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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

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. Due to a recent spike in cases, the Karnataka Government has declared dengue as an “epidemic” and to that effect has issued a notification under the Karnataka Epidemic Diseases Regulations, 2020. As part of the notification, the government has empowered Municipal Corporations across the state to carry out inspections of sites for compliance with mosquito prevention measures.
Source: bit.ly/3ThmkGK

2. Industry associations of manufacturers of Drugs and Medical Devices have called for an amendment of the Drugs (Prices Control) Order, 2013 to make pricing guidelines uniform for both Scheduled and non-scheduled formulations.
Source: bit.ly/3AJuTUn

3. India’s Central food regulator, the Food Safety and Standards Authority of India has issued a notification to re-operationalize The Food Safety Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022, in the interim of formulating new regulations.
Source: bit.ly/3ASeVYj

4. It is reported that IT’s upcoming meeting scheduled for 9th September, the Goods and Services Tax Council may take a decision on removing the existing 18% Goods and Services Tax on health insurance policies.
Source: bit.ly/3TjjrWa

5. In pursuance of its larger and long-term project of fighting and reducing anti-microbial resistance, the World Health Organization has issued a guidance directing management of “antibiotic waste” generated by manufacturers, which contributes to rising levels of anti-microbial resistance.
Source: bit.ly/4g922t1

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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 Union Health Ministry of India has been allocated a budget of Rs 90,958.63 crore for the financial year 2024-2025 in the Parliament’s interim Union Budget 2024 session. This budget is 12.96% higher than the budget that was allocated for the financial year 2023-24.
Source: bit.ly/3YnHCWu

2. The Union Health Ministry of India has announced a revision in the basic customs duties (BCD) with an aim to align with domestic capacity expansion for medical equipment such as X-ray tubes, flat panel detectors, including scintillators that will be used in the manufacture of medical X-ray machines for medical, surgical, dental, or veterinary use. The custom duty will be reduced from 15% to 5% until 31st May 2025.
Source: bit.ly/4fgx6GI

3. India’s Environment Ministry has issued a draft guidelines relating to the Uniform Consent Fee and the Grant, Refusal, or Cancellation of Consent to Establish & Consent to Operate. These guidelines aim to streamline the consent mechanism under the provisions of the Water Act and Air Act, enhance ease of doing business, minimize the compliance burden on industries, and reduce duplication of work concerning the issuance of consents.
Source: bit.ly/4cQs6af

4. India’s Environment Ministry has notified an Public Liability Insurance (Amendment) Rules, 2024. This amendment aims to increase scope of public liability insurance to environmental damage that may be caused by industrial accidents.
Source: bit.ly/3YihHjg

5. The India’s Central Drug Regulator (CDSCO) is reportedly planning to exempt the need for testing Cough Syrups intended for export to the US, UK, Canada, the European Union, Japan, Australia, Singapore, Korea, and Switzerland at prescribed laboratories.
Source: bit.ly/4df0ZFz

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s drug regulator will implement the mandate of printing of QR codes to curb counterfeiting. The top-selling brands have reportedly said that they have already started integrated QR codes and bar codes for tracking and compliance checks.
Source: bit.ly/4d80PzG

2. Indian Health Ministry has issued draft rules under the Drugs and Cosmetics Act, 1940 relating to compounding of minor offences and violations. The draft rules establish a system for companies to settle minor violations of the Act, like manufacturing drugs without proper procedures, outside of court. Companies can apply to a designated compounding authority with relevant documents, and if approved, avoid prosecution. This aims to resolve issues efficiently without lengthy court cases, but serious offenses like selling adulterated drugs are not eligible for compounding.
Source: bit.ly/3zLSKlT

3. India’s Drug Control Officers collective proposal to Indian Government for changing the name of the Drugs and Cosmetics Act, 1940 to ‘Bharatiya Aushadhi awam Chikitsa Upakaran Adhiniyam’ has received mixed responses from the industry and various stakeholders. While some have reasoned that change of name of the Act is the need of the hour and should be done as early as possible, others have questioned the need and purpose of the exercise.
Source: bit.ly/4d9IsdV

4. India’s Pharmacy Regulator, the Pharmacy Council of India (“PCI”) has extended the deadline for submission of statutory documents till 31st July, 2024 by new institutions and existing institutions that have applied for introduction of new course. PCI stated that the documents should be submitted on its compliance portal only. No other mode other than the PCI Compliance portal will be entertained for submission of documents.
Source: bit.ly/3y0YeZE

5. Indian Health Minister stresses on India’s need for world class regulatory framework for Pharma and Medical Device Industry to ensure better quality of products. The Minister also stated the importance of transparency in India’s apex drug regulator the Central Drugs Standard Control Organisation (CDSCO). The Union Health Minister stated that it is important for CDSCO to be in continuous dialogue with the drugs and medical devices industry to understand their issues and support them to fulfill the quality expectations and standards of CDSCO.
Source: bit.ly/4d5XuBd

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Supreme Court has issued its decision in a matter concerning the legality of exercise of powers by the National Pharmaceutical Pricing Authority (NPPA) in levying overcharging fees against an entity that claimed not to be a “distributor” or a “dealer” as defined under the Drugs (Prices Control) Order, 1995, since it had a dual role. The Court held that there is no mutual exclusivity between a dealer and a distributor, and dismissed the appeal.
Source: bit.ly/3xPkgP1

2. The National Medical Commission, has mandated the presence and maintenance of a Tobacco Cessation Centre at all hospitals attached to Medical Colleges across the country.
Source: bit.ly/3WdIjzk

3. To curb rise in misleading advertisements, the Central Government may soon introduce regulation to restrict the advertisement of Diabetes, Sex Hormone and Oncology medication, and may require approval and permission to make claims of efficacy for these Drugs.
Source: bit.ly/46nCjst

4. The Ministry of Health and Family Welfare has published Draft Drugs (Amendment) Rules, 2024 whereby it intends to amend Rule 96 requiring inclusion of details of Drug excipients on retail labels of Drugs.
Source: bit.ly/463YZO9

5. The European Commission has published and adopted the Artificial Intelligence Act, which will regulate the inclusion and integration of AI into Medical Devices and In-Vitro Devices. This Act is set to come into force on the 2nd August 2024.
Source: bit.ly/3Y5qCUV

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Central Government is mulling including non-prescription Neutraceuticals currently regulated by the Central government food regulator the Food Safety Standards Authority of India, under the price control regime similar to Drug price regulation under the Drugs (Prices control) Order, 2013.
Source: bit.ly/4cRZVb7

2. The Supreme Court in continuation of prior orders issued acknowledging the concerns raised in a petition seeking to address the shortage of life saving Antiretroviral Drugs in the country, has granted the request of the petitioner to discuss the access of quality Antiretroviral Drugs to persons dealing with HIV.
Source: bit.ly/4cAATg9

3. The Central Government has issued a Draft Notification proposing amendment to the Drugs Rules, 1945, mainly intending to introduce restriction on advertising Drugs listed in Schedule G of the Rules.
Source: bit.ly/3Whm0Ke
Source: bit.ly/3VZZ0Or

4. Then United States Federal Trade Commission is set to take action against Drug supply middlemen and major pharmacy chains for use of anticompetitive tactics in negotiating Drug prices.
Source: bit.ly/3WgtAom

5. The World Health Organization has issued a new and updated list of pathogens, to reorient the prioritization in combating Antimicrobial Resistance.
Source: bit.ly/4czZdiw

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s central food regulator has approved a proposed Amendment to the Food Safety Standards (Labelling and Display) Regulations, 2020, to now indicate the per-serving Recommended Dietary Allowances, sugar, salt and sodium content in larger font.
Source: bit.ly/4bB3IYw

2. Association of Indian Medical Device Industry has requested the Ministry of Finance to increase the import tariffs on Medical Devices, correct the inverted duty structure, and to introduce new cap on trade margin in a bid to encourage the development of indigenous industry and competition.
Source: bit.ly/3VWQSOP

3. The Ministry of Consumer Affairs has set up a meeting with Automobile manufacturers operating India, and various Automobile manufactures Associations in an effort to onboard these companies on the Right-to-Repair portal maintained by the Ministry, and which has already onboarded several consumer electronics companies.
Source: bit.ly/4coI0bD

4. The Supreme Court, in the course of ongoing proceedings, has granted the Central Government an additional period of 8 weeks to frame a National Policy on Distribution of Menstrual Products (to adolescent children).
Source: bit.ly/4cTgvGV

5. The European Commission’s Medical Device Coordination Group has issued a new guidance amending the Guidance on “Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746” regarding the classification of In-Vitro Medical Devices at the pre-market introduction stage. The new amendment provides differential Conformity Assessment for the Devices based on their classification; The guidance has also provided an annex differentiating an In-Vitro Medical Device and a Companion Diagnosis.
Source: bit.ly/3Y2Ffbs

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.

Supreme Court of India pulls up State Licensing Authority for failing to take action against misleading advertisements by leading ayurvedic manufacturer
India’s Central Ayush Ministry recently filed an affidavit in the Supreme Court of India to explain the steps it has taken against a leading manufacturer of Ayurvedic products after receiving several complaints against the manufacturer for making false and derogatory claims against modern medicine. The affidavit states that no action has been taken in the past two years by the State Licensing Authority, despite several orders from the Supreme Court, Right to Information (RTI’s), and directives from the Prime Minister’s Office (PMO). The Supreme Court has now asked the State Licensing Authority to issue its reply.
Source: bit.ly/4aDTxmc

Relaxation of penalties for certain offences involving drugs, medical devices and cosmetics to take effect from December 31, 2024
The Indian Government has decided to relax the penalties for offences relating to drugs, medical devices and cosmetics that are of the nature of violation of conditions of license or failure to label in the prescribed manner. These offences typically invited punishment of imprisonment and fine, but may now be compounded by the payment of a penalty both before or after institution of prosecution. The decision was notified under the Jan Vishwas (Amendment of Provisions) Act, 2023. The Government has now notified the date of coming into effect of the relaxation as December 31, 2024.
Source: bit.ly/3U0yhS4
Source: bit.ly/3THGUjd

Major technology company admits to collecting information from private browsing, agrees to destroy data as part of the settlement
A major technology company, known for operating a popular internet search engine, has agreed to destroy billions of data records to settle a lawsuit. The suit claimed that the search engine company was secretly tracking the internet use of people who thought that they were browsing privately. Under the settlement, the search engine will update disclosures about what it collects in “private” browsing and will also let the users block third party cookies for five years.
Source: bit.ly/3vIwHL9

Industry demands that US FDA should give prior notice before conducting remote regulatory assessments
The US Food and Drug Administration’s (USFDA’s) revised guidance for conducting remote regulatory assessments (RRAs) has received comments from the industry. A clear demand from the industry is that the US FDA should provide advance notice for mandatory assessments and discuss observations before taking any regulatory action.
Source: bit.ly/3xieXXJ

Written patient consent required for sensitive examinations on anesthetized patients in US
The United States Department of Health and Human Services has recently released a new guidance as per which hospitals have to mandatorily obtain written informed consent from anesthetized patients for breast, pelvic, prostate, and rectal exams performed on them for educational and training purposes. If hospitals do not obtain the explicit consent and violate the patient privacy rights, they may become ineligible for participation in the Medicare and Medicaid programs, as well as become liable for fines and investigations.
Source: bit.ly/3U1M8aX

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.

Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO
The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward.
Source: bit.ly/3TEO74B

Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel
The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India.
Source: bit.ly/3VsdCaQ

Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements
As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company.
Source: bit.ly/3vu45VQ

Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided.
In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity.
Source: bit.ly/3vkn7hu

EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period.
The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market.
Source: bit.ly/3Vr9zeK

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.

Hospitals and pharma companies in India bought electoral bonds worth 9 billion Rupees
Indian hospitals and pharma companies have reportedly bought electoral bonds for approximately Rs. 900 crore. Electoral bonds bought by businesses are later encashed by political parties, and until recently, the identity of businesses that bought electoral bonds was kept confidential.
Source: bit.ly/43qtXyz

New portal for filing consumer complaints to be introduced
India’s Central Consumer Protection Authority (CCPA) will reportedly launch a dedicated online complaint portal for consumers to file complaints against misleading advertisements and unfair trade practices. The timing of the launch of the portal is intended to coincide with World Consumer Rights Day (March 15).
Source: bit.ly/3ViSKCP

New guidelines that will differentiate brand extension and surrogate advertisements to be notified soon
India’s Central Consumer Protection Authority (CCPA) has reportedly formed a committee to deal with the issue of differentiation of genuine brand extensions from surrogate advertisements. Brand extensions are advertisements by companies that extend existing brands into new product categories. For example, advertisements by alcohol companies to sell music CDs, glasses, soda, etc. under the same brand name. However, if the products covered brand extensions are not available for sale in the open market, then such advertisements become surrogate advertisements.
Source: bit.ly/3Tll3hn

EU may soon adopt a single compulsory license regime for medicines in crisis situations
The European Union Parliament is reportedly going to consider a proposal to allow manufacturers of critical medicines to manufacture them for all member states without the consent of the patent holder in crisis situations. Under the current law, even if one State of the EU grants a compulsory license to a manufacturer to manufacture a critical medicine in a crisis situation, the medicine cannot be exported or sold in other EU states unless the concerned State also grants some kind of immunity against the import of such medicine into that State.
Source: bit.ly/3Vp0Iud

Brand owners now responsible for collection of any plastic packaging waste
The Ministry of Environment has amended the Plastic Waste Management (Amendment) Rules, 2024. All brand owners who use plastic packaging on the product package are obligated to collect plastic packaging waste. However, if the brand owners have met the Extended Producer Responsibility targets by contracting with a registered recycler, then physical collection of plastic packaging waste may not be required.
Source: bit.ly/3PrvG0L