Posted on

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 apex consumer court, the National Consumer Disputes Redressal Commission (NCDRC), has discharged a Kerala hospital and its doctor from allegations of negligence in an IVF case. The complainants had claimed that procedural lapses led to the failure of the treatment, but the commission found no evidence to support these claims and dismissed the charges.
Source: bit.ly/4fqZkxk

2. The Madhya Pradesh Medical Council reportedly proposes to introduce a system for renewing the doctor’s registration every five years. This will help track how many doctors are still in the state, how many have moved abroad, and how many passed away. The said measure aims to keep the medical registry updated and to ensure compliance with current medical standards.
Source: bit.ly/3ZU6XHX

3. The Delhi High Court has directed the Delhi Medical Council to ensure that patients can access doctor’s qualifications and mandated the public display of credentials. This decision addresses rising concerns about unqualified practitioners and delays in the verification process, aiming to enhance transparency and patient safety in healthcare.
Source: bit.ly/3VFWc9Q

4. India’s central food regulator, the Food Safety and Standards Authority of India (FSSAI), has released an updated list of recognized food testing laboratories, detailing their NABL accreditation validity as of December 12, 2024. These laboratories are authorized to analyze food samples under the Food Safety and Standards Act, 2006. The list includes validity details and contact information for laboratories in the Northern Region, with recognition guidelines governed by FSSAI’s directives.
Source: bit.ly/3ZREIK5

5. The Ministry of Environment, Forest and Climate Change has released a draft of Solid Waste Management Rules, 2024, to address unmanaged solid waste. The draft rules, published on December 9, 2024, will require compliance from various waste generators, including hotels and institutions, and will come into effect on October 1, 2025. The public is invited to submit objections or suggestions regarding the proposed rules by February 7, 2025.
Source: bit.ly/4fgKzw

Posted on

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

Posted on

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.

Guidelines to differentiate brand extension from surrogate advertising issued
In a meeting with stakeholders, the Department of Consumer Affairs (DoCA) has clarified the difference between brand extension advertisements which are permitted, and surrogate advertisements which are not permitted. A brand extension advertisement should not contain direct or indirect references to prohibited products. It should also not use colour, layout, or presentations associated with the prohibited products.
Source: bit.ly/42PKVGk

Draft Pharmacovigilance Guidance Document published for comments
A draft of the revised Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products has been published for comments. The last date for providing comments is March 23, 2024. This guidance document facilitates MAHs to setup & implementation of uniform Pharmacovigilance System for pharmaceutical products in the Indian market in the post-licensure period.
Source: bit.ly/3SSrfgw

Many small and medium pharmaceutical manufacturing units have been ordered shut down after increased surveillance
India’s central drug regulator, Central Drugs and Standards Control Organization (CDSCO), and state-level drug licensing authorities have reportedly issued show-cause notices to several drug small and medium manufacturers in the State of Punjab and Himachal Pradesh on grounds of poor quality control, and have also directed some of them to stop manufacturing.
Source: bit.ly/3I88UqP

Pharma MNCs exit domestic market due to regulatory headwinds
Many multinational pharmaceutical companies are reportedly cutting back on operations and manufacturing in India as part of a global strategic review due to regulatory headwinds on account of price control, rising costs, competition, and unfavourable intellectual property climate.
Source: bit.ly/42PaWW9

Frozen embryos should be treated as children: US Court
The Alabama State Supreme Court has ruled that frozen embryos in test tubes should be treated as ‘children’. This ruling has forced in vitro fertilization (IVF) providers in Alabama to stop treating patients, raising questions about the procedure’s continued availability in the state.
Source: bit.ly/3I8T4vR