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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

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.

New Departmental Guidelines for sampling of Spurious Drugs, Medical Devices and Cosmetics Published
India’s apex regulatory body for drugs, medical devices and cosmetics, the Central Drugs Standards Control Organization, has published revised sampling guidelines for inspectors to follow in various states. All inspectors are required to collect at least 9 samples of drugs, and 1 sample of cosmetic or medical device in each month. The inspectors are supposed to be alert about feedback received from citizens and doctors in deciding which drugs, cosmetics and medical device brands they ought to sample and test for compliance with laws.
Source: bit.ly/3SDnLym

Social Media companies asked by High Court to handover details of persons who fraudulently operated certain accounts and channels
The Delhi High Court has ordered major social media companies including Facebook and Telegram to disclose identities of users accused of misusing trademark of major venture capital firm to cheat users by soliciting bogus investments. The court has also ordered concerned social media companies to provide details on action they will take to prevent further violation.
Source: bit.ly/3HXkxAP

WhatsApp and emails may be used to send legal notices for demanding unpaid amounts: High Court
The Allahabad High Court has reiterated that notice in cheque bounce case sent by WhatsApp or e-mail will be considered valid notice for the purposes of recovery under The Negotiable Instruments Act, 1881, and it will be presumed to have been dispatched and served on the same day.
Source: bit.ly/48f8Xf6

Popular Party Drugs added to list of Psychotropic Substances
The Indian Government has added popular synthetic party drugs, ADB-BUTINACA, Alpha-PiHP and 3 Methylmethcathinone (3-MMC), to list of psychotropic substances and notified small and commercial quantity of these substances for the purpose of fixing quantum of punishment for unlawful possession. Possessing psychotropic substances without permission or prescription is an offence under Narcotic Drugs and Psychotropic Substances Act, 1985.
Source: bit.ly/48ghuhM

WHO recommends antibiotics which should be exclusively put to human use to reduce chance of antimicrobial resistance
The World Health Organization (WHO) has updated its Medically Important Antimicrobials for Human Use (WHO MIA List), and reclassified antimicrobial drugs on basis of potential impact on human heath to limit the use of identified antimicrobials in other populations such as in plants and animals. The WHO hopes that reducing use of critical antimicrobial drugs in other population will reduce pace of antimicrobial resistance.
Source: bit.ly/49eVll9

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.

Human Rights body to probe sale of drugs with identical brand names in India
The National Human Rights Commission (NHRC) in India has taken suo motu cognizance of a newspaper report which stated that many drugs in India were being sold with identical brand names for treating different medical conditions. NHRC has issued notice to Secretary, Ministry of Health and Family Welfare and Central Drugs Regulator, asking for detailed report within four (04) weeks.
Source: bit.ly/3SB8WfB

India’s Environment Regulator to take action against unregistered recyclers and refurbisher of battery waste
India’s Central Pollution Control Board (CPCB) has issued direction to all State Pollution Control Board (SPCB) and Pollution Control Committees (PCCs) to ensure compliance with Battery Waste Management Rules, 2022 by recyclers and refurbishers of battery waste. CPCB has directed SPCB/PCC to carry out drives identifying informal / illegal battery waste recyclers, and physically verify facilities of existing waste recyclers. All battery waste recyclers and refurbishers are obligated to register under Battery Waste Management Rules, 2022.
Source: bit.ly/3OGJTGI

Difference of manufacturing process will not take away ability of manufacturer of product manufacturer to enforce product patent, if the product is covered by Product-by-Process Patent: High Court
The Delhi High Court of India has held that a product-by-process patent would be enforceable even if the alleged infringement relates to manufacturing of a product using process which is different than the one claimed in patent. The High Court was dealing with a matter relating to manufacture of a compound called Ferric Carboxymaltose (FCM) which was patented by the Innovator. The defendants had raised an argument that they are not covered by the patent because they were following a different process to manufacture FCM. However, the argument was rejected by the High Court.
Source: bit.ly/3OGtr9C

Manufacturers of medical devices who do not wish to disclose name and address of manufacturing facility, may apply for neutral code on central portal
The Indian medical devices regulator, Central Drugs Standard Control Organization (CDSCO) has direct all the manufacturers of medical devices for export purposes to submit the applications for neutral code through online system of medical devices portal only. If a neutral code is declared on the label of package, it does not have to bear the name and address of the manufacturer. The online portal is now functional to accept the applications.
Source: bit.ly/3SWgTxn

Recommendations for COVID legislation received from Law Commission of India
The Law Commission of India has submitted its report titled “A Comprehensive Review of the Epidemic Diseases Act, 1897″ to the Government of India. The commission has recommended either to amend the existing law or enact the new legislation to address the underlying gaps in the Epidemic Diseases Act, 1897. The 1897 was relied on by the Government of India to introduce various controls during the COVID pandemic, including lock downs.
Source: bit.ly/3SWMdMm

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.

Innovator Pharma Company questions biosimilar trial on ground of non-procurement of comparator drug from authorized sources
A multinational pharmaceutical company has questioned the veracity of a biosimilar drug trial before India’s clinical trial regulator, The Drugs Controller General of India (DCGI), on grounds that the comparator drug, a biologic, was not procured from authorized sources, thereby putting clinical trial subjects at risk and casting shadow over appropriateness of the clinical trial.
Source: bit.ly/49tJmjj

Indian IPR regime well-equipped to handle AI generated works and there is no proposal to amend the law in context of AI generated content: Ministry of Commerce & Industry
India’s Minister of Commerce & Industry, while replying to a question in India’s parliament, has clarified that user of Generative AI should obtain permissions of owner of original copyrighted work processed by Generative AI technology before using the AI generated content for commercial purposes. The Minister further clarified that there is neither any proposal to create any separate right nor to amend the law in the context of AI-generated content.
Source: bit.ly/48cK4R8

Guidelines to distinguish nutraceuticals and drugs which have same or similar composition soon
The Indian Government has reportedly formed a high-level committee to address complaints that products which have identical or similar compositions are being approved as nutraceuticals, drugs or ayurvedic formulations, depending on the regulatory pathway chosen by the manufacturer. Under the current law, nutraceuticals are not permitted to make claims of treatment or cure on the label, however there are reports of non-compliance with this requirement.
Source: bit.ly/49bvaMb

Preparing a list of unvaccinated employees does not amount to violation of privacy: Madras High Court
India’s Madras High Court has held that the action of preparation of list of employees who have not received COVID-19 vaccinations and subsequent circulation of such list amongst employees of company would not amount to violation of privacy. The High Court was hearing a criminal complaint filed by an employee of the Company under Information Technology Act, 2000 on grounds that the Company had breached the said law sharing his personal information as part of list of unvaccinated employees.
Source: bit.ly/42yExmP

Couples seeking surrogacy on medical grounds are able to use donor sperm or egg, in spite of law to the contrary, by approaching a High Court
Following the precedent set by Supreme Court, the Bombay High Court has permitted two couples to use donor eggs for surrogacy owing to medical issues faced by the Couple. The development is important because The Surrogacy (Regulation) Rules, 2022 explicitly prohibits the use of donor gametes for surrogacy. In the past, Karnataka High Court has also granted similar reliefs to a couple facing medical challenges to conceive using own gametes while seeking a surrogate to deliver the baby.
Source: bit.ly/42yczHP