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. To combat antimicrobial-resistance the Drugs Consultative Committee, which advises the Central and State Governments on conduct of Drug regulation in the country, has, in its 64th meeting recommended amendment to the Drug Rules to regulate sale of antibiotic Drugs to manufacturers who may not have a license under the Drug regulations.
Source: bit.ly/4evHfhA

2. The Punjab and Haryana High Court upheld the position that under the Narcotic Drugs and Psychotropic Substances Act, 1985, upon seizure, the entirety of the bulk of the seized substance need not be sent to the Forensic Laboratory, rather merely a select homogenized sample thereof would be sufficient.
Source: bit.ly/4gx15uL

3. The Supreme Court has ordered the Central Government Ministry of Health and Family welfare, and the Government of Kerala to file counter-affidavits explaining the delayed action in setting up a special committee to study the effectiveness of the Rabies vaccine.
Source: bit.ly/3MXwwAE

4. The High Court of Bombay has struck down the insertion of Rule 3 of Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Amendment Rules, 2023, which empowered the government to set up fact-check units on the ground that this violated the fundamental right to equality and to carry on trade and business.
Source: bit.ly/4diYthg

5. The United States Federal Trade Commission has formally initiated litigation against Pharmacy Benefit Managers which act as middlemen between Drug Companies and Insurers, for deliberately driving the price of insulin higher for consumers and receiving rebates from manufacturers in the process.
Source: bit.ly/3zrNfcq

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

India’s Central Pollution Control Board has issued final warning to all Producers, Importers, Brand Owners and Plastic Waste Processors, to complete Extended Producer Responsibility (EPR) registration on dedicated EPR portal latest by June 30, 2024, or face punishment.
Source: bit.ly/4cgRsxK

India’s Health Ministry has published Guidelines for Ethical Use of Leftover De-identified/ Anonymous Samples for commercial purposes.
Source: bit.ly/3RIc0XE

The Committee on Energy and Commerce in Congress of the United States of America has sought reply from US Food and Drugs Administration (US FDA) about institutional weaknesses in US FDA’s foreign inspection program over variations in inspection outcomes from India and China.
Source: bit.ly/3RF3xEH

India’s Karnataka High Court has formed a sub-committee to draft rules for establishing Intellectual Property Division (IPD) in Karnataka High Court. IPD benches are established with specialised judges to cater to Intellectual Property Disputes.
Source: bit.ly/4bmOVR8

India’s Kerala High Court, in a recent case, has framed guidelines for prosecuting guardian of a minor, or the owner of a vehicle driven by a minor, for offences involving vehicle driven by the minor.
Source: bit.ly/3RHALDn

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

The US Food and Drug Administration (FDA) has finalized guidance on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The latest guidance extends the US FDA’s existing inspection standards for drug manufacturing companies to include device manufacturing companies as well.
Source: bit.ly/3XCVD2s

The Department of Pharmaceuticals (DoP) expanded its committee on drug and medical device pricing reform and added key public stakeholders to the committee as special invitees. This special invitees include patient advocacy groups, healthcare providers, and the medical community.
Source: bit.ly/3XDmJ9z

Indian government has formed a committee to assess the feasibility of allowing nutraceutical production within existing drug manufacturing facilities. This follows the recent update to Schedule M of Drugs Rules, 1945, which mandates separate production areas for nutraceuticals and pharmaceuticals.
Source: bit.ly/45JefzF

India’s Drugs Technical Advisory Board (DTAB) is evaluating a ban on chloramphenicol and nitrofuran antibiotics in animal feed due to misuse concerns in poultry and livestock.
Source: bit.ly/3zleFAo

New guidelines on the withdrawal of life support from terminally sick patients have been released by the Ministry of Health and Family Welfare (MOHFW) for healthcare providers and are to remain open for public comments for one month. The guidelines emphasize patient’s autonomy and their right to decline life-sustaining treatment (LST), even if doing so results in death.
Source: bit.ly/3RH4D2P