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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.

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

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Daily Health News Wrap – 01 Feb 2024

01 Feb 2024

Important clarifications issued by Central Pollution Control Board w.r.t. Extended Producer Responsibility (EPR) compliances under E-waste Management Rules, 2022.
India’s Central Pollution Control Board (CPCB) has released certain notices and guidance document under E-Waste (Management) Rules, 2022 which have a significant impact on EPR obligations.
Sources: –
FAQ for E-waste: bit.ly/3HHuiCU
Fee Structure for registration for Recyclers: bit.ly/3SpMBkS
Notice for Producers:  bit.ly/48XXFwK
Notice for Recyclers: bit.ly/48XhbJK
Important clarification issued by India’s Central Pollution Control Board (CPCB) under E-waste Management Rules, 2022 (EWM) for the importers of Electrical and Electronic Equipment (EEE) who are not required to comply with Extended Producer Responsibility (EPR) requirements
India’s Central Pollution Control Board has issued a clarification under E-waste Management Rules, 2022 (EWM Rules) identifying importers of Electrical and Electronic Equipment (EEE) who are not required to be registered as Producers under EWM Rules and therefore do not need to fulfil Extended Producer Responsibility (EPR) obligations. Such producers are required to submit certain documents to Customs/Port authorities as a proof of submission of those documents to CPCB.
Source: bit.ly/42kj9Bq
Indian Government extends the deadline for application of quality control order for certain drugs
Indian Central Government has extended the dates of applicability of Quality Control Orders (QCO) of Morpholine, Acetic Acid, Methanol and Aniline to 1st August 2024, 3rd August 2024, 3rd August 2024 and 3rd August 2024 respectively.
Source: bit.ly/48XokK3
Indian Government extends timelines for submission of application under Production Linked Incentive (PLI) scheme
The Department of Pharmaceutical under the Indian Ministry of Chemicals and Fertilizers has extended the timeline for medical device manufacturing companies to submit the application under the Production Linked Incentive (PLI) Scheme till the end of February 2024. The PLI scheme aims to promote domestic manufacturing of class B medical devices.
Source: bit.ly/47Y4UDx
New Guidelines for effective performance of Environment Regulators issued by Supreme Court of India
The Supreme Court of India has recently issued stringent guidelines which ensure the efficient functioning of environmental protection authorities and the enforcement of environmental regulations across the country. The court also upheld the reconstitution of the Central Empowered Committee (CEC), which is tasked with compliance with judicial orders pertaining to environmental conservation.
Source: bit.ly/3SFwscs