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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 drug regulator, CDSCO has directed state drug regulators to direct manufacturers of Doxycycline formulations to incorporate CNS side Effects as an adverse drug reaction such as restlessness, anxiety, irritability, nervousness, and dizziness in the caution section of the package insert/ Promotional literature following recommendation by the Subject Expert Committee on Antimicrobial and Ant Parasite.
Source: short-url.org/1perz

2. India’s National Consumer Disputes Redressal Commission (NCDRC) ruled that prescribing allopathic medicines without a recognised medical qualification is negligence and deficiency in service. It directed an eye centre to pay ₹2 lakh compensation plus interest to a patient who permanently lost vision due to such unqualified prescriptions.
Source: short-url.org/1k96-

3. The Directorate of Drugs Control under the Government of Tamil Nadu has issued a public advisory warning citizens against the manufacture, sale and online distribution of unapproved oral nicotine pouches. Show-cause notices have been served to major online sellers for marketing products whose safety, efficacy and quality have not been established in India.
Source: short-url.org/1perD

4. The Multidisciplinary Committee advising the National Pharmaceutical Pricing Authority has recommended a five-year exemption from the Drug Price Control Order, 2013 for nafithromycin, India’s first indigenous antibiotic. The move follows patent confirmation by the Central Drugs Standard Control Organisation and the Indian Patent Office, allowing pricing flexibility and encouraging domestic antibiotic innovation.
Source: short-url.org/1k973

5. India’s National One Health Mission has reportedly invited expressions of interest from qualified organisations to develop artificial intelligence tools for early detection of emerging pathogens across human, animal and environmental systems. The government-backed programme will fund research and development to strengthen disease surveillance and pandemic preparedness nationwide efforts.
Source: short-url.org/1k977

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, CDSCO has requested state drug regulators to direct manufacturers of Carbimazole formulations to incorporate agranulocytosis as an adverse drug reaction in Prescribing Information Leaflets (PIL) following recommendation by the Subject Expert Committee on Endocrinology and Metabolism.
Source: short-url.org/1pcz1

2. The Central Pollution Control Board (CPCB) has introduced a Common EPR Portal to unify all Extended Producer Responsibility activities under one platform. Through Single Sign-On (SSO), users can access Plastic, E-Waste, Battery, Tyre and Used Oil Management portals, and the EPR Trading Platform with one login. Registration is mandatory, with no additional fee.
Source: short-url.org/1pcz4

3. The Madras High Court has reportedly strongly criticised the practice of imposing non-compete and non-solicitation clauses on doctors in employment contracts, calling such restrictive covenants “unlawful on the face of it” and questioning their enforceability in healthcare settings. The bench indicated it will discourage hospitals from using these clauses, emphasising doctors’ freedom to practice and patient choice.
Source: short-url.org/1pcz6

4. The National Pharmaceutical Pricing Authority has reportedly deferred a decision on creating a separate price ceiling for cementless knee implants. The Multidisciplinary Committee will invite subject experts and manufacturers for detailed deliberations. Until a final determination is made, all companies must continue complying with the existing ceiling prices.
Source: short-url.org/1k7in

5. India’s drug regulator CDSCO is enhancing the online WHO-GMP Certificate of Pharmaceutical Product (CoPP) application via its ONDLS portal, partnering with C-DAC and state authorities to replace manual submissions. The digital shift aims to cut delays, improve transparency, and boost export readiness for Indian pharma manufacturers.
Source: short-url.org/1pcze

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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 Legal Metrology (General) Rules, 2011 has been amended to introduce mandatory metrological and technical standards for continuous clinical electrical thermometers used in human and veterinary care. The rules prescribe accuracy thresholds, testing protocols, labelling norms, environmental tolerance, and type-approval requirements impacting manufacturers, importers, and hospital-grade device suppliers.
Source: short-url.org/1k3IL

2. The Delhi High Court is examining a challenge to mandatory vegetarian/non-vegetarian dot labelling on toothpaste and toiletry products. Noting conflicting regulatory positions, the Court has directed Legal Metrology authorities and the Drugs Controller General of India (DCGI) to hold a joint meeting to determine whether such labelling should remain compulsory or voluntary. The matter is listed for further hearing on April 27.
Source: short-url.org/1p8RE

3. The Union Health Ministry will unveil SAHI (Strategy for AI in Healthcare for India) and BODH (Benchmarking Open Data Platform for Health AI) at the India AI Summit 2026, under the Ayushman Bharat Digital Mission, the initiatives institutionalise AI governance, validation and privacy-preserving benchmarking nationwide.
Source: short-url.org/1k3Iu

4. India’s Delhi High Court has reportedly urged authorities to ensure real-time hospital bed and emergency service data through the NextGen e-Hospital digital platform. It ordered full implementation across government hospitals, including linkage to a mobile app for public access, and called for technical support and broader adoption to improve emergency care and patient treatment.
Source: short-url.org/1p8Ry

5. The All India Organisation of Chemists and Druggists (AIOCD) has reportedly warned Prime Minister Narendra Modi that AI-generated fake medical prescriptions are enabling illegal online drug sales by unregulated e-pharmacies. The group wants government to action to withdraw certain regulations, close illegal platforms, and ban AI-generated prescriptions to protect public health.
Source: short-url.org/1p8Rs

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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 Directorate General of Foreign Trade (DGFT), has extended the Annual Remission of Duties and Taxes on Exported Products (RoDTEP) Returns filing deadline for FY 2023-24 from November 30, 2025 to March 31, 2026, with a ₹15,000 composition fee. Missing the extended deadline may lead to denial of RoDTEP benefits or scrip cancellations.
Source: h7.cl/1p1E2

2. The National Pharmaceuticals Pricing Authority (NPPA) has directed manufacturers and marketing companies to revise the Maximum Retail Prices (MRP) of 17 life-saving cancer drugs following their exemption from Customs Duty. Downward change in Duties/taxes should be passed on to consumers at the retail level, Form V must be submitted along with issue of to dealers and NPPA.
Source: h7.cl/1jXJ8

3. The Tea Board of India has issued updated guidelines for tea warehouse licence applications and renewals. The specifications that a warehouse must meet have been specified in the guidelines. Modifications of warehouse license is allowed only for floor area changes, and renewals can be auto-processed. Non-submission of requisite documents may lead to rejection without fee refund.
Source: h7.cl/1p1DR

4. Indian Council of Medical Research (ICMR) has reportedly directed that clinical trials in India focus on local genetics, diets, and lifestyles rather than rely on Western research. The move addresses rising lifestyle diseases and aims to produce more relevant evidence. Multicentre trials with government funding will study therapies suited for Indian patients, potentially improving effectiveness and access.
Source: h7.cl/1p1Ef

5. The Department of Pharmaceuticals has reportedly invited stakeholder comments on the amended list of 354 medical devices exempted from restrictions on global tender enquiries. The exemption, valid until March 31, 2027, allows public procurement agencies to source these devices internationally, subject to review of adequate domestic manufacturing capacity.
Source: h7.cl/1jXJk

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 authority (CDSCO) reportedly flagged 35 drugs manufactured in Telangana as Not of Standard Quality (NSQ), including painkillers, antacids and antibiotics. These medicines, failed quality or labelling standards, resulting in regulatory and manufacturing oversight gaps. Affected batches are reportedly recalled, and show-cause notices are issued.
Source: h7.cl/1oCiU

2. The Indian Pharmacopoeia Commission (IPC) has entered into three strategic Memoranda of Understanding (MoUs) with the Goa State Pharmacy Council (GSPC), Quality Council of India (QCI), and HLL Infra Tech Services Limited. These collaborations aim to strengthen pharmacovigilance systems, enhance professional competencies, and promote uniform standards for medicine quality and patient safety across India.
Source: h7.cl/1oCj1

3. India and United States has agreed under an interim trade framework to address long-standing barriers for US medical devices, eliminate restrictive import licensing procedures, and review adoption of US or international standards within six months to boost market access. The move is part of broader efforts to improve MedTech trade and bilateral economic cooperation
Source: h7.cl/1jzb3

4. Delhi High Court disposed of a trademark infringement suit after parties reached an amicable settlement. The defendant acknowledged superior trademark rights of the plaintiff in trademark “Blue Heaven”, agreed to permanent injunction, withdrew trademark applications, paid damages and costs, removed online listings, and enabled refund of court fees as ordered.
Source: h7.cl/1oCj9

5. Indian Council of Medical Research is reportedly rolling out an AI-based surveillance system under the National One Health Mission to detect zoonotic diseases early. By integrating human, animal, and environmental data, it will identify unusual patterns, provide real-time decision support, and help prevent local outbreaks from escalating into pandemics.
Source: h7.cl/1jzeb

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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 has reportedly agreed to reduce tariffs on a broad range of U.S. exports, including medical devices, manufactured goods and chemicals from about 13.5% to zero. Lower tariffs on medical devices from the US would help hospitals and clinics in India to procure advanced equipment more cheaply, improving healthcare delivery and access.
Source: h7.cl/1ow26

2. US FDA has shut down over 200 illegal online pharmacy websites linked to an India-based criminal network. The sites allegedly sold unapproved and counterfeit medicines to U.S. consumers, raising serious public health concerns and highlighting the need for stronger regulation and cross-border cooperation.
Source: h7.cl/1ow29

3. The Indian government is reportedly examining a proposal to mandate pharmaceutical companies to allocate at least 1% of their net profits for free medicines during health emergencies by amending the Drugs Rules, 1945. However, the move faces legal constraints, as CSR spending is governed by the Companies Act, 2013. The central drugs regulator, CDSCO, is reassessing the proposal’s feasibility.
Source: h7.cl/1ow2c

4. The Association of Indian Medical Device Industry (AiMEd) has reportedly opposed any reconsideration or easing of policy restrictions on importing refurbished or pre-owned medical equipment. Association has urged the government to uphold the ban on imports, enforce stricter regulations by emphasizing the strengthening of indigenous innovation like Make in India.
Source: h7.cl/1ow2i

5. A leading fast moving consumer goods manufacturer has filed a suit in the Calcutta High Court, alleging deceptive imitation of its biscuit packaging and trade dress by a rival. The suit seeks injunction against sale and distribution, claiming consumer confusion and unfair competition. The court has taken the matter on record and scheduled further hearing shortly.
Source: h7.cl/1jt71

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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 Karnataka Health Department has proposed introducing QR codes on medicine strips and boxes to help visually impaired patients access key drug information via smartphone scanning under the IMPACT-VIP programme. Details such as dosage, composition, and expiry dates can be accessed, and the proposal may be sent to the Centre for wider implementation.
Source: h7.cl/1o2Wy

2. India’s central drugs regulatory authority (CDSCO) has released a draft guidance outlining regulatory requirements and online procedures for importing in-vitro diagnostic medical devices. The document aims to streamline approvals under Medical Devices Rules, 2017. Comments from stakeholders are invited within 15 days.
Source: h7.cl/1j0Wg

3. The Government of India has in the Union Budget 2026–27 announced measures to position India as a hub for medical tourism, biopharmaceutical manufacturing and traditional medicine. The government will establish five regional medical hubs, expand Ayurveda, Yoga, Unani, Siddha and Homeopathy infrastructure, and strengthen research, manufacturing capacity and employment across the healthcare value chain.
Source: h7.cl/1o2WE

4. The Government of India is planning to amend the Drugs and Cosmetics Act to tighten oversight of pharmaceutical opioids, proposing stricter penalties, higher fines, and enhanced monitoring of manufacturing and sales to curb misuse, diversion, and illegal distribution while strengthening regulatory enforcement.
Source: h7.cl/1j0Wr

5. Indian Pharmacopoeia Commission has issued a formal circular urging all Medical Device Marketing Authorisation Holders (MAHs) to strictly comply with adverse event reporting requirements under the Materiovigilance Programme of India (MvPI). The move is aimed at bolstering patient safety and enhancing the post-market surveillance ecosystem for medical devices across India.
Source: h7.cl/1o2WQ

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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 Government of India has in the Union Budget 2026–27, removed basic customs duty on 17 cancer drugs to reduce treatment costs. The move aims to ease the financial burden on patients, particularly for high-cost imported therapies, and improve access to essential cancer medicines across the country.
Source: h7.cl/1nZbu
#Drugs #Cancer #CustomDuty #Slashed #Budget2026

2. The Supreme Court of India has held that administering stem cell therapy for Autism Spectrum Disorder (ASD) outside an approved clinical trial setting is unethical and amounts to medical malpractice. The Court clarified that such therapy is not recognised as a sound and established medical practice due to the lack of scientific validation of safety and efficacy. The same is permissible only for an approved and monitored clinical trial with the intent to advance science.
Source: h7.cl/1nZbb

3. Maharashtra’s State Blood Transfusion Council has reportedly warned blood banks against collecting excess blood and transferring it to other states for profit. Violations, including commercial supply to plasma fractionation companies, may invite licence cancellation, as centres are directed to collect only patient-linked requirements to protect voluntary donation ethics.
Source: h7.cl/1iYh-

4. The Enforcement Directorate reportedly conducted searches at twenty six locations across multiple states as part of a probe into illegal international narcotics trafficking and money laundering. Investigations revealed a structured interstate drug network, leading to seizure of cash, narcotic substances, contraband, and incriminating documents indicating organised distribution and laundering activities.
Source: h7.cl/1nZbD

5. The Government of India has proposed amending the Drugs Rules, 1945 to designate Navi Mumbai International Airport (NMIA) as an authorised drug import entry point, making it a 12th approved airport, improving logistics and reducing congestion at existing ports. Stakeholders have been requested to submit comments withing 30 days.
Source: h7.cl/1nZbN

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The 90 Day Rule: Indian Drug and Medical Device Regulator (CDSCO) tightens query response timelines on applications 

India’s Central Drug and Medical Device Regulator, The Central Drugs Standard Control Organisation (CDSCO), has made it clear that it will reject product applications if the official queries to the applications are not responded within 90 days from the date of receipt of the first official reminder.

Background
On January 16, 2026, CDSCO issued a public notice informing the general public that it has initiated a time-bound reminder and rejection mechanism to ensure timely disposal of the pending applications. As per CDSCO, a large number of product applications across categories such as new drugs, cosmetics, biologics, medical devices and IVDs are pending since 8 to 10 years because of non- submission of responses to queries on product application raised on the official electronic submission portal (SUGAM portal).

In the notice, CDSCO issued a final warning to applicants whose application has been pending for more than two years for want of response to queries and who have received three reminders from CDSCO requesting submission of response to query. If such applicants fail to respond to queries within 30 days from date of public notice i.e. by 14 February 2026, it will result in rejection of the application.

The CDSCO also used the opportunity to inform the public that it has instituted a structured reminder mechanism for queries to applications under which it was going to issue three reminders to applicants in relation to unresponded queries. This structured reminder system and consequences of failing to respond to queries are discussed in the paragraphs below.

CDSCO’s Structured reminder mechanism
Under the structured reminder mechanism, CDSCO has decided that it will issue reminders at fixed intervals to applicants who do not respond to the official queries to an application in the following manner:

  • First Reminder- CDSCO will issue the first reminder if it does not receive response to query. The time-period that CDSCO will wait for response to queries before it issues the first reminder has not been specified.
  • Second reminder – If no response to queries is received within 30 days of first reminder, a second reminder will be issued o.
  • Third reminder – If no response to queries is received within 30 days of second reminder, a third and final reminder will be issued.
  • Disposal Notice – If no response to queries is received within 30 days of issuance of third reminder, CDSCO will issue dispose the application.

Will the disposal of application due to non-response to queries be treated as rejection of the application effectively barring the applicant to make the same application again?
The disposal by CDSCO should not be treated as rejection of the application. This means that the applicant should be able to apply for license again for the same products, even if the application for same products has been rejected before for want of response to queries.

Whether the government fees paid be refunded or reused or adjusted in case of disposal of application of CDSCO on grounds of non-response to queries?
As per the public notice, the government fees paid will not be refunded or reused or adjusted once the underlying application is disposed by CDSCO due to non-receipt of response to queries despite three reminders.

What will happen to product applications that are pending for more than two years?
Where an application has remained pending for over two years, but no queries have been raised by CDSCO, there is currently no clarity on how such cases will be treated. Based on the language and intent of the public notice, such applications should not be disposed, because the structured reminder mechanism gets triggered only when queries raised by CDSCO are not responded to by the applicants.
Where queries have been raised in the application, but the applicant is yet to receive three reminders from CDSCO as described in the structured reminder mechanism, it is unclear what will happen because the public notice does not provide any guidance on this issue. In our view, such applications should not get disposed by CDSCO for want of response since the disposal of application under the structured reminder mechanism can happen only after issuance of three reminders by CDSCO. However, CDSCO is free to follow its own processes and cannot be blamed for disposal of application without notice on the ground that the applicant has not responded to queries and appears to have abandoned the application.

Is it possible to seek extension of the timeline?
It is unclear whether CDSCO will entertain extension of timeline beyond the timeline of 90 days prescribed under the structured reminder mechanism. The Public Notice leaves some flexibility for making an application for extension of timeline. However, the final decision on extension of timeline beyond the 90 day window under the structured reminder mechanism will rest with CDSCO.

Is it possible to partly respond to CDSCO’s queries and respond to remainder of the queries later?
It is unclear whether CDSCO will entertain partial response to queries as sufficient to stop the 90 day clock under its structured reminder mechanism. However, in the event of time-crunch, it may be pragmatic to submit a partial response to queries than to submit no response at all.

What is timeline for CDSCO to issue queries after submission of an application?
CDSCO has not committed to a timeline to review application and issue queries to applicants.

What is the timeline within which an applicant must respond to queries raised on the application to avoid receipt of first reminder from CDSCO?
CDSCO has not indicated any expectation on timeline within which applicants should respond to its queries to avoid receiving the first reminder.

Will State Drug and Medical Device Licensing Authorities also follow structured reminder mechanism and dispose applications due to non-response to queries?
The State Drug and Medical Device Licensing Authorities are not bound to follow the structured reminder mechanism as published by CDSCO in its public notice. For all practical purposes, the structured reminder mechanism should be assumed to be applicable to CDSCO only.

There is a statutory timeline prescribed for processing most product license applications. What happens to the statutory timeline is the impact of query on statutory timeline of processing of an application?
The statutory timelines prescribed for processing drug, medical device or cosmetic license by CDSCO or State Licensing Authority are considered to be suspended upon receipt of queries from the regulatory authority.

Take-away for industry
It may be pragmatic for manufacturers and importers of drugs and medical device manufacturers to respond official queries received to their product applications at the earliest opportunity and in the best possible way, to avoid repeat queries or reminders from CDSCO. It is possible that some queries may require more time to respond than other queries, at which time appropriate regulatory strategy should be formulated to address all queries so as to avoid disposal or rejection of application and consequent loss of valuable time and government fees.

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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 Food Safety and Standards Authority of India has issued draft amendments to the Food Business Licensing Regulations mandating food manufacturers to keep daily production and raw-material records and to follow FIFO/FEFO storage norms. Retailers and non-manufacturers are exempt. The move strengthens traceability, inventory control, and food safety compliance. Public comments are invited within 30 days of Gazette publication.
Source: h7.cl/1iFOX

2. Madras High Court has ruled that the word “Vapo” is a descriptive and generic term derived from “vapour” and cannot be claimed exclusively by any party, rejecting petitions seeking cancellation of trademarks for “Vaporin” products. The Court held that the rival marks and trade dress are distinct and unlikely to cause consumer confusion.
Source: h7.cl/1nG6S

3. India’s Central Government has amended Uniform Consent Guidelines under the Air and Water Acts to simplify industrial approvals and cut delays. Key changes include consolidated consents covering multiple environmental laws, faster timelines for red-category industries, and Consent to Operate remaining valid until cancelled. Inspections, audits, and cancellation powers remain to ensure environmental compliance.
Source: h7.cl/1iFAP

4. The India–EU free trade agreement is set to eliminate duties on about 90% of European medical devices imported into India, reducing tariffs that earlier went up to 27%. The agreement is expected to lower costs and improve access to advanced technologies, Indian manufacturers are seeking regulatory alignment and mutual recognition to overcome non-tariff barriers.
Source: h7.cl/1iFAU

5. The India–EU Free Trade Agreement is expected to expand opportunities for Indian traditional medicine in Europe. In EU countries where no specific regulations exist, AYUSH practitioners will be allowed to offer services based on their Indian qualifications. The agreement also provides long-term certainty for setting up AYUSH wellness centres and clinics across EU member states.
Source: h7.cl/1iFAX