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.

1. The Supreme Court has stayed the repeal of Sec. 170 of the Drugs, Rules 1945 which regulated Advertisement of AYUSH products by the AYUSH Ministry, to address the ultra-vires nature its policy regarding AYUSH advertisement.
Source: bit.ly/4e4qOZz
Source: bit.ly/4dDnIvK

2. The National Commission for the Indian System of Medicine has restated its position, as it has taken in an advisory issued earlier on 16th July, that practitioners of AYUSH medicine should not represent themselves as “Cannabis experts” as it may constitute a “Misrepresentation of qualification” under Regulation 27 of the National Commission for Indian System of Medicine (Ethics and Registration) Regulation, 2023.
Source: bit.ly/3APXRls
Source: bit.ly/4cLHaFl

3. The Supreme Court has issued a Notice to the Central and State Governments and their departments, seeking a response on policy position regarding braille accessibility and integration into (1) Medical packaging, (2) Consumer Goods packaging, and (3) Implementation of braille in all aspects of public and private sectors.
Source: bit.ly/3AHLUOP

4. The office of Director General of Foreign Trade has issued draft modalities for setting up E-commerce Export Hubs which will support infrastructure for cross-border e-commerce trade, and has requested for submission of detailed proposals for set-up of E-commerce Export Hubs.
Source: bit.ly/3ASWEd6

5. The Drug Enforcement Administration, part of the United States Department of Justice has issued a notice that it will be holding hearings regarding the subject-matter of a Federal level reclassification of Cannabis from a Schedule I to Schedule III substance.
Source: bit.ly/4dCiQXN

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.

1. Use of artificial yellow food coloring ‘Tartrazine’ in food items like moong dal is not food adulteration as ‘Tartrazine’ is a permitted food coloring under the Prevention of Food Adulteration Rules, 1955; India’s Supreme Court.
Source: bit.ly/4718Tk4

2. Food Safety and Standards Authority of India (FSSAI) has withdrawn the clarification for selling / marketing of milk and milk products in the name of A1 & A2 for further consultation. Previously, FSSAI had clarified that it is misleading to differentiate milk and milk products on whether they are made from A1 milk or A2 milk and had thereby directed to remove such claims from such products including e-commerce websites.
Source: bit.ly/4778axU

3. Retail prices to be reportedly reduced by 50% of anti-diabetic drug Empagliflozin, which is expected to go off patent in March 2025 under Drugs Price Control Order, 2013.
Source: bit.ly/470IFxW

4. Indian Pharmaceutical Industry has urged to amend and delete the term “retailer” from the definition of dealer under Drugs Price Control Order, 2013 (DPCO). Manufacturers and importers are required to furnish price list to dealers. The inclusion of ‘retailer’ within the definition of ‘dealer’ has led to confusion over the extent of this obligation, potentially extending the manufacturer’s and importer’s liability beyond wholesalers to include retailers as well. If approved, Retailers, who typically interact with consumers directly, would be excluded from the manufacturer’s direct regulatory responsibilities, thereby allowing the focus to remain on the wholesale distribution channel.
Source: bit.ly/3ABX4Vs

5. QR Codes / Bar Codes may reportedly be made mandatory for vaccines, cancer drugs and antibiotics to validate the authenticity of drugs and prevent the supply of counterfeits.
Source: bit.ly/475pDGH

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.

1. All medical practitioners (doctors) who practice modern medicine will have to mandatorily register on the new National Medical Register established by the National Medical Commission.
Source: bit.ly/3YYlPoE

2. The Indian Government is reportedly considering to ban 34 multivitamin drugs.
Source: bit.ly/4e0490u

3. The Indian Government is planning to publish a new policy for promoting bio-technology sector called BioE3 (Biotechnology for Economy, Environment and Employment) Policy.
Source: bit.ly/3MiPNfw

4. A leading e-commerce giant has set up rest areas facility for its delivery partners in India. The rest area will have facilities like air conditioning, seating areas, drinking water, and mobile charging stations as a measure to provide them better working conditions.
Source: bit.ly/3MkPYHl

5. Amid rising cases of mpox globally, the World Health Organization (WHO) has reportedly relaxed the rules for its health partners to hold commercial discussions on mpox vaccines. It has also declared that partners like GAVI and UNICEF can begin purchasing mpox vaccines before WHO approves them.
Source:  bit.ly/3Z0RWV0

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.

1. Indian pharmaceutical manufacturers will have to prove compliance with revised Good Manufacturing Practices at the time of renewal of manufacturing license, as per media reports.
Source: bit.ly/3MAGjg9

2. A woman who has filed for divorce should be treated as a divorced woman for the purposes of medical termination of pregnancy, and therefore will have the right to terminate her pregnancy: High Court
Source: bit.ly/4fNDhT7

3. The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA), will invite an officer not below the rank of Deputy Controller of Patents and Designs, to evaluate eligibility for exemption of patented drug from application of price control law.
Source: bit.ly/46Ya8jY

4. A new scheme to boost domestic medical device industry in India is under works and will reportedly be launched in a month.
Source: bit.ly/4fUqrSU

5. A new portal for reporting adverse events of drugs, vaccines and medical devices has been launched by Indian Pharmacopoeia Commission. The adverse event may be reported by consumers and medical practitioners.
Source: bit.ly/4dxeUXY

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 Drug Controller in Kerala has reportedly stated that there is no objection to display discount on flex board of retail drug stores. However, all retail drug stores are required to display a price list of medicines which will allow consumer to evaluate which drugs are available at a discount and make informed choices.
Source: bit.ly/4ctkgT3

2. As per India’s Central Food Regulator, the claim of 100% fruit juice on packaging of juices which are reconstituted from fruit concentrate, or which are not reconstituted but to which water has been added, is misleading and therefore prohibited. Any pre-printed packaging material which contains the misleading claim should be utilized by the Food Business Operators (FBOs) before 31st December 2024. Fruit juices manufactured before 31st December 2024 but which carry the misleading claim on the package will be permitted to be sold in the market until their expiry.
Source: bit.ly/4fV2gDN

3. A trademark infringement suit filed by a U.S. fast-food burger chain has been decided in favor of a Pune-based burger joint on the grounds of prior use and honest use in India.
Source: bit.ly/4dGZLmY

4. Indian medical gloves manufacturers have raised strong objection with Indian government about ongoing import of chlorinated gloves into India despite there being a ban on its use by healthcare facilities.
Source: bit.ly/3AyqQdG

5. 12% of all spices tested between May and July have reportedly failed to meet quality standards.
Source: bit.ly/3AwNV0b

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. A national association of medical professionals, the Indian Medical Association has declared a 24-hour nationwide withdrawal of non-emergency services from 6 a.m. on 17th August, 2024 to protest against the alleged rape and murder of a trainee doctor at the state-run hospital in Kolkata. Essential services will be continued, but outpatient departments and elective surgeries will be halted. The withdrawal will operate across all sectors wherever modern medicine doctors are providing services.
Source: https://bit.ly/3YYu5oC

2. Under the direction of the Union Health Ministry, the National Medical Commission (NMC) has advised all medical colleges and institutions to create a policy that will ensure that all staff members, including faculty, medical students, and resident physicians, have a safe place to work on campus. Adequate safety precautions in the OPD, wards, casualties, hostels, and other open spaces on campus and in the residential quarters should be guaranteed by the policy.
Source: bit.ly/3YTA0eY

3. The National Green Tribunal has set aside a pharmaceutical company’s environmental clearance to expand its facility on grounds that even though it has an effluent treatment plant, the absence of pharmaceutical waste in treated waste water cannot be ruled out. The said pharmaceutical company was going to let out treated waste water into the sea and this may harm neighbouring aqua farms and have an adverse effect on human health when such aquatic food is consumed.
Source: bit.ly/3SVOneF

4. India’s anti-trust regulator, the Competition Commission of India (CCI), has dismissed a complaint alleging cartelisation by 29 pharmaceutical companies to manipulate government tenders for procurement of medicines on grounds that the compliant was vague and did not disclose sufficient details.
Source: bit.ly/3SXLPgl

5. The US government has announced first set of price cuts to popular prescription drugs which are part of  the government’s Medicare programme. The revised prices of the drugs, which include widely used blood thinners and arthritis medications, will take effect from 2026.
Source: bit.ly/3AFf94I

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 number of cosmetic products which can be added to a single application for the import registration certificate of cosmetics has been limited to fifty (50) products from 16th August 2024.
Source: bit.ly/4dbUnrX

 2. The Central government has reportedly prepared a draft of the Standard Veterinary Treatment Guidelines (SVTG) covering 274 diseases across 12 major livestock species with an aim to create uniform treatment protocols, lessen variation in prescription practices, and improve compliance among veterinarians and other prescribers.
Source: bit.ly/3SNEnnU

3. The Supreme Court of India has given a deadline of 12th October 2024 to implement the law for regulation of allied healthcare practitioners.
Source: bit.ly/3SNqR3L

4. The Madras High Court has reportedly directed the Indian Council of Medical Research (ICMR) to opine whether there were vested interests involved in the ban on pioglitazone, an antidiabetic drug, which was later revoked.
Source: bit.ly/3SLbmcm

5. The US Food & Drug Administration (FDA) has reportedly rejected a proposal to approve psychedelic – MDMA as a treatment for post-traumatic stress disorder (PTSD) citing safety and efficacy concerns.
Source: bit.ly/3YDYqJf

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 Ministry of Agriculture and Farmers Welfare of India has issued Millets Grading and Marking Rules, 2024 (“Millet Rules”) which regulates packing, marking and labelling of millets intended for direct human consumption.
Source: bit.ly/4dkddNJ

2. India’s central drug regulator, the Central Drugs Standard Organisation, has circulated draft guidelines on good distribution practices for pharmaceutical products to ensure product traceability throughout the supply chain.
Source: bit.ly/4fGXKZy

3. India’s top consumer forum, the National Consumer Disputes Redressal Commission (“Commission”) has awarded a compensation of Rs.65 lakhs in a medical negligence case in which the doctors performed an elective surgery on a patient who was suffering from pre-existing ailment, which ultimately resulted in the death of the patient. The commission did not accept the defence of the hospital that the patient’s next of kin had consented to the procedure and were aware of the risks.
Source: bit.ly/3AgWYSK

4. Suicide Capsules are not medical devices or medicines: Swiss Medical Agency.
Source: bit.ly/4djGFU0

5. The Ministry of AYUSH has informed that it has identified approximately 26000 cases of misleading advertisements, but the State AYUSH departments have issued notices only 358 brands in last 4 years.
Source: bit.ly/4fJ7bYi

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. A leading pharmaceutical association reportedly has urged the Indian government to implement a predictable drug pricing policy by refraining from using Para 19 of the Drug Pricing Control Order, which gives power to the Government to cap prices of non-essential drugs and medical devices in public interest without advance notice.
Source: bit.ly/4dw7a8j

2. The National Consumer Disputes Redressal Commission (NCDRC) has held that doctors who have qualification of M.B.B.S, M.D. (medicine) are sufficiently qualified to treat ICU patients without requiring additional specialized intensive care training since no such training has been prescribed by National Medical Commission.
Source: bit.ly/3Yts4kh

3. Australia has approved the medical use of MDMA (Methylene Dioxy Methyl Amphetamine) and psilocybin for treating PTSD and depression. The drugs will be available under strict regulations, with treatments costing between A$15,000 and A$30,000, and with no current insurance coverage.
Source: bit.ly/46CttHg

4. India’s Central Food regulator, (FSSAI) has reintroduced restriction on re-using cooking oil that has developed total polar compounds (TPC) of more than 25% by adding fresh oil. Any cooking oil that has 25% or more content of TPC is not permitted to be used.
Source: bit.ly/4d8pvIT

5. India’s Department of Consumer Affairs has extended the last date for receiving public comments on the proposed amendment of rule 3 of the Legal Metrology (Packaged Commodity) Rules, 2011 to 30th August 2024. The proposed amendment aims to close loopholes and ensure that all bulk packages are labelled clearly and consistently, just like retail products.
Source: bit.ly/4dgRE0n

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. India’s Central Board of Indirect Taxes and Customs (CBIC) has restored the concessional 10% import duty on lab chemicals starting August 1, with the condition that the importers declare that the goods will be used for lab or R&D purposes only, and will not be traded or sold after import. However, undenatured ethyl alcohol remains excluded and continues to face a 150% duty.
Source: bit.ly/3yjWrPv

2. India’s Union Health Ministry has urged the Board of Control for Cricket in India (BCCI) and the Sports Authority of India (SAI) to take measures to prevent surrogate advertising of tobacco and alcohol products by sportspersons. This move aims to curb indirect promotion of such products through sports sponsorship and advertising, and to safeguard public health and prevent the normalization of tobacco and alcohol consumption.
Source: bit.ly/3WKcaRg

3. India’s Union Minister, on behalf of life insurance corporation employees, has requested India’s Finance Minister to withdraw the 18% GST imposed on life and medical insurance premiums as high tax rate is burdensome and could negatively impact the accessibility and affordability of essential insurance services.
Source: bit.ly/4c5QXWd

4. India’s state consumer forum has directed an insurance company to pay the mediclaim to the claimant on the grounds that pre-existing conditions of diabetes mellitus cannot be the cause for cardiac arrest as diabetes is a lifestyle related ailment and denial of entire mediclaim is not acceptable when such ailment is so pervasive in India.
Source: bit.ly/4d6iDLZ

5. India’s AYUSH ministry has disclosed that it has received 38,539 complaints of misleading advertisements related to Ayush drugs in the last seven years. These complaints have been reported to the State Licensing Authorities (SLAs) for further action.
Source: bit.ly/4c84cpt