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 extended the timelines for the filing of Extended Producer Responsibility (EPR) annul returns by producers of Battery waste and E-waste for the Financial Year (FY) 2023-2024 till 31st March 2025 and 31st January 2025 respectively. For E-waste the extension of timelines also applies to the filing of quarterly returns for the abovementioned FY.
Source: bit.ly/3WthHei
Source: bit.ly/4gcsPmW

2. India’s National Pharmaceutical Pricing Authority (NPPA) has issued an office memorandum (OM) requesting manufacturers and marketing companies of the scheduled formulations nicotine used for nicotine replacement therapy (NRT) to furnish the Price to Retailer (PTR) and Moving Annual Turnover (MAT) data, in value terms for October 2023, within 7 days from the issue of the OM. A format for submitting these details is also provided in the OM. This information is being sought to fix the ceiling prices of these formulations.
Source: bit.ly/4gnoEFb

3. India’s Central Drugs Standard Control Organization (CDSCO) has released a guidance document to support the development of rapid diagnostics for pathogen identification and Antimicrobial Susceptibility Testing (AST). The document offers guidance to innovators and developers on evaluating their tests and demonstrating their effectiveness.
Source: bit.ly/4heX8ue

4. The Kerala High Court (KHC) recently ruled that magic mushrooms are not classified as narcotic substances under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. After reviewing the legal status of psychedelic fungi, the honourable court concluded that since magic mushrooms are not specifically scheduled under Act, they are not subject to its restrictions.
Source: bit.ly/3CiZv0k

5. India’s Central Pollution Control Board (CPCB) has released draft guidelines for the Pharmaceutical Industry in India, which are currently classified as highly polluting. The guidelines outline criteria for the establishment of pharmaceutical units, including mandatory minimum distances from sensitive areas. Stakeholders and the public are invited to submit their comments and suggestions on the draft guidelines by February 5, 2025.
Source: bit.ly/4h1GC0Y

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 Food regulator, the Food Safety Standards Authority of India, now requires linking of new licenses with the Permanent Account Number (PAN) of the applicants, additionally existing Food Business Operators have been requested to keep their PAN data up-to-date.
Source: bit.ly/48QImab

2. The Telangana Drugs Control Authority has issued notices to private hospitals in Hyderabad and Telangana, requiring stricter compliance with purchasing requirements for Narcotics Drugs, under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS).
Source: bit.ly/4hJQoWf

3.  The Ministry of Environment, Forest and Climate Change has relaxed penalties under the E-Waste Rules, 2022 and the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. From hereon, the contravention of any provision of these Rules shall not give rise to environmental compensation.
Source: bit.ly/4fqrp8W

4. In pursuance of an ongoing process for recovery of sums on account of a judgment of the Court for misleading conduct by the Respondent, the Supreme Court has issued an Order to auction the Trade Mark of a prominent Indian Hospital chain, while at the same time refusing to make provision for valuating the same.
Source: bit.ly/3Z1rcDf

5. European Union Drug Regulator considering proposal to reduce the duration of regulatory data protection available to companies.
Source: bit.ly/4hGEvQZ

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. The State Consumer Disputes Redressal Commission (SCDRC) has directed a consultant surgeon at a hospital in Erode to pay ₹5 lakh as compensation to the family of a patient who died during treatment for colon cancer. The Commission concluded that while there was no medical negligence during the surgery, the surgeon failed to secure proper cardiac evaluation prior to the procedure, which was deemed a significant oversight.
Source: bit.ly/3UHgY8t

2. The All India Organization of Chemists and Druggists (AIOCD) has raised concerns over a potential partnership between a popular fast delivery company and an online pharmacy aimed at delivering medicines within 10 minutes. AIOCD warns that this ultra-fast delivery model may bypass essential safety regulations, compromising patient safety and increasing the risk of antimicrobial resistance due to unregulated medicine distribution.
Source: bit.ly/4hzeSBr

3. The Drugs Controller General of India (DCGI) has mandated that no cosmetics can be imported unless their ‘use-by’ date is at least six months from the import date. The regulator also prohibited the import of cosmetics containing hexachlorophene and those tested on animals post-November 2014.
Source: bit.ly/4hElgr2

4. The Supreme Court has directed the National Medical Commission (NMC) to establish new guidelines for admitting persons with disabilities into medical courses, emphasizing the need for inclusivity in the healthcare sector. This decision follows a case involving a candidate with muscular dystrophy who was initially disqualified from pursuing an MBBS due to stringent disability criteria.
Source: bit.ly/3YAwWCG

5. The Central Pollution Control Board (CPCB) has issued guidelines to be used by State Pollution Control Boards (SPCBs) and Pollution Control Committees (PCCs), to assess and determine the processing capacities of E-Waste recycling facilities.
Source: bit.ly/3YBbcGK

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 Ministry of Corporate Affairs (MCA) has set a Deal Value Threshold (DVT) of ₹2,000 crore for mergers and acquisitions under the Competition (Amendment) Act, 2023. Transactions wherein the target company having substantial business in India if exceeds the given threshold, will have to obtain prior approval from the Competition Commission of India (CCI).
Source: bit.ly/3MGohZM

2. Ayurvedic businesses seeking to advertise ayurvedic drugs in Kerala must reportedly must secure permission from Kerala Drugs Control Department before making misleading and exaggerated claims via advertising. Advertisements made without approval will face legal repercussions.
Source: bit.ly/3AYOsbu

3. India’s Central Pollution Control Board (CPCB) has issued Environmental Compensation (EC) guidelines to address non-compliance with Extended Producer Responsibility (EPR) registration requirements, non-fulfilment of EPR obligations, non-filing of annual returns, among other violations under the E-waste Management Rules, 2022. These guidelines also regulate the cost of EPR certificates for fulfilling EPR obligations.
Source: bit.ly/3B05aY8

4. India’s Goods and Services Tax (GST) Council has decided to reduce the tax rate on cancer drugs – Trastuzumab Deruxtecan, Osimertinib and Durvalumab to 5% from the previous tax rate of 12%. The Council is reportedly set to finalize reductions in tax rates for health and life insurance premiums in its next meeting in November 2024.
Source: bit.ly/3zd6NB2

5. Medical Colleges in India must reportedly meet the safety and security measures of women doctors, nurses and students to get recognition from the Medical Education Regulator, National Medical Commission.
Source: bit.ly/3XEGNrT