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. 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

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 Environment Ministry has proposed to introduce extended producers responsibility for scrap of non-ferrous metals by way of amendment to Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2016.
Source: bit.ly/4fQHG7E

2. The deadline for declaration and registration of exotic animal species in possession of various individuals, organizations, zoos, etc is 28th August 2024. The registration of these exotic animal species is to be done in the PARIVESH 2.0 portal.
Source: bit.ly/3XaaXTA

3. India’s apex telecom regulator, the Telecom Regulatory Authority of India (“TRAI”) has issued directions to curb misuse of messaging services and protect consumers from fraudulent practices. TRAI has mandated that the messages containing URLs/ APKs/ OTT links/ Call back numbers, which are not whitelisted will not be sent with effect from 1st September 2024.
Source: bit.ly/3Xeorhb

4. A Texas Court has stayed the operation of ban on non-compete agreements stating that the Federal Trade Commission (FTC) lacks the authority to ban non-compete agreements which was supposed to go into effect 4th September 2024.
Source: bit.ly/3SYlZsy

5. The Supreme Court of India, while observing the working conditions of doctors and healthcare professionals and their susceptibility to violence, has constituted a ten (10) member task force to formulate a national framework (protocol) for ensuring their safety and facilities. The task force will submit its interim report within three (3) weeks and final report within two (2) months.
Source: bit.ly/4cHpv1C

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. 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

Posted on

Can cooking oil be lawfully reused in India? An analysis of law and recent KFC case

Under Indian law, it is not unlawful to reuse cooking oil, provided certain conditions and thresholds are not crossed by food businesses. In this article, we will examine the thresholds and conditions associated with reusing cooking oil. We will also examine the Madras High Court order which protected a fast-food chain outlet against arbitrary action of suspension of license for reusing cooking oil.

Thresholds and Conditions for Reuse of Cooking Oil

The Food Safety and Standards Authority of India (FSSAI) is the regulatory body responsible for quality of food for consumers. It regulates the use and reuse of cooking oil and issues directions from time to time.

The FSSAI has recommended that “re-heating and reuse of oil should be avoided as far as possible”. It has further recommended that cooking oil should be reheated a maximum of three times, and that ideally it should be heated only once. However, these recommendations are for guidance only are not binding on food businesses.

The only legal restriction on reusing vegetable cooking oil is that the Total Polar Compounds (TPC) developed in cooking oil due to reheating cannot exceed 25%[1]. According to FSSAI, any cooking oil whose TPC content is more than 25% is unsafe for human consumption and is thereby prohibited for use.

In order to keep a check on TPC content in reused vegetable cooking oil, FSSAI has directed that food businesses using 50 litres or more of cooking oil per day to maintain records detailing oil usage, including type, quantity used and discarded, and disposal date. Such food businesses are required to dispose the used cooking oil (UCO) only to FSSAI-approved aggregators or collection agencies.[2]

Adding fresh cooking oil to used cooking oil

In 2019, FSSAI directed food businesses to ensure that used cooking oil should not be topped with fresh cooking oil.[3]

Legal consequences of reusing cooking oil

Any violation of the 25% TPC threshold limit may result in suspension or cancellation of food license[4], as well as imprisonment or fine.[5]

Madras High Court’s intervention in unlawful suspension of license for reusing cooking oil

In Thoothukudi, Tamil Nadu, the FSSAI through Tamil Nadu Food Safety and Drug Administration Department (“Department”) suspended (i.e. temporarily cancelled) the license of one Kentucky Fried Chicken (“KFC”) outlet on grounds that it was reusing cooking oil and was adding a filtration agent, namely Magnesium Silicate Synthetic (“MSS”), to the cooking oil.

KFC challenged the suspension before the Madras High Court. On review, the High Court found that prima facie Magnesium Silicate Synthetic (MSS) does not appear to be a banned substance. On the contrary, it is an approved filtration agent. The Court further observed that there is no legal bar on reusing cooking oil.

For these reasons, and also on account of the fact that the Department did not follow due process before suspending the license, the Court passed an interim order staying the suspension of license and allowed the KFC outlet to resume operations.

Can Magnesium Silicate Synthetic (MSS) be added to reused cooking oil?

Magnesium Silicate Synthetic is a food additive that is primarily used as an anticaking agent and as a carrier for flavours in different food items. The Food Safety and Standards (Food Products Standards and Food Additives) Regulation, 2011 limits the use of anti-caking agents in such cases where its use is specifically permitted.[6] Synthetic Magnesium Silicate (or Magnesium Silicate Synthetic) is recognized an additive that may be used as clarifying agents or filtration aid in edible oils[7] and therefore may be lawfully used as a filtration aid in cooking oil.

Conclusion

The controversy surrounding reuse of cooking oil by restaurants seem to be manufactured, since the law surrounding reuse of cooking oil is very clear – vegetable cooking oils may be reheated and reused so long as the TPC content in the cooking oil does not exceed 25%. It is, however, recommended that cooking oil should not be reheated more than three times, though following such recommendation is not a legal requirement.

 

[1] The Food Safety and Standards (Licensing and Registration of Food Businesses) First Amendment Regulations, 2017, available at: https://www.fssai.gov.in/upload/uploadfiles/files/Gazette_Notification_Quality_Vegetable_Oil_03_11_2017.pdf  and Section 2.3.15(8) of FSS (Prohibition and Restriction on Sales) Regulations, 2011, available at: 61f381c576d16SOP_Cooking_Oil_28_01_2022.pdf (fssai.gov.in)

[2] Direction under Section 16(5) of the FSS Act regarding disposal and collection of Used Cooking Oil, available at:  5c6271f25d447Direction_Reused_Cooking_Oil_07_02_2019.pdf (fssai.gov.in)

[3] Direction under Section 16(5) of the FSS Act regarding disposal and collection of Used Cooking Oil, available at: 5c6271f25d447Direction_Reused_Cooking_Oil_07_02_2019.pdf (fssai.gov.in)

[4] Regulation 2.1.8 (4) of the Food Safety and Standards(Licensing and Registration of Food Businesses) Regulations, 2011, available at: https://www.fssai.gov.in/upload/uploadfiles/files/Licensing_Regulations.pdf

[5] Section 55, 57 and 59 of the Food Safety and Security Act, 2006 (“Act”), and Section 274, 275 of the Bharatiya Nyaya Sanhita, 2023.

[6] 3.1.7: Anticaking Agents: 1) Restriction on use of anticaking agents. No anticaking agents shall be used in any food except where the use of anticaking agents is specifically permitted. [Page 430, Part III, Section 4, the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations of 2011].

[7]Direction under Section 16(5) of the FSS Act regarding compliance w.r.t. Processing Aids under Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations of 2011, available at:  https://fssai.gov.in/upload/advisories/2024/03/65f2d680c053cApproved%20direction%20under%20Section%2016_5%20regarding%20compliance%20w.r.t.%20Processing%20Aids%20under%20FSS_FPS&FA_Regulations_2011.pdf

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 State Excise Department of Orissa has recently issued a notification to declare separated leaves of the Cannabis plant, also referred to as Bhang, as “intoxicant” under the State Excise law. Prior to this notification, Orissa was one of the few states where Bhang was not regulated as intoxicant.
Source: bit.ly/46J2NVn

2. India’s drug price regulator, NPPA, has rejected a price revision plea of a manufacturer of drug on grounds that it had failed to communicate revision of prices of the drug in Form II of Drugs (Prices Control) Order, 2013 within prescribed timeline of 15 days.
Source: bit.ly/3M6bBuX

3. The Bombay High Court has observed that an egg/ sperm donor in an in-vitro fertilization scenario cannot seek the same rights as a parent.
Source: bit.ly/3YQVPeO

4. All entities who are not registered as telemarketers will not be able to make promotional calls. If any complaint is received against such entity, then it will be blacklisted for two years.
Source: bit.ly/3AsgYSM

5. The Telecom Regulatory Authority of India, the country’s internet and telecommunications regulator has issued an order to telecom and internet service providers to disconnect and remove access for unregistered telemarketers who are carrying out voice-promotional calls. Once disconnected, such persons shall be required to submit a compliance report within 1 week, and may be given an opportunity to register with the TRAI.
Source: bit.ly/4dD3eCE

 

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 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

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. Doctors can sell medicines to their patients without obtaining a separate license for selling drugs after complying with all the conditions specified under the Drugs Rules, 1945: Bombay High Court
Source: bit.ly/4cqy94s

2. Drugs which are approved in USA, UK, Japan, Australia, Canada and EU have been exempt from requirement to conduct clinical trials in India before securing a marketing approval, if they fall into the categories of Orphan Drugs for Rare Diseases, Gene and Cellular Therapy Products, New Drugs used in Pandemic Situations, New Drugs for Special Defense Purposes, and New Drugs that represent a significant therapeutic advance.
Source: bit.ly/4cmWZ4W

3. India’s Central Drug Regulator (CDSCO) has made it mandatory to follow WHO Technical Report Series (TRS) guidelines in so far as they relate to Good Manufacturing Practices, such as the “WHO Good Manufacturing Practices for Sterile Pharmaceutical Products.”
Source: bit.ly/3yyC4y6

4. India’s Central Government is reportedly planning to introduce a separate marketing practices code for medical devices. The proposed code aims to establish a voluntary framework to regulate marketing practices within the medical devices industry.
Source: bit.ly/4dvF6BY

5. Indian Government has revised hazardous residue standards for fruits and vegetables meant for domestic consumption and introduced new hazardous residue standards for fruits and vegetables meant for export purposes. Fruits and vegetables meant for export should comply with standards set by the Codex Alimentarius Commission or the importing country’s requirements.
Source: bit.ly/4fDKLYM

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