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 Food Safety and Standards Authority of India (FSSAI) has directed to reduce the sample size of Vitamin D2 for analysis as it is an expensive ingredient. Earlier a sample of 500g was drawn for analysis, however now a sample of at least 50g is to be drawn i.e., two samples of 25g each, from the imported consignment and after the analysis, the remaining 25g should be returned to the importer making the sample collection process more cost-effective.
Source: bit.ly/4gN4R2m
2. The Federation of Pharmaceutical Entrepreneurs (FOPE) has highlighted the growing concern of Not of Standard Quality (NSQ) drugs in India and has proposed critical changes to the Drugs and Cosmetics Rules thereby calling for the inclusion of temperature, humidity, and photosensitive drugs under Schedule P. This proposed inclusion aims to enforce stricter shelf-life regulations for these types of drugs, ensuring they are subject to rigorous stability studies to verify their quality and safety throughout their shelf life.
Source: bit.ly/49VvAYw
3. The Telangana pharmaceutical industry has raised several concerns with the Department of Pharmaceuticals (DoP) and the Central Drugs Standard Control Organization (CDSCO), seeking clarity on certain provisions in the Revised Schedule M. These concerns primarily revolve around discrepancies between mandatory requirements and the WHO guidelines, which are generally regarded as voluntary and non-binding. The industry has also raised concerns about the production of nutraceuticals in facilities that are primarily designed for pharmaceutical manufacturing.
Source: bit.ly/49R29Xs
4. The National Pharmaceutical Pricing Authority (NPPA) has given an extension to one of the leading manufacturer of drug for the continued manufacturing of two of its scheduled Tetanus formulations until December 31, 2025. This extension follows company’s submission of Form IV, requesting approval to discontinue these formulations. Under Para 3 of the Drugs (Price Control) Order (DPCO), 2013, the government has the authority to direct manufacturers of active pharmaceutical ingredients (API), bulk drugs, or formulations to manufacture the drugs for adequate supply and accessibility of essential medicines.
Source: bit.ly/49TcdPC
5. The India’s Goods and Services Tax (GST) Council has introduced several significant changes to GST. Notably, gene therapy has been exempted from GST, and the decision on taxing restaurant services provided by electronic commerce operators at 5% has been deferred for further review. Additionally, the Council has clarified that caramel popcorn, due to its added sugar content, will attract a higher tax rate compared to salted or plain variants.
Source: bit.ly/3BFBNuT