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Regulation/Guidelines

Ethics Committee Guidance Amid COVID-19 Pandemic In India

Ethics preparedness is the capability of the public health system to protect and have the ability to quickly respond to by having in place an ethical framework that would build trust and guide measures to recover from health emergencies. ICMR Bioethics unit, NCDIR, Bengaluru, along with COVID19 National Ethics Committee (CoNEC), released a guidance document regarding the ethical conduct of clinical research in India.

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News

ANCILLARY CARE TO THE CLINICAL TRIAL SUBJECTS

Decided by the Expert Committee that there should be provision for providing ancillary care to patients suffering from any other illness during the trial.

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News

Govt forms panels to frame guidelines & SOPs for approval of new drugs, trials, banning drugs

The Union health ministry has constituted two expert committees to formulate policy guidelines and standard operating procedures (SOPs) for approval of new drugs, clinical trials, banning of drugs and Fixed Dose Combinations (FDCs).

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Regulation/Guidelines

CDSCO Announced Clinical Trials Conduct Rules During COVID-19 Outbreak

This guidance document covers the actions that sponsors of ongoing clinical trials affected by the present pandemic should take to ensure the integrity of the research studies and interpretation of study results while safeguarding the safety of clinical trial participants as a priority

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Feature

EC Registration Support

As per the new regulations under rule 122 DD, CDSCO has made it mandatory for all Ethics committee to get registered with CDSCO so as to get authority to review and accord its approval to clinical trial protocol.

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Insight

Initiatives on Global Clinical Trials

  India has been an attractive destination for clinical trials because of its large population and varied demographics. Despite having tremendous potential, only 1–2% of global clinical trials are being conducted in India. To utilize its full potential with respect to the trained GCP professionals, trained investigators as well as […]

Insight

Subject Expert Committee’s Updates

The Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. It is the Central Drug Authority for fulfilling functions allocated to the Central Government under the Drugs and Cosmetics Act. […]

Insight

CLINICAL TRIAL

It is acknowledged within the pharmaceutical industry that clinical trials represent the single most expensive aspect of a drug, or treatment, development process.

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