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There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in thewake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard ControlOrganisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of EthicsCommittees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, aswell as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research. [ABSTRACT FROM AUTHOR]

Objective: The Delhi State Drug Policy was adopted in 1994 following which the first Essential Medicines List (EML) was developed in 1996. The Delhi State Essential Medicines Formulary was brought out in 1997. A need was felt to revise the formulary to match with the EML as the EML is renewed every 2 years. Materials and Methods: A survey was undertaken to elicit the opinions of the doctors practicing in the state on the usefulness of the formulary before revising and printing the updated version. The survey covered dispensaries, 10-20 bedded hospitals, 100-bedded hospitals and two tertiary care hospitals. Discussions were focused on questionnaires on attitudes toward adopting Essential Medicines Formulary using a 10-point scale. Results: Of the 200 doctors approached, only 90 doctors completed the questionnaire. Sixty-nine respondents (76.6%) had received the copy of the formulary. Most practitioners welcomed the formulary and were satisfied with the coverage and selection of the medicines. Most respondents (76.9%) agreed that a well-developed formulary would improve the quality of the public health care system, although they had reservations about the authority, relevance and effect on professional autonomy. Conclusion: About 74% of the respondents used the formulary in clinical practice as a source of medicine information, which makes its regular revision necessary. [ABSTRACT FROM AUTHOR]