The Union Ministry of Health and Family Welfare has issued a draft amendment to the Drugs Rules, 1945, introducing a key regulatory distinction under Schedule K between liquid antiseptics meant for household use and those intended for hospital or institutional use. The draft amendment has been notified as G.S.R. 759(E) in the Gazette dated 16 […]
Scientific Promotion of Pharmaceuticals Products in India Principles for promotion promote medicines in a country after marketing authorizations have been granted in that country. medicines are promoted only for the approved indication(s), consistent with approved prescribing information. Promotional information Consistent with FDA-approved prescribing information (where it includes benefit claims for the medicine). Promotional materials […]
THE REGULATORY FILING MA FOR FORMULATIONS IN THE EU What is the process for regulatory filings for formulations in the EU? What are the costs involved & the usual timeline for approval? Either the European Medicines Agency (EMA) or a national Competent Authority considers the dossier submitted by the applicant and determines whether or not […]
THE ENVIRONMENTAL, SOCIAL, AND GOVERNANCE (ESG) Understanding and Mitigating the Risk The environmental, social and governance (ESG) landscape is rapidly expanding and becoming increasingly diverse, complex, and risk laden. We are entering a new pivot point for ESG, moving from voluntary to mandatory disclosure of many ESG-related risks, observing a global increase […]
The function of patent law is to enable a patent holder to prohibit a third party from making, using, selling, importing, or otherwise violating their rights with respect to a patented invention. Primarily, patents can be classified into three types: utility patents, design patents, and plant patents. Utility patents refer to patents that are […]
Compliance Requirements for Single-Use Plastic Guidelines Company must adhere to the Plastic Waste Management Rules, 2016, as amended, which provide the statutory framework for the enforcement of the rules. The Company must comply with the ban on identified single-use plastic items listed below, effective from 1st July 2022: – Earbuds with […]
Dark patterns are exploitative practices used on the internet to deceive consumers. They include actions like adding items to a shopping cart without user consent, changing prices during checkout, and creating false urgency to prompt purchases. The Advertising Standards Council of India (ASCI) has issued new guidelines to combat deceptive […]
14 FDCs prohibited. S.O. 2394(E) The Central Government u/s26 A of the Drugs and Cosmetics Act, 1940 vide SO 2394 (E) prohibited the manufacture for sale, sale, and distribution for human use of drug fixed dose combination of 14 FDCs. This is pursuant to the directions given by the Hon’ble Supreme […]
Key Components of the Code of Conduct: All members commit to hold ourselves to the highest standards and voluntarily commit that our operations shall operate with the following safeguards: Processing of medicines against Prescription Scheduled medicines must be processed only against a copy of a prescription (physical or scanned copy) of a registered […]
INTRODUCTION The company has developed software medical devices that are supported by AI, with their flagship products being SYmpi and CIE, which cater to the needs of both patients and doctors. They have already received the testing licensing from CDSCO, and are now looking to acquire further clinical trials and other licenses. […]