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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. The Competition Commission of India (CCI) has reportedly raided offices of big advertisement and broadcasting firms as well as industry associations, on suspicion of fixing ad rates and undertaking price collusion. It is uncommon for CCI to raid industry associations, indicating possibility of cartelization.
The raid may affect advertisement by top brands.
Source: bit.ly/4iYMx7r

2. Pharmaceutical exporters have raised concerns about requirement to submit legal undertaking from API manufacturers in order to secure Export NOC from the Central Drug Regulator (CDSCO), on grounds that the APIs are procured from traders and not manufacturers, and manufacturers won’t readily agree to give legal undertaking. A new Export NOC system was introduced in March 2025 to expedite issuance of export NOC
Source: bit.ly/4iZDqTY

3. Representatives of leading cosmetics brands are reportedly demanding a separate law for regulation of cosmetics. The demand stems from the fact that cosmetics are regulated together with drugs under the current law i.e. Drugs and Cosmetics Act, 1940, because of which cosmetics are under system of significant licensing and inspection. The industry expects the law to require post-market notification as opposed to pre-market licensing.
Source: bit.ly/3DSCT7B

4. Google has recently announced a new health care update to its Search platform called the “What People Suggest” Feature, currently available only in the US. This new feature allows individuals with specific health conditions to compare their experiences with others. It utilizes artificial intelligence to collate online feedback from patients sharing similar diagnoses, enabling users to find insights on managing their conditions.
Source: bit.ly/421sKgK

5. The West Bengal Drug Control Administration is reportedly taking steps to closely monitoring discount pharmacies in order to eliminate counterfeit drugs. As part of the drive, inspectors will verifying purchase sources, inspect medicines, and enforce strict measures to ensure drug quality and public safety.
Source: bit.ly/4hIBxKk

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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 Department of Pharmaceuticals (DoP) has invited applications for R&D funding in six key areas- (1) New Chemical Entity, New Biological Entity and Phyto-pharmaceuticals (2) Complex generics and Biosimilars (3) Precision medicine (Targeted innovative therapeutics) (4) Medical devices (5) Orphan Drugs and (6) Drug development for AMR funding upto INR 100 Cr (1000   illion) is available.
Source: bit.ly/41AvbXF
Source: bit.ly/4bJLVQU

  1. The Indian government is reportedly considering lowering tariffs on imports of US medical devices to ease trade tensions. Such a policy decision would run counter to India’s Make in India policy and preference to procure medical devices manufactured in India for government hospitals.
    Source: bit.ly/41zI3x8
  1. The UK Government is reportedly proposing to raise the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2%. The ‘payment rate’ is the revenue that pharma companies refund to government from sales of branded medicines to the National Health Service (NHS)
    Source: bit.ly/3DSk30j
  1. France has become the second European country, after Denmark, to ban per- and polyfluoroalkyl substances (PFAS) in certain products, including cosmetics, textiles, and ski wax addressing concerns over health and environment. The production, import, export, and sale of PFAS-containing goods will be prohibited in France from  January 2026
    Source: bit.ly/420sUVI
  1. The European Commission has proposed a bill to reduce the European Union’s dependence on India and other countries for antibiotics and other essential medicines by requiring Member States to procure medicines on parameters other than price, in order to incentivize domestic manufacturing. The bill, called Critical Medicines Act, is under consideration.
    Source: bit.ly/4ii2whc
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 has notified that the application process for issuance of permission for import of additional variant of approved cosmetics into the country, will henceforth be conducted through additional module which will be activated on the SUGAM portal from the 22nd February 2025.
Source: bit.ly/3CQu6m2

2. The National Chemists’ Association has sought a meeting with India’s drug price regulator the National Pharmaceutical Pricing Authority (NPPA) to highlight concerns that the obligation on chemists to publicly display the prices of all drugs being sold, may be a very heavy burden for the industry.
Source: bit.ly/3QfYFor

3. The Pune Municipal Corporation (PMC) has issued show-cause notices to 97 private nursing homes and hospitals for violations of the Bombay Nursing Home Registration Act and Maharashtra Nursing Home Registration Rules. Key breaches include non-compliance with fire safety regulations, lack of patient complaint mechanisms, inadequate staffing, and failure to meet other legal standards like displaying contact information and maintaining proper treatment tariffs.
Source: bit.ly/41bya9P

4. In a recently published guideline, the United States Food and Drug Administration has expanded the applicability of Predetermined Change Control Plans (PCCPs) scheme, now requiring manufacturers to notify any post-market changes made to devices, which operate using Artificial Intelligence and not just those devices that use Machine Learning.
Source: bit.ly/4aZ3D2i

5. A Federal Court in the United States has recently dismissed the petition of a prominent drug manufacturer claiming “unfair business practices” by a pharmacy selling compounded versions of a patented drug, on the ground that the pharmacy has ceased to market and sell the compounded version of the drug.
Source: bit.ly/4aYtVSa

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 Drugs Controller General of India (DCGI) has directed the cosmetics industry to follow regulatory protocols and warned them against making “unusual and misleading claims” about the product that may overlap with the pharmaceutical sector. During a meeting with the cosmetics industry, the industry stakeholders sought relaxation of strict regulations for imported cosmetics, citing frequent custom rejections and significant financial losses.
Source: bit.ly/4eBnhBK

2. The Indian Pharmacopoeia Commission (IPC) has announced the implementation of the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs). Version 2.0, will be effective from 1st February 2025. The document aims to strengthen the pharmacovigilance systems of MAHs in India.
Source: bit.ly/4hRV1xH

3. The Pharmacy Council of India (PCI) has directed all registered pharmacists to verify their profiles on DIGI-PHARMed portal with their Ayushman Bharat Health Account (ABHA) numbers within 45 days. This verification aims to integrate pharmacists with the Healthcare Professional Registry (HPR).
Source: bit.ly/4fOxgVk

4. The U.S. Food and Drug Administration (FDA) has issued a warning to an Indian pharmaceutical company for manipulating product data, reports, and relevant details, as well as violating Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
Source: bit.ly/491sW2M
Source: bit.ly/4i249j5

5. The U.S. Food and Drug Administration (FDA) has issued a warning to a Chinese drugmaker for restricting investigators’ access to its facility and records, as well as limiting photography during a recent inspection. The manufacturer received a warning letter outlining significant violations of Current Good Manufacturing Practice (CGMP) guidelines for finished pharmaceuticals.
Source: bit.ly/491sW2M
Source: bit.ly/4i249j5

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. An interministerial committee constituted by the Department of Pharmaceuticals has proposed that health-supplements and nutraceuticals should be regulated as “Drugs” to ensure better quality control and to streamline insurance regulation as well.
Source: bit.ly/40QCmfk

2. In its recent meeting, the Ayurveda Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) has proposed to amend the Drugs Rules and regulate the retail sale of AYUSH medicine, which would empower drug inspectors to inspect these premises and collect and examine samples.
Source: bit.ly/3Cve0xR

3. The CDSCO is set to hold a round-table meeting for all Cosmetics industry stakeholders, including manufacturers and marketers to discuss issues including expansion of permission for cosmetics manufacturers to manufacture topical products.
Source: bit.ly/4ey6nDX

4. The Supreme Court dismissed a Special Leave Petition filed in response to the decision of the Delhi High Court seeking Order to mandate Doctors to explain side-effects to patients, holding that since there is no obvious issue highlighted with the side-effect information legally required to be presented by manufacturers, it is not necessary to require Doctors to do the same.
Source: bit.ly/48WLP70
Source: bit.ly/3UV5MoM

5. In a recent decision, the Supreme Court held that when examining petitions concerning procedural irregularities under the Arbitration and Conciliation Act, 1996, Courts should limit their examination to merely determining whether a valid arbitration agreement is existing and whether there is a preliminary dispute regarding appointment of Arbitrators.
Source: bit.ly/4ezdTP6

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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. The State Consumer Disputes Redressal Commission (SCDRC) has directed a consultant surgeon at a hospital in Erode to pay ₹5 lakh as compensation to the family of a patient who died during treatment for colon cancer. The Commission concluded that while there was no medical negligence during the surgery, the surgeon failed to secure proper cardiac evaluation prior to the procedure, which was deemed a significant oversight.
Source: bit.ly/3UHgY8t

2. The All India Organization of Chemists and Druggists (AIOCD) has raised concerns over a potential partnership between a popular fast delivery company and an online pharmacy aimed at delivering medicines within 10 minutes. AIOCD warns that this ultra-fast delivery model may bypass essential safety regulations, compromising patient safety and increasing the risk of antimicrobial resistance due to unregulated medicine distribution.
Source: bit.ly/4hzeSBr

3. The Drugs Controller General of India (DCGI) has mandated that no cosmetics can be imported unless their ‘use-by’ date is at least six months from the import date. The regulator also prohibited the import of cosmetics containing hexachlorophene and those tested on animals post-November 2014.
Source: bit.ly/4hElgr2

4. The Supreme Court has directed the National Medical Commission (NMC) to establish new guidelines for admitting persons with disabilities into medical courses, emphasizing the need for inclusivity in the healthcare sector. This decision follows a case involving a candidate with muscular dystrophy who was initially disqualified from pursuing an MBBS due to stringent disability criteria.
Source: bit.ly/3YAwWCG

5. The Central Pollution Control Board (CPCB) has issued guidelines to be used by State Pollution Control Boards (SPCBs) and Pollution Control Committees (PCCs), to assess and determine the processing capacities of E-Waste recycling facilities.
Source: bit.ly/3YBbcGK

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 Supreme Court has ruled that a medical practitioner can only be held accountable for medical negligence if he lacks the necessary training or expertise or if he fails to use his reasonable skill in providing treatment, not because his treatment was unsuccessful.
Source: bit.ly/4e2eEzN

2. The Food and Drug Administration (FDA), Pune division has seized stock worth ₹1 crore due to misleading claims in two separate incidents. This includes ₹78 lakh worth of toothpaste with anti-inflammatory claims and ₹22 lakh worth of cosmetics with suspicious labels. In both cases, the FDA has alleged a violation of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and the samples have been sent for laboratory analysis.
Source: bit.ly/40hcyJa

3. India’s central drug regulator (CDSCO) has identified a list of 18 drugs declared as Not of Standard Quality (NSQ). The action has come after several states and union territories failed to report NSQ data, prompting the CDSCO to emphasize the need for timely submissions to enhance drug safety oversight.
Source: bit.ly/48njBSE

4. India’s central drug regulator (CDSCO) has identified four drug samples as spurious after drug inspectors in several states inspected them in September. Since the seized batch was not manufactured by the relevant pharmaceutical businesses, the manufacturer reported it as counterfeit. Drug samples are collected from sales and distribution locations as part of ongoing regulatory monitoring, and examined, and a list of spurious drugs is posted on the CDSCO portal once a month.
Source: bit.ly/3YqYqdE

5. To enhance guidelines and standards for the use of disinfectants and antiseptics in healthcare settings, the Indian Pharmacopoeia Commission (IPC) has released a draft of the new general chapter on disinfectants and antiseptics (Version 3.0) for public comments. The last date to submit comments is 8th December 2024.
Source: bit.ly/3YmXtmL

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. In the most recent 91st Meeting of the Drugs Technical Advisory Board (DTAB) which advises the central government on drug regulatory policy matters, the DTAB has recommended the use of QR code to identify genuine anti-cancer medication, in recognition of recent cases of spurious drugs sale coming to light.
Source: bit.ly/3zP609I

2. The DTAB, has provided rationale for its decision to reject waiver of Clinical Performance Evaluation for IN-Vitro Devices (IVDs) which are already approved internationally. The DTAB expressed its opinion that the performance of IVDs are variable based on the population, and their performance and effectiveness cannot be taken for granted across demographic lines.
Source: bit.ly/3ZV6hT7

3. The Indian Ministry of Environment Forest and Climate Change has notified the new Ecomark Rules, aimed at replacing the erstwhile Ecomark Scheme, 1991. These rules specify criteria for approving ecomark for a product including: recyclability, reduction in pollution and use of non-recyclable resources, and sustainability of production process.
Source: bit.ly/3TXRP9a

4. The Bombay High Court clarified that any seized sample would have to be separated and the individual components of the Cannabis plant identified, because Ganja is defined under the Narcotic Drugs and Psychotropic Substances, Act 1985 only as the “flowering tops” of the Cannabis plant, and for that reason the seeds and leaves cannot be counted towards identifying whether an accused was carrying “commercial quantity” of Ganja.
Source: bit.ly/3NgyD2P

5. In a departure from government policy, the Drugs Consultative Commission (DCC) decided that including the International Nomenclature of Cosmetics Ingredients would be difficult to accommodate, and for that reason all cosmetics manufacturers should continue to adhere to the applicable standards set by the Bureau of Indian Standards (BIS) for their ingredients.
Source: bit.ly/3NduBbB

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 Supreme Court has stayed the repeal of Sec. 170 of the Drugs, Rules 1945 which regulated Advertisement of AYUSH products by the AYUSH Ministry, to address the ultra-vires nature its policy regarding AYUSH advertisement.
Source: bit.ly/4e4qOZz
Source: bit.ly/4dDnIvK

2. The National Commission for the Indian System of Medicine has restated its position, as it has taken in an advisory issued earlier on 16th July, that practitioners of AYUSH medicine should not represent themselves as “Cannabis experts” as it may constitute a “Misrepresentation of qualification” under Regulation 27 of the National Commission for Indian System of Medicine (Ethics and Registration) Regulation, 2023.
Source: bit.ly/3APXRls
Source: bit.ly/4cLHaFl

3. The Supreme Court has issued a Notice to the Central and State Governments and their departments, seeking a response on policy position regarding braille accessibility and integration into (1) Medical packaging, (2) Consumer Goods packaging, and (3) Implementation of braille in all aspects of public and private sectors.
Source: bit.ly/3AHLUOP

4. The office of Director General of Foreign Trade has issued draft modalities for setting up E-commerce Export Hubs which will support infrastructure for cross-border e-commerce trade, and has requested for submission of detailed proposals for set-up of E-commerce Export Hubs.
Source: bit.ly/3ASWEd6

5. The Drug Enforcement Administration, part of the United States Department of Justice has issued a notice that it will be holding hearings regarding the subject-matter of a Federal level reclassification of Cannabis from a Schedule I to Schedule III substance.
Source: bit.ly/4dCiQXN

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