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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. Several global pharmaceutical companies have approached the European Commission demanding assistance in maintaining operations in the EU and to help Europe keep the pharma industry including measures to compensate them for the cost of pharmaceutical innovations. This move comes in the face of threatened U.S. tariffs on imports.
Source: bit.ly/3RgXrK6

2. A pharma giant has allegedly breached the UK’s Prescription Medicines Code of Practice Authority (PMCPA) for its cancer drug’s misleading prescribing information, which failed to clearly state that women using hormonal contraceptives needed to take additional measures to prevent pregnancy while on the drug.
Source: bit.ly/4lzu3MO

3. India’s Department of Pharmaceuticals (DoP) has invited expression of interest for selecting an agency to conduct a comprehensive study of India’s pharmaceutical and medical device supply chains, in order to identify regulatory hurdle.
Source: bit.ly/42zIx6O

4. Central Drugs Standard Control Organisation has directed States and Union Territories to urgently stop the manufacture, sale, and distribution of 35 unapproved Fixed Dose Combinations licensed without safety and efficacy evaluation under New Drug and Clinical Trials rules, 2019. Authorities must investigate, take action, and report compliance to ensure public health and regulatory consistency.
Source: bit.ly/4cw43hg

5. China has amended its GB 9685 standard for additives in food contact materials. The changes include expanded use in silicone rubber, revised usage limits, updated additive names, and new safety calculations. These updates, effective March 2025, aim to improve consumer safety and industry compliance.
Source: bit.ly/4cGqBfE

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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. CDSCO has proposed a draft list to revise the existing classification list of cardiovascular and neurological devices, categorizing 351 cardiovascular and 202 neurological devices under a risk-based classification. Stakeholders can review and submit feedback within 30 days via a Google Form before finalization.
Source: bit.ly/3QYf29q

2. The central government has no plans to set up a special tribunal for medical negligence cases. Instead, such cases are handled by State Medical Councils, which can take disciplinary action against doctors. Appeals can be made to the National Medical Commission (NMC).
Source: bit.ly/42jt9LX

3. The 2025 National Trade Estimate Report states that unclear licensing guidelines and import procedures under India’s Medical Device Rules have delayed U.S. exports of refurbished medical devices. Since April 2024, CDSCO has suspended approvals for existing and new import licenses, effectively blocking refurbished medical device imports.
Source: bit.ly/4lfgp1s
Source: bit.ly/41W3pWY

4. The Central Consumer Protection Authority fined three lotion companies for falsely claiming in e-commerce ads that their products whiten skin instantly. The Bureau of Indian Standards found no scientific proof. The companies removed their ads and were warned of a ₹50 lakh fine for repeat violations.
Source: bit.ly/3G2pB94

5. India’s Delhi High Court upheld Consumer Protection Authority guidelines barring automatic service charges addition in restaurant bills. It was further held that collecting such service charge under other names constitutes an unfair trade practice. Additionally, GST cannot be charged on service charges.
Source: bit.ly/4j88ukG

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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 Ministry of Health and Family Welfare has developed ONDLS Portal for receiving applications from small and medium scale pharmaceutical manufacturers who wish to avail benefit of extension from requirement to comply with new Good Manufacturing Practices (GMP) under revised Schedule M. Such applications must be strictly submitted online before lapse of three months from February 11, 2025. Submission of hard copy applications will no longer be accepted.
Source: https://bit.ly/4iEFh0U

2. The Indian Ministry of Health is working with Bureau of Indian Standards (BIS) to develop a standardized invoice format for hospitals, nursing homes, clinics and diagnostic centers. Once notified, clinical establishments will have to follow a standard invoice format with detailed and transparent breakdown of charges incurred by patient.
Source: https://bit.ly/4c4CM5w

3. India’s Supreme Court has held that even in consumer contracts which contain arbitration clauses, a consumer has the right to decide whether to pursue arbitration or approach the consumer forum for resolution of consumer dispute. The Court further reiterated that consumer disputes are non-arbitrable unless the consumer voluntarily opts for arbitration.
Source: https://bit.ly/4c4CPOK

4. The Directorate General of Foreign Trade (DGFT) has decided to withdraw the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme benefits for exports arising from Advance Authorizations (AAs), Special Economic Zones (SEZs), and Export Oriented Units (EOUs).
RoDTEP Scheme helps pharmaceutical exporters to get refund on taxes and duties on export.
Source: https://bit.ly/4c43M59

5. The Food Safety and Drug Administration (FDA) of Karnataka has reportedly increased inspections to address the issue of adulteration of tea powders and spices.
The decision has been taken due to reports of addition of harmful substances in food products, with the goal of reducing health risks to the public.
Source: https://bit.ly/4cjrdrr

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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. A medical device company has received compensation calculated at 25% of sales generated by a counterfeiting entity. The Court opined that 25% was a conservative profit margin for awarding damages. The Court has additionally awarded exemplary damages to punish the counterfeiting entity.
Source: bit.ly/4kHWYhn

2. The Indian Pharmaceutical Alliance (IPA) has reportedly questioned the authenticity of an US study linking India-made generic medicines to higher rates of serious adverse events (SAEs) calling the claims unfounded. IPA highlighted that Indian manufacturing facilities undergo stringent inspections by regulators like the FDA, and lower costs are due to production efficiencies, not compromised quality.
Source: bit.ly/4kEqkx8

3. The Indian government is reportedly considering exemption of health and life insurance premiums from the current 18% GST. The GST Council has sought input from the Insurance Regulatory and Development Authority of India (IRDAI), with the industry advocating for a reduction to 12% instead of a complete exemption or lower rate (5%), to be able to claim Input Tax Credit (ITC) on taxes paid for business operations.
Source: bit.ly/3Fu3dFx

4. India’s Health Ministry has reportedly directed the Drug Controller General of India (DCGI) to focusing on eliminating poor-quality medicines, supporting small pharma manufacturers (MSMEs), and refining medical device regulations. The move is aimed at enhancing global trust in Indian medical products and exports.
Source: bit.ly/3DHeK3J

5. The Director General of Foreign Trade (DGFT) has invited comments on proposed changes to export policy for Special Chemicals, Organisms, Materials, Equipment and Technologies (SCOMET), which seek to fast-track grant of approval. SCOMET goods typically face strict export controls.
Source: bit.ly/3Fr2Uva

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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. Various State Pharmacy Councils are reportedly planning to issue notices to pharmacists who work in medical shops that advertise discounts through physical discount boards, warning them that working in such shops is unethical and illegal, and may result in cancellation of registration.
Source: bit.ly/4h0LByd

2. India’s Supreme Court has stayed the Kerala High Court order which had directed Central Government to continue to support a patient suffering from rare disease, even after the medical expense of the patient crossed the Rs. 50 lakh limit imposed by The National Policy for Rare Diseases.
Source: bit.ly/41B8zHE

3. Beverage manufacturers will have to use rigid plastic packaging such as PET bottles that contain at least 30% recycled plastic content. India’s Ministry of Environment had introduced this requirement as part of Extended Producer Responsibility (EPR) for plastic producers.
Source: bit.ly/4hVwTts

4. State Drug Controllers are reportedly finding it difficult to prosecute drug manufacturers based in other states who manufacture substandard drugs because information required for prosecution is not readily made available by State Licensing Authority of State in which the manufacturer is located.
Source: bit.ly/4h5WvTj

5. India’s Central Drug Regulator (CDSCO) is reportedly planning to simplify Export No Objection Certificate (NOC) issued for unapproved drugs, by removing buyer and quantity-specific limitations, based on the exporting company’s export history. This may improve regulatory efficiency and ease manpower strain.
Source: bit.ly/3F3Tdm6

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FAQs on Regulation of Class A Non-Sterile, Non-Measuring Medical Devices in India

The regulatory landscape for medical devices in India has evolved significantly, with the recent focus on regulation of non-sterile, non-measuring medical devices in India.

On October 14, 2022, India’s medical device regulator, the Central Drugs Standard Control Organization (“CDSCO”), notified a new category of Class A Non-Sterile Non-measuring (“NSNM”) medical devices by way of an amendment to Medical Devices Rules, 2017 (“MDR”).

These medical devices although are low risk medical devices, they still have to meet standards for safety, quality, and performance. Whether you’re a manufacturer, importer, or distributor, understanding these regulations is crucial for ensuring your products meet the necessary requirements for market entry.

 1. What are Class A medical devices?
Class A medical devices are considered to be low-risk devices. The classification of medical devices is determined according to the parameters set forth in the First Schedule of the Medical Devices Rules, 2017 (MDR). Class A devices are further divided into two categories:

  • Non-Sterile, Non-Measuring (NSNM) devices
  • Sterile and Measuring devices

2. Who determines risk classification of Class A medical devices?
The risk classification of medical devices in India is determined by the Central Licensing Authority, which is the Central Drugs Standard Control Organisation (CDSCO).

3. What are non-sterile medical devices?
Non-sterile medical devices are those that are marketed in a non-sterile state

4. What are non-measuring medical device?
The non-measuring medical devices are medical device that are not intended for use as measuring tool.

Some of the examples of measuring medical devices are:
a. Device for the delivery of liquid to the human body
e.g., medicine spoons, cups, droppers, without graduation or scale or display of measuring unit, etc.

b. Device for displaying trends of physiological parameters
e.g., Urine bags without graduation or scale, callipers for obesity.

5. Is the Class A NSNM registration applicable to Class A In-vitro diagnostic devices?
No, the Class A NSNM registration applies only to medical devices and does not extend to In-vitro diagnostic devices.

6. Whether License is required to import or manufacture Class A NSNM medical devices in India?
No, under the Medical Devices (Sixth Amendment) Rules, 2022, a license is not required for the importation or manufacture of Class A NSNM medical devices in India.

7. Is a license required for the sale of Class A NSNM medical devices?
No, there is no requirement for a license to sell Class A NSNM medical devices.

8. What is the government fee payable for registration?
There is no prescribed government fee for the registration of Class A NSNM medical devices.

9. Are price control regulations applicable to Class A NSNM medical devices?
Yes, price control regulations are applicable to Class A NSNM medical devices. The Drug (Price Control) Order, 2013 governs the regulation of prices for drugs and medical devices.

10. Is ISO 13485 and a Free Sales Certificate required for registration of Class A NSNM medical devices?
No, ISO 13485 certification and a Free Sales Certificate are not required for the registration of Class A NSNM medical devices.

11. Do Class A NSNM medical devices need to comply with the labelling requirements under MDR?
Yes, Class A NSNM medical devices are required to comply with the labelling requirements as specified under the Medical Devices Rules, 2017 (MDR). These labelling requirements are mandatory.

 12. What are the consequences of manufacturing or importing unregistered devices?
Manufacturing or importing unregistered medical devices constitutes a violation of Indian law and may result in penalties or legal action.

Note: These FAQs are provided for informational purposes based on our understanding of the relevant laws and regulations. They should not be construed as legal advice, professional guidance, or an endorsement of any particular industry practice.

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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 drug price control authority, the National Pharmaceutical Pricing Authority (NPPA) has issued an Office Memorandum instructing drug manufacturers to revise the prices of the drugs on which customs duty has been reduced.
Source: bit.ly/4gNNEVW

2. The Materiovigilance Programme of India’s Ministry of Health and Family Welfare has published an updated Draft Adverse Event Reporting Form for In-Vitro Medical Devices seeking public comment. The last date for receiving public comment is 5th March 2025.
Source: bit.ly/3Qn7kW2

3. In its recent meeting, the Drugs Consultative Committee (DCC), a policy advisory committee to India’s drug regulator, has raised the proposal to include Anti-microbial drugs in the definition of “New Drug” under the New Drugs and Clinical Trial (Rules), 2019 in an attempt to heighten the oversight of antimicrobial drugs.
Source: bit.ly/3QqZlao

4. India’s Union Ministry of Health and Family Welfare has revealed plans to include the human papillomavirus (HPV) vaccine in the national immunization program this year. During the recent Budget session of Parliament, Minister of State for Health stated that the details for its implementation are currently being worked out.
Source: bit.ly/4hH6dMR

5. Representatives of the Pharmaceutical industry in the United States are set to meet with the new administration in a bid to revise price-control regulations, and the United States government’s right to negotiate Drug Prices with pharmaceutical companies.
Source: bit.ly/4i5UEP4

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. India’s Ministry of Health and Family Welfare (MoH&FW) has released the Drugs Amendment Rules, 2025, extending the deadline for implementing revised Good Manufacturing Practices (GMP) under Schedule M for small and medium drug manufacturers until December 31, 2025. Manufacturers are required to submit an application to the Central Licensing Authority for seeking the extension within three months of the notification.
Source: bit.ly/4gCo0U8

2. The Supreme Court has virtually summoned the Chief Secretaries of Andhra Pradesh, Delhi, and Jammu & Kashmir to explain their failure to act on misleading medical advertisements. The Court found these states non-compliant with previous orders on enforcing Rule 170 of the Drugs Rules, which prohibits advertisements of Ayurvedic, Siddha, or Unani drugs without licensing authorities’ approval.
Source: bit.ly/42Sm6vn

3. India’s National Medical Commission (NMC) has clarified that the Telemedicine Practice Guidelines 2020 do not allow Registered Medical Practitioners (RMPs) to remotely authenticate pathology and radiology lab reports without physical presence and supervision. This follows an RTI application which sought clarification on the use of cloud-based technologies like Telepathology and Teleradiology for signing and authenticating lab reports.
Source: bit.ly/40VinKX

4. India’s Ayushman Bharat Digital Mission (ABDM) has made significant strides, with millions of Ayushman Bharat Health Accounts (ABHA) created and a large number of health records linked to ABHA. This is part of the mission’s effort to build an interoperable digital health ecosystem. Thousands of health facilities have registered on the Health Facility Registry (HFR), and many healthcare professionals are now listed on the Healthcare Professional Registry (HPR). The mission also focuses on supporting rural areas through technology interventions like telemedicine, enhancing access to healthcare services.
Source: bit.ly/41ektXT

5. The European Medicines Agency (EMA) has introduced a standard procedure for manufacturers of certain high-risk medical devices to receive scientific advice on their intended clinical development strategy and proposals for clinical investigations. This initiative aims to enhance safety and performance by offering expert guidance on regulatory requirements before devices are submitted for approval. The move is designed to foster innovation while ensuring that devices meet rigorous standards.
Source: bit.ly/4jWxfRZ

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 level drug regulator the Central Drugs Standards Control Organization (CDSCO) has issued a correction to the list of Fixed Drug Combinations for which manufacturing licenses can be obtained directly from the state regulators. The updated list is available on the website of the CDSCO at the given link.
Source: bit.ly/4hnPvSI

2. India’s Nursing professional regulator, the Nursing Council of India has issued Regulations prescribing the institutional and educational standards required to conduct the Nurse Practitioner in Pediatric Nursing Program.
Source: bit.ly/40IkEsV

3. A district level Consumer Disputes Redressal Commission has recently held that insurance providers cannot deny claims of policy-holders, on grounds of a medical issue arising out of “pre-existing conditions” if the “pre-existing conditions” is not the sole cause of the medical condition for which claim as made.
Source: bit.ly/3Q7gbLs

4. India’s Ministry of Health and Family Welfare has recently notified the updated grievance redressal system, and new physical verification procedure for empanelled hospitals aimed at improving service offering under the government’s public healthcare scheme.
Source: bit.ly/3WMQbc7

5. Industry groups make a representation to the European Policymakers to withdraw its recent AI Public Liability Directive protocol which sought to introduce non-contractual civil liability rules to artificial intelligence used by service providers, claiming that the non-contractual nature of the civil liability will disrupt existing supply-chains based on contractual understanding between service providers and receivers.
Source: bit.ly/4hK9sTp
Source: bit.ly/4hKflzQ