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 Drug Controller General of India (DCGI) has directed all State and UT Drug Controllers to regularly sample kumkum and colour powders at religious sites for testing for synthetic ingredients due to public health concerns. Kumkum is regulated as a cosmetic in Indian law and must meet BIS standards covering heavy metal limits, microbial safety, prescribed testing methods, and mandatory packaging and labelling requirements.
Source: h7.cl/1nnwz

2. India’s Ministry of Agriculture & Farmers Welfare has released the draft Pesticides Management Bill, 2025 to replace the Insecticides Act, 1968. The farmer-centric bill proposes stronger regulation of spurious pesticides, higher penalties, digital processes, mandatory lab accreditation, and promotion of biopesticides and indigenous manufacturing. Stakeholders can submit comments in the prescribed format by 4 February 2026.
Source: h7.cl/1inPA

3. The Tea Board of India has issued revised guidelines for registration of manufacturers of flavoured tea, reaffirming that every factory manufacturing flavoured tea must be registered as a bonafide manufacturer with the Tea Board. This makes the registration process for flavoured tea manufacturers clearer and more structured.
Source: h7.cl/1nnx8

4. The European Parliament has approved measures to strengthen EU supply of essential medicines by reducing dependence on non-EU countries. The proposals support domestic manufacturing through strategic projects, priority funding, EU-favoured procurement, joint purchasing, and coordinated stockpiles to prevent shortages of critical medicines such as antibiotics, insulin and vaccines.
Source: h7.cl/1nnwI

5. India’s Central Drug regulator has given approval to manufacture and sell a generic version of Ozempic (semaglutide) for diabetes, ahead of its patent expiry in March 2026. The company plans to launch 12 million injectable pens in the first year and partner locally for distribution. The company is also awaiting similar approval for the obesity drug Wegovy.
Source: h7.cl/1nnwM

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 Competition Commission of India has ordered three Maharashtra liquor trade associations to cease anti-competitive practices, including influencing prices and restricting market access. The CCI found the groups violated the Competition Act and directed them to stop such conduct, though no monetary penalties were imposed.
Source: h7.cl/1g7kN

2. The Punjab government has issued strict new directives for private hospitals to curb exploitation, including mandated humane treatment protocols and safeguards in sensitive situations like patient death. The move aims to strengthen patient rights and accountability in healthcare delivery amid public concerns over unethical practices.
Source: h7.cl/1l0ob

3. Karnataka’s Health Minister has reportedly cautioned private hospitals against conducting unnecessary caesarean deliveries for financial gain, stating that violations under the Karnataka Private Medical Establishments Act may attract penalties up to fifty thousand rupees and potential cancellation of registration, following due process, if establishments fail to comply with regulatory directions.
Source: h7.cl/1l0p7

4. The All India Organisation of Chemists and Druggists has reportedly urged the Prime Minister to halt illegal e-pharmacy operations and withdraw proposed drug regulations, warning that unregulated online medicine sales, especially antibiotics, violate key laws and dangerously accelerate antimicrobial resistance, creating a significant threat to India’s public health system.
Source: h7.cl/1l0o0

5. The Indian Medical Parliamentarians’ Forum has reportedly warned that funding gaps and delays in India’s Rare Disease Policy are disrupting life-saving enzyme therapy for Lysosomal Storage Disorder patients. Over 60 patients have exceeded the ₹50-lakh cap and nearly 100 face imminent treatment loss, prompting urgent calls for expanded funding and sustained government support.
Source: h7.cl/1g7iS

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 Maharashtra Medical Council is set to launch a portal to register homeopathy practitioners who hold a one-year “Certificate Course in Modern Pharmacology” (CCMP), per government directive. Doctors’ groups have opposed this by stating that this move undermines MBBS standards, risks public health, and have demanded the notification’s immediate withdrawal.
Source: short-url.org/1eGvx

2. A renowned hospital has launched a ‘Living Will Clinic’ to help terminally ill patients document their medical preferences when recovery is not possible. Patients can predefine interventions like ventilation, CPR, surgery or home-vs-hospital death, appoint a healthcare representative, during critical moments.
Source: short-url.org/1eFVl

3. Computer Emergency Response Team – India (CERT-In) has mandated annual cybersecurity audits for all MSMEs starting September 1, 2025. Key mandates include, establishing a minimum security baseline, reporting incidents within six hours, keeping 180-day system logs, conducting yearly vulnerability assessments, and providing regular employee cybersecurity training.
Source: short-url.org/1eFVu
Source: short-url.org/1a5Na

4. The Delhi government has decided to establish a special committee under the Health Department to suppress the sale of counterfeit medicines across the city. Four specialised teams will conduct midnight raids especially near hospitals and medical shops. Seized drugs will go through laboratory testing to confirm authenticity.
Source: short-url.org/1a5Gx

5. Drug Controller General of India has directed state authorities in Gujarat and Delhi to take action against drug marketers associated with manufacturers who failed risk based inspections. Labels in some cases listed marketers with invalid addresses. Actions may include cancelling licences, stopping production, suspending product permissions however, it may disrupt the medical supply.
Soruce: short-url.org/1aatp

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 Karnataka health department has become the first state to implement the Supreme Court’s 2023 directive on a patient’s right to die with dignity. The government issued an order appointing medical experts to a secondary medical board to determine when life-sustaining treatment can be halted for terminally ill patients.
Source: bit.ly/3CEYPlX

2. Central government of India has published amended Water Pollution Guidelines to streamline the process of obtaining consent for industrial plants that may cause water pollution with an aim to simplify compliance and enhance ease of doing business for industries. The guidelines outline procedures for obtaining, renewing, and potentially losing consent to establish or operate such plants. These guidelines exempt certain category of project from obtaining the clearances. It also states that the projects that required the Environmental Clearance (EC) as per Environmental Impact Assessment (EIA) Notification, 2006 are exempted from obtaining the Consent to Establish (CTE) separately.
Source: bit.ly/3WOVyaK

3. India’s National Medical Commission (NMC) thereby upholding the patients’ rights is considering to authorize the patients to appeal against the orders of State Medical Commission (SMC). Earlier, only doctors were authorized to file an appeal against the decision of SMC.
Source: bit.ly/4grUoZq

4. The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) are working together to improve the accuracy of In-Vitro Diagnostic (IVD) tests in India. They have released a draft manual for Standard Performance Evaluation Protocols, inviting stakeholder comments. These protocols outline methods for evaluating the performance of IVDs used to diagnose diseases like Chikungunya, Dengue, and Zika. After the consultation period, ICMR and CDSCO will review the feedback and finalize the protocols for official adoption.
Source: bit.ly/3QhIAyF

5. Major drug manufacturer in India has received approval from the Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) to import and market tislelizumab injection, a cancer treatment drug. SEC waived the local clinical trial requirement under certain conditions, recognizing the drug as an orphan drug for an unmet medical need in India. Noting its approval in the USA, Europe, UK, Australia, China, and other countries, the committee also advised the company to submit safety and efficacy data for Indian patients, ensuring patient rights are considered.
Source: bit.ly/4hHyKSi

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO
The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward.
Source: bit.ly/3TEO74B

Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel
The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India.
Source: bit.ly/3VsdCaQ

Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements
As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company.
Source: bit.ly/3vu45VQ

Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided.
In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity.
Source: bit.ly/3vkn7hu

EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period.
The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market.
Source: bit.ly/3Vr9zeK