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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.

1. The State Excise Department of Orissa has recently issued a notification to declare separated leaves of the Cannabis plant, also referred to as Bhang, as “intoxicant” under the State Excise law. Prior to this notification, Orissa was one of the few states where Bhang was not regulated as intoxicant.
Source: bit.ly/46J2NVn

2. India’s drug price regulator, NPPA, has rejected a price revision plea of a manufacturer of drug on grounds that it had failed to communicate revision of prices of the drug in Form II of Drugs (Prices Control) Order, 2013 within prescribed timeline of 15 days.
Source: bit.ly/3M6bBuX

3. The Bombay High Court has observed that an egg/ sperm donor in an in-vitro fertilization scenario cannot seek the same rights as a parent.
Source: bit.ly/3YQVPeO

4. All entities who are not registered as telemarketers will not be able to make promotional calls. If any complaint is received against such entity, then it will be blacklisted for two years.
Source: bit.ly/3AsgYSM

5. The Telecom Regulatory Authority of India, the country’s internet and telecommunications regulator has issued an order to telecom and internet service providers to disconnect and remove access for unregistered telemarketers who are carrying out voice-promotional calls. Once disconnected, such persons shall be required to submit a compliance report within 1 week, and may be given an opportunity to register with the TRAI.
Source: bit.ly/4dD3eCE

 

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Supreme Court has issued its decision in a matter concerning the legality of exercise of powers by the National Pharmaceutical Pricing Authority (NPPA) in levying overcharging fees against an entity that claimed not to be a “distributor” or a “dealer” as defined under the Drugs (Prices Control) Order, 1995, since it had a dual role. The Court held that there is no mutual exclusivity between a dealer and a distributor, and dismissed the appeal.
Source: bit.ly/3xPkgP1

2. The National Medical Commission, has mandated the presence and maintenance of a Tobacco Cessation Centre at all hospitals attached to Medical Colleges across the country.
Source: bit.ly/3WdIjzk

3. To curb rise in misleading advertisements, the Central Government may soon introduce regulation to restrict the advertisement of Diabetes, Sex Hormone and Oncology medication, and may require approval and permission to make claims of efficacy for these Drugs.
Source: bit.ly/46nCjst

4. The Ministry of Health and Family Welfare has published Draft Drugs (Amendment) Rules, 2024 whereby it intends to amend Rule 96 requiring inclusion of details of Drug excipients on retail labels of Drugs.
Source: bit.ly/463YZO9

5. The European Commission has published and adopted the Artificial Intelligence Act, which will regulate the inclusion and integration of AI into Medical Devices and In-Vitro Devices. This Act is set to come into force on the 2nd August 2024.
Source: bit.ly/3Y5qCUV

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.

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.

Manufacturers of tobacco products required to register their packing machine(s) with tax authorities
India’s Central Board of Indirect Taxes and Customs (CBIC) has postponed the timeline for manufacturers of tobacco products such as pan-masala, chewing tobacco, smoking mixtures, etc. to report their production capacity. CBIC had in January this year announced that producers must register their filling and packing machines and report these details. The measure was set to be implemented from 1st April 2024. However, the new effective date for implementation of the timeline is now 15th May 2024.
Source: bit.ly/3xz7400

NPPA releases draft ceiling price calculation sheets of seven scheduled formulations
The National Pharmaceutical Pricing Authority (NPPA) has published a preliminary calculation of ceiling prices for seven drug and vaccine formulations, inviting feedback from stakeholders within a ten-day period. These ceiling prices have been adjusted to reflect the minimum and maximum market prices of the products, in accordance with the updated Schedule I of the Drugs (Prices Control) Order, 2013, aligning with the National List of Essential Medicines (NLEM), 2022. The move shall be affecting major pharmaceutical giants in the business of ORS, vaccines and more.
Source: bit.ly/3UhjK4J

High Courts should interfere only when the case in lower court was decided by fraud or collusion: Supreme Court of India
While deciding an appeal against the order of the High Court, the Supreme Court of India observed that the High Court should apply care and caution while entertaining the petitions under Article 226 of the Constitution. The Court further explained that, in case of an already available alternative statutory remedy, the High Court should interfere in the matter only when the case is decided by fraud or collusion, otherwise an order in the same matter by the High Court will mean reopening the issues that have achieved finality.
Source: bit.ly/4cNGwIJ

Goa FDA to get the status of “US FDA observer” amid surge in increase in retail and wholesale licenses
The Goa Food and Drug Administration (FDA) has been extended the invitation to participate as “FDA observer” for inspections conducted by the USFDA India Office. This development came as a result of increase in retail and wholesale licenses issued by Goa FDA and their familiarity with the US FDA’s inspection process.
Source: bit.ly/3UfqIHq

Rejecting apology of the Directors of a Company for misleading advertisements, the Supreme Court sets caution for FMCG companies
Observing caution for fast-moving consumer good (FMCG) companies, the Supreme Court of India has refused to accept an apology from a major Indian Ayurvedic medicine manufacturer for misleading advertisements regarding its products in contravention of an undertaking provided to the Court. The Supreme Court stated that misleading advertisements by FMCG companies result in deceiving innocent consumers and play with public health.
Source: bit.ly/3PYqoKq

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.

E-Commerce websites instructed to avoid marketing Milk/ cereal/ malt based drinks as “Energy Drinks”
India’s Food Standards Regulator (the Food Safety Standards Authority of India) has issued an advisory to e-commerce websites, requiring them to ensure that proprietary foods, i.e. foods that are not categorized under the Food Standards Regulations, specifically those currently registered as analogues to milk/ cereal/ malt based beverage, should not be advertised as “Health Drink”/ “Energy Drink”, as only carbonated/ non-carbonated water-based flavoured drinks are regulated as “Health Drink” and “Energy Drink”.
Source: bit.ly/3xlfzvD

Drug Price Regulator may examine prevalent drug substitution and discounting prices offered by major drug retail stores in India
The Indian Central Drugs Regulator (CDSCO) has reportedly requested the Central Drugs Price Regulatory Body (NPPA) to investigate drug substitution and discounting practices of a major pharmacy chain on the basis a complaint raised by State Chemists and Druggists’ Association of the State of Karnataka (KCDA). In its complaint, the KCDA has alleged that the major pharmacy chain has been deliberately undercutting prices, sustained by substitution of prescribed drugs with other cheaper but identical formulations and unreasonably increasing its profit margins, which is currently violative of regulations applicable to pharmacists, as well as pricing norms of drugs.
Source: bit.ly/4cJSJOg

Vaccine manufacturers may have to provide manufacturing and sales data to government soon
The advisory body to India’s Central Drugs Regulator, the Drugs Consultative Committee, has requested various State-level Drug Licensing Authorities to ensure submission of details of the manufacture and sale of vaccines within the states to the Central Drugs regulator (Central Drugs Standards Control Organization), for the purpose of meeting obligation for the Global Benchmarking of Vaccines of the World Health Organization.
Source: bit.ly/3PJkAEw

Major Ayurvedic Medicine manufacturer may be on hook for contempt of court after Supreme Court rejects its apology for publishing misleading advertisements
In its ongoing proceedings against a major Ayurvedic medicine manufacturer for publication of misleading advertisements in contravention of undertaking given by it to the Supreme Court, the Court has refused to accept the apology which was tendered by the manufacturer, and rejected submissions of the manufacturer that: (1) The restriction on advertisement under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is archaic and may be relaxed since the manufacturer now has scientific data to back its claims, and (2) that the manufacturer should not be held liable for an advertisement issued by an independent marketing department.
Source: bit.ly/4akJen5

Australia updates Medical Device Recall Procedure
The Australian Therapeutics Goods Administration, which regulates medical devices at the central level in the country, has published a revised version of the Uniform Recall Procedure for Therapeutic Goods (URPTG), which relaxes regulatory burden of importers and manufacturers of medical devices. The revised URPTG provides additional clarity on procedure for immediate recall, clarifying timing of release of recall information by the regulator, modifying Customer Response Forms, and eases the filing requirements under the law by making all templates for recall action publicly available on the website of regulator.
Source: bit.ly/3TAZJEo

Posted on

TOP 5 HEALTH LAWS & 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.

Central Drug Regulator to have open-door meetings with Industry twice a week
In a first, perhaps anywhere in the world, India’s top officer in the Drug Regulator’s office, the Drugs Controller General of India (DCGI), has announced that there will be walk-in meetings for the industry every Tuesday and Thursday between 5 and 6 pm, where industry can present its problems and suggestions directly before the officer. The move is aimed at improving Ease of Doing Business in India.
Source: bit.ly/48k9MmX

Waiting for Drug Price Regulator to fix retail prices of new drugs before they can be launched will adversely impact industry
An association of pharmaceutical manufacturers has reportedly submitted an appeal before the Drug Price Regulator, National Pharmaceutical Pricing Authority (NPPA), to recall its notice which directs drug manufacturers to delay launch of new drug until the retail prices of those products have been fixed and notified by NPPA. The association has submitted that notice will negatively impact drug manufacturers’ businesses and cause significant losses.
Source: bit.ly/48cUJvf

Regulatory Data Exclusivity on negotiation table between India and Europe during FTA talks
As per media reports, European Free Trade Association has demanded regulatory data exclusivity for drugs during the discussion on proposed Trade and Economic Partnership Agreement. If India accepts the demand, then Indian domestic drug manufacturers will not be able to rely on clinical trial data of innovator drug manufacturer for obtaining regulatory approvals in India, thereby impacting cost and timelines for generic drugs entry in Indian market.
Source: bit.ly/3T01NHe

Insurance Regulator has proposed to increase free-look time for insurance policies from 15 days to 1 month
As part of the recently published draft IRDAI (Protection of Policyholders’ Interests and Allied Matters of Insurers) Regulations, 2024, the Insurance Regulator (IRDAI) has proposed to increase the free-look time for insurance policies from 15 days to 1 month. The free-look time is the time by which a policy holder of an insurance policy can cancel an insurance policy after purchasing it without liability to him.
Source: bit.ly/3T1PcDr

New York City has sued major social media companies for affecting mental health of youth and children
The New York City Mayor has announced that his administration has sued major social media companies on ground that they have intentionally designed platforms to purposefully manipulate and addict children and teens to social media applications.
Source: bit.ly/3OLyZPY