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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 Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO) have released Version 2.0 of the “Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products”. This document facilitates the submission of the safety profiles of drugs by MAHs (manufacturer, marketer, or importer of a drug) and outlines the timeline for the process.
Source: bit.ly/4dctGCs

2. India’s Central Drug Regulator (CDSCO) is reportedly considering a proposal to change the color of all antimicrobial drug strips to blue for safer usage and to visually differentiate these drugs to curb antimicrobial resistance (AMR). This proposal would apply to pharmaceutical drugs and medicines, including antibiotics, antivirals, anti-parasitics, and antifungal drugs.
Source: bit.ly/47BUL0P

3. India’s Department of Food and Public Distribution (DFPD) has asked the leading edible oil associations in India to maintain the maximum retail price (MRP) of edible oil until the stocks of the edible oil that are imported at 0% and 12.5% basic customs duty (BCD) are exhausted. The Government of India has increased the BCD on various edible oils, which is effective from 14th September 2024, to support domestic oilseed prices.
Source: bit.ly/4e9Gwmj

4. The International Organization for Standardization (ISO) has released the second edition of ISO 23500-1:2024, outlining requirements for the preparation and quality management of fluids used in hemodialysis and related therapies. This standard guides practitioners on handling dialysis and substitution fluids for advanced treatments like hemodiafiltration and hemofiltration.
Source: bit.ly/3Bjlzqt
Source: bit.ly/4gskk8H

5. India’s Maharashtra Food and Drugs Administration (FDA) has taken action against an Ayurvedic drug manufacturing company by seizing its products and prohibiting the further distribution of its Ayurvedic drugs due to improper labeling. The company has made false and misleading claims about the drugs and its treatment in its advertisements, which are prohibited under the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, and Rules, 1955.
Source: bit.ly/3ZucKUU

Posted on

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. India’s Drugs Consultative Committee (DCC) has reportedly recommended to make Sugam portal database of all the products with brand names accessible to the general public to address the issue of different drug formulations of different therapeutic categories being sold with same or similar brand names in the nation.
Source: bit.ly/3XMWBbV2. The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has revised the accreditation standards for hospitals which will come into effect on January 1, 2025. No surveillance assessment will be conducted as per the old accreditation standard by NABH after 31st March 2025.
Source: bit.ly/47ydjPr

3. India’s Central Food Regulator will approve import of food consignments from Bhutan on the strength of Health Certificate issued by Bhutan Food and Drug Authority provided they are manufactured by the approved list of establishments of Bhutan.
Source: bit.ly/4gmtRxY

4. U.S. Food and Drug Administration has warned a major pharmaceutical company for making false and misleading claims about the benefits of a migraine pill in a television advertisement by a famous sports person. The claims were made against the results that were demonstrated in clinical trials.
Source: bit.ly/4gtau6m

5. A group of experts constituted by NITI Aayog to prepare a framework for action for emergency response and preparedness to address future pandemic, has recommended making the Central Drugs Standard Control Organisation (CDSCO) an independent regulatory authority. They have recommended to provide CDSCO with approved Standard Operating Procedures (SOPs) for Accelerated Emergency Use Authorisation for innovations and provisions for fast-tracking the process during pandemics.
Source: bit.ly/3XNynys

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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. India’s Central Pollution Control Board (CPCB) has issued Environmental Compensation (EC) Guidelines to address non-compliance with Extended Producer Responsibility (EPR) registration, labelling requirements, failure to fulfill EPR obligations, and non-filing of annual returns, among other violations under the Battery Waste Management Rules, 2022. The guidelines outline formulas for determining Environmental Compensation (EC) in different cases of non-compliance with the Battery Waste Management Rules, 2022.
Source: bit.ly/3ZkGVOe
Source: bit.ly/4ehqaI4

2. India’s Food Safety and Standards Authority of India (FSSAI)  has extended the availability of Instant (Tatkal) Food License and Registration nationwide, with the exception of Chandigarh, Himachal Pradesh, and Meghalaya. Previously, this provision was limited to few states and Union Territories. The Instant (Tatkal) Food License and Registration provision came into effect on 31st August, 2024.
Source: bit.ly/3XGxBDo

3. India’s Bureau of Indian Standards (BIS) has notified amendments to various products, including Disposable Baby Diapers, Absorbent Cotton Gauze, Cotton Bandage Cloth, Sanitary Napkins, and Disposable Baby Diapers. All products imported, sold, or marketed in India must comply with these revised standards by 22nd February, 2025.
Source: bit.ly/4dZsFz8

4. India’s Department of Pharmaceuticals (DoP) has issued a issued notification under Drug Price Control Order,2013 (DPCO) thereby extending the current ceiling price for orthopedic knee implant systems until 15th September, 2025.
Source: bit.ly/3Tn6ASI

5. India’s central drug regulator (CDSCO) has suspended the manufacturing and marketing license of a pharmaceutical company due to the false and misleading claims that its eye drops could augment near vision within 15 minutes and the company’s failure to address queries raised by the drug regulators concerning these claims.
Source: bit.ly/4e04yAn

6. India’s Supreme Court, while hearing a case on the ban of commercial surrogacy, observed that the interests of surrogate mothers must be safeguarded. The Court emphasized the need for a regulatory system like “surrogate banks” to ensure that surrogate mothers are not exploited and their rights are upheld.
Source: bit.ly/4gePgsS

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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

Posted on

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. India’s central food regulator, Food Safety and Standards Authority of India (FSSAI) has said that it is misleading to differentiate milk and milk products on whether they are made from A1 milk or A2 milk. All manufacturers and marketers and e-commerce entities have been directed to stop claims of A1 and A2 proteins present in the milk. All manufacturers have been given six months to exhaust all of the pre-printed labels containing claims about A1 and A2 proteins.
Source: bit.ly/4dz5awA

2. The Central Pollution Control Board (CPCB) has released updated guidelines for assessing environmental compensation to be levied on entities that violate the Plastic Waste Management Rules, 2016, including Extended Producer Responsibility (EPR) obligations.
Source: bit.ly/46Uh9lX

3. India’s Ministry of Health has banned the 156 fixed-dose combination (FDC) medications, commonly known as “cocktail drugs,” which include multivitamins, antibiotics, and painkillers. The ministry’s rationale is that these drugs have no there is no therapeutic justification and pose a risk to human health, even though there are safer alternatives available.
Source: bit.ly/3XfRVeq

4. The US Food and Drug Administration (FDA) has issued a draft guidance on pre-determined change control plans (PCCPs). The guidelines offer manufacturers a way to specify prospective modifications to a device and apply for premarket authorization for those changes in a marketing submission for the device. This eliminates the need for them to obtain FDA approval for each major change before it is implemented. The draft guidance is open to receiving comments from industry stakeholders till November 20, 2024.
Source: bit.ly/3AtTY5B

5. The Medicines and Healthcare products Regulatory Agency (MHRA), an agency of the Department of Health and Social Care in the United Kingdom, has ruled that a biopharmaceutical company has violated the country’s drug regulations by using a LinkedIn post to advertise prescription-only medicines to the general public.
Source: bit.ly/4fSmKgt

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.

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

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.

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

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.

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

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.

1. India’s Health Minister has reportedly confirmed that Central Drugs Standard Control Organization (CDSCO) will be the sole regulator of veterinary medicines in India and there is no proposals to establish a separate regulatory body for veterinary medicines in India.
Source: bit.ly/4cbgTQe

2. India’s Food regulator (FSSAI) has warned against use of unapproved non-specified ingredients, such as “Deionized apple juice concentrate,” in fruit juices.
Source: bit.ly/46swOZq

3. The State Drug Regulator (FDA) of Maharashtra is reportedly going to start an inspection drive to identify doctors and hospitals which are running an open shop for medicines without holding a valid pharmacy license.
Source: bit.ly/46rtHAZ

4. The Principal Bench and State Benches of Goods and Services Tax Appellate Tribunal (GSAT) have been established with effect from 1st September 2023.
Source: bit.ly/3A86tDM

5. The US Food & Drugs Administration (FDA) has warned a pharmaceutical company for sponsoring a celebrity paid promotion campaign on social media, in which the influencer promoted a drug but did not disclose essential risk information. The FDA found the post to be misleading.
Source: bit.ly/46rtI81

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. Multinational Pharmaceutical Companies in India have reportedly sought relaxation of mandatory 50% cut in price of essential medicines after expiry of patent on ground that it hinders innovation.

Source: bit.ly/4bWhHIN

2. India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has issued directions to the effect that if any food sample is found to be unsafe in the primary lab report, it would result in an order prohibiting further distribution of such food. If the food sample is confirmed to be unsafe by a referral food lab, then the food will have to be recalled.

Source: bit.ly/3Yji2SR

3. A nutritional supplement firm was fined by District Consumer Commission for making misleading claims on the label of its protein supplement regarding the nature of protein content. According to the commission, making misleading claims on label amounts to deficiency of services.

Source: bit.ly/4dcHoWs

4. India’s Jammu and Kashmir High Court has dismissed a criminal complaint instituted against a retailer of medicines for failing to reveal details of manufacturer of a spurious drug. The High Court held that since the Drug Inspector already had the details, the non-provision of requested information did not constitute an offence under The Drugs and Cosmetics Act, 1940.

Source: bit.ly/4bSxPLd

5. India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has introduced a new license category for registration of direct sellers. Direct sellers are not permitted to sell infant milk and infant milk substitutes.

Source: bit.ly/4fdxhlZ