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 Drugs Consultative Committee (DCC) has reportedly recommended to make Sugam portal database of all the products with brand names accessible to the general public to address the issue of different drug formulations of different therapeutic categories being sold with same or similar brand names in the nation.
Source: bit.ly/3XMWBbV2. The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has revised the accreditation standards for hospitals which will come into effect on January 1, 2025. No surveillance assessment will be conducted as per the old accreditation standard by NABH after 31st March 2025.
Source: bit.ly/47ydjPr

3. India’s Central Food Regulator will approve import of food consignments from Bhutan on the strength of Health Certificate issued by Bhutan Food and Drug Authority provided they are manufactured by the approved list of establishments of Bhutan.
Source: bit.ly/4gmtRxY

4. U.S. Food and Drug Administration has warned a major pharmaceutical company for making false and misleading claims about the benefits of a migraine pill in a television advertisement by a famous sports person. The claims were made against the results that were demonstrated in clinical trials.
Source: bit.ly/4gtau6m

5. A group of experts constituted by NITI Aayog to prepare a framework for action for emergency response and preparedness to address future pandemic, has recommended making the Central Drugs Standard Control Organisation (CDSCO) an independent regulatory authority. They have recommended to provide CDSCO with approved Standard Operating Procedures (SOPs) for Accelerated Emergency Use Authorisation for innovations and provisions for fast-tracking the process during pandemics.
Source: bit.ly/3XNynys

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.

Good Distribution Practices may be implemented in India for pharmaceutical products soon
India’s Drugs Consultative Committee (DCC) has recommended that draft of revised Good Distribution Practices (GDP) guidelines for pharmaceutical products should be made mandatory soon. The DCC is of the view that there is a gap in the law which requires owners of premises such as warehouses to ensure appropriate storage condition for drugs, but no such requirement exists for transporters who transport the drugs, and this affects the quality of drugs.
Source: bit.ly/49cMPCk

TB vaccine clinical trials begins in India
A Hyderabad based biotechnology company has started Phase 3 clinical trials of tuberculosis (TB) vaccine called MTBVAC among the adults in India. The vaccine is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from human strain, unlike the BCG vaccine.
Source: bit.ly/495Zuak

Medical and Sales Representatives’ body says new Pharma Marketing Code lacks teeth
The Federation of Medical and Sales Representatives’ Associations of India (FMRAI) has criticized the newly notified Uniform Code for Pharmaceuticals Marketing Practices (UCPMP), describing it as a futile effort. It stated that the new code lacks statutory enforcement and contains no explicit penal provisions against unethical marketing by pharmaceutical and medical device companies.
Source: bit.ly/495ZAic

Fire safety in hospitals should be evaluated by Government before Summer Season: Disaster Management Body
India’s Union Health Ministry and National Disaster Management Authority (NDMA) have jointly issued an advisory to all States and Union Territories (UT’s) to take proactive measures to check fire safety compliance of all hospitals before the incoming summer season.
Source: bit.ly/4akq9Bg

No change in surrender value norms for life insurance policies: Insurance Regulator
The Insurance Regulatory and Development Authority of India (IRDAI) has decided to retain the current surrender value requirements for life insurance policies due to concerns over higher surrender value expressed by the industry. Surrender value in life insurance is an amount paid by the insurer to the policyholder when the policy is terminated prior to the policy’s maturity date.
Source: bit.ly/43zOkcL