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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 Maharashtra government plans to amend the Mumbai Nursing Home Registration Rules, 1949, following concerns from the Indian Medical Association (IMA) over the 2021 amendment, which mandated staffing and infrastructure requirements for small hospitals. The new amendments aim to align regulations with industry recommendations to improve infrastructural and staffing feasibility for healthcare providers.
Source: bit.ly/3CFx3G1

2. The European Medicines Agency has set 23rd July 2025 as the date for implementation of updated International Council for Harmonisation (ICH) guidelines on Good Clinical Practises. This latest version of the guidelines encourages the sponsors to design trials that are fit for purpose and sufficient to provide confidence in the trial’s results.
Source: bit.ly/3CG9rky

3. In the 1st half of Financial Year 2025, the National Pharmaceutical Pricing Authority’s (NPPA) overcharging demands from pharma companies dropped sharply, while the number of cases surged by over 50% compared to last year. This reflects a rise in enforcement actions but a decline in penalty amounts imposed.
Source: bit.ly/4jGCGnY

4. The amended version of European Union’s (EU) Medical Devices Regulations, 2017 introduced Section 10a to enhance transparency and availability of medical devices. It mandates early notification of supply disruptions, extends IVD transition periods, enables a gradual roll-out of Eudamed, and imposes new responsibilities on economic operators.
Source: bit.ly/414XApt

5. A Parliamentary Panel has urged the Ministry of Ayush to strengthen regulations for adverse effects reporting and ensure regular post-marketing surveillance of Ayush medicines. It has requested a detailed status report on actions taken to enhance the regulatory framework for reporting adverse effects and ensuring drug safety and efficacy.
Source: bit.ly/4gzfzZP

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 Food Safety and Standards Authority of India (FSSAI) has waived off the registration fees of hawkers for the grant of registration certificate and renewal of registration certificate with effect from 28th September 2024. The registration certificate will now be issued for five years only. Previously an option for selection of validity from one to five years was available to the applicant.
Source: bit.ly/4dy8EyA

2. Drug manufacturers submitting false or misleading information may reportedly face legal action from the Drugs Controller General of India (DCGI). As of now, the Drugs Rules, 1945 contains no provision addressing the problem of providing false, falsified, or misleading information for receiving regulatory approvals. As per the plan, the applicant may face debarment in addition to product suspension and cancellation for misleading the licensing authority.
Source: bit.ly/3Nh4D6V

3. An exemption has been granted for the generation of E-way bills for the transportation of job work, storage, and warehousing of goods, specifically turmeric, chilli (genus: Capsicum), and raisins, by the Maharashtra Government. This exemption applies on the condition that such goods are transported within the State of Maharashtra for a distance of up to fifty kilometers with no cap on consignment value.
Source: bit.ly/4dxlj4M

4. India’s Ministry of Health and Family Welfare (MoH&FW) is reportedly considering a proposal to classify all antibiotics as ‘new drugs’ under the New Drugs and Clinical Trials Rules, 2019. The aim is to regulate all antibiotics centrally through Central Licensing authority (CDSCO) rather than by State Licensing Authorities. The proposal also seeks to amend labelling requirements under the Drugs Rules, 1945, to address the rising concern over Antimicrobial Resistance (AMR), which has been highlighted as a global health priority.
Source: bit.ly/3ByExtw

5. Concerns over the potential harmful effects of hormonal contraceptives, particularly emergency contraceptive pills (ECP) or morning-after pills, have prompted India’s Central drug authority (CDSCO) to constitute an expert panel to discuss the possibility of requiring a doctor’s prescription before purchasing these drugs. The proposal to amend Drugs Rules is under examination by the three member committee constituted by CDSCO. As of now, hormonal contraceptives falling under Schedule K of the Drugs rules can be purchased without a prescription from a physician.
Source: bit.ly/4dFTXcT