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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 Ministry of Corporate Affairs has broadened fast-track merger eligibility to include more unlisted firms and companies with debt under INR 100 crore and no defaults, as well as mergers involving holding companies and their unlisted subsidiaries even if not wholly owned streamlining consolidation and ease-of-business push.
Source: shorturl.at/viKVh

2. India’s Ministry of Health and Family Welfare has proposed amendments to the New Drugs and Clinical Trials Rules, 2019, expanding provisions for test licenses. The draft mandates prior permission or notification for manufacturing investigational drugs for trials, bioavailability/bioequivalence studies, and analysis and excludes sensitive categories sex hormones, cytotoxics, beta-lactams, biologics with live microorganisms, and narcotic/psychotropic substances from the simplified notification pathway.
Source: short-url.org/1dQTc

3. The Karnataka Pharma Retailers & Distributors Organization (KPRDO) urged reconsideration of a new 24×7 medicine delivery service via a quick commerce platform, citing conflict with longstanding pharmacy owners, regulatory hurdles amid a Delhi High Court injunction banning online medicine sales, and risks of drug misuse via teleconsultations.
Source: shorturl.at/lldc0

4. Drug regulators from five northern states reportedly met in Chandigarh to address counterfeit and psychotropic drug threats. They agreed to form an interstate coordination committee, adopt a unified tracking portal, conduct surprise inspections, implement SOPs, and strengthen cross-border enforcement through stricter legal and regulatory actions.
Source: shorturl.at/NG50D

5. The Supreme Court has refused to entertain a plea challenging the legality of declaring individuals as “brain dead” under the Transplantation of Human Organs and Tissues Act, 1994. The Court emphasized that the determination of brain-stem death is a matter of legislative policy and declined to question its validity.
Source: shorturl.at/MPWKA

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 Drugs Standard Control Organization clarified that labelling, overprinting, or stickering is strictly permitted for imported drugs. These activities require a valid manufacturing license, appropriate facilities, and adherence to labelling norms. Original labels must remain visible to maintain regulatory transparency and ensure clear identification of modifications and responsibilities.
Source: bit.ly/4kjfBYw

2. The Himachal Pradesh High Court held that vicarious liability for supplying substandard drugs requires proof that an individual was responsible for the company’s operations. Without such evidence, partners cannot be held liable, and only the company itself can be prosecuted for manufacturing or selling defective drugs.
Source: bit.ly/3Hfap9o

3. India’s Ministry of Health has released draft Drugs Rules proposing mandatory testing for bacterial endotoxins or pyrogens in injectable drugs. The rules require drug sales to be supervised by a competent person, with timely reporting of any changes. Exemptions apply to non-antimicrobial drugs used in food and beverage manufacturing. Feedback from stakeholders invited by June 30, 2025.
Source: bit.ly/4jomruw

4. West Bengal’s Drugs Control Administration mandates wholesalers and retailers to verify QR codes on top-selling brands and ensure purchases through authorized channels, aiming to curb counterfeit drug circulation.
Source: bit.ly/4krbkCj

5. The Bureau of Indian Standards (BIS) seized products worth ₹90 lakh from a Bengaluru warehouse for allegedly using the ISI mark without authorization, raising concerns for compliance in product sourcing and labelling across industries.
Source: bit.ly/4jppfr4

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.

1. India’s Environment Ministry is planning to exempt white category industries i.e., low environment risk industries from the requirement to obtain consent before establishing and operating an Industry provided the industry makes a self-declaration to the concerned pollution control board.
Source: https://bit.ly/3LygA7t
Source: https://bit.ly/4d7nqNv

2. India’s environment ministry is planning to exempt industries who have already obtained Environmental Clearance (EC) from obtaining environmental consent to establish the industry.
Source: https://bit.ly/3LygA7t
Source: https://bit.ly/4d7nqNv

3. After Odisha and West Bengal, other states in India are reportedly considering to allow online sale and home delivery of alcoholic beverages.
Source: https://bit.ly/3WiXAyu

4. Indian Pharmacopoeia Commission (IPC) has waived off the Target Animal Batch Safety Test (TABST), which involved administering vaccine overdoses to animals to test each batch of vaccine for safety of a specific species starting from 1st July 2024.
Source: https://bit.ly/3WAR8U3
Source: https://bit.ly/4fgy3is

5. EU antitrust regulators have officially accepted a pharmaceutical giant’s pledge not to disparage its competitor’s iron deficiency treatment medicine.
Source: https://bit.ly/3zSqMFn

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.

Insurance Regulator Removes Barrier to offering Insurance Policy to Senior Citizens among other underserved demographics
India’s Central level Insurance regulator the IRDAI has recently issued the Insurance Regulatory and Development Authority of India (Insurance Products) Regulations, 2024, where it has removed the barrier to insurance for persons over the age of 65 years. Previously, persons defined as “Senior Citizens” were not catered to, in terms of fresh insurance policy offerings.
Source: bit.ly/3JsNLIj

Pharmacists who were not personally dispensing medication at pharmacy penalized by Karnataka Pharmacy Council
The Executive Committee of the Pharmacy Council of the Indian State of Karnataka, by exercise of powers under Section 36 of the Pharmacists Act, 1948 has decided to take disciplinary action against certain Pharmacists for violation under Section 42 whereby only Pharmacists are permitted to dispense medication. It was found that several Pharmacists in the state were absent from their posts and had only been registered with their pharmacies for namesake.
Source: bit.ly/3QB2jtJ

Consumer Affairs Ministry has urged FSSAI to initiate Action against major food manufacturer for high sugar content in infant formula
India’s Central Consumer Affairs Secretary, in a recent letter to the Central Food Regulator (FSSAI), has urged it to initiate action against a major food product manufacturer, in light of the recent serious allegations regarding the heightened sugar content in the infant formula the company has been marketing in India.
Source: bit.ly/3xUo0Ox

India’s Central Bank has published Draft Circular regulating Point-of-Sale Payment Aggregators: Requiring compliance with Guidelines for online Payment Aggregators
India’s Central Bank, the Reserve Bank of India, has issued a Draft Circular for regulation of Payment Aggregators providing point-of-sale services, whereby, within 3 months of publication of final version of this Notification, all entities that are currently providing such services will be mandated to adapt and comply with all requirements concerning Guidelines on governance, merchant on-boarding, customer grievance redressal and dispute management framework, baseline technology recommendations, security, fraud prevention and risk management framework, as provided in a prior Notification on Regulation of Payment Aggregators and Gateways published in 2020.
Source: bit.ly/3U7NwY7
Source: bit.ly/3w55rHa

EU may revise categorization of Personal vs Commercial Confidential Data in Marketing Authorization Process
The European Union Regulator has begun consultation regarding an update to the current regulation surrounding what constitutes Personal data vs Commercial Confidential data in respect of protecting business secrets in marketing authorization applications submitted by pharmaceutical and medical devices companies.
Source: bit.ly/3JvpCRA