knowledge-service-img

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 […]

Read More

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).

Read More

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.

Read More

Regulation/Guidelines

Fourth Amendment in Drugs & Cosmetics Rules, 2013

Following are the rules to amend the Drugs & Cosmetics Rules, 1945, namely-These rules may be called the Drugs & cosmetics (Fourth Amendment) Rules, 2013

Read More

News

REQUIREMENT OF LOCAL TRIAL FOR A GENERIC OR BIO-SIMILAR IN OTHER COUNTRY LIKE USA FOR ITS APPROVAL IN THE COUNTRY

The drugs considered generics and similar biologics (biosimilars) in other countries like USA that have been marketed in such countries for more than four years and have a satisfactory report would be approved for marketing in India

Read More

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.

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.

SUBSCRIBE FOR UPDATES Here

Have a Query?