Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. we hope you enjoy reading it.
1. The Revised Schedule M of the Drugs Rules, 1945 which has come into force on the 28th December 2023, is now fully applicable to all manufacturers with turnover less than Rs. 250 Crores starting from 1st January 2025.
Source: bit.ly/4iZXAOt
2. India’s Central Drug Regulator has directed that the process to file applications for (1) addition of new Clinical Trial Site and (2) Change of Principal Investigator should henceforth be made online through the SUGAM Portal maintained by the regulator. An application for addition of clinical trial site is deemed approved if no objection received in 30 days of upload and an application for change of Principal investigator is deemed approved on the day of upload.
Source: bit.ly/4j1Kwbp
3. In order to curb instances of re-use and re-branding of expired food products by businesses India’s Central Food Regulator is now requiring all licensed Food Business Operators to upload the following data to the online portal on a quarterly basis once feature is activated:
a. Quantity of food items rejected due to not meeting quality standards.
b. Quantity of expired food items returned by the business.
c. A detailed report of how the expired/ rejected food items were handled, including manner of disposal/ return/ destruction.
Provided that all licensed business should commence record-keeping in preparation of activation of upload feature on FoSCoS portal.
Source: bit.ly/3PjW8sP
4. The Delhi High Court recently held that a claim for medical negligence cannot be sustained on the basis that the patient had a certain expectation with respect to the quality of care, holding that no evidence was forthcoming that the Doctor’s conduct lead to harm to the patient.
Source: bit.ly/49YPn9m
5. The Foreign Contribution (Regulation) Rules, 2011 have been amended, permitting associations to carry-forward the unspent administrative expenses into the next financial year, provided that reason for carry-over needs to be mentioned in Form FC-4.
Source: bit.ly/4gOxvAo