Conduct post-marketing surveillance on abdominal painkiller: CDSCO to states

The move comes nearly seven years after a Parliamentary committee flagged the drug’s clinical trial approvals as “outrageous” case of a potential nexus between pharmaceutical companies and experts important to the regulator’s approval process.

New guidelines being planned for streamlining recall of medicines

At present, there is little clarity on how effectively regulators are able to remove such products from the market after they are found to have quality issues.


CDSCO flags ranitidine over possible presence of carcinogenic impurity

In its letter, a copy of which The Indian Express reviewed, the regulator has also asked states to inform it of any action taken in this matter “at the earliest”.

Implant Files: New licensing terms for medical devices, govt looks to Singapore

The Indian Express investigation, conducted in association with The International Consortium of Investigative Journalists (ICIJ), found how the first Bill to regulate medical devices was drafted 12 years ago but was still not enacted.

What the data on oxytocin ‘misuse’ show

Oxytocin is chemically synthesised and sold by pharmaceutical companies across the world, and used as a drug during childbirth because it can contract the uterus and induce delivery, control bleeding, and promote the release of breast milk.

Government body deliberates over online pharmacy

According to Drug Controller General of India, G N Singh, the online scenario may change now.


Clinical trials in India: Modi govt plans to clip wings of drug regulator

Clinical trial permissions have been stalled after SC rescinded regulator’s nod for 157 clinical trials.

Public health first

Drug regulation needs an overhaul. Start with more investment in human resources, infrastructure.

10 die per week in drug trials in India

The government will be analysing mortality figures during drug trials in India following WHO data

New rules seek compensation for clinical trial deaths

Faced with criticism on its clinical trial regulations,the Ministry of Health and Family Welfare has undertaken a slew of measures to streamline them

CDSCO Videos

Implant files: How medical devices that are recalled in the US are still in use in India

The Indian Express-ICIJ investigation finds that at least 57 medical devices, many used in critical care, were being sold in India when the US Food and Drug Administration (FDA) clamped down on them for a range of faults over the last two years.