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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. A medical device company has received compensation calculated at 25% of sales generated by a counterfeiting entity. The Court opined that 25% was a conservative profit margin for awarding damages. The Court has additionally awarded exemplary damages to punish the counterfeiting entity.
Source: bit.ly/4kHWYhn

2. The Indian Pharmaceutical Alliance (IPA) has reportedly questioned the authenticity of an US study linking India-made generic medicines to higher rates of serious adverse events (SAEs) calling the claims unfounded. IPA highlighted that Indian manufacturing facilities undergo stringent inspections by regulators like the FDA, and lower costs are due to production efficiencies, not compromised quality.
Source: bit.ly/4kEqkx8

3. The Indian government is reportedly considering exemption of health and life insurance premiums from the current 18% GST. The GST Council has sought input from the Insurance Regulatory and Development Authority of India (IRDAI), with the industry advocating for a reduction to 12% instead of a complete exemption or lower rate (5%), to be able to claim Input Tax Credit (ITC) on taxes paid for business operations.
Source: bit.ly/3Fu3dFx

4. India’s Health Ministry has reportedly directed the Drug Controller General of India (DCGI) to focusing on eliminating poor-quality medicines, supporting small pharma manufacturers (MSMEs), and refining medical device regulations. The move is aimed at enhancing global trust in Indian medical products and exports.
Source: bit.ly/3DHeK3J

5. The Director General of Foreign Trade (DGFT) has invited comments on proposed changes to export policy for Special Chemicals, Organisms, Materials, Equipment and Technologies (SCOMET), which seek to fast-track grant of approval. SCOMET goods typically face strict export controls.
Source: bit.ly/3Fr2Uva

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 Department of Consumer Affairs has requested comments from stakeholders regarding the declaration of units of measurement for the net quantity of food wrapping paper and aluminum foils used for carrying food products. The proposal suggests including both “weight” and dimensions (length x breadth), i.e., kg and meters x meters (or cm x cm), rather than only weight or dimensions. This proposal aims to inform consumers about the actual quantity of packing material delivered.
Source: bit.ly/3Yld47H

2. The Indian Pharmacopoeia Commission (IPC), under India’s Health Ministry, has released an updated Medical Device Adverse Event Reporting Form for the reporting of Medical Device Adverse Events (MDAEs). The form states that reporting any MDAE will not have any legal implications for the reporter, and the reporter’s identity will be protected and kept strictly confidential.
Source: bit.ly/3XYGbwc

3. India’s Ministry of Health and Family Welfare (MoH&FW) is considering a proposal to amend the timelines for conducting audits and verifying compliance for grant of manufacturing license for medical devices in India. Currently, the Medical Devices Rules, 2017, do not specify these timelines, leading to delays in Quality Management System (QMS) inspections and the subsequent compliance verification processes.
Source: bit.ly/3ZXbr12

4. India’s Ministry of Health and Family Welfare (MoH&FW) is considering a proposal to restrict the eligibility requirements for qualifying as a competent person for obtaining a wholesale license for the sale, stocking, exhibition, or distribution of drugs in India to those with a pharmacy background, specifically D. Pharmacy, B. Pharmacy, M. Pharmacy, Pharm D, or individuals who are Registered Pharmacists.
Source: bit.ly/3ZXbr12

5. The Ministry of Health and Family Welfare (MoH&FW) is considering a proposal to ensure mandatory reporting of Serious Adverse Events (SAE) related to medical devices, including In-Vitro Diagnostic Medical Devices, by the manufacturer or importer of these devices in India. Currently, under the Medical Devices Rules 2017, there is no mandatory requirement for reporting such events by the license holder.
Source: bit.ly/3ZXbr12