Tag: HealthcareRegulation

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 product	Previous GST rates	New GST rates effective from September 22, 2025
1	Thermometers for medical, surgical, dental or veterinary usage	18%	5%
2	Instruments and apparatus for medical, surgical, dental or veterinary uses for physical or chemical analysis.	18%	5%
3	All diagnostic kits and reagents	12%	5%
4	Surgical rubber gloves or medical examination rubber gloves	12%	5%
5	Contact lenses and Spectacle lenses	12%	5%
6	Spectacles, corrective [including goggles for correcting vision]	12%	5%
7	Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments	12%	5%
8	Mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus	12%	5%
9	Other breathing appliances and gas masks, excluding protective masks having neither mechanical parts nor replaceable filters	12%	5%
10	Apparatus 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 like	12%	5%
11	All goods- napkins and napkin liners for babies, clinical diapers	12%	5%
12	Blood glucose monitoring system (Glucometer) and test strips	12%	5%
13	Wadding, 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 purposes	12%	5%
14	Sterile 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 tapes	12%	5%
15	Patent Ductus Arteriosus / Atrial Septal Defect occlusion device	12%	5%

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