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 Supreme Court’s National Task Force (NTF), panel of eminent doctors constituted to make an action plan for ensuring the safety of healthcare workers, has opined that there is no requirement for enacting a separate central legislation to protect the doctors as there are already enough legal provisions to ensure their safety.
Source: bit.ly/4fVmIDK

2. India’s Directorate General of Foreign Trade (DGFT) has issued a trade notice to harmonize and streamline pharma export process and bring in line Schedule-II (Export Policy) with the latest tariff codes under the Finance Act, 2024. A draft of Schedule-II covering Chapters 01-98 of the ITC (HS) codes is open for public feedback and comments till 27th November 2024.
Source: bit.ly/3Zo7SR3

3. India’s Ministry of Environment, Forest, and Climate Change has informed that all registered Producers, Importers, and Brand Owners (PIBOs) under the Extended Producer Responsibility (EPR) regime of Plastic Packaging registered during FY 2022-24 are required to file their Annual Returns (AR) for FY 2023-24 by 30th November 2024. Failure to do so will result in their AR being auto-filed and levy of penalty i.e., EPR targets for FY 2024-25 will be increased by 25% over and above the EPR target for FY 2023-24.
Source: bit.ly/3JqZRBH

4. To safeguard patient data and mitigate cybersecurity risks posed by vendor networks, Indian hospitals are reportedly advancing in cybersecurity practices. 89% of hospitals have implemented third-party risk management systems however only 10% hospitals have adopted holistic data privacy programs, underscoring area for improvement. Hospitals are reportedly recommended to allocate 12-15% of their budget over the next two years to cybersecurity and digital infrastructure to remain resilient against cyber threats.
Source: bit.ly/3Oj1ggl

5. The United States Drug Enforcement Administration (DEA) has reportedly extended pre-pandemic telehealth regulations for prescribing controlled substances till 31st December, 2025. This decision allows telemedicine providers to continue prescribing controlled medications without requiring in-person visits, while the agency evaluates public feedback on proposed permanent regulations.
Source: bit.ly/3YTYUcK

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 FSSAI has issued an advisory urging Food Business Operators (“FBOs”) to ensure compliance with the Hon’ble Supreme Court’s decision in IMA & Anr vs Union of India & Ors to curb misleading advertisements.  As per the advisory, FBOs must generate and upload a self-certificate on the Ministry of Information & Broadcasting’s Broadcast Seva portal before telecasting or publishing any advertisement. (Copy of advisory attached).
Source: bit.ly/3AFzkQy

2.  The World Health Organization’s (“WHO”) Intergovernmental Negotiating Body (“INB”) Ambassador has reportedly informed that the pandemic agreement will not be adopted at the special World Health Assembly (“WHA”) next month, as countries need more time to conclude complex negotiations, including those on the proposed Pathogens Access and Benefit Sharing (“PABS”) system.
Source: bit.ly/3As8uLP

3. A response to a Right to Information (RTI) application seeking the status of Draft Drugs and Magic Remedies (Objectionable Advertisements) (Amendment) Bill, 2020 (“DMR(OA) (Amendment) Bill”) has revealed that it is still pending. The amendments were intended to enable stricter action against misleading advertisements, as well as to widen the scope of the Drugs and Magic Remedies (Objectionable Advertisements) Act by introducing 24 diseases and disorders. The DMR(OA) (Amendment) Bill has been pending with the Ministry of Health and Family Welfare, since 2020.
Source: bit.ly/3Obgtjf

4. The Delhi High Court has granted an ex-parte interim injunction restraining AquaKind Labs LLP from using the suffix “KIND” in their trade name “Aquakind” and ruling in favor of Mankind Pharma. This ruling was based on the reasoning that AquaKind Labs’ name was deceptively similar to the registered trademark “MANKIND”, potentially causing confusion in the pharmaceutical market and to the consumers.
Source: bit.ly/4hIoXMw

5. The Ministry of Environment, Forest and Climate Change has published the Water (Prevention and Control of Pollution) (Manner of Holding Inquiry and Imposition of Penalty) Rules, 2024, outlining procedures for holding inquiries and imposing penalties under section 45B of the Water (Prevention and Control of Pollution) Act (“Water Act”). The Rules will come into force upon the publication in the Official Gazette.  (Copy of rules attached.)
Source: bit.ly/3UONcyC

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 National Pharmaceutical Pricing Authority (NPPA) has directed drug manufacturers to reduce the maximum retail price (MRP) of three crucial cancer drugs i.e., Trastuzumab Deruxtecan, Osimertinib, and Durvalumab. This is in line with reduction of customs duty and GST rates on these medications.
Source: bit.ly/4fBQ3Dd

2. Delhi High Court has granted a permanent injunction against a pharma company which had imitated the design and presentation of a drug manufactured by another pharma company. This ruling highlights the requirement for pharma companies to ensure a distinctive packaging to avoid copyright Infringement claims.
Source: bit.ly/40AprhH

3. The All India Organization of Chemists and Druggists (AIOCD) has urged the Drug Controller General of India (DCGI) to restrict a partnership between a rapid delivery platform and an e-pharmacy, citing concerns over regulatory and quality compliance issues that could potentially jeopardize patient safety.
Source: bit.ly/4fDJEqS

4. The Himachal Pradesh High Court has directed the state government to implement a QR code system to assess the quality of medicines in the state. This QR code will provide consumers with key information about the medicine, including production and expiry dates, unit details, batch numbers, and component specifics in order to enhance consumer awareness and transparency in medicine quality.
Source: bit.ly/3YE20Bw

5. UK government is set to launch ‘World-First’ Genomics-Led pandemic warning system. The system will utilize the technology to flag and monitor potential outbreaks of bacterial or viral diseases.
Source: bit.ly/4fBdyw6

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 Ministry of Textiles has further extended the timeline for the implementation of the Medical Textiles (Quality Control) Order, 2023. The new deadline is now 1st January 2025, for disposable baby diapers, sanitary napkins, reusable sanitary pads, and period panties. Earlier, the implementation date was 1st October, 2024.
Source: bit.ly/3Afz4rd

2. India’s Subject Expert Committee (SEC) has granted permission to a leading pharma company for importing and marketing the drug for a rare blood disorder, paroxysmal nocturnal hemoglobinuria (PNH), in India by waiving the requirement to conduct local clinical trials. The proposal was presented before SEC and SEC noted that the drug is approved in 35 countries including the US, European Union, Japan, and others and eventually agreed for a local clinical trial waiver.
Source: bit.ly/3BZ2MkU

3. India’s Ministry of Commerce and Industry is reportedly providing a significant boost to exporters through launch of new online portals like “Jan Sunwai” and “Enterprise Resource Planning (ERP).” These initiatives aim to reduce bureaucratic hurdles, enhance transparency, and facilitate smoother operations, ultimately leading to faster resolutions of trade issues.
Source: bit.ly/3Aeyl9N

4. The India Pharmacopoeia Commission (IPC), under the Ministry of Health and Family Welfare, attended a Joint Working Group Meeting with national regulatory authorities from Bhutan, Mauritius, Mozambique, Nepal, the Solomon Islands, and Sri Lanka. The meeting focused on strengthening pharmacopoeial cooperation and establishing an annual forum for ongoing cooperation.
Source: bit.ly/3A1eY43

5. India’s Department of Pharmaceuticals (DoP) has recently rejected the review applications from five major pharmaceutical companies, upholding the ceiling prices set for various strengths of the modified release (MR) formulations of the high blood pressure drug metoprolol. The companies argued that the pricing authority erred in its calculations by combining both the plain and modified release formulations of metoprolol 25 mg and 50 mg tablets. They pointed out that the National List of Essential Medicines (NLEM) 2022 does not include the modified release forms of metoprolol. However, the National Pharmaceutical Pricing Authority (NPPA) contended that in the absence of specific mention of any variant, these formulations can be considered alongside the conventional formulations.
Source: bit.ly/3AaMHYJ

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. Application process for (1) Manufacture/ import a New Drug/ formulation, or conduct clinical trial, (2) Manufacture/ import of new bulk drug substance, and (3) Import of finished formulation of a new drug will henceforth exclusively take place online on the SUGAM portal, and processing of offline application has been retroactively paused from 16th August 2024.
Source: bit.ly/3z9EX92 

2. All registered Doctors are required to re-register their MBBS qualifications on the newly operationalized National Medical Register Portal and shall be provided a Unique Identification Number.
Source: bit.ly/3TyGpsl
Source: bit.ly/3zy4PLE3. The central drugs regulator of India, the Drugs Controller General of India has issued a revised Guidelines and checklists for Zonal, Sub-Zonal and Port-officers of the State Drug Authorities providing updated policy on how to conduct their duties.
Source: bit.ly/3TuM2b3

4. The Indian Pharmacopoeia Commission has clarified that in the event of a conflict of interpretation between the newly released digital version of the Indian Pharmacopoeia 2022, and the print version the print version shall win out.
Source: bit.ly/4gqZ2IA

5. In addition to requiring audio-visual warnings during presentation of films, the Central government will require all online curated content publishers to display a non-skippable anti-tobacco audio-visual advertisement, as well as place a static message for the duration of display of use of tobacco and tobacco products in the curated content. This requirement shall be effective form March 2025.
Source: bit.ly/3XMqTvq

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 drug regulator (CDSCO) has released draft guidelines on Good Clinical Practices Rules to align India’s clinical trial rules with international standards. The draft is open for comments by October 12, 2024.
Source: https://bit.ly/3XpPdSr

2. India’s premier consumer forum ordered a major medical device manufacturer to pay compensation to one of the claimants who had suffered adverse reactions as a result of faults in the surgical-implants which they had received from it.
Source: https://bit.ly/3ztLCe5

3. India’s statutory body regulating medical education, National Medical Commission (NMC) has issued revised guidelines removing sodomy and lesbianism from the category of unnatural sexual offences from its curriculum of medical education.
Source: https://bit.ly/3Xr5Kp7

4. India’s union health ministry has expanded the health insurance scheme under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) to cover citizens aged 70 years and above, regardless of their income. The ministry will issue new, unique cards to senior citizens for the availment of the benefit.
Source: https://bit.ly/3XsD2nQ

5. The US Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) hearing aid. The hearing aid will be integrated into the hearing device of a giant electronic brand through software updates allowing the device to function as personalised hearing aid. The feature is aimed at helping users with their perceived mild-to-moderate hearing impairment.
Source: https://bit.ly/4e2LEsn

 

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 Department of Pharmaceuticals (DoP) released the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) providing guidelines to medical device companies for regulating monetary and non-monetary incentives given to Healthcare Professional (HCPs) for eliminating unethical conduct while organising promotional and training programs for such HCPs. The UCMPMD also sets guidelines for establishment of an ethics committee and entering of complaints on the UCMPMD portal set by the DoP.
Source: bit.ly/3AWUnOm

2. The pharmaceutical company that launched eye drops claiming that they can eliminate near-sightedness in 15 minutes has clarified that its claims were based on approved indications for treatment and Phase 3 clinical trial data and are not unethical or false.
Source: bit.ly/3z0wSn3

3. The Bombay High Court has granted an interim injunction to a Fast-Moving Consumer Goods (FMCG) company manufacturing health drinks against another FMCG company manufacturing fibre-nutritional drinks for circulating advertisements on WhatsApp groups that allegedly denigrated and disparaged the latter’s products.
Source: bit.ly/3APlUkz

4. The National Medical Commission (NMC) has withdrawn its previously issued public notice for the discontinuation of all courses offered by the College of Physicians & Surgeons (CPS), Mumbai as it was earlier regarded as being beyond the powers of the college to provide conduct examinations and award degrees. However, the earlier notification now stands withdrawn.
Source: bit.ly/3Zisquh

5. The US Court has held that expert testimony is a requirement in all medical negligence cases, and it is not enough for the claimant to establish that the doctor had not communicated the box-label warning to the patient or patient’s family, especially in cases where the patient’s claim was based on the absence of informed consent.
Source: bit.ly/3Zo6HkC

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

Self-Declaration under the UCPMP 2024: Should One Submit

In March 2024, Department of Pharmaceuticals (“DoP”) published a guidance titled ‘The Uniform Code for Pharmaceutical Marketing Practices, 2024’ (“UCPMP”) which lays down the standards for interaction between pharmaceutical and medical device industry and  healthcare practitioners. The UCPMP 2024 replaced a similar 2015 guidance.

More recently, the DoP has issued a Standing Order which implores importers, manufacturers and marketers of drugs and medical devices to submit a self-declaration signed by the seniormost executive of the organization promising compliance with UCPMP. If the entity is a member of an industry association, then the self-declaration has to be submitted to the industry association, and if not, then to the DoP at the email address: dop.ucpmp@gov.in.

In this article, we have examined whether there is any legal requirement for importers, manufacturers and marketers of pharmaceuticals and medical devices to provide self-declaration under UCPMP. We have also examined the consequence of providing the self-declaration and ramification of not providing such self-declaration.

Background to UCPMP Self-Declaration

The UCPMP itself has language which gives the DoP the ability to issue Standing Orders to introduce new guidelines which should be read as if they are part of UCPMP.

Through the Standing Order On 28th May 2024The DoP introduced a new self-declaration requirement in addition to the self-declaration requirement already existing under UCPMP 2024. The UCPMP had a self-declaration expectation under which the seniormost executive of the organization had to declare that the organization had complied with the UCPMP in the financial year (April – March) that had elapsed. The new self-declaration requirement, which was introduced by the Standing Order, now expects the senior executive to undertake that the organization will comply with UCPMP in the ongoing/ upcoming financial year.

Is UCPMP enforceable as a law?

India’s Supreme Court has affirmed that for any circular, order, notification or similar direction issued by any governmental department to be considered enforceable, it has to be issued under the scheme of an existing  legislation.

The UCPMP is neither a legislation nor has it  been issued under the scheme of any existing legislation. Therefore, it should not be considered enforceable as a law in India. In other words, no government department or authority including the DoP should be able to take any action if an importer, manufacturer or marketer of pharmaceuticals or medical devices is unable to comply with UCPMP.

Is a Standing Order issued under UCPMP enforceable as law?

India’s Supreme Court has held that standing orders issued in exercise of administrative powers of any department are only enforceable if such Standing Order(s) are based on powers granted under a parent statute. As indicated in paragraphs above, the UCPMP is not a law. Therefore, a Standing Order issued in pursuance of UCPMP should not be treated as enforceable by law.

Is giving the Self-Declaration mandatory? What are the consequences of not giving the self-declaration?

Since UCPMP is not law and Standing Order issued through it which expects submission of the Self-Declaration is not legally enforceable, there should not be any adverse legal consequence of not giving the self-declaration.

However, if an entity is part of a pharmaceutical or medical device industry association, then the association may suspend or expel the entity from the association for failing to submit the undertaking.

The association and DoP may also take other steps, such as reprimand the entity and require a full apology to be published, however such a step would be disproportional and therefore improbable.

If the self-declaration is submitted, but the entity fails to comply with UCPMP, then what happens?

In general, whether the entity gives the self-declaration (undertaking) or not, the consequences of non-compliance of UCPMP will not change. These consequences are:

  1. Suspension or expulsion of the entity from the concerned pharmaceutical or medical device association of which the entity is member;
  2. Reprimand of the entity;
  3. Requiring the entity to a full apology to be published;
  4. Requiring the entity to issue a corrective statement;
  5. Requiring the entity to recover any sums or articles given or received in contravention of the UCPMP;
  6. Recommending the matter of breach to concerned governmental body having appropriate jurisdiction.

However, if the undertaking is given, and there is a non-compliance of UCPMP, there may be serious consequences.

Consequences of non-compliance with UCPMP after submission of self-declaration

Under India’s penal codes, it is punishable to give a declaration which the person knows is or believes to be false, or does not believe to be true, which is received by an authority as evidence of a fact.

The language of the self-declaration states that the entity shall provide “all required assistance to authorities for the enforcement” of UCPMP.

In the event of any inquiry into non-compliance of UCPMP, if the entity does not co-operate with DoP or panel of auditors appointed by UCPMP, there is a possibility that the DoP may initiate criminal prosecution on grounds of providing a false undertaking that the entity will assist in the enforcement of the UCPMP.

Similarly, if it is established that the entity has breached UCPMP, then DoP may initiate criminal prosecution on grounds of providing false undertaking that the entity shall comply with the UCPMP.

The chance of such prosecution succeeding in trial is not guaranteed however, due to a strong technical defence that exists with every entity who has given the self-undertaking: which is that the undertaking was given without knowledge or belief that it would be treated as ‘evidence of fact’. However, the possibility of a different outcome cannot be completely ruled out.

Tax Consequence of providing the self-undertaking under UCPMP

The Supreme Court has ruled in Apex Laboratories Pvt. Ltd. v Deputy Commissioner of Income Tax (2022) 7 SCC 98 that any expense incurred by an entity in the pharmaceutical or medical device industry, in the course of its dealings with Doctors, that results in an violation of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, in the hands of Doctors, will be an expense impermissible for deduction under Sec. 37(1) of the Income Tax Act, 1961.

The Supreme Court, however, has not ruled that any expense incurred in its dealings with Doctors by an entity in  pharmaceutical or medical device industry which may be in violation of the UCPMP will also be an expense impermissible for deduction under Sec. 37(1) of the Income Tax Act, 1961.

The recent amendment to Sec. 37(1) of the Income Tax Act, 1961 which has given “guidelines” the status of law such that any expense incurred in violation of “guidelines” would also be an expense impermissible for deduction, would not extend to UCPMP even though it is a “guideline”, because the scope of the term “guidelines” under this provision may include only those guidelines which apply to the receiving party of any expense sought to be deducted under Sec. 37(1), in the current fact scenario: Doctors. By implication, it would not cover any other guideline such as UCPMP which may apply to the pharmaceutical and medical device industry.

Therefore, the current position of law is that an expense incurred in violation of the UCPMP will be inadmissible for deduction only when the violation also results in a violation of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, or any other law or guideline. However, if the self-declaration is given by an entity then it may vitiate defences available in proceedings before the tax authorities.

Conclusion

It is clear that UCPMP is not law and therefore non-submission of self-declaration \by itself should not result in any legal action.

In fact, submission of the self-undertaking may invite more serious repercussions as opposed to non-submission of the self-undertaking. Therefore, the importers, manufacturers and marketers of pharmaceuticals and medical devices should adopt a cautious approach to submitting the self-undertaking under UCPMP.

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