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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. The Karnataka health department has become the first state to implement the Supreme Court’s 2023 directive on a patient’s right to die with dignity. The government issued an order appointing medical experts to a secondary medical board to determine when life-sustaining treatment can be halted for terminally ill patients.
Source: bit.ly/3CEYPlX

2. Central government of India has published amended Water Pollution Guidelines to streamline the process of obtaining consent for industrial plants that may cause water pollution with an aim to simplify compliance and enhance ease of doing business for industries. The guidelines outline procedures for obtaining, renewing, and potentially losing consent to establish or operate such plants. These guidelines exempt certain category of project from obtaining the clearances. It also states that the projects that required the Environmental Clearance (EC) as per Environmental Impact Assessment (EIA) Notification, 2006 are exempted from obtaining the Consent to Establish (CTE) separately.
Source: bit.ly/3WOVyaK

3. India’s National Medical Commission (NMC) thereby upholding the patients’ rights is considering to authorize the patients to appeal against the orders of State Medical Commission (SMC). Earlier, only doctors were authorized to file an appeal against the decision of SMC.
Source: bit.ly/4grUoZq

4. The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) are working together to improve the accuracy of In-Vitro Diagnostic (IVD) tests in India. They have released a draft manual for Standard Performance Evaluation Protocols, inviting stakeholder comments. These protocols outline methods for evaluating the performance of IVDs used to diagnose diseases like Chikungunya, Dengue, and Zika. After the consultation period, ICMR and CDSCO will review the feedback and finalize the protocols for official adoption.
Source: bit.ly/3QhIAyF

5. Major drug manufacturer in India has received approval from the Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) to import and market tislelizumab injection, a cancer treatment drug. SEC waived the local clinical trial requirement under certain conditions, recognizing the drug as an orphan drug for an unmet medical need in India. Noting its approval in the USA, Europe, UK, Australia, China, and other countries, the committee also advised the company to submit safety and efficacy data for Indian patients, ensuring patient rights are considered.
Source: bit.ly/4hHyKSi

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 Central Pollution Control Board (CPCB) has directed Plastic Waste Processors (PWPs) to upload valid GST e-Invoices for the sale of product for the purpose of EPR certificate generation on the EPR portal for plastic packaging. The invoices must include key details like Buyer GST number, Seller GST Number, IRN No., HSN code, Invoice Number and QR code, ensuring they are signed, clearly visible, and readable.
Source: bit.ly/4fGikIn

2. India’s Food Safety and Standards Authority of India (FSSAI) has reportedly constituted a panel that is in the process of finalizing guidelines to monitor microplastics and nanoplastics in food and bottled water. This move follows alarming findings of their presence in both branded and non-branded salt and sugar products consumed in India.
Source: bit.ly/4iXJrl4

3. India’s Karnataka High Court has temporarily barred government action against pharmaceutical companies manufacturing nutraceuticals in drug-licensed facilities until its next hearing. This follows challenges by industry bodies and stakeholders against Schedule M of the Drugs and Cosmetics Act, which prohibits the production of non-drug items, like nutraceuticals, in drug manufacturing premises.
Source: bit.ly/41WVEQI

4. Doctors in the Indian state of Maharashtra have raised concerns over a directive from the state’s Food and Drugs Control Department (FDA), which allows homeopaths with a modern pharmacology certificate to prescribe allopathic medicines, despite a pending case in the Bombay High Court. They have also questioned the eligibility of homeopaths to prescribe modern medicine. The directive permits chemist retailers and wholesalers in the state to sell allopathic medicines prescribed by such homeopaths.
Source: bit.ly/424Awbg

5. The Chief Medical and Health Officer (CMHO) of a district in Madhya Pradesh, India, has warned private hospitals against employing BAMS/BHMS doctors as RMOs or duty doctors, particularly in ICUs and emergency departments, instead of qualified MBBS doctors and the violations may lead to registration cancellations under the Nursing Home Act. This comes amid nationwide concerns over patient safety and the misuse of medical designations, with healthcare experts calling for stricter oversight and accountability.
Source: bit.ly/3DOcMhw