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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 Central Drugs Standard Control Organisation (CDSCO) has introduced a prior intimation system for the submission of applications for analytical or non-clinical testing in Forms CT-10, CT-12, and CT-13 under the New Drugs and Clinical Trials Rules, 2019 through the National Single Window System (NSWS) portal. The system does not apply to sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, or narcotic and psychotropic substances.
Source: short-url.org/1qC6E

2. The Government of India is reportedly considering stricter regulation of nicotine lozenges to curb access by minors and non-smokers. The Drugs Technical Advisory Board (DTAB) has reportedly recommended removing 2 mg nicotine lozenges from the exemption, which currently allows certain nicotine replacement therapy (NRT) products to be sold without a drug sale licence. If implemented, nicotine lozenges would largely be restricted to sale through licensed pharmacies.
Source: short-url.org/1lt4O

3. India’s central food regulatory authority (FSSAI) has recently in a Central Advisory Committee meeting urged states and UTs to strengthen enforcement against high-risk food commodities such as milk, edible oils, spices and honey. It called for risk-based inspections, faster recruitment of food safety officers, improved grievance redressal systems, and data-driven surveillance to strengthen monitoring and improve nationwide food safety oversight.
Source: short-url.org/1lt4V

4. Karnataka government has reportedly proposed banning the use of social media by children under the age of sixteen. Chief Minister Siddaramaiah announced the move during the state budget speech, stating that the measure aims to reduce the harmful effects of excessive mobile phone usage on minors across the state.
Source: short-url.org/1lt4-

5. India has outlined a five-pillar strategy to integrate artificial intelligence across healthcare, focusing on governance, data platforms, innovation, workforce capacity, and real-world validation. The framework aims to scale AI-driven diagnostics, public-health surveillance, and digital health infrastructure for pharma, med-tech, and health-tech companies to collaborate in data-driven healthcare innovation.
Source: short-url.org/1lt50

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 NPPA’s Multi-Disciplinary Committee (MDC) flagged a typographical error in major pharmaceutical drug manufacturing company’s IPDMS Form I, reporting retail price of tablet as ₹13 per tablet instead of ₹91, leading to incorrect pricing. MDC has cautioned the manufacturer to avoid such negligence to prevent procedural delays.
Source: short-link.me/1aSCE

2. The Indian government has reportedly clarified that there is no official classification of drugs as “life-saving drugs.” However, to ensure affordability and accessibility, 930 formulations listed in the National List of Essential Medicines (NLEM) are under price control, leading to significant price reductions and improved patient access.
Source: short-link.me/16tjO

3. The Chhattisgarh High Court, in a recent interim order, has permitted Bachelor of Pharmacy (B.Pharm) graduates to apply for Pharmacist (Grade-II) posts under the National Health Mission (NHM). The court deemed the NHM’s exclusion of degree holders as arbitrary, a violation of Articles 14 and 16 of the Constitution.
Source: short-link.me/1aSCL

4. Indian pharmaceutical exports specifically generics and biosimilars -are currently exempt from the U.S. tariffs, underscoring their indispensable role in ensuring affordable, high-quality medicines for U.S. consumers. With about 40% of generics and 15% of biosimilars in the U.S. supplied by India, Pharmexcil has reportedly urged sustained collaboration to preserve stable, resilient pharmaceutical supply chains.
Source: short-link.me/1aSCW

5. United States Food and Drug Administration experts recommended dropping the “black box” warning on estrogen-based menopause therapies, especially low dose vaginal estrogen arguing the label has deterred women from effective treatment. They cited updated evidence showing benefits in reducing heart attack and bone fracture risk. In India, doctors are optimistic this move will boost confidence in hormone therapy, which remains underused despite its potential benefits for millions of postmenopausal women.
Source: short-link.me/1aSCZ