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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.

New Framework to be created to separately regulate prices of Medical Devices
In response to demands from industry associations, India’s Central Drug Price Regulator, the National Pharmaceutical Pricing Authority (NPPA), in collaboration with the Department of Pharmaceuticals is reportedly in the process of developing a special pricing framework for Medical Devices comparable to similar prevailing regulations in other jurisdictions.
Source: bit.ly/49Wh8hc

Testing Standards for stability testing of In-Vitro Diagnostic Medical Devices have been prescribed to obtain manufacturing/ import license
India’s Central Drugs Standards Regulator (CDSCO) has released a draft Guideline regarding conduct of Stability Studies for In-Vitro Diagnostic Medical Devices (IvDMD). These guidelines cover the standards and testing for determining the overall shelf life, individual component stability, stability during transportation as well as, in-use stability of IvDMD. These guidelines are applicable for all manufacturers who are in preparation of submitting a pre-market review document in pursuance of obtaining a manufacturing/ import license under the Medical Devices Rules, 2017.
Source: bit.ly/4aP4TUJ

Students pursuing courses in Indian System of medicine will have to give exit test prior to applying for Registration as a practitioner of Indian System of Medicine: Delhi HC
In a recent decision, the Delhi High Court has held that only those students that have already obtained their respective recognized qualifications (either a BAMS, or BUMS degree) would be permitted to initiate the process for registering as a practitioner of Indian Traditional Medicine. This decision was taken on the basis of Sec. 15(1) of the National Commission for Indian School of Medicine Act, 2020 which mandates a common final exit test to be cleared prior to registration with State Register.
Source: bit.ly/3JxjPLo

Government relaxes obligation of deductees to pay higher TDS for persons whose PAN remained inactive for FY 2023-2024
In pursuance of Circular No. 3 of 2023, a person whose PAN (Permanent Account Number) has become inoperative has been subject to a higher rate of TDS. The Central Board of Direct Taxes has issued a notification recently, which relaxes this obligation of persons to deduct at a higher rate of TDS, for all transactions dated till 31st March 2024 provided that the linked PAN is reactivated before 31st May 2024.
Source: bit.ly/4aR96HE

AI Taking up more of Doctors’ time since it needs more training and monitoring
In a set of recently published studies at various teaching hospitals, it was revealed that using AI to manage patient interaction and medical records to assist Doctors has in fact, lead to Doctors spending more time on the tasks delegated to the AI, since the Doctors were now required to train and supervise the AI in addition to carrying out their regular responsibilities for these tasks.
Source: bit.ly/3Wg75QU

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