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 …
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. Supreme Court clarifies when a patient’s negligence may be reduced due to pre-existing conditions India’s Supreme Court has laid down the situations in which a patient’s claim for …
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. India’s Supreme Court extends scope of misleading advertisement review to multinational and domestic FMCG manufacturers, doctors In a proceeding against a major Ayurvedic products manufacturer for publication of …
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. Strict quality checks to be done by the food regulatory authority of powdered spices in India Food Safety and Standards Authority of India (FSSAI) has announced plans to …
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 …
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. Indian Government may introduce Digital Competition Bill before the Parliament in November 2024 In an effort to curb anticompetitive conduct in the digital marketplace, the Indian government may …
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. Draft Guidance on Vaccine Approval and Quality Monitoring at port of Import published by Central Drug Regulator for Public Commect The Central Government has recently published a draft …
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. Draft GDP guidelines for pharmaceutical products published for comments India’s Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document titled “Guidelines on good distribution practices …
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. Guidance for making regulatory applications for biological and biotechnology products such vaccines may be revised soon India’s central drug regulator, Central Drugs Standards Control Organization (CDSCO), has issued …
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 …
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. Delay condonation should be evaluated based on reasons provided and not merits of case: Supreme Court In a recent decision, the Supreme Court held that in condoning delay for a filing …
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. Environmental Compensation Guidelines for Plastic Waste Published India’s Central Pollution Control Board (CPCB) has issued guidelines for the assessment of Environmental Compensation (EC) for violation of The Plastic …
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. Indian Government may soon have to explain why traditional medicines are outside the scope of its flagship Universal Health Coverage scheme, or include it India’s Delhi High Court …
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. Indian government intends to create a new AI law to protect news publishers’ rightsThe Indian government plans to introduce a new artificial intelligence (AI) law that will safeguard …
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. No significant hike in prices of essential medicines: Indian GovernmentIndia’s Ministry of Health and Family Welfare has issued a clarification in response to reports about the significant increase …
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 …
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. Supreme Court of India pulls up State Licensing Authority for failing to take action against misleading advertisements by leading ayurvedic manufacturerIndia’s Central Ayush Ministry recently filed an affidavit …
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. Corporate hospitals may soon have to comply with advertisement norms applicable to doctors India’s National Medical Commission (NMC), which regulates the conduct of medical practitioners (doctors), has endorsed the …
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. Star-rating for energy efficiency on white goods to be under stricter government regulation Indian Government may reportedly introduce rules for non-branded products to validate star rating for energy …
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. Criminal prosecution for drug related offences can start only on the basis of a drug inspector’s complaint: Supreme CourtIndia’s Supreme Court has confirmed that only a drug inspector, …
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. All manufacturers, importers and brand owners of products using plastic packaging must register by 31st March 2024 with Pollution Control Board India’s Pollution Control Board has given a …
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 soonIndia’s Drugs Consultative Committee (DCC) has recommended that draft of revised Good Distribution Practices (GDP) guidelines for …
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. Body massagers cannot be ‘sex toys’ just because they can have alternative use: High Court In a recent ruling, the Bombay High Court has held that body massagers cannot be …
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. Indian government may reconsider its decision of prohibiting manufacture of drugs and nutraceuticals, health supplements in same facilityThe Indian government is reportedly reconsidering its decision to act against …
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. Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCOThe Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has …
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. Prior Government approval not necessary for using unreliable or untested artificial intelligence (AI) in IndiaIndia’s Ministry of Electronics and Information Technology (MeitY) has revised its controversial advisory 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. Hospitals and pharma companies in India bought electoral bonds worth 9 billion RupeesIndian hospitals and pharma companies have reportedly bought electoral bonds for approximately Rs. 900 crore. Electoral …
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. Panel of auditors to audit the promotional expenses of pharma and medical device companies will be appointed soon: GovernmentThe Secretary, Department of Pharmaceuticals, has reportedly said that the …
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 marketing code for pharmaceutical companies notified; Pharmaceutical Associations to set up dedicated portal for handling complaints of violationsThe Department of Pharmaceuticals has notified Uniform Code for Pharmaceutical …
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. 𝐃𝐨𝐜𝐭𝐨𝐫 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐯𝐢𝐜𝐚𝐫𝐢𝐨𝐮𝐬𝐥𝐲 𝐥𝐢𝐚𝐛𝐥𝐞 𝐭𝐨 𝐩𝐚𝐲 𝐜𝐨𝐦𝐩𝐞𝐧𝐬𝐚𝐭𝐢𝐨𝐧 𝐞𝐯𝐞𝐧 𝐢𝐟 𝐡𝐢𝐬 𝐚𝐝𝐯𝐢𝐜𝐞 𝐰𝐚𝐬 𝐩𝐫𝐨𝐩𝐞𝐫 𝐛𝐮𝐭 𝐰𝐚𝐬 𝐧𝐨𝐭 𝐟𝐨𝐥𝐥𝐨𝐰𝐞𝐝 𝐛𝐲 𝐡𝐨𝐬𝐩𝐢𝐭𝐚𝐥 𝐬𝐭𝐚𝐟𝐟: 𝐍𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐬𝐮𝐦𝐞𝐫 𝐂𝐨𝐦𝐦𝐢𝐬𝐬𝐢𝐨𝐧India’s apex consumer forum, the …
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. Airlines have to obtain single caterer license and provide invoice containing description of license number for chargeable in-flight mealsIndia’s food regulator, The Food Safety and Standards Authority of …
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. Surgical gloves and single-use medical gloves to be under Quality ControlIndia’s Department of Pharmaceuticals (DoP) is reportedly considering regulating surgical gloves and single-use medical examination gloves by way …
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. Policy on online sale of drugs to be framed within four monthsIndia’s Delhi High Court has directed the Ministry of Health and Family Welfare to come up with …
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. Discount offered by Pharmacies and Chemist Stores through bill boards and social media will result in action against Pharmacists in MaharashtraThe State-level Council responsible for regulation of Pharmacists …
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. Scientific works are not protected under India’s Copyright Law: High CourtIndia’s High Court of Andhra Pradesh has held that India’s copyright law only protects original literary, dramatic, musical …
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. India takes baby steps in regulation of Artificial Intelligence, puts in place prior consent requirement before deployment of AIIndia’s Ministry of Electronic & Information Technology has reportedly advised …
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. State Consumer Commissions continue to dilute intermediary safe-harbour protection for e-commerce marketplaceA State Consumer Commission in India has held a major e-commerce marketplace company liable for delivery of …
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. India announces completion of Genome Sequencing ProjectThe Department of Biotechnology (DBT) has announced the completion of the Genome India Project, the largest project to sequence 10,000 genomes of …
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. Major Indian Ayurvedic Medicine Manufacturer to be tried for Contempt of Court for publishing misleading drug advertisementsIndia’s Supreme Court is reportedly set to issue a Contempt Notice to …
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. Drug manufacturing facility cannot manufacture food products: Central Drugs RegulatorIndia’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to …
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. India’s new criminal law regime to take effect from July 1, 2024The three criminal laws, namely, Bhartiya Nyaya Sanhita, Bhartiya Nagrik Suraksha Sanhita, Bharatiya Sakshya Adhiniyam that will …
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. Guidelines to differentiate brand extension from surrogate advertising issuedIn a meeting with stakeholders, the Department of Consumer Affairs (DoCA) has clarified the difference between brand extension advertisements which …
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. Couples seeking surrogacy will be allowed to use donor gametes only if either partner suffers from a disabling medical conditionIndia’s Ministry of Health and Family Welfare has notified …
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. Greenwashing Regulations Published for CommentsIndia’s Ministry of Consumer Affairs has published the Draft Guidelines for the Prevention and Regulation of Greenwashing, 2024, which seek to regulate the advertisement …
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. India’s Competition Watchdog gets new powers to issue interim orders to stop potentially infringing action, until case is finally decidedThe Indian Government has made Section 33 of The …
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. Indian Government tacitly endorses use of AI in screening patientsIndia has started a pilot telemedicine project called “Aarogya-Doctor on Wheels”. The unique aspect of the pilot project is …
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. Doctor’s failure to co-operate with Drug Administration in disclosing name of manufacturer of drugs found in his possession is unlawful, but does not warrant imprisonment if the quantity …
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 weekIn a first, perhaps anywhere in the world, India’s top officer in the Drug Regulator’s office, the …
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 PublishedIndia’s apex regulatory body for drugs, medical devices and cosmetics, the Central Drugs Standards Control Organization, …
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 IndiaThe National Human Rights Commission (NHRC) in India has taken suo motu cognizance of a …
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 sourcesA multinational pharmaceutical company has questioned the veracity of a biosimilar drug trial …
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 …
Rounding-off Principles for Drugs and Medical Devices under Drugs (Prices Control) Order, 2013
In this article, we have discussed rounding-off principles that manufacturers and importers of drugs and medical devices should follow while determining the maximum retail price (MRP) of their products. What is rounding-off?Rounding-off refers to adjusting a fractional price of a drug or medical device to the nearest rupee, or the nearest paisa, depending on the …
PERMISSIBLE PRICE INCREASE AND CALCULATION OF OVERCHARGED AMOUNT UNDER DRUG PRICES CONTROL ORDER (DPCO)
The Division Bench of the High Court of Delhi, in the case of Union of India v Bharat Serums, has laid down how the overcharged amount should be calculated by India’s drug price control regulator, National Pharmaceutical Pricing Authority (“NPPA”). The judgement will have a significant impact on existing as well as future demands for …
Frequently Asked Questions on the New Menu Labelling Requirement for Food Service Establishments in India
The packaging and labelling of food items served in a food service establishment in India is regulated by The Food Safety and Standards (Packaging and Labelling) Regulations, 2011 (“Regulations”). The Regulations were amended in August 2020 to introduce the concept of menu labelling for the first time in India. Menu labelling means the process of …
All fertility and surrogacy clinics in India now required to obtain registration under new law
Starting April 22, 2022, all fertility clinics, gamete banks and surrogacy clinics across India will have to commence the process of applying for registration with the National ART and Surrogacy Registry. The Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021 (which, for the sake of convenience, will be collectively referred to …
Pricing Information of Medical Devices Marketed in India to be Submitted to National Pharmaceutical Pricing Authority (NPPA) by March 10, 2021
India’s medical device price regulator has issued a direction to importers and manufacturers of 24 categories of medical device to submit price-related information, including the price at which they sell medical devices to distributors and hospitals in India, by March 10, 2021. Background In India, medical devices are regulated not just for quality, but also …
Legal Considerations for Awareness Campaigns on Persons with Disabilities in India
Across the world, December 3 is observed as the International Day of Disabled Persons. The United Nations has designated it as a day that “aims to promote the rights and well-being of persons with disabilities in all spheres of society and development, and to increase awareness of the situation of persons with disabilities in every …
Legality of use of CBD Oil in India, and why NDPS Act does not apply to it
Recreational use of Cannabis (Ganja) and its resin (Charas or Hashish) was outlawed in India in 1985 by the Narcotic Drugs and Psychotropic Substances Act, 1985 (“NDPS Act”). The NDPS Act itself was the result of India’s commitment under the Single Convention on Narcotic Drugs, 1961 (“Single Convention”). Interestingly, neither the NDPS Act nor the …
Indian Law on advertisement of brand extensions of alcohol and tobacco products and how it poised to become tougher
India’s Ministry of Information & Broadcasting (MIB) recently put out an advisory for private satellite TV channels to ensure that liquor, tobacco and other intoxicants are not advertised directly or indirectly on their channels in violation of existing law, i.e. the Cable Television Network Rules, 1995 (CTNR). Under CTNR, satellite TV channels are prohibited from …
Draft risk classification of all yet-to-be regulated medical devices and IVDs in India published, comments invited until Oct. 2
In February of this year, India’s Health Ministry had notified a new definition of medical devices with an intent to bring all medical devices under the purview of Medical Devices Rules, 2017 (MDR). Prior to such notification, only 37 categories of medical devices that it had notified were regulated by MDR. The new definition took …
Dedicated portal for online filing of consumer grievances under new consumer protection law in India now live
The Consumer Protection Act, 2019 (CPA) was enforced on July 20, 2020 and it replaced the decades old The Consumer Protection Act, 1986. One of the key features of the CPA is the option with consumers to file a complaint electronically. The portal where consumers can file their complaint electronically is now live at the …
Legality of making COVID-19 defence or immunity claims in India
India’s central drug regulator, the Drugs Controller General of India, has reportedly served a notice on a major FMCG company in India to explain why action should not be taken against it for making a misleading claim that its hand sanitizer is a “immunity booster” and that it “kills inactive coronavirus”. This points to an …
New Consumer Protection law in India: A Simple Overview (Seller Beware!)
On July 20th, 2020, the new Consumer Protection Act, 2019 came into force in India, replacing the previous enactment of 1986. The new Act overhauls the administration and settlement of consumer disputes in India. It provides for strict penalties, including jail terms for adulteration and for misleading advertisements. More importantly, it now prescribes rules for the …
Alcohol-Based Hand Rubs and Sanitizers - Regulatory requirements, uncertainties and important considerations for doing businesses in India
Summary: Due to the sudden spurt of demand for hygiene products due to COVID-19 virus pandemic, several manufacturers and marketers in India are now selling hand sanitizers containing ethanol or isopropyl alcohol as an active ingredient. However, regulatory uncertainties, especially surrounding requirement of drug license for stock and sale and scope of price control are …
India’s new price regulation for medical devices and equipment – impact on price and supply chain due to Drugs (Prices Control) Order, 2013
Summary On February 11, 2020, the Indian Government had gazetted a notification that brought all medical devices and medical equipment sold in India under existing quality and safety regulatory framework by declaring them as “drugs”. However, this notification has exposed all medical devices to India’s drug price control regulation that was put in place to …
India’s new Telemedicine Practice Guidelines – Analysis and Do’s and Don’ts for Doctors offering teleconsultation
Summary: The Indian Government has published Telemedicine Practice Guidelines (“Telemedicine Guidelines”) on March 25, 2020. These guidelines finally clarify India’s position on the legality of teleconsultation. It is now perfectly legal to provide teleconsultation by registered medical practitioners (M.B.B.S and above) in line with the requirements of the Telemedicine Guidelines. It has been clarified that …
All medical devices in India to be regulated as “drugs” – Medical Devices (Amendment) Rules, 2020
Summary: The Indian law that regulates quality and safety of medical devices has been amended and it will now apply to all medical devices, effective April 1, 2020. Prior to the amendment, only 37 categories of medical devices were regulated or were notified to be regulated in near future in India. The immediate consequence of …
All medical devices to be regulated: Draft rules notified in India
The Ministry of Health and Family Welfare in India has notified the Draft Medical Devices (… Amendment) Rules, 2019 (Draft Rules) for public comments on October 18, 2019. By notifying these rules, the Indian Government has made its intention clear to regulate all medical devices in a phased manner. As of date, only twenty-three categories …