US FDA withdraws approval for Makena, Covis Pharma’s preterm birth prevention drug
The US FDA has been pushing to withdraw the drug since 2020 but Covis insisted that the FDA wait for data from another…
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Regulations/Policies
Strides’ Bangalore facility gets EIR from USFDA
The company’s flagship facility was inspected by the USFDA between December 5 and 9, 2022, and a form 483 listing three…
US FDA completes inspection of Alkem’s manufacturing facility in Indore
In response to Form 483 issued by the US FDA containing one observation, the company had submitted a detailed CAPA plan to the…
Dr Rajeev Raghuvanshi appointed as new DCGI
The Union Public Service Commission (UPSC) had recommended his name for the DCGI’s post a few weeks back
Govt taking steps to produce high value pharmaceuticals: Mansukh Mandaviya
He said that manufacturing of components of high-end medical devices in the country will be another big step in moving towards…
Lupin receives EIR from US FDA for its injectable facility in Nagpur
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
We are talking to vendors to develop ERP for IPC so that our whole working process turns digital
Dr Rajeev Singh Raghuvanshi, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission (IPC), speaks exclusively to…
EU plans changes to pharma law to avoid medicine shortages
Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency (EMA) says.
WHO announces plans to establish a TB Vaccine Accelerator Council
The council will facilitate the licensing and use of effective novel TB vaccines catalysing high-level alignment among funders,…
NPPA revises ceiling prices of 128 medicines
As per the notification, the ceiling price of one Amoxicillin capsule has been fixed at Rs 2.18; one tablet of Cetirizine at Rs…
USFDA allows abortion pills to be sold at retail pharmacies
The FDA had first said it would be making those changes in December 2021 when it announced it would relax risk evaluation and…
Cough syrup deaths: India seeks details from Uzbekistan on investigations
Union Health Minister Mansukh Mandaviya said further action would be taken based on the inspection of the pharma company
CDSCO carries out inspection at Marion Biotech
The inspection was conducted under the directions of Dr Mansukh Mandaviya, Union Minister of Health & Family Welfare and…
CDSCO orders audits of pharmacovigilance system of importers and manufacturers of human vaccines
The CDSCO order also asked the importers and manufacturers to also furnish some of their documents to the directorate at the…
Delhi HC rules in favour of Natco in patent infringement case
Dismisses patent suit filed by FMC Corporation
Government should make IP certification mandatory for IPAs used in pharma industry
Vikas Biyani, Retired Assistant Commissioner, Maharashtra FDA, explains why it is critical to mandate the use of IPA with the…
Revised EU GMP Annex 1‐ Manufacture of sterile medicinal products
The main driver for the update was to reflect changes in regulatory and manufacturing environments which include a clear shift to…
Top 300 brands to have QR codes from August 1, 2023
QR codes/barcodes to be on primary packaging label or, in case of inadequate space, on the secondary package label that stores…
Indian patent office hears pre-grant patent oppositions on evergreening of bedaquiline patent
Applicants will now be given a chance to respond
US Senate passes FDA Modernisation Act
The legislation has the potential to spare animals, bring safer and better treatments to patients, and drive down drug prices