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 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

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. The Indian government has made it mandatory for students pursuing medical education in Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa, and Homoeopathy (AYUSH) to clear the National Exit Test (NExT) after graduation. This requirement will apply to medical graduates from the 2021-2022 batch.
Source: bit.ly/4egpEdy

2. India’s central drug regulator (CDSCO) has asked a pharmaceutical company to explain its claims that its eyedrops can augment near vision in 15 minutes and that it has received marketing approval from CDSCO.
Source: bit.ly/4eyIWLp

3. The Bombay High Court restricted the CEO of a leading e-commerce luxury brand from hiring individuals from another e-commerce beauty brand on grounds that the CEO was misusing employee personal data that it had access to when he was the Chief Business Officer of the rival e-commerce beauty brand.
Source: bit.ly/4glsuzN

4. India’s central drug regulator (CDSCO) has issued an order providing guidance for industry on Pharmacovigilance Requirements for biological products.
Source: bit.ly/4dVKiQ7

5. India’s Directorate General of Foreign Trade (DGFT) has released a public notice amending the timeline for meeting the export obligation of drugs which have been imported from unregistered source.
Source: bit.ly/47qXv1a

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. 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

Madras High Court Greenlights Online Sale of Drugs and Medical Devices in India

online_sale_of_drug_and _medical_devices

Introduction

The Division Bench of Madras High Court in its recent order has confirmed that online pharmacies and online marketplaces of medicines and medical devices can continue to operate under existing law i.e. Drugs and Cosmetics Act, 1940 and Rules, 1945.

In doing so, the Court reversed the order passed by a Single Judge Bench of the same Court in 2018, which had effectively ordered e-pharmacies and e-marketplaces to stop business.

In this article, we will discuss the developments leading up to the recent Court order.

Background of 2018 court order banning online sale of medicines

On 17.12.2018, The Single Judge Bench of Madras High Court surprised e-pharmacies and e-marketplaces by ordering that till the Central Government did not publish rules for regulation of e-pharmacies, “the on-line traders are bound not to proceed with their on-line business in drugs and cosmetics.”

The rationale behind such an order was that without any proper framework regulating the online sale of drugs, there may arise chances of potential misuse of health and safety. The Court felt that amendments to the Drugs Rules, 1945 were necessary before allowing the online sale of drugs. The Court also directed the state government to notify the proposed Drugs and Cosmetics Amendment Rules, 2018 in the state Gazette, latest by 31.01.2019, for online sale of drugs within the state.

However, after passing the order, at the request of e-pharmacies and e-marketplaces, the Court decided to defer the implementation of the order until 20.12.2018 so that they could prefer an appeal against the order.

Ad-interim stay of 2018 order

The e-pharmacies and e-marketplaces preferred an appeal against the order of the Single Judge, on 02.01.2019 the Division Bench temporarily stayed the operation of the Single Judge Bench.

The Bench felt that a sudden ban would disrupt access to medication for those who relied on online pharmacies, particularly for home deliveries. However, the Division Bench agreed with the Single Judge Bench on the need for appropriate regulation for the online sale of drugs and directed the Central Government to finalize a framework for the regulation of online sale of drugs.

Reversal of 2018 order

The Division Bench has now passed a final order in the appeal. It has explicitly allowed the online sale of drugs, with a condition that any online sale of drugs must be routed through licensed druggists and chemists only.

In doing so, it has endorsed the lawfulness of operation of e-pharmacies and e-marketplaces, which are currently doing business through dealers and retailers who have a license for sale or distribution of drugs under Drugs Rules, 1945.

The Court decided to dispose of the appeal primarily on the grounds that the Delhi High Court is already hearing a matter with identical issues and the Central government is in the process of preparing a new policy for the online sale of drugs.

Order from Delhi High Court

The Delhi High Court is currently hearing a batch of writ petitions in which the petitioners have challenged the legality of the online sale of drugs and medical devices. Unlike the Madras High Court, the Delhi High Court has never held that the online sale of medicines is bad in law. The Delhi High Court has always maintained a position that the online sale of medicines and medical devices by licensed retailers is not unlawful. However, the Delhi High Court has time and again expressed concerns that the Central Government is yet to finalize a framework for the regulation of online sale of drugs and medical devices, despite the fact that the draft rules for the regulation of online sale of drugs were published in 2018 for comments and the Central Government has already received comments. The Court has now given the Central Government a last opportunity to put in place a policy framework for online drug sales by July 2024.

Conclusion

The order of the Madras High Court is welcome as it removes the ambiguity that existed in relation to the legality of the online sale of drugs and medical devices. Now, the fate of e-pharmacies and online marketplaces for medicines and medical devices is inextricably linked to the outcome of the petition filed in the Delhi High Court and the decision of the Central Government to introduce (or delay the introduction of) a framework for online sale of drugs and medical devices.

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.

Indian government may reconsider its decision of prohibiting manufacture of drugs and nutraceuticals, health supplements in same facility
The Indian government is reportedly reconsidering its decision to act against pharmaceutical companies who are manufacturing nutraceuticals, health supplements and drugs in the same facility, due to objections raised by small scale manufacturers. The previous Good Manufacturing Practices (Schedule M) for drugs gave some concession to manufacturers of drugs to manufacture nutraceuticals and health supplements in the same facility. However, no such concession exists under revised Good Manufacturing Practices (Schedule M) published in December 2023.
Source: bit.ly/3x59lQo

Exporters of Indian farm produce are facing phytosanitary challenges
Indian agricultural exports, including fruits and vegetables, are reportedly finding it difficult to enter regions like Europe, Australia, and the US due to tough phytosanitary requirements and thresholds such as high pesticide content. In response, India’s Commerce Ministry is reportedly creating a data set on export consignments of agricultural exports that were refused by European countries and other nations on grounds of phytosanitary non-compliances, resulting in significant trade hurdles regardless of duty relaxations. A phytosanitary certificate is required for the export of agricultural products to ensure that the produce is pest-free, disease-free, and meets other health requirements such as traceability at the farm level.
Source: bit.ly/4ctvxnB

Indian government has established Fact Check Units to check spread of fake news
The Indian Ministry of Electronics and Information Technology has appointed the Press Information Bureau of the Ministry of Information and Broadcasting as Fact Check Unit to address fake and misleading news against Central Government. The fact check unit of the central government is expected to vet all the online content related to the business of the central government. Any content identified as fake by the unit will be taken down from the internet.
Source: bit.ly/3Px3Yj8

The Centre gives more time to states to establish Allied Healthcare Councils
India’s Ministry of Health and Family Welfare has extended the timeline for states to establish state allied and healthcare councils by six months. State Governments have to setup State Councils for Allied Healthcare by November 2024. The National Commission for Allied and Healthcare Professions Act 2021, which regulates quality of allied and other healthcare professionals in India, will be operationalized once the State Councils have been established.
Sourve : bit.ly/3PxeZ4d

Integrated Veterinary Health Certificates (VHC) mandatory after 30th June,2024 for import of milk and milk products into India
The Food Safety and Standards Authority of India (FSSAI) has extended the deadline for implementing its decision to require imported food consignment of milk and milk products to be supported by an integrated veterinary health certificate. The requirement will take effect on July 1, 2024. From that date, only those milk and milk products that are supported by integrated veterinary health certificates will be allowed importation into India. The Integrated Veterinary Health Certificate must demonstrate that imported milk and milk products meet both the FSSAI’s food safety standards and the Department of Animal Husbandry and Dairying’s (DAHD) sanitary criteria.
Source: bit.ly/3TIh53F

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.

Major Indian Ayurvedic Medicine Manufacturer to be tried for Contempt of Court for publishing misleading drug advertisements
India’s Supreme Court is reportedly set to issue a Contempt Notice to a major Ayurvedic medicines manufacturer in India after it found out that the manufacturer had published a misleading advertisement claiming permanent relief for certain chronic conditions such as Diabetes and Liver Cirrhosis. In November 2023, the manufacturer had given an undertaking to the Supreme Court that it will not publish misleading advertisements or disparage allopathy. The Supreme Court has also questioned the Indian government for its inaction over publication of misleading advertisements by the manufacturer despite existence of a law which makes publication of misleading advertisement punishable with imprisonment.
Source: bit.ly/42U33yI

Doctors will have to obtain registration with State Medical Council of every State where they practice: Delhi HC
The High Court of Delhi has upheld the legality of a notice issued by Delhi Medical Council which made it mandatory for Doctors to register with the Council if they wanted to practice in the State of Delhi. The Doctors argued that it was an onerous requirement which would require them to register in every State they practice in. However, the Court held that the intent of the law is to require Doctors to register in every State that they practice in, and that Doctors have the option to register with multiple State Medical Councils in India.
Source: bit.ly/3TgHANw

Cosmetic Importers asked to provide sales details in a bid to curb import of counterfeit cosmetics
In an effort to curb the import of counterfeit cosmetic products, India’s Central Cosmetics Regulator, Drugs Controller General of India, has directed importers of cosmetics who import cosmetics already registered by authorized importers, to furnish annual sales details such as number of consignments, imported quantity, total cost of imported cosmetics of each consignment, along with warehouse details.
Source: bit.ly/42T2IMR

Central Government has to fix ceiling prices of medical treatment within 2 months: Supreme Court
The Supreme Court has directed the Central Government publish ceiling prices for medical treatments offered by Hospitals all over the country within 2 months. If the Central Government fails to do so, the Supreme Court has said that it will direct Central Government to fix medical treatment costs stipulated under Central Government Health Scheme as ceiling price of medical treatment offered by Hospitals for the whole country.
Source: bit.ly/3wsyHHs

India Seeks to delay implementation of EU Carbon Emissions Limits
India is set to conduct negotiation with the European Union regarding the implementation of the Carbon Control Regime, seeking a complete elimination of the Carbon Border Adjustment Mechanism, failing which India will seek an extension of timelines for reduction of emissions. It is expected that in order to comply with requirements under EU Carbon Control Regime, Indian exporters will have to make significant capital investment will increase cost of production.
Source: bit.ly/42S7DxH