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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 Ministry of Consumer Affairs has set a timeline for compliance with amendments to the Legal Metrology (Packaged Commodities) Rules, 2011. Changes to labelling provisions will be enforced on either January 1st or July 1st, after a minimum 180-day transition period from notification. The revised rules mandate clear, legible, and standardized labels on packaged goods, ensuring consumers have key details such as net quantity, MRP, manufacturing date, country of origin, and manufacturer information. This move is aimed at enhancing consumer protection, business ease, and reducing compliance burdens for industry stakeholders.
Source: bit.ly/3CxjgRQ

2. The Supreme Court of India ruled that domicile-based reservation for postgraduate medical admissions under State Quotas violates the right to equality under Article 14 of the Constitution. However, the Court clarified that the judgment will not impact existing domicile reservations or affect students currently studying or who have already graduated under such categories.
Source: bit.ly/4juOHwG

3. India’s Central medical devices regulator, Central Drugs Standard Control Organization (CDSCO) and Indian Council of Medical Research (ICMR) has issued a draft standard In-Vitro Diagnostics (IVDs) evaluation protocol to evaluate the quality and performance of IVD’s. The protocol once approved will be used by IVD manufacturers testing labs in India. Public comments are invited on the draft standard before March 15, 2025.
Source: bit.ly/3QhIAyF

4. India’s Ministry of Health and Family Welfare has confirmed the addition of the Human Papillomavirus (HPV) vaccine to the country’s Universal Immunization Program (UIP), a major step in preventing cervical cancer, which is one of the leading causes of cancer-related deaths among women in India. While the vaccine’s inclusion in the UIP has been officially announced, the exact timeline for its roll-out has yet to be determined. The move aims to combat cervical cancer by offering free vaccination to girls aged 9-14 years.
Source: bit.ly/3WHhkgp

5. China has approved its first stem cell therapy for commercial use, despite mixed clinical trial results. The therapy is intended for patients with neurological disorders, including spinal cord injuries. The approval has raised concerns about the safety and effectiveness of the treatment, as the trials showed only limited evidence of efficacy, and there are calls for more rigorous oversight in stem cell-based treatments.
Source: bit.ly/3WI0Uoa

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 Drug regulator, the Central Drugs Standards Control Organization (CDSCO) has issued an instruction manual for manufacturers and importers of devices not having predicate devices, to file Periodic Safety Update Report on the Medical Device Portal.
Source: bit.ly/4g5ORaV

2. India’s Delhi High Court held in a recent order that petitions regarding patent infringement, during the lifetime of a patent will continue to be valid even after the expiry of the term of the patent itself, since the cause of action has arisen at a time when the patent was still active.
Source: bit.ly/3PL3TYU

3. India’s central level regulator of the medical profession and education, the National Medical Commission has issued a draft Teachers’ Eligibility Qualifications, where it is proposed to permit non-medical personnel with Masters and PhD level degrees to teach Anatomy, Physiology and Biochemistry at medical educational institutions.
Source: bit.ly/40HAW6o

4. A premier commercial body of India’s restaurant business operators are currently mulling legal action against quick-commerce companies which have created a business model of undercutting the restaurant business through the use of private-label food products.
Source: bit.ly/4auFgsV

5. The European Pharmacopoeia has adopted three general standards for mRNA based vaccines, (1 mRNA vaccines for human use (5.36), covering mRNA packaged in lipid nanoparticles, (2) mRNA substances for the production of mRNA vaccines for human use, and (3) NA templates for the preparation of mRNA substances. These standards are expected to set a framework of control for regulatory control and approval of mRNA vaccines across the EU and all jurisdictions that accept EU Pharmacopoeia standards.
Source: bit.ly/4ar8HMK

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UCPMP 2024 – Highlights and Summary of Key Differences from UCPMP 2015

India’s Department of Pharmaceuticals (DoP) has published The Uniform Code For Pharmaceutical Marketing Practices, 2024 (UCPMP 2024). The UCPMP is a code that governs the interaction between the industry and healthcare practitioners (HCPs/doctors) in India. The UCPMP 2024 replaces the UCPMP 2015, and is applicable to both pharma and medical device companies.

In the paragraphs below, we have summarized the business-critical changes between UCPMP 2024 and UCPMP 2015.  The expression ‘company’ refers to both pharma and medical device companies, unless the context suggests otherwise.

Enforceability: The UCPMP 2024 is ‘kind of’ ‘somewhat’ mandatory. The text of UCPMP 2024 does not carry the word ‘voluntary’ as UCPMP 2015 did, but at the same time, it also does not have any statutory backing. It appears that the DoP is planning to enforce it through ‘audit’ mechanism. Under UCPMP 2024, DoP has the power to order an audit of any company upon receipt of a complaint of violation of UCPMP 2024 against the company. In case the audit proves a breach, the DoP may ‘recommend’ appropriate government agencies (such as the Income Tax Department and the National Pharmaceutical Pricing Authority) to take action against the company. An appellate body, which is headed by the Secretary, DoP, also has the power to ‘prescribe’ penalties to defaulting companies. Separately, the CEO of the company has to give an undertaking that the company shall abide by UCPMP 2024 will extend all assistance to ‘authorities’ for its enforcement.

Medical Education and Training: Companies can sponsor or organize conferences, workshops and trainings for doctors by themselves without having to necessarily collaborate with another entity, such as an association of doctors. Such conferences, workshops and trainings cannot be held outside India. The details of such events and expenses incurred by the company will have to be published on the company’s website. The record of these expenses may be audited by auditors appointed by the DoP. If the DoP auditors find discrepancies in the records, they will bring them to the attention of appropriate government agencies and authorities.

Hospitality and travel: During conferences and workshops, all doctors including delegates may be served modest meals. However, delegates cannot be offered travel facilities. Speakers may be offered both hospitality and travel facility.

Brand reminders: A company may supply doctors with informational and educational materials such as e-journals and dummy device models as brand reminders, provided that the total worth of each item does not exceed Rs. 1000. There is no cap on how many brand reminders can be given to the doctor. However, a brand reminder should not have an independent commercial value for the doctor.

Engagement of HCPs as a Consultant: Companies can continue to engage doctors as consultants for research, but the research has to be ‘bona fide’. The DoP is expected to provide more clarity on this issue.

Monetary grants: Companies cannot offer monetary grants under any pretext now, including for educational purposes to doctors who are pursuing training, residency, or fellowship.

Sample packs: A company may offer a doctor up to 12 sample packs of medicines each year. However, these sample packages should be properly marked as ‘not for sale.’ The monetary value of samples distributed by a company should not exceed 2% of its domestic sales.

Further changes to UCPMP 2024: The DoP has reserved powers to modify or limit the scope of UCPMP by issuing standing orders from time to time.

It is important that industry takes cognizance of the changes because any non-compliance with UCPMP 2024 may negatively impact a company’s industry standing and perception amongst doctors.  India’s tax department has also been disallowing any expenses which have been incurred in contravention of UCPMP, so a mistake may prove very expensive.