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 Ministry of Health has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019, proposing to remove the provision dealing with the provisional registration of Ethics Committees. The designated authority will now directly grant final registration in Form CT-03 after scrutiny of Form CT-01, or reject with written reasons.
Source: h7.cl/1oifC

2. Bulk Drug Manufacturers Association of India has launched a marketing portal enabling Indian pharmaceutical companies to promote and source active pharmaceutical ingredients, intermediates, pallets, and contract development and manufacturing services, supporting both domestic and international markets through an integrated vendor management system with no cost registration for buyers.
Source: h7.cl/1oifJ

3. The Department of Pharmaceuticals has extended the deadline for submitting applications under the Common Facilities for Medical Device Clusters (CFMDC) sub-scheme to 15 February 2026. The scheme supports shared testing infrastructure for medical devices, including cardiac and orthopaedic implants, infusion pumps, imaging equipment, and Class B, C, and D IVDs.
Source: h7.cl/1jfLz

4. The Maharashtra government has issued a resolution by introducing a new fee structure at state-run hospitals from effective from January 16, 2026. ₹5 for OPD registration, ₹10/day for inpatient admission, and up to ₹40,000 for major surgeries like joint replacements. Diagnostic services, ICU care, and ambulance services also have updated charges. Implementation across hospitals is pending.
Source: h7.cl/1oiwW

5. The Indian Pharmacopoeia Commission is reportedly taking efforts to develop more biosimilar in alignment with governments Biopharma Shakti initiative. This move aims to align Indian quality standards with global benchmarks and strengthen the country’s biologics and biosimilars ecosystem.
Source: h7.cl/1jfLU

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 Department of Pharmaceuticals has invited proposals under the CFMDC scheme to strengthen shared testing infrastructure for medical devices, including cardiac and orthopaedic implants, infusion pumps, endoscopic systems, imaging equipment such as X-ray and MRI, and Class B, C, and D IVDs. The initiative aims to improve access to common testing facilities in India.
Source: h7.cl/1hMz2

2. The Department of Pharmaceuticals (DoP) has issued a public notice proposing the inclusion of 11 additional pharmaceutical formulations, including patented biologics and proprietary insulin products, under the Global Tender Enquiry (GTE) exemption list for FY 2025–26. Domestic manufacturers have been invited to submit objections by January 19, 2026, in the attached form.
Source: h7.cl/1hMz7

3. The Supreme Court of India has issued notices to the Union Ministries of Law, Health and AYUSH on a PIL seeking to declare AYUSH practitioners as Registered Medical Practitioners (RMP) under the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954. An RMP is allowed to display a signboard or notice on their clinic premises indicating that they provide treatment for diseases listed in the Act, which others are prohibited from advertising.
Source: h7.cl/1hMz8

4. Delhi High Court held that in patent disputes involving life-saving drugs, courts must prioritise public interest. Injunctions should not block patient access unless infringement is clearly established through product-to-claim mapping. Where issues are technical and triable, alternative safeguards can protect patentees without withdrawing essential therapies during litigation.
Source: h7.cl/1mK20

5. Indian importers of aluminium beverage cans are reportedly requesting the government to extend the deadline for BIS certification and marking requirements. This follows shortages caused by rising demand and delays in BIS approvals. The quality control order was issued in April 2025, beverage companies have increased imports from West Asia and Sri Lanka to prevent supply disruptions.
Source: h7.cl/1hMzd

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 Pondicherry Drugs Control Department has mandated 100% batch-wise testing of all medicines sold in Pondicherry using Central Drugs Standard Control Organisation-accredited labs. The directive covers pharmacies, wholesalers, clinics, and public and private hospital stores, requiring immediate quality testing for every drug batch.
Source: h7.cl/1mwLy

2. The Central government told the Delhi High Court that judicial orders reducing GST on air purifiers would breach the Constitution’s separation of powers, asserting that GST rate decisions rest solely with the GST Council. It also labelled the PIL seeking medical-device status and tax cut as a “motivated attempt,” warning against judicial overreach.
Source: h7.cl/1hzJ2

3. The Delhi High Court has sought a response on a plea seeking revocation of a patent covering a widely used diabetes and anti-obesity medicine, ahead of its expiry in March. The petition alleges lack of novelty and attempts to extend exclusivity, amid growing interest from domestic manufacturers nationwide.
Source: h7.cl/1mwLG

4. The Medical Device Coordination Group (MDCG) has issued new guidance on post-market surveillance (PMS) for medical devices and IVDs under the EU regulations. The guidance outlines PMS system setup, data collection, analysis, and integration with quality management to ensure ongoing safety, performance, and regulatory compliance across the product lifecycle.
Source 1: h7.cl/1hzJ7
Source 2: h7.cl/1hzJ8

5. India’s central drug regulator, guided by a high-level DCC report, is reportedly launching the second phase of the National Action Plan on Antimicrobial Resistance (NAP-AMR) to combat antimicrobial resistance. Measures include banning OTC antibiotic sales, stamping prescriptions, real-time tracking, promoting new antibiotic R&D, stricter Schedule H/H1 controls, and extended producer responsibility for disposal.
Source: As essential antibiotics fail, regulator mulls R&D push, curbs on misuse
Source: h7.cl/1mwLP

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 Drugs Standard Control Organization (CDSCO) has launched a new online Risk Classification Module for medical devices, excluding IVDs. Effective 27 November 2025, applicants can seek classification for devices not listed in CDSCO’s published list via the portal, simplifying regulatory approvals for Medical Devices.
Source: h7.cl/1kNrH

2. Indian Council of Medical Research (ICMR) and India’s Central Drug authority CDSCO (IVD Division) has jointly developed the MedTech Mitra IVD Innovators Handbook to guide developers through clinical validation. It outlines key milestones, regulatory and ethical expectations, and evidence requirements, helping innovators plan effectively and generate strong clinical data to support the safety and efficacy of their diagnostic products.
Source: h7.cl/1kNrK

3. Rajya Sabha members urged the government to ban misleading surrogate ads promoting tobacco and liquor, citing rising cancer and heart disease cases. During debate on the Central Excise (Amendment) Bill, 2025, they sought stricter controls, awareness campaigns and higher taxes to curb tobacco use and protect public health.
Source: h7.cl/1fVMQ

4. The Delhi High Court has declined to grant injunctive relief against an Semaglutide manufacturer, thereby permitting the manufacture and export of semaglutide to jurisdictions where no valid patent protection subsists. The Court clarified that while export to non-patent markets is permissible, the sale or distribution of the drug within India remains prohibited until expiry of the relevant patent.
Source: h7.cl/1kNrT

5. The Indian government has introduced the Health Security se National Security Cess Bill, 2025, proposing a new cess on the installed machinery or processes used for the manufacture of goods such as pan masala, with scope to include other products in future. The cess will apply across all production methods, machine-based, manual, or hybrid.
Source: h7.cl/1kNrW

Posted on

Frequently Asked Questions (FAQ’s) on regulatory compliances associated with GST rate reduction of medical devices in India

On September 03, 2025, The Goods & Services Tax Council has announced the reduction in Goods and Services Tax (GST) rates for medical devices, medical equipment, medical apparatus and IVDs listed at the end of this article (“listed medical devices”). The reduced GST rates will come into effect on September 22, 2025. In this article, we have answered frequently asked questions (FAQs) about compliance associated with the reduction in GST rates for those listed medical devices which declare the Maximum Retail Price (MRP) on their package.

[If you are short on time, please read response to Q.3 and 4]

GST reduction and its impact on existing stock

1. Will the reduced GST rates apply to stock of medical devices already present in the market, and if so, will the MRP of such medical devices have to be reduced?

Yes. The reduced GST rates will apply to all of the stock of the listed medical devices sold on or after September 22, 2025, irrespective of the fact that it was manufactured, imported or packed prior to September 22, 2025.

The MRP of the stock of listed medical devices available in the market on or after September 22, 2025 will have to be reduced to reflect the reduction in GST rates, and the revised GST rate applicable to listed medical devices and the reduced MRP will have to be communicated to all wholesale and retail dealers by the manufacturers and importers of listed medical devices. However, the MRP declared on the package of the listed medical devices need not be re-labelled or re-stickered. We have discussed this aspect in our response to Q. 5-9 below.

2. Is it possible to retain same MRP on stock of medical devices present in the market after reducing GST?

No. While it is generally permissible to increase MRP of medical devices by up to 10% in India, doing so for stock of medical devices which was manufactured or imported prior to September 22, 2025 may tantamount to denying trade and customers the benefit of reduction of GST, which is not permissible under India’s GST laws and is generally regarded as unlawful ‘profiteering’.

Compliances to be undertaken on account of reduction in GST rate

3. Which mandatory compliances should a manufacturer or importer of medical devices undertake before September 22, 2025 to ensure compliance with applicable laws?

Manufacturers and importers of the listed medical devices should undertake the following steps as soon as possible, but no later than September 21, 2025:

  • Circulate a notice informing wholesale and retail dealers about revised applicable GST rate and reduced MRP, effective September 22, 2025, and ensure that the Director of Legal Metrology (Central Government) and the Controller of Legal Metrology of States and Union Territories receive a copy of the circulated notice.
  • Circulate a revised price list of listed medical devices manufactured or imported or marketed by the company in Form VI of DPCO to wholesale and retail dealers, State Drug Controllers, National Pharmaceutical Pricing Authority (NPPA) and Department of Pharmaceuticals (DoP), indicating revised GST rates and the revised MRP effective from September 22, 2025. The revised price list may be circulated through any suitable communication channel, including WhatsApp and Email.

[Note: The Director of Legal Metrology has relaxed the requirement to publish advertisements in one or more newspapers informing the trade and public about the revised applicable GST rate and reduced MRP]

4. Which mandatory compliances should be undertaken by a manufacturer or importer of medical devices after September 22, 2025 to ensure compliance with applicable laws?

Manufacturers and importers of the listed medical devices should undertake the following steps as soon as possible on or after September 22, 2025, in addition to declaring reduced MRP on package:

  • Submit the revised price list in Form VI of DPCO on the IPDMS portal of NPPA, on or before October 6, 2025.
  • File Form II of DPCO to report a decrease in MRP on IPDMS Portal of NPPA, on or before October 6, 2025, applicable only if the listed medical device falls under the list of scheduled formulations under DPCO.

Re-labelling of existing stock of medical devices with revised MRP

5. Is it mandatory to declare reduced MRP on the label of stock of medical devices available with wholesale and retail dealers, which has been manufactured in India or imported into India before September 22, 2025?

No. It is not mandatory to declare reduced MRP on the label of stock of listed medical devices available with wholesale and retail dealers which has been manufactured India or imported into India before September 22, 2025. However, all listed medical devices manufactured in India or imported into India on or after September 22, 2025 must declare reduced MRP on its label. If there is pre-existing packaging material which contains pre-printed MRP, then it may be used to pack listed medical devices which are manufactured on or before March 31, 2026, in the manner as described in response to Q. 16.

6. Is it mandatory to declare reduced MRP on the label of medical devices stored at manufacturer’s or importer’s warehouse, which has been manufactured in India or imported into India before September 22, 2025?

No. It is not mandatory to declare reduced MRP on the label of listed medical devices stored at manufacturer’s or importer’s warehouse, which has been manufactured in India or imported into India before September 22, 2025, provided steps described in response to Q. 3 have been taken.

However, if a manufacturer or importer of listed medical devices wishes to voluntarily declare reduced MRP on label of medical devices, then we have described the compliances to be followed in our response to Q. 7, 8 and 9.

It is recommended that the unsold stock of listed medical devices stored at manufacturers or importer’s warehouse should be re-labelled with reduced MRP before sale to trade, in order to reduce risk of allegation of overcharging or profiteering due to failure of retailer to sell at reduced MRP despite being notified by the manufacturer or importer about the reduction of MRP.

7. Is any permission required to re-label medical devices with reduced MRP on account of reduction of GST?

No. There is no permission required to re-label medical devices to reflect reduced MRP on account of reduction of GST, provided such re-labelling is done before December 10, 2025 in case of all imported medical devices and domestically manufactured Class C and Class D medical devices. In case of domestically manufactured Class A and Class B medical devices, the timeline for re-labelling to reflect reduced MRP on account of reduction in GST rate will be communicated by respective State’s Medical Device Licensing Authority (example – State Drug Controller, State Food and Drug Department), but under no condition should such re-labelling be done beyond December 31, 2025.

Please note that the re-labelling to reflect reduced MRP on account of reduction in GST is subject to conditions which are discussed in response to Q. 8 below.

8. If a manufacturer or importer wishes to declare revised MRP on stock of medical devices which was manufactured in India or imported into India before September 22, 2025 and that stock is available with wholesale and retail dealers or that is present in manufacturer’s or importer’s warehouse, what are the legal compliances that such manufacturer or importer should be aware of?

Assuming the manufacturer or importer has complied with the mandatory requirements outlined in response to Q. 3 and 7 above, it may lawfully declare revised MRP by re-labeling stock of listed medical devices which has been manufactured in India or imported into India before September 22, 2025, after fulfilling the below-mentioned conditions:

  • The original MRP must remain visible, and the revised MRP must not be overwritten on it.
  • The stocks should be re-called in a phased manner to avoid any shortage of the listed medical devices in the market.

9. What are the permitted ways of declaring reduced MRP on the pack of medical devices on account of reduction in GST?

Assuming the manufacturer or importer has complied with the mandatory requirements outlined in response to Q. 3, 7 and 8, the manufacturers and importers of listed medical devices may declare reduced MRP on pack of listed medical devices by stamping or affixing stickers or by online printing.

Compliances applicable to wholesale and retail dealers

10. How are wholesale and retail dealers expected to know the revised GST rate and reduced MRP applicable to medical devices stocked by them, if the stock of medical devices available with them does not carry on the label a declaration of reduced MRP as of September 22, 2025?

As indicated in response to Q. 3, all manufacturers and importers of listed medical devices are required to notify wholesale and retail dealers about revised GST rates and reduced MRP latest by September 21, 2025 by circulating a revised price list which is effective from September 22, 2025.

Accordingly, on or after September 22, 2025, all wholesale and retail dealers of the listed medical devices must refer to the revised price list received from the manufacturer or importers of listed medical devices before selling stock of listed medical devices in their possession.

11. What are the compliances applicable to wholesale and retail dealers who have stock of the medical devices manufactured in India or imported into India prior to September 22, 2025?

On or after September 22, 2025, all wholesale and retail dealers must:

  • Sell listed medical devices at reduced MRP after applying revised GST rates;
  • Verify the reduced MRP against the revised price list received from the manufacturer or importer of listed medical devices
  • Display of revised price lists of the listed medical devices received from the manufacturers or importers on a conspicuous part of the premises where they carry on business; and
  • Not alter, tamper, over-sticker or re-label the existing product packaging.

Penalties for non-compliance

12. What are the consequences of failure to circulate revised price list in Form VI to wholesale and retail dealers before September 22, 2025?

Non-submission of Form VI after reducing MRP is a violation of DPCO and may lead to penal action under the Essential Commodities Act, 1955 resulting in fine and imprisonment.

13. What are the consequences of non-submission of Form II of DPCO before October 6, 2025?

Non-submission of Form II of DPCO is deemed to be a failure to reduce MRP of listed medical devices by the manufacturer or importer despite reduction in GST rates. The manufacturer or importer may be held liable for overcharging consumers and be required to pay the overcharged amount, along with interest and a penalty. It may also result in criminal prosecution under The Essential Commodities Act, 1955, inviting fine and imprisonment if convicted.

14. What are the consequences of failure to notify dealers about applicable revised GST rates and reduced MRP before September 22, 2025?

Failure to notify dealers about applicable revised GST rates and reduced MRP before September 22, 2025 may invite fine.

Requirement for obtaining a manufacturing license or NOC from State Licensing Authority for re-labelling

15. Will declaration of reduced MRP on packages of medical devices be considered to be “manufacturing” and require a manufacturing license or NOC from State Licensing Authority or CDSCO?

The re-labelling of a medical device may be legally construed as manufacture of medical devices under The Drugs and Cosmetics Act, 1940 (D&C Act), and such manufacturing activity requires a license from the Licensing Authority under D&C Act. The Licensing Authority in case of imported medical devices and domestically manufactured Class C and Class D medical devices is CDSCO. The Licensing Authority in case of domestically manufactured Class A and Class B medical devices is State Licensing Authority (for example – State Drug Control Department, State Food and Drug Administration).

For the limited purpose of reducing MRP due to revision of applicable GST rates, CDSCO has given concession to importers of medical devices and domestic manufacturers of Class C and Class D medical devices until December 10, 2025 to re-label stock of listed medical devices with reduced MRP without requiring license or NOC from CDSCO.

Some State Licensing Authorities, such as Jharkhand State Drug Administration, has reportedly given concession to domestic manufacturers of Class A and Class B medical devices in Jharkhand State to relabel stock of listed medical devices with reduced MRP without requiring license or NOC from the said State Licensing Authority until December 31, 2025. It is important for domestic manufacturers of Class A and Class B to check locally about the date until which stock of listed medical devices may be re-labelled with reduced MRP without requiring a license or NOC from State Licensing Authority.

Any re-labelling activity done beyond the prescribed date may invite application of requirement to obtain license from CDSCO or relevant State Licensing Authority.

Use of existing packaging material with pre-printed MRP

16. If the manufacturer or importer has packaging material with pre-printed MRP, can it be used for packaging medical devices manufactured after September 22, 2025?

Yes. Packaging material or wrappers bearing the pre-printed MRP that could not be exhausted by the manufacturer or importer prior to September 22, 2025 may be used for packaging of listed medical devices manufactured after September 22, 2025 until March 31, 2026.

However, the manufacturer or importer must declare the revised MRP on the packaging without hiding or over-writing the pre-printed MRP. The revised MRP may be declared by stamping, stickering or online printing.

If the packaging material with pre-printed MRP contains Unit Sale Price (USP) calculated on the basis of pre-printed MRP, then it is not mandatory to declare the revised USP calculated on the basis of reduced MRP. However, if the manufacturer or importer wishes to voluntarily declare the revised USP on the package alongside old USP calculated on the basis of pre-printed MRP, it is permitted to do so.

List of Medical Devices whose GST Rates have been reduced

Sr. No.Name of the productPrevious GST ratesNew GST rates effective from September 22, 2025
1Thermometers for medical, surgical, dental or veterinary usage18%5%
2Instruments and apparatus for medical, surgical, dental or veterinary uses for physical or chemical analysis.18%5%
3All diagnostic kits and reagents12%5%
4Surgical rubber gloves or medical examination rubber gloves12%5%
5Contact lenses and Spectacle lenses12%5%
6Spectacles, corrective
[including goggles for correcting vision]		12%5%
7Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments12%5%
8Mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus12%5%
9Other breathing appliances and gas masks, excluding protective masks having neither mechanical parts nor replaceable filters12%5%
10Apparatus based on the use of X-rays or of alpha, beta or gamma radiations, for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, X-ray tubes and other X-ray generators, high tension generators, control panels and desks, screens, examinations or treatment tables, chairs and the like12%5%
11All goods- napkins and napkin liners for babies, clinical diapers12%5%
12Blood glucose monitoring system (Glucometer) and test strips12%5%
13Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes12%5%
14Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental haemostatics; sterile surgical or dental adhesion barriers, whether or not absorbable; Waste pharmaceuticals] [other than contraceptives] Ostomy appliances including pouch or flange, stoma adhesive paste, barrier cream, irrigator kit, sleeves, belt, micro-pore tapes12%5%
15Patent Ductus Arteriosus / Atrial Septal Defect occlusion device12%5%

Disclaimer:This article contains personal views of the authors and should not be considered as legal advice.

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. Central Board of Indirect Taxes and Customs (CBIC) has issued Notification revising GST rates effective September 22, 2025, after the 56th GST Council meeting. The GST rates for medical devices, drugs, food, beverages, and cosmetics have been notified.
Source: short-url.org/1f8PY

2. India’s Central Drugs Standard Control Organization (CDSCO) and Indian Council of Medical Research (ICMR) have issued a unified national protocols for evaluating in-vitro diagnostic kits for Chikungunya, Dengue, Zika and others. These guidelines set strict criteria on sensitivity, specificity, and quality, ensuring accurate diagnostics and strengthening regulatory oversight to improve access to quality-assured diagnostic kits in India.
Source: short-url.org/1f8Q4

3. The National Medical Commission has advised medical colleges to strengthen rabies case management via regular training, surveillance, and community outreach. Colleges must guarantee continuous supply of anti-rabies vaccine (ARV) and anti-rabies serum (ARS), maintain a register of animal bite exposure cases, and report suspected rabies cases through state nodal officers via IHIP under IDSP.
Source: short-url.org/1f8Qh

4. The Directorate General of Health Services is set to introduce new regulations establishing minimum standards for medical sample collection and transportation. These standards aim to ensure that blood, urine, and swab samples are handled by trained professionals and transported under proper conditions, including maintaining a cold chain, to prevent contamination and ensure accurate test results.
Source: short-url.org/1f8Qw

5. The Drugs Control Administration (DCA), Telangana suspended licences of 165 medical shops and permanently cancelled seven for retailing MTP kits without valid prescriptions or licensed supervision. 800+ inspections revealed violations including OTC sales of abortifacient drugs (mifepristone, misoprostol), lack of required records, and dispensing without qualified pharmacists.
Source: short-url.org/1f8QF

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 Department of Pharmaceuticals has amended the UCMPMD 2024, clarifying valuation of free evaluation samples at stockist price if self-manufactured or average purchase price if sourced externally. Companies in multiple associations may submit disclosures through one, with prior intimation to others and notification to the Department when switching.
Source: short-link.me/18ym-

2. India’s Health Ministry has proposed amendments to the New Drugs and Clinical Trials Rules, 2019, enabling simplified approval for bioavailability and bioequivalence (BA/BE) studies of oral drugs approved in India or select countries, for export purposes. The draft exempts certain drug categories and caps sample size at 48. Stakeholders may submit objections or suggestions by 27 September 2025.
Source: short-link.me/1d3UX

3. Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO) have released draft protocols for evaluating In-Vitro Diagnostics (IVDs) for tuberculosis, including drug-resistant strains. Stakeholders can submit comments by September 7, 2025. Final protocols will be based on this feedback before final clearance is given by ICMR and CDSCO.
Source: short-link.me/18ylZ

4. India’s Punjab and Haryana High Court has ruled that legible medical prescriptions is a fundamental right of patients and doctors must write prescriptions in capital letters until Digitalization. PGIMER Chandigarh’s “Doctor Desk” e-prescription system is expected to be implemented within two years.
Source: short-link.me/18ym7

5. The Ministry of Health and Family Welfare has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019. The proposals reduce approval timelines from ninety to forty-five working days and introduce a simplified notification system for manufacturing certain drugs meant for analytical and preclinical testing.
Source: short-link.me/1d3Vg

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 Indian Council of Medical Research and India’ central drug authority “CDSCO” have released draft standard protocols for evaluating In-Vitro Diagnostic kits for Influenza, SARS-CoV-2, RSV, Malaria, Dengue, Nipah, and other pathogens. Pharma and diagnostics stakeholders can submit comments by 25 August 2025, after which revisions will be minimal before final adoption.
Source: short-link.me/1b0iM

2. India’s Supreme Court has disposed of a plea challenging misleading AYUSH medicine ads and vacated its stay on the omission of a rule which had removed the requirement for state-level pre-approval of Ayurvedic, Siddha, and Unani drug advertisements. With the rule deleted, companies can advertise without state clearance.
Source: short-link.me/16ALo

3. The All India Organisation of Chemists and Druggists has urged the government to ban ultra fast ten minute delivery of high risk prescription medications by quick commerce platforms, citing threats to public health, rising drug misuse, ghost prescriptions, and a disregard for established regulatory safeguards.
Source: short-link.me/1b0iY

4. India’s Health Ministry has launched SHRESTH Index to benchmark and strengthen state drug regulatory systems. The data-driven framework will guide improvements in infrastructure, manpower, digitization, inspections, and grievance redressal. Upcoming measures include expanding the Not of Standard Quality (NSQ) Dashboard to all states as well.
Source: short-link.me/1b0j6

5. India’s public health organisations call for mandatory front of pack warning labels on food items high in fats, sugar, and salt, replacing Indian Nutrition Rating (or Health Star Rating) system. They cite rising diet related deaths and rapid ultra processed food growth.
Source: short-link.me/16ALH

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. Supreme Court Calls Unethical Clinical Trials a Critical and Serious Issue, Orders Detailed Report from Government. The Supreme Court of India recently heard a Public Interest Litigation (PIL) filed by a public health rights NGO, highlighting unethical clinical trials causing serious adverse effects and deaths of the participants. The Court directed the Central Government to submit a detailed report within four weeks addressing concerns such as transparency, accountability, provisions for criminal actions against sponsors/investigators and other points raised by the petitioners.
Source:  bit.ly/4bW7QEB

2. Group of therapists have approached the Bombay High Court, alleging police harassment under the Immoral Traffic (Prevention) Act, violating their trade and dignity rights. The Maharashtra government informed the Court about a 12-member committee drafting guidelines for regulating spa and massage centers. The guidelines will cover important aspects such as licensing procedures, operational standards, and the regulation of cross-gender massages.
Source: bit.ly/4c4hG7s

3. India’s Health Department of Karnataka has clarified that Essential Narcotic Drugs (END) in the state will now be regulated under the Central Narcotic Drugs and Psychotropic Substances (NDPS) Rules, replacing the previous state regulations. As a result, hospitals and medical institutions recognized as RMIs by the state drug regulator no longer need state-level permission to stock these drugs. However, other narcotic drugs in Karnataka will continue to be regulated according to state NDPS Rules.
Source: bit.ly/4l1XDdY

4. The list of drugs taking a shift from prescription-only to over-the-counter (OTC) is reportedly to be released soon. A sub-committee is drafting guidelines, which may categorize OTC drugs for sale in pharmacies or in general stores, similar to practices in Western countries.
Source: bit.ly/4hJjCDB

5. MedTech Europe has released a report outlining the administrative burdens caused by the non-harmonized authorization process for IVD performance studies & the increased post-market and clinical reporting requirements for medical devices under the new medtech regulations. The report also proposes several solutions, including streamlining approvals for multinational studies, digitalizing processes, and allowing manufacturers to consolidate key reports.
Source: bit.ly/42jN4dJ