TOP 5 HEALTH LAWS AND POLICY UPDATES

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. India’s Parliamentary Committee on Consumer Affairs, Food and Public Distribution, has noted in a recent report, that the National Test House (NTH) of the Consumer Protection Department does not currently have the expertise or offer the services for regulation certification of Radiation Emitting Medical Devices (including MRI machines and X-Ray machines etc.).
Source: bit.ly/4iKKIfi

2. The National Human Rights Commission of India, having taken Suo-Moto cognizance of a recent report concerning the negligent transfusion of blood to a patient in Rajasthan, has issued Notices to the Chief Secretary of the State of Rajasthan to conduct a thorough investigation into the circumstances of negligent blood transfusion.
Source: bit.ly/3ZCj4Z0

3. The Indian Minister of State for Health has clarified that the Central Drug Regulator, currently does not have any intention or proposal to ban Rantidine in the country, and that State Drug Controllers have been instructed to test for the levels of possible carcinogen N-nitrosodimethylamine in the wake of a warning issued by the United States Food and Drug Administration and European Medicines Agency.
Source: bit.ly/3P2aKgf
Source: bit.ly/49GB4pR

4. India’s Central Drugs Regulator, in supersession of an earlier Amendment in 2022, has issued an amendment to the Medical Devices Rules, specifying laboratories, and the Medical Devices that the laboratories are designated to test.
Source: bit.ly/3PnjiyF

5. The European Medicines Agency is set to implement to the proposed Electronic Product Information program to adapt pharmaceutical label information for easier representation on e-commerce platforms after conducting a successful pilot program.
Source: bit.ly/3DyWkS8

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Indian Drug Manufacturers will have to put in place prompt and effective recall procedure soon
At a meeting called by India’s Health Ministry with drug manufacturers, the Ministry has reportedly reminded all drug manufacturers that they will have to put in place a prompt and effective drug recall system. Such a drug recall system is a mandatory requirement of revised Schedule M of Drugs Rules, 1945, which is scheduled to come into effect on 27th June 2024 for large enterprises, and on 27th December 2024 for small and medium scale enterprises.
Source: bit.ly/3wbgKgZ

India’s central food regulator to conduct own testing and investigation into pre-packed spices manufactured in India
India’s Central Food Regulator (FSSAI) has recently issued a statement declaring that it is currently in the process of collecting samples of fruit and vegetables, fish products and spices and culinary herbs, as part of its scheduled surveillance for salmonella and other contaminants. This statement has come in light of the recent ban by Governments of Hong Kong and Singapore on certain brands of Indian spices, on the basis that the products contained Ethylene Oxide, a known carcinogen that can cause breast cancer and lymphoma.
Source: bit.ly/3UFCXgH

Supreme Court seeks explanation from Central Government on proposal to fix prices for ophthalmologic procedures
The Supreme Court has issued a Notice to the Central Government, seeking response on the nature of power and viability of regulations that permit government to uniformly fix the prices across private hospitals for Ophthalmologic procedures. The Court has clubbed this matter along with a pending case, where the Central Government has been directed by the Supreme Court to determine a policy to fix uniform prices for procedures done at private hospitals.
Source: bit.ly/4bzRdx9

If husband is unable to contribute gamete, then wife is not barred from seeking gamete from a donor for IVF: High Court
In a recent decision, the Calcutta High Court has held that, under India’s current regulatory regime surrounding In-Vitro Fertilization (IVF), there is no restriction that requires that either the egg or the sperm must come from the couple seeking the IVF themselves. A married woman may seek to obtain sperm from a third party donor.
Source: bit.ly/3Uocq68

Excessive prescription and use of Antibacterial medicine in treatment of COVID-19 has increased global Antimicrobial Resistance: WHO
The World Health Organization has recently posted findings from its Global Clinical Platform for COVID-19, which are an anonymized repository of worldwide treatment data. These findings have revealed that there has been rampant over-prescription and use of antibiotics worldwide, in the course of treating COVID-19, which has contributed to the globally rising Antimicrobial Resistance problem.
Source: bit.ly/4dnzWcb