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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 issued a clarification stating that only Indian-issued manufacturing, import, and sale licenses from the Central or State Licensing Authorities as applicable are mandatory for all medical devices in India. Procurement agencies and hospitals must require these licenses in technical bids. Any foreign certifications may be added but cannot replace mandatory Indian approval.
Source: h7.cl/1jTDc

2. India’s pharmaceutical industry is reportedly upgrading quality systems, regulatory alignment and scientific rigour as the Central Drugs Standard Control Organization (CDSCO) as tightens requirements for bioavailability and bioequivalence of oral drugs. Post-approval changes now require stronger data, dissolution studies, and risk-based evaluation. The move aligns India with global regulatory expectations and aims to enhance drug reliability, consistency, and overall patient safety.
Source: h7.cl/1jTDs

3. MNC drugmakers are urging CDSCO to grant 10-year regulatory data exclusivity for novel drugs, arguing it will protect first-mover clinical trial data, boost innovation, and attract R&D investment. This follows CDSCO’s sought industry feedback on rules that require the first applicant to conduct clinical trials and bioequivalence studies, while the subsequent filers could skip the trials.
Source: h7.cl/1jTDC

4. Raids by the Kerala Drugs Control Department in Kozhikode, Thrissur and Thiruvananthapuram revealed that discount pharmacies are stocking a wide array of counterfeit and poor-quality medicines, facilitated by weak inspection and unregulated distribution networks. Stakeholders are now urging Central Drugs Standard Control Organization (CDSCO) intervention.
Source: h7.cl/1jTDY

5. The National Accreditation Board for Testing and Calibration Laboratories has issued a guidance document to strengthen quality at medical laboratory sample collection centres, outlining requirements, hygiene and transport protocols, temperature control measures, and strict oversight to ensure integrity and reliability of patient test results across all facilities.
Source: h7.cl/1jTEn

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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 Supreme Court of India has urged the Union Government to consider giving legal backing to the Uniform Code of Pharmaceutical Marketing Practices, 2024, noting that the current voluntary framework lacks effective enforcement and leaves patient unprotected. The Court indicated it may issue interim guidelines and sought detailed proposals for a statutory, government-enforced framework.
Source: h7.cl/1jDIt

2. The Competition Commission of India (CCI) has approached the NCLAT to clarify whether privacy safeguards for non-advertising data sharing should also apply when a social media platform shares user data with its parent company for advertising purposes. This follows the lifting of a five-year ban on such data sharing,
Source: h7.cl/1ePhT

3. India’s central drug regulator (CDSCO) reportedly plans for a digital tracking system for high-risk solvents like diethylene glycol and batch-level reporting to prevent cough-syrup contamination. Authorities are also increasing scrutiny of unlicensed rural pharmacies and considering removal of the Schedule K exemption that currently eases regulatory requirements for selling cough syrups.
Source: h7.cl/1ePhW

4. The Directorate General of Foreign Trade (DGFT) has resolved a long-standing issue affecting pharmaceutical exporters by clarifying redemption of Advance Authorisations (AAs) impacted by the old CGST Rule 96(10). The move addresses compliance hurdles for duty-free raw material imports for the pharma sector.
Source: h7.cl/1jDHw

5. Indian government has launched the National Action Plan on Antimicrobial Resistance (NAP-AMR) 2.0 (2025–29) to counter rising drug resistance. The plan sets clear timelines, strengthens surveillance, curbs antibiotic misuse, boosts lab and infection-control capacity, and adopts a One Health approach through coordinated, multi-ministerial action against the growing AMR threat.
Source: h7.cl/1jDHD

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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 Electronics and Information Technology has notified phased enforcement of the Digital Personal Data Protection Act 2023. Implementation will follow a phased timeline of 12-18 months, introducing consent-based processing, mandatory breach reporting, children’s safeguards, expanded data rights, and a digital-only Data Protection Board, marking the structured rollout of India’s data protection framework.
Source: minilink.pro/1jA7S

2. India’s Ministry of Electronics and Information Technology (MeitY) has recently notified the Digital Personal Data Protection Rules, 2025. The rules mandate clear consent, breach reporting, children’s data safeguards, and a digital-only Data Protection Board. Compliance is phased over 18 months, along with penalties for violations.
Source: minilink.pro/1eLQj

3. The National Pharmaceutical Pricing Authority has extended the existing ceiling prices for orthopaedic knee implants by one more year until November 15, 2026. Manufacturers and importers of orthopaedic knee implants will have to maintain the existing prices till November 15, 2025.
Source: minilink.pro/1jA8h

4. The Food Safety and Standards Authority of India has integrated its Food Import Clearance System with the Central Board of Indirect Taxes and Customs under the SWIFT 2.0 platform. This integration enables faster, more transparent, and technology-driven food import clearance, reducing delays, improving efficiency, and supporting India’s broader trade facilitation objectives.
Source: minilink.pro/1jA97

5. The Union Cabinet has approved the Credit Guarantee Scheme for Exporters (CGSE), offering up to INR 20,000 crore in collateral-free credit with 100 % guarantee via National Credit Guarantee Trustee Company (NCGTC). Including both MSME and non-MSME exporters, the scheme aims to boost liquidity, aid market diversification, and enhance global competitiveness of Indian exports.
Source: minilink.pro/1eLQH

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 National Pharmaceutical Pricing Authority has ordered drug and medical device importers, manufacturers, and brand owners to revise MRPs from September 22, 2025, in line with GST Council decisions. Firms must issue revised price lists, inform dealers, retailers and consumers about the reduction in GST rates, and publish advertisements, while re-labelling old stocks is optional if compliance at the retail level is ensured.
Source: short-url.org/19LMW

2. Directorate General of Health Services (DGHS) has revoked its earlier order barring physiotherapists from using the “Dr” prefix, after receiving recommendations from the National Commission for Allied and Healthcare Professions (NCAHP) and facing strong objections from professional bodies. The previous directive, said physiotherapists are allied health professionals and not entitled to use “Dr” to prevent misleading patients. DGHS stated the matter requires further examination.
Source: short-url.org/19LN2

3. With new GST rates kicking in from September 22, 2025, FMCG companies are urging the government to allow sales of products in current packaging (with old MRP) but at revised lower prices. They warn that forcing re-packaging could lead to over ₹2,000 crore in packaging waste and major losses across supply chains.
Source: short-url.org/19LNc

4. The Supreme Court has asked all Indian state governments to reply in four weeks about how they are enforcing the Pre Conception and Pre Natal Diagnostic Techniques Act, giving data since May 1, 2015, on prosecutions, acquittals, and appeals, after noting that many acquittals are never challenge.
Source: short-url.org/1ekQ6

5. India’s Union Minister of State for Health has reportedly inaugurated the National Virus Research & Diagnostic Laboratory (VRDL) Conclave 2025, announcing a new portal and protocols for in-vitro diagnostics (IVD) validation. The initiative aims to speed up and simplify validation. India is also expanding VRDL capacity, bio-safety labs, and outbreak surveillance.
Source: short-url.org/19LNy

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 NPPA’s Multi-Disciplinary Committee (MDC) flagged a typographical error in major pharmaceutical drug manufacturing company’s IPDMS Form I, reporting retail price of tablet as ₹13 per tablet instead of ₹91, leading to incorrect pricing. MDC has cautioned the manufacturer to avoid such negligence to prevent procedural delays.
Source: short-link.me/1aSCE

2. The Indian government has reportedly clarified that there is no official classification of drugs as “life-saving drugs.” However, to ensure affordability and accessibility, 930 formulations listed in the National List of Essential Medicines (NLEM) are under price control, leading to significant price reductions and improved patient access.
Source: short-link.me/16tjO

3. The Chhattisgarh High Court, in a recent interim order, has permitted Bachelor of Pharmacy (B.Pharm) graduates to apply for Pharmacist (Grade-II) posts under the National Health Mission (NHM). The court deemed the NHM’s exclusion of degree holders as arbitrary, a violation of Articles 14 and 16 of the Constitution.
Source: short-link.me/1aSCL

4. Indian pharmaceutical exports specifically generics and biosimilars -are currently exempt from the U.S. tariffs, underscoring their indispensable role in ensuring affordable, high-quality medicines for U.S. consumers. With about 40% of generics and 15% of biosimilars in the U.S. supplied by India, Pharmexcil has reportedly urged sustained collaboration to preserve stable, resilient pharmaceutical supply chains.
Source: short-link.me/1aSCW

5. United States Food and Drug Administration experts recommended dropping the “black box” warning on estrogen-based menopause therapies, especially low dose vaginal estrogen arguing the label has deterred women from effective treatment. They cited updated evidence showing benefits in reducing heart attack and bone fracture risk. In India, doctors are optimistic this move will boost confidence in hormone therapy, which remains underused despite its potential benefits for millions of postmenopausal women.
Source: short-link.me/1aSCZ

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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 Delhi High Court declined to grant an interim injunction against four influencers who criticized a popular protein brand’s product in YouTube videos. The Court ruled that their comments, based on lab reports, constituted fair comment in public interest and not defamation.
Source: bit.ly/3GxgRIw

2. The Supreme Court of India has ruled that the limitation period for filing appeals under the Commercial Courts Act, 2015, begins from the date the judgment is pronounced, not when the party receives the judgment copy. The Court held that delay in seeking a certified copy doesn’t justify condoning limitation period.
Source: bit.ly/432T5fc

3. An Indian District Consumer Disputes Redressal Commission has ruled against an insurance company for unfair trade practices after it denied a valid accident claim. The complainant signed the discharge voucher but added the words “with protest” to express his disagreement, which led to its denial.
Source: bit.ly/4jtaZi1

4. India’s Department of Pharmaceuticals (DoP) has reportedly requested export data from Pharmexcil, under the Ministry of Commerce and Industry, amid ongoing trade restrictions with Pakistan. The move is aimed at assessing the flow of pharmaceutical products between the two countries.
Source: bit.ly/42Osz96

5. Swissmedic has invited feedback on the International Council for Harmonisation (ICH) Guideline M13B, which aims to harmonize bioequivalence study designs and data analysis methods for immediate-release solid oral dosage forms like tablets, capsules, and granules/powders for oral suspension. Stakeholders may submit feedback until July 9, 2025.
Source: bit.ly/44bvFq2

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 Food regulator, the Food Safety Standards Authority of India, now requires linking of new licenses with the Permanent Account Number (PAN) of the applicants, additionally existing Food Business Operators have been requested to keep their PAN data up-to-date.
Source: bit.ly/48QImab

2. The Telangana Drugs Control Authority has issued notices to private hospitals in Hyderabad and Telangana, requiring stricter compliance with purchasing requirements for Narcotics Drugs, under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS).
Source: bit.ly/4hJQoWf

3.  The Ministry of Environment, Forest and Climate Change has relaxed penalties under the E-Waste Rules, 2022 and the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. From hereon, the contravention of any provision of these Rules shall not give rise to environmental compensation.
Source: bit.ly/4fqrp8W

4. In pursuance of an ongoing process for recovery of sums on account of a judgment of the Court for misleading conduct by the Respondent, the Supreme Court has issued an Order to auction the Trade Mark of a prominent Indian Hospital chain, while at the same time refusing to make provision for valuating the same.
Source: bit.ly/3Z1rcDf

5. European Union Drug Regulator considering proposal to reduce the duration of regulatory data protection available to companies.
Source: bit.ly/4hGEvQZ

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 been made an affiliate member of the International Medical Device Regulators Forum (IMDRF). The application submitted by the Indian Government has been accepted contingent on the adoption of comprehensive regulation of Medical Devices in alignment with the existing international standards.
Source: bit.ly/3TQ1GOb

2. India’s Ministry of Health and Family Welfare has introduced Guidelines for Withdrawal of Life Support in Terminally Ill Patients, which sets out the institutional oversight requirements to facilitate ethical and informed decision-making in this regard.
Source: bit.ly/4eReyf6

3. The Supreme Court has held that in case of criminal suits which have an overwhelming civil quality, i.e. are based on private wrongs, where the parties to such criminal suits have already settled with each other, High Courts should exercise their powers under Sec. 482 of the CrPC and quash the underlying criminal proceedings.
Source: bit.ly/4dyF1wQ

4. India’s Central Drugs regulatory authority the Central Drugs Standards Control Organization (CDSCO) has decided that it will initiate action against a manufacturer of eye-drops, which had recently made social-media posts and conducted conferences regarding its new product, which had come under scrutiny for the claim that it would manage near-sightedness, and in pursuance of that, forwarded the matter to the State Drug Regulator of the state of Gujarat where the company is based.
Source: bit.ly/4dtuYJL

5. A prominent US based medical systems and medical devices manufacturer which has suffered a data-breach of its systems leading to the leak of sensitive personal and medical information of its patients, is currently facing a class-action lawsuit on grounds that the breach was caused due to non-adherence to industry standard practices in data storage and security.
Source: bit.ly/3BHdjRl

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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 State Excise Department of Orissa has recently issued a notification to declare separated leaves of the Cannabis plant, also referred to as Bhang, as “intoxicant” under the State Excise law. Prior to this notification, Orissa was one of the few states where Bhang was not regulated as intoxicant.
Source: bit.ly/46J2NVn

2. India’s drug price regulator, NPPA, has rejected a price revision plea of a manufacturer of drug on grounds that it had failed to communicate revision of prices of the drug in Form II of Drugs (Prices Control) Order, 2013 within prescribed timeline of 15 days.
Source: bit.ly/3M6bBuX

3. The Bombay High Court has observed that an egg/ sperm donor in an in-vitro fertilization scenario cannot seek the same rights as a parent.
Source: bit.ly/3YQVPeO

4. All entities who are not registered as telemarketers will not be able to make promotional calls. If any complaint is received against such entity, then it will be blacklisted for two years.
Source: bit.ly/3AsgYSM

5. The Telecom Regulatory Authority of India, the country’s internet and telecommunications regulator has issued an order to telecom and internet service providers to disconnect and remove access for unregistered telemarketers who are carrying out voice-promotional calls. Once disconnected, such persons shall be required to submit a compliance report within 1 week, and may be given an opportunity to register with the TRAI.
Source: bit.ly/4dD3eCE

 

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.

Indian Government may introduce Digital Competition Bill before the Parliament in November 2024
In an effort to curb anticompetitive conduct in the digital marketplace, the Indian government may introduce a draft Digital Competition Bill in the Parliament in November 2024. Laws regarding predatory pricing, exclusive tie-ups that restrict market access for users of digital platforms from accessing third-party applications are all intended to be covered by the bill.
Source: bit.ly/3W5ADk1

Supreme Courts rejects apology of a major Ayurvedic medicine manufacturer in an ongoing contempt case
In an ongoing proceeding against a major Ayurvedic medicine manufacturer for publication of misleading advertisements and the ongoing contempt case, the Supreme Court rejected manufacturer’s apology to the Court and gave it a week’s time to issue a public statement apologising for misleading advertisements and making comments against allopathic medicines.
Source: bit.ly/49HMFTV

Specific law to apply over general law only if the offense perfectly covers all elements of the offence under general law: Bombay High Court
The Bombay High Court has held that the Information Technology Act, 2000 will supersede the Indian Penal Code if an offence is covered under both the legislations. The Court reasoned the ruling by stating that where an offence matches the definition in both general and specific laws, but specific law encompasses all elements of the general law’s definition, the specific law will take precedence over a general law. However, if the special law provision does not exhaustively deal with all the ingredients of the offence, the general law will take precedence.
Source: bit.ly/3Qc2CuK

India’s food regulator may investigate presence of sugar infant food products
India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), is reportedly investigating the presence of sugar in infant products of a major food company, in light of news reports that the company did not sell infant food products with sugar in developed countries.
Source: bit.ly/3Q8Lx4Q

Colorado introduces first law to protect consumer’s brainwaves
The state of Colorado has introduced a first of a kind law in the United States that aims to protect the data found in a person’s brainwaves. The legislation is seen to be a measure to protect consumers’ personal data in the light of rapid advancements in neurotechnology making scanning, analysing and selling mental data increasingly accessible.
Source: bit.ly/3xKHipO