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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

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RECENT NPPA NOTICES AND THEIR IMPACT ON THE MEDICAL DEVICE INDUSTRY

Several medical devices companies have recently received an official letter (“Letter”) from the National Pharmaceutical Pricing authority (“NPPA”) directing them to register on the Integrated Pharmaceutical Database Management System (“IPDMS”) portal and file applicable forms under the Drugs (Prices Control) Order, 2013 (“DPCO”) within 15 (fifteen) days of issue of the Letter.

In this article, we have explained the legal background to these Letters, the consequences of non-compliance with NPPA directions, and the common issues faced by industry while complying with these requirements.

What is IPDMS?

IPDMS is an online platform developed by the NPPA to enable importers, manufacturers and marketers of drugs and medical devices to submit product pricing and related data in accordance with the requirements of the DPCO.

The pricing data submitted to NPPA through the IPDMS forms the basis for monitoring and enforcement activities carried out by NPPA against importers, manufacturers and marketers of medical devices under the DPCO.

Powers of NPPA to direct submission of product pricing and related data

Paragraph 29 of the DPCO mandates importers, manufacturers and marketers of medical devices to maintain such records as may be directed by the NPPA, including sale records, and empowers NPPA to call for and inspect such records at the premises of the manufacturer, importer and marketer of medical devices. Paragraph 30 of DPCO, empowers NPPA to enter and search any place, seize any medical device and records of purchase or sale of medical device.

The Letter has been issued in exercise of powers to call for records under Paragraph 29 and 30 of DPCO read with the Essential Commodities Act, 1955.

Consequences of non-compliance

Failure to comply with directions issued by NPPA may trigger enforcement actions under paragraphs 29 and 30 of the DPCO.

More critically, non-compliance has serious personal liability implications. Under Section 7(1)(a) of the Essential Commodities Act, any contravention of orders issued under Section 3 of the Act, including the DPCO, constitutes a criminal offence. In such cases, directors, key managerial personnel, and individuals responsible for the conduct of the business of the company may be proceeded against and can face severe penal consequences, including imprisonment and substantial fines.

It is important for company leadership to recognise that non-compliance with NPPA directions is not a routine regulatory lapse, but a matter that can expose senior management and directors to potential criminal prosecution.

How to ensure compliance of directions issued by NPPA under the Letter?

As indicated above, medical device companies that have received the Letter are required to undertake mandatory registration on the IPDMS portal and to file the applicable forms as prescribed under the DPCO within 15 (fifteen) days of the date of issue of the Letter. From compliance perspective, the companies receiving the Letter are required to undertake the following actions:

a) Registration of the company (corporate entity)

b) Registration of manufacturing plants (foreign and / or domestic)

c) Registration of products (medical devices and their model numbers)

d) Filing of applicable forms on the IPDMS portal, as directed by NPPA.

These requirements apply regardless of whether the devices are presently subject to price control (scheduled formulations) or are only covered under price monitoring (non-scheduled formulations) provisions.

Key concerns faced by medical devices companies:

Medical device manufacturers, importers, and marketers are currently grappling with several practical challenges while implementing DPCO compliance, including the following:

  • Uncertainty on the applicability of DPCO to medical devices intended for institutional sale.

  • Retrospective exposure concerns, as NPPA communications often require submission of historical pricing and sales data, potentially triggering past non-compliance scrutiny.

  • Challenges in maintaining prices due to volatile raw material and import costs.

  • Complexity in price reporting arising from differential pricing across distributors and supply chains.

  • MRP declaration on package despite the package being intended for institutional sale (not invoiced to end users)

  • Multiple model numbers for a single product, resulting in lengthy product lines and bulky data uploads on the IPDMS portal.

These operational issues underscore the need for a structured internal compliance mechanism and careful regulatory assessment.

Conclusion

Compliance with the provisions of DPCO and the directions issued by the NPPA is mandatory for all medical device importers, manufacturers, and marketers operating in India. Companies must urgently assess their DPCO applicability, ensure timely registration on the IPDMS portal, and file the prescribed forms in accordance with regulatory requirements. Failure to do so may result in regulatory scrutiny, potential financial exposure, and personal liability for directors and senior management under the provisions of DPCO and the Essential Commodities Act.

Disclaimer: This article is intended for general information purposes only and does not constitute legal advice.

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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

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

On September 03, 2025, The Goods & Services Tax Council has announced the reduction in Goods and Services Tax (GST) rates for medicines. 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 medicines (other than ayurveda and homeopathy medicines).

[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 medicines already present in the market, and if so, will the MRP of such medicines have to be reduced?

Yes. The reduced GST rates will apply to all the stock of medicines already present in the market 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 medicines available in the market on or after September 22, 2025 will have to be reduced to reflect the reduction in GST rates, and the reduced MRP along with the revised GST rates applicable to medicines will have to be communicated by the manufacturers and importers of medicines to all wholesale and retail dealers. However, the MRP declared on the package of medicines 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 medicines present in the market after reducing GST?

No. While it is generally permissible to increase MRP of medicines by up to 10% in India if they are not essential medicines (i.e. if they are not scheduled formulations under DPCO), doing so for stock of medicines which were 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 medicines undertake before September 22, 2025 to ensure compliance with applicable laws?

Manufacturers and importers of medicines should circulate a revised price list of medicines manufactured or imported or marketed by the company in Form V 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.

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

Manufacturers and importers of medicines 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 V 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 medicine is part of list of scheduled formulations under DPCO.

    • Re-labelling of existing stock of medicines with revised MRP

5. Is it mandatory to declare reduced MRP on the label of medicines available with wholesale and retail dealers, which have 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 medicines available with wholesale and retail dealers which are manufactured in India or imported into India before September 22, 2025.

However, all such medicines manufactured in India or imported into India on or after September 22, 2025 must declare reduced MRP on their label.

6. Is it mandatory to declare reduced MRP on the label of medicines stored at manufacturer’s or importer’s warehouse, which have 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 medicines stored at manufacturer’s or importer’s warehouse, which have been manufactured in India or imported into India before September 22, 2025 provided the compliance described in response to Q. 3 have been taken.

However, if a manufacturer or importer of medicines wishes to voluntarily declare reduced MRP on the label of medicines, then the compliances described in response to Q. 7, 8 and 9 should be followed.

It is recommended that the unsold stock of medicines 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 medicines with reduced MRP on account of reduction of GST?

Yes. While there is a prevailing understanding that all State Licensing Authorities (SLAs) in India have temporarily relaxed the requirement to obtain a manufacturing license or NOC by the manufacturers or importers for declaring reduced MRPs on medicines manufactured or imported by them before September 22, 2025, it may be pragmatic to confirm this understanding locally with the SLA of the State in which re-labelling is sought to be carried out before doing the re-labelling.

For example, in Delhi, it is mandatory for manufacturers and importers to obtain a No Objection Certificate (NOC) from the Delhi Drug Control Department prior to declaring reduced MRP on the label of medicines on account of revision of GST and no time-limit has been specified before which such re-labeling may be carried out on the label of medicines.

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 and Q.9 below.

8. If a manufacturer or importer wishes to declare revised MRP on medicines which were manufactured in India or imported into India before September 22, 2025 and whose stock is available with wholesale and retail dealers or 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 medicines which have 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.
  • Other declarations on the label should not be affected.
  • The stocks should be re-called in a phased manner to avoid any shortage of the medicines in the market.

9. What are the permitted ways of declaring reduced MRP on the pack of medicines 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 medicines may declare reduced MRP on pack of medicines by stamping or affixing stickers or by 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 medicines stocked by them, if the stock of medicines 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 medicines 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 in Form V which is effective from September 22, 2025.

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

11. What are the compliances applicable to wholesale and retail dealers who have stock of medicines 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 medicines at reduced MRP after applying revised GST rates;
  • Verify the revised GST rate and reduced MRP against the revised price list in Form V received from the manufacturer or importer of medicines;
  • Display the revised price lists of medicines 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 V to wholesale and retail dealers before September 22, 2025?

    The failure to circulate Form V before September 22, 2025 may result in recovery of the difference between old MRP and revised MRP from the manufacturer or importer of medicines as ‘overcharging’, along with interest and penalty, even though overcharged amount has been realized by the wholesale dealer or retail dealer.

    The failure to submit Form V on the IPDMS portal on or before October 6, 2025 will constitute a violation of DPCO and may lead to penal action under the Essential Commodities Act, 1955 including 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 medicines 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. Form II is required to be submitted only in case of reduction of MRP of medicines which are classified as scheduled formulations under DPCO.

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

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

    The re-labelling of a medicine may be legally construed as manufacture of medicine 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 manufacturing of medicines in India is the respective State Licensing Authority i.e. SLA (for example – State Drug Control Department, State Food and Drug Administration). Such a license is require from SLA irrespective of whether the drug is manufactured in India or imported into India,

    As indicated in response to Q. 7, the possibility and time-limit for carrying out the re-labelling of medicines with reduced MRP should be checked locally with the respective SLA in each state where the re-labelling is sought to be carried out prior to undertaking re-labelling.

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

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    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. 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

    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 extended the application deadline for Round V of its Production-Linked Incentive (PLI) scheme to 21 June 2025, giving pharma companies additional time to apply. Applications can only be made online through the given link in the circular.
    Source: bit.ly/4kn1e4J

    2. The Delhi High Court has barred a leading Ayurvedic manufacturer from airing advertisements claiming superiority of its Chyawanprash, ruling that freedom of commercial speech doesn’t justify misleading claims for regulated drugs. It has further emphasized stricter scrutiny on drug-related marketing to prevent false efficacy claims and consumer deception.
    Source: bit.ly/4kqs63F

    3. The Madras High Court has clarified that importing Ayurvedic drugs into India does not require an import license, provided the products conform to the standards set for domestically manufactured equivalents. This precedent emphasizes regulatory alignment with Indian pharmacopoeia standards and could facilitate smoother market entry for Ayurvedic importers while ensuring consistent quality.
    Source: bit.ly/4lgEXH2

    4. The National Pharmaceutical Pricing Authority (NPPA) will change its official website from nppaindia.nic.in to nppa.gov.in effective 15 July 2025. The new domain will host all notifications, pricing orders, data systems, and circulars. Stakeholders are advised to update their records and bookmarks to ensure uninterrupted access to NPPA services during the transition phase. The old domain will temporarily redirect users.
    Source: bit.ly/44AXWF9

    5. The National Pharmaceutical Pricing Authority (NPPA) has issued an Order thereby fixing the ceiling prices for I.V. fluids (non-glass with special features). Now the product I.V. fluids (non-glass with special features) cannot be sold beyond the fixed prices.
    Source: bit.ly/44gE4rR

    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 Multidisciplinary Committee, in its recent meeting has reportedly decided to co-opt experts from AIIMS, MAMC, SIC Safdarjung and NIPER to evaluate industry requests for a distinct ceiling price on cementless knee implants. Under Drugs Price Control Order, 2013, manufacturers may petition for separate pricing if their product shows innovation or superiority over existing variants.
    Source: bit.ly/3HQpizr

    2. The Bureau of Indian Standards (BIS) has introduced two important standards, IS/IEC 63203-201-1:2022 which outlines the standards for measurement methods for basic properties of conductive yarns used in wearable electronic textiles and, IS 19173 (Part 1):2025 which is aligned with IEC/TR 80002-1:2009, offers guidance on applying ISO 14971 to medical device software, strengthening risk management practices.
    Source: bit.ly/4ejatBw

    3. The National Human Rights Commission has reportedly directed AIIMS Delhi to submit a report within 15 days following allegations that neuroradiology doctors bypassed institutional procurement norms, referring patients to buy flow-diverter brain implants from a private vendor. The complaint highlights significant cost burden and potential human rights violations.
    Source: bit.ly/4kY4PqY

    4. The Customs, Excise, and Service Tax Appellate Tribunal (CESTAT), New Delhi Bench, ruled that packing or repacking parts of Vibratory Compactors and Wheeled Tractor Loader Backhoes does not constitute “manufacture” under Central Excise Act, so no excise duty is payable.
    Source: bit.ly/4eispvP

    5. The Sikkim High Court has ordered the State Government to conduct the periodic inspections of all industries including pharmaceutical companies to verify that no effluents are being discharged into rivers. The court also noted groundwater extraction and urged timely completion of the Sikkim Springs & Groundwater Regulation Bill, 2025.
    Source: bit.ly/4k5z1yW

    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 (NPPA) plans to consult subject matter experts to determine a separate pricing structure for cementless knee implants, aiming to ensure affordability and accessibility for patients requiring these advanced medical devices.
    Source: bit.ly/43XywRM

    2. The Indian Pharmaceutical Alliance (IPA) has expressed opposition to the government’s recent directive limiting the entry of medical representatives into Central government hospitals, arguing that such restrictions could hinder the dissemination of critical medical information to healthcare professionals.
    Source: bit.ly/4kDnNCZ

    3. The Ministry of Electronics and Information Technology (MeitY) is considering the discontinuation of the bundled consent mechanism, proposing stricter regulations to enhance data privacy and security standards in digital platforms.
    Source: bit.ly/4kE8qdH

    4. India has asserted its stance on protecting pharmaceutical innovations, countering recent patent infringement allegations from Switzerland, and emphasizing the country’s commitment to safeguarding public health interests.
    Source: bit.ly/4n66Lzd

    5. The U.S. Department of Agriculture is set to introduce new dietary guidelines for schools, aiming to reduce added sugars and sodium in meals, promote plant-based options, and support local agriculture, thereby enhancing student health and nutrition.
    Source: bit.ly/3Hzzv2P