knowledge-service-img

News

New Medical Device Rules To Be Rolled Out In 2018

The Drugs and Cosmetics Act, 1940, has been governing drugs and medical devices since 1940 and has received multiple iterations each year. Owing to the significant changes that have occurred in the healthcare and pharmaceutical industry and constant requests from leaders in these industries, an overhaul was long overdue. In […]

Read More

News

APPLICATION TO MARKET NEW CHEMICAL ENTITIES (NCEs)

The Expert Committee decided that if India participates in GCT for NCE's to be used for diseases prevalent in our population, approval should be sought from CDSCO for marketing these NCEs in India after approval for marketing in the innovator country or in regulated markets.

Read More

News

APPLICATION TO MARKET NEW CHEMICAL ENTITIES (NCEs)

The Expert Committee decided that if India participates in GCT for NCE's to be used for diseases prevalent in our population, approval should be sought from CDSCO for marketing these NCEs in India after approval for marketing in the innovator country or in regulated markets.

Read More

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.

Read More

News

Labeling of Cautionary Note under Rule of 97 of Drug & Cosmetic Act – (No. DCGI/MISC/572012)

Rule 97 of Drug & Cosmetics Act 1945, provides for printing caution/ Warning in respect of drugs covered under Schedule H, Schedule G and substance covered under the purview of Narcotic & Psychotropic drugs Act, 1985 for the information of patients, doctors pharmacists and others so that there is no misuse of these drugs.

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

News

Self-Assessment/Audit of Unit for GMP/GLP Compliance

The Indian government has brought about some major changes with regards to the rules and regulations governing the manufacturing to enhance the quality of products used in the healthcare industry. As India being a major market for the healthcare-related products and its services, these modifications to the existing regulations are […]

News

Top Five Trends Changing the Game in Global Healthcare IT

stethoscope in two years, preferring to examine his patients with a handheld ultrasound unit to view a patient’s heart in real-time. In 2012 alone, physicians in the U.S. are expected to increase their use of smartphones and tablets by 81 per cent.

News

CLINICAL TRIAL ON MEDICAL DEVICE

Decided by the Expert Committee, the procedures for Clinical Trial approval, accreditations of investigators, sites, Ethics Committee and other conditions would be similar to the clinical trials of New Drug/ Vaccines.

SUBSCRIBE FOR UPDATES Here

Have a Query?