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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

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All fertility and surrogacy clinics in India now required to obtain registration under new law

Starting April 22, 2022, all fertility clinics, gamete banks and surrogacy clinics across India will have to commence the process of applying for registration with the National ART and Surrogacy Registry.

The Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021 (which, for the sake of convenience, will be collectively referred to as “the new laws”) came into force on January 25, 2022, to regulate the fertility and surrogacy industry in India.

A National ART and Surrogacy Registry has been constituted and operationalised under the new laws, which will serve as a central database of all clinics and banks in the country. All clinics are mandatorily required to make an application for registration on the Registry website and submit it to the relevant appropriate authority for the state by June 21, 2022. It should be noted that as of today, the appropriate authority for each state has not been notified, but it is expected to be notified within the next few days.

At present, the application for registration involves declaration qualified staff, equipment and nature of procedure undertaken.

In future, clinics and banks may have to demonstrate that they meet the minimum standards of physical infrastructure, facilities, laboratory and diagnostic equipment, and specialised manpower for clinics and banks, that may be prescribed by The National Reproductive Technology and Surrogacy Board (“Board”). If clinics and banks fail to do so, the application for registration may be rejected. As on date, the Board has not yet been set up, so the minimum standards are yet to be prescribed.

Therefore, it may be pragmatic for fertility clinics, gamete banks and surrogacy clinics to make application for registration on the Registry website without delay to avoid any interruption in business and operations in future.