orphan drugs or drugs for tropical diseases. To facilitate access, regulators and all stake holders need to be actively involved in identifying difficulties and seeking solutions to ensure that there is no compromise in the area of public health safety.

In this regard, transparency and accountability are cornerstones that help to  strengthen the regulatory framework. “Cooperation, communication and trust between state regulatory authorities would strengthen the effectiveness of national regulation and international collaboration. Transparency is an important aspect of regulatory systems and helps to build public confidence while facilitating information exchange among the state regulators,” Dr Jagashetty pointed out.

This is where the regulatory guidelines, procedures and criteria as well as data about approved medicines  covering negative and positive assessment  reports of drugs including pharmacovigilance should be made accessible on public domain.

It is now becoming increasingly important to provide training in pharmacovigilance, risk management, communicating drug information, rational drug use and crisis preparedness. With certain drugs being approved based on conditions like finalization and reporting of phase IV studies, regulatory authorities should collaborate on harmonizing the terms of conditional approval and develop systems to allow sharing of information on medicines in this category, he said.

Addressing the issue of pharmacopoeias in a changing regulatory environment, he said that standards for bulk drugs and finished formulations should be issued by the regulator to ensure quality of drugs particularly generics. Collaborations between regulatory authorities and pharmacopoeia commissions and the World Health Organization should ensure that increased awareness on these aspects would help create a conducive environment to cultivate better management practices. Good regulatory practices ensuring  transparency, accountability and proper coordination between state drug control departments need to be built into the system  to reinforce trust and good governance, stated Dr Jagashetty.