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

The new criminal code, Bharatiya Nyaya Sanhita (BNS) has replaced the Indian Penal Code (IPC) and introduced stricter penalties for medical negligence. Registered Medical Practitioners can now face up to two years in jail and fines for medical negligence. The new law will apply from July 1, 2024.
Source: bit.ly/3RXnx5t

The Central Pollution Control Board (CPCB) has extended the last date of filing of annual returns by the registered producers, importers, brand owners (PIBOs) and plastic waste processors for FY 2022-24 and FY 2023-24 respectively till September 2024. The earlier timeline to file the annual returns were June 30, 2024 and April 30, 2024 respectively.
Source: bit.ly/3XQtxAY

In an effort to decrease reliance on imports and to promote domestic production of medical devices, the Department of Pharmaceuticals (DoP) reportedly intends to launch a new program that will provide shared facilities for medical device parks or clusters that are formed with the exclusive financial assistance of the state governments.
Source: bit.ly/3xU6b2u

The Enforcement Directorate (ED) is investigating an alleged nationwide network of contraband dealers and has placed several pharmaceutical companies under scrutiny who are engaged in the production of drugs and opioids as a measure to prevent the creation of illicit distribution networks through fraudulent sale and supply bills.
Source: bit.ly/3VNzoEw

The United States Food and Drug Administration (USFDA) has published a draft guidance that removes the requirement of undertaking switching studies for applicants undertaking an approval for treating Biosimilars as interchangeable. The USFDA has now made switching studies optional for biosimilar approvals. Hence, persons applying for approval for Biosimilars may now use computer modelling based on the current acceptable analytical technologies to demonstrate the Biosimilars as interchangeable.
Source: bit.ly/4eQUudy