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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.

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Mandatory Documents to be submitted for import of ayurvedic drugs

INTRODUCTION
In India, the regulatory framework for Ayurvedic drugs has remained unclear, as the forms prescribed under the Drugs Rules, 1945 (“Drugs Rules”) for obtaining an import license are not appropriate for Ayurvedic drugs.
The Madras High Court in the case of M/s Axeon Marketing India v. Assistant Commissioner of Customs has clarified the steps to be followed for the import of Ayurvedic drugs into India.
In this article we have listed the documents required and steps to be followed for the import of ayurvedic drugs into India.

The following are the essential steps to be followed, along with the required documents:

1. Submission of regulatory documents
Despite the absence of specific licensing forms, importers should proceed by compiling a comprehensive documentation to present to Customs authorities and the State Licensing Authority (“SLA”). This should include:
– Copy of invoice
– Packing list which includes the details of contents of each package
– Manufacturer’s test report
– Manufacturing license (from the country of origin)
– Specimen sample
– Label (The label must comply with the labelling requirements given under Rule 161 of the Drugs Rules.)

2. Testing by Central Drugs Standard Control Organization-accredited laboratory (“CDSCO lab”)
It is now mandatory that imported Ayurvedic drugs be tested at a CDSCO lab in India to ensure compliance with Indian safety and quality standards. The imported drug must meet standards equivalent to those applicable to similar Ayurvedic drugs already manufactured and approved in India.
– The importer is required to submit imported drug samples to a CDSCO lab, where testing will be conducted under the supervision of SLA of the state in which the laboratory is located.
– The cost for testing will be borne by the Indian importer
– If a satisfactory report is received from such laboratory, the concerned SLA will issue a certificate confirming that the manufacturing process of the imported drugs is in conformity with the process prescribed for the manufacture of ayurvedic drugs in India.

3. Submission of certificate issues by SLA
– A copy of the certificate issued by the SLA must be submitted to the Customs Department.

4. Receipt of Assistant Drug Controller’s No Objection Certificate (“NOC”)
– This document is issued by the port office of CDSCO.
– The NOC indicates that the consignment meets all applicable regulatory requirements
– Invoice, packing list, manufacture’s test report, manufacturing license, specimen sample, label may be examined before giving NOC by port office.

CONCLUSION
A guidance document governing the import of Ayurvedic drugs already existed, however, it did not mandate testing of the imported drug by a CDSCO lab. After the recent judgment by the Hon’ble Madras High Court, this requirement has now been made compulsory. Therefore, importers must comply with this requirement, along with all other steps outlined above, to obtain import clearance.

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Frequently asked questions (FAQs) regarding filing of self-declaration and disclosure of marketing expenditure by medical device companies in India under UCMPMD

Introduction

The Uniform Code for Marketing Practices in Medical Devices, 2024 (UCMPMD) requires all medical device companies in India to submit a self-declaration-cum-undertaking from its CEO (“Self-Declaration”) and a disclosure of marketing expenditures in a prescribed format (“Marketing Expenditure Disclosure”).

As part of Marketing Expenditure Disclosure, the medical device company has to disclose the expenditure incurred by it on free evaluation samples, Continuing Medical Education (CME) event/Continuing Professional Development (CPD)/Seminars and such other events conducted by the medical device company or organized through third parties such as professional associations of HCPs. When a medical device company conducts a CME/CPD event, information relating to the associated expenditure must be disclosed on the company’s website. However, if such an event is organized by a third party, details of the expenditure, along with a statement of funding sources, must be published on the organiser’s website.
The self-declaration and expenditure disclosure for any financial year have to be submitted anytime before the expiry of two months from the end of every financial year. Accordingly, the deadline for filing the declaration is May 31, 2025 for the financial year 2024-25.
In this article, we have sought to respond to some of the frequently asked questions about these compliances.

1. Where is the self-declaration and disclosure of marketing expenditure form required to be submitted?

The Self Declaration is required to be submitted with the industry association of which the medical device company is a member. The Self-Declaration, once submitted to the association, will get published on the website of such industry association.

If a medical device company is not part of any association, or is part of more than one association, it can submit the self-declaration at dop.ucpmp@gov.in.

In addition, the Self-Declaration and Marketing Expenditure Disclosure are required to be submitted on the UCPMP Portal of the Department of Pharmaceuticals (DoP). The said portal was not functioning at the time of publication of this article.

2. Is it legally mandatory to submit a self-declaration and disclosure of marketing expenditure?

While UCMPMD is not a law, we understand that various medical device associations have taken interest in enforcing compliance of the UCMPMD among its members. If a medical device company is not a member of an association, then there may not be any real consequence for it if it fails to submit a Self-Declaration and Marketing Expenditure Disclosure.

3. Is the requirement of submission of self-declaration and disclosure of marketing expenditure applicable to only importers or manufacturers of medical devices or to marketers and distributors of medical devices as well?

The UCMPMD applies to any medical device company which is engaged in activities covered by the UCMPMD, including promotion and marketing of medical devices, and therefore applies to not just importers and manufacturers , but also to marketers and distributors of medical devices.

4. Do small and medium-size medical device companies have to submit self-declaration and disclosure of marketing expenditure?

Small and medium-sized medical device companies are not exempt from applicability of UCMPMD. Therefore, they should also submit the Self-Declaration and Marketing Expenditure Disclosure.

5. What happens if a medical device company does not submit self-declaration and disclosure of marketing expenditure?

If a medical device company fails to submit the required Self-Declaration and Marketing Expenditure Disclosure, it may face disciplinary action from its industry association. Such actions can include suspension, expulsion, public reprimand, or the requirement to issue corrective statements. Please note that there are no direct and upfront legal consequences for non-submission.

6. If a medical device company CEO submits a self-declaration of compliance with UCMPMD but it is later found that the company has not complied with UCMPMD, will there be any personal consequence for the CEO of the Company for giving a false declaration?

No. There should not be any personal consequences for the CEO of the medical device company, in case it is later discovered that the medical device company has breached the UCMPMD. While the UCMPMD states that “the Chief Executive Officer is itself responsible for the adherence to this Code”, the UCMPMD itself does not stipulate any penalty or consequence for CEO in case of non-adherence , and Indian Courts have repeatedly held that the CEO is not liable for acts or omissions of the Company unless there is a causal connection between CEO and said acts and omissions (for example, where they have knowledge of breach or consent to specific acts or omissions by the company).

7. Is it mandatory to co-operate with regulatory authorities in any enforcement or regulatory action after giving an undertaking to that effect?

The Self-Declaration contains an undertaking that the medical device company will extend all required assistance to authorities for the enforcement of the UCMPMD. However, if for any reason, the medical device company does not wish to co-operate with the authorities, then there should not be any legal consequences for the medical device company for doing so. The consequences, if any, may arise at the level of industry association (refer response to FAQ 5) or from an optics perspective where non-co-operation despite promise may be perceived as evidence of wrongdoing or guilt.

8. What if a medical device company submits incorrect or incomplete information in the disclosure of marketing expenditure?

The Marketing Expenditure Disclosure form contains a reference to Section 405 of Companies Act, 2013 which provides for punishment in case the information provided is incorrect or incomplete in any material respect. However, from legal perspective, it appears highly improbable that Section 405 can be used by authorities against a medical device company for submitting incorrect or incomplete information, because Section 405 has certain pre-conditions for enforcement which are not met by UCMPMD. Moreover, Section 405 can only be used against companies, and not proprietorships or partnership firms.

Please note, however, that any information (including incorrect or incomplete information) may be flagged to regulators including tax authorities which may result in tax related consequences.

9. Are the costs of sponsorship of speakers who are HCPs required to be disclosed?

It depends. The Marketing Expenditure Disclosure requires disclosure of cost of sponsorship of CME events organized by company or sponsored by company (and organized by third party).

If a medical device company has budgeted expenditure towards cost of travel and hospitality of HCPs in events either organized or sponsored by it, then it ought to be disclosed. However, it ought not to be disclosed as a separate line item (only aggregate total expenditure ought to be disclosed).

If, however, a medical device company has sponsored costs of travel of HCP who is a speaker, at an event that is neither organized or sponsored by it, then such an expenditure is permitted and may not have to be disclosed.

10. Are the costs of travel and hospitality of HCPs who are consultant required to be disclosed?

No. The disclosure requirement does not extend to travel and hospitality costs for HCPs who serve as consultants or advisors under a valid contract, since such engagement with the HCP are permitted and also falls outside the scope of CME,CPD events.

11. Are the costs of travel and hospitality of HCPs who are customers required to be disclosed?

The costs of sponsoring travel and hospitality of existing or potential customers of medical equipment, who happen to be HCPs, is a grey area under UCMPMD. However, the disclosure requirement specifically extends to payments or support for CME, CPD, training, seminars, conferences, and workshops. Applying the principle of ejusdem generis, only those payments or benefits that are similar in nature to CME, CPD, training, seminars, conferences, or workshops fall under the disclosure requirement. Therefore, costs of travel and hospitality of HCPs who are customers may not be required to be disclosed.

12. If the foreign affiliate of the medical device company has sponsored the cost of travel and hospitality of the HCP, are such costs required to be disclosed?

The UCMPMD does not apply to foreign affiliates of medical device companies. So, if a foreign affiliate of a medical device company sponsors travel and hospitality of an Indian HCP, whether for India or International travel, it should not be governed by UCMPMD. Please note that there is a principle of law which states that what cannot be done directly cannot also be done indirectly. Therefore, the medical device company in India shouldn’t use (and shouldn’t appear to be using) foreign affiliate to pay for travel and hospitality of Indian HCPs.

13. Are commercial packs which are provided free of charge (FOC) to customers for demonstration or commercial evaluation supposed to be disclosed?

The UCMPMD would ideally cover FOC products that are given for demonstration or sample purposes, since such activities may fall within the scope of promotion or marketing. Therefore, such commercial packs may have to disclosed as well.

On a separate note, it is worth nothing that UCMPMD requires companies to maintain detailed records of all free evaluation samples distributed, including the quantities and recipients.

14. Is the expenditure incurred on putting stalls at events or advertisement at events required to be disclosed by medical device companies?

Yes, the definition of “expenditure” is non-exhaustive and includes various forms of actions such as advertising, installation of stalls, and providing souvenirs. Hence, a medical devices company undertaking such expenditures can be said to be organising a CME Event through a third party, triggering disclosure requirements.

[Note: These FAQs are provided for informational purposes based on our understanding of the relevant laws and regulations. They should not be construed as legal advice, professional guidance, or an endorsement of any particular industry practice.]

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FAQs on Regulation of Class A Non-Sterile, Non-Measuring Medical Devices in India

The regulatory landscape for medical devices in India has evolved significantly, with the recent focus on regulation of non-sterile, non-measuring medical devices in India.

On October 14, 2022, India’s medical device regulator, the Central Drugs Standard Control Organization (“CDSCO”), notified a new category of Class A Non-Sterile Non-measuring (“NSNM”) medical devices by way of an amendment to Medical Devices Rules, 2017 (“MDR”).

These medical devices although are low risk medical devices, they still have to meet standards for safety, quality, and performance. Whether you’re a manufacturer, importer, or distributor, understanding these regulations is crucial for ensuring your products meet the necessary requirements for market entry.

 1. What are Class A medical devices?
Class A medical devices are considered to be low-risk devices. The classification of medical devices is determined according to the parameters set forth in the First Schedule of the Medical Devices Rules, 2017 (MDR). Class A devices are further divided into two categories:

  • Non-Sterile, Non-Measuring (NSNM) devices
  • Sterile and Measuring devices

2. Who determines risk classification of Class A medical devices?
The risk classification of medical devices in India is determined by the Central Licensing Authority, which is the Central Drugs Standard Control Organisation (CDSCO).

3. What are non-sterile medical devices?
Non-sterile medical devices are those that are marketed in a non-sterile state

4. What are non-measuring medical device?
The non-measuring medical devices are medical device that are not intended for use as measuring tool.

Some of the examples of measuring medical devices are:
a. Device for the delivery of liquid to the human body
e.g., medicine spoons, cups, droppers, without graduation or scale or display of measuring unit, etc.

b. Device for displaying trends of physiological parameters
e.g., Urine bags without graduation or scale, callipers for obesity.

5. Is the Class A NSNM registration applicable to Class A In-vitro diagnostic devices?
No, the Class A NSNM registration applies only to medical devices and does not extend to In-vitro diagnostic devices.

6. Whether License is required to import or manufacture Class A NSNM medical devices in India?
No, under the Medical Devices (Sixth Amendment) Rules, 2022, a license is not required for the importation or manufacture of Class A NSNM medical devices in India.

7. Is a license required for the sale of Class A NSNM medical devices?
No, there is no requirement for a license to sell Class A NSNM medical devices.

8. What is the government fee payable for registration?
There is no prescribed government fee for the registration of Class A NSNM medical devices.

9. Are price control regulations applicable to Class A NSNM medical devices?
Yes, price control regulations are applicable to Class A NSNM medical devices. The Drug (Price Control) Order, 2013 governs the regulation of prices for drugs and medical devices.

10. Is ISO 13485 and a Free Sales Certificate required for registration of Class A NSNM medical devices?
No, ISO 13485 certification and a Free Sales Certificate are not required for the registration of Class A NSNM medical devices.

11. Do Class A NSNM medical devices need to comply with the labelling requirements under MDR?
Yes, Class A NSNM medical devices are required to comply with the labelling requirements as specified under the Medical Devices Rules, 2017 (MDR). These labelling requirements are mandatory.

 12. What are the consequences of manufacturing or importing unregistered devices?
Manufacturing or importing unregistered medical devices constitutes a violation of Indian law and may result in penalties or legal action.

Note: These FAQs are provided for informational purposes based on our understanding of the relevant laws and regulations. They should not be construed as legal advice, professional guidance, or an endorsement of any particular industry practice.

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Labelling requirements under Plastic Waste Management Rules, 2016

As per Plastic Waste Management Rules, 2016, until 1st July 2025, the mandatory declarations on the label of the plastic packaging material should be mentioned on each category of plastic packaging material or plastic packaging of the product. However, starting from 1st July 2025, the declarations can be made in one of the following ways. Please note that this requirement is not in addition to the existing requirements rather a relaxation to declare the mandatory declarations on the plastic packaging material.

Link to the amendment copy: bit.ly/41hEGun

  •  In a barcode or Quick Response (QR) code printed on the plastic packaging
  • In the product information brochure
  • Printed on each individual plastic packaging material
  • Printed on the plastic packaging with the unique number issued under any applicable law (awaiting more clarity from CPCB on this point)

Additionally, the manner of declaration must also be communicated to CPCB.

The labelling requirements required to be printed on plastic packaging material are described below:

  • Name of the importer/brand owner
  • EPR registration certificate number.
  • Thickness of flexible plastic packaging (e.g., plastic sachets, pouches, covers, and carry bags).
  • For recycled plastic packaging: Please declare “recycled having [—–specify percentage—–] of recycled plastic” along with a mark as shown below and conform to the Indian Standard: IS 14534: 2023 titled as “Plastics — Recovery and Recycling of Plastics Waste — Guidelines”

  • The acronyms PET (Polyethylene terephthalate), HDPE (High-density polyethylene), V (Vinyl/PVC), LDPE (Low-density polyethylene), PP (Polypropylene), PS (Polystyrene), and “Other” mentioned above refers to all other resins and multi-materials like ABS, PPO, PC, PBT, etc.
  • For compostable plastic packaging: Please declare “compostable only under industrial composting” and comply with IS/ISO 17088:2021, titled “Specifications for Compostable Plastics.”
  • For biodegradable plastic packaging: Please declare “Biodegradable in [— specify number of days —] only in the [— specify recipient environment, e.g., soil, landfill, water, etc. —].”
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India’s new promotion code for medical devices – Key highlights and enforceability – Uniform Code for Marketing Practices in Medical Devices (UCMPMD)

India’s Department of Pharmaceuticals (DoP), which is the administrative department responsible for the formulation and implementation of policies relating to drugs and medical devices, has published a new set of guidelines called the ‘Uniform Code for Marketing Practices in Medical Devices’ or UCMPMD. These guidelines seek to lay down the ethical framework of interaction of medical device industry with healthcare practitioners (“HCPs”) and standards for promotion and marketing of medical devices in India.  

The UCMPMD borrows heavily from other industry codes in India, namely the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), and international codes such as the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry. The key similarity being that it is very much a self-regulating governing code, which means that the administration of the code will be done by medical device industry association(s) in India. It is not a codified law or a legal code in a strict sense. However, any decision (or lack of decision) of an industry association in the adjudication of a complaint of breach of UCMPMD is appealable to a body comprising of representatives of DoP, which makes the UCMPMD a quasi-legal code that appears like a law but isn’t a law. The DoP, however, maintains that the medical device industry should strictly comply with UCMPMD.  

In the paragraphs below, we have summarized key provisions of UCMDMP and the consequences of a breach of UCMPMD. 

Key Highlights of UCMPMD 

Self-declaration of compliance with UCMPMD and disclosure of expenditure on marketing activities to DoP: Starting 2025, before the end of May every year, the executive head of the every medical device company will have to submit a self-declaration in the prescribed format, which will effectively state that the business was conducted in compliance with UCMPMD in the previous financial year (April – March) and that the business will continue to operate in compliance with UCMPMD in the coming financial year as well. The self-declaration also contains an undertaking that the company will ‘extend all required assistance’ to authorities for the enforcement of the code. Along with the self-declaration, the company will also have to provide a statement of disclosure of expenditure incurred in the previous financial year towards sponsorship of third-party and internal HCP educational and training programs, and in the distribution of free evaluation samples to HCPs. 

Extending travel and hospitality to HCPs: The code does not permit the medical device industry to sponsor travel and hospitality of HCPs except in limited circumstances, which are (i) when the HCP is a speaker in medical education or professional development program; or (ii) when HCP is a speaker or participant in advanced clinical training program conducted outside India, which is specifically approved by the DoP. It is possible to take an interpretation that a medical device company should be able to offer travel and hospitality to HCPs for participating in its own product training program organised in India. However until further clarity comes from the DoP, there will be a question mark over extension of travel and hospitality to HCPs for participating in training programs in India.  

Provision of modest meals during events: The UCMPMD prohibits hospitality which is of the nature of hotel stay, expensive cuisine, and resort accommodation. In other words, UCMPMD prohibits extravagant or excessive hospitality. Therefore, the provision of modest meals and other customary extension of courtesy at the event in the form of modest alcohol, should not be prohibited by UCMPMD. 

Sponsoring third-party educational programs: The code permits the medical device industry to sponsor third-party educational programs, as long as the educational programs are conducted by specified entities. The specified entities are medical colleges, teaching institutions, universities, hospitals, professional associations of HCPs, academic and research institutions such as NIPER, ICMR, DBT, CSIR laboratories, trusts and associations of the medical device industry. 

Conducting internal training and education programs (Product or hands-on training): The medical device industry is permitted to conduct training and education programs of its own, and invite HCPs to these programs. However, before conducting training and education programs, the industry has to ensure that it has put in place a guideline on expenditure incurred for such programs. At the time of conducting the program, it has to comply with the guidelines. 

Selection of speakers and attendees for educational and training programs: The code requires the medical device industry to have a well-defined policy and process for (i) selection of speakers and participants for its training and education programs specifically and (ii) incurring expenditure on training and education programs. 

Disclosure of funding towards training and education programs: The medical device industry is expected to share details of all education and training events on its website, including expenditures incurred on the events conducted by them. The expression ‘expenditure’ includes all expenses incurred for the event including sponsorship, travel, lodging, hospitality, advertisement, stalls, souvenirs etc. There is no format for disclosure that has been provided by DoP for disclosure on the website. 

Engaging HCPs as consultants and advisors: The UCMPMD allows the medical device industry to engage HCPs as consultants and advisors, provided the following conditions are met: (a) it should be for bona fide research services (b) it should be documented by a consultancy agreement and (c) there should be a consultancy fee or honorarium payment under the arrangement. The scope of expression ‘research’ is not defined, and should cover any technical and professional service which is within the scope of education and experience of the HCP. 

Extending travel and hospitality to HCPs who are consultants: The UCMPMD is silent on whether travel and hospitality may be offered to HCPs who are consultants or advisors in general. However, if an HCP is a consultant and is speaking at an educational event sponsored by the industry, then travel and hospitality may be offered to such consultants. 

Providing monetary grants or cash to HCPs: The code prohibits the medical device industry from providing monetary grants or cash to HCPs. However, it is silent on whether monetary grants may be paid to hospitals and other institutions and entities. 

Giving of gifts: It is not permissible to give gifts or pecuniary benefits or advantages of any kind to HCPs, either directly by the medical device industry or indirectly by distributors, wholesalers, or retailers. 

Promotion of medical devices: The code requires the medical device industry to promote medical devices only after receiving marketing approval, and the promotion of medical devices should be consistent with the documents submitted for obtaining marketing approval, specifically the instruction for use (IFU) or the directions for use (DFU). The promotional material given to HCPs ought to contain a declaration that “additional information is available on request”, and whenever requested such information should be made available to HCPs within a reasonable timeframe by ‘authorized sources’ of the company. The names of the HCPs should not be used for promotional purposes. In case a company pays for, or arranges, the publication of any promotional material in any journal, then it should not appear as an editorial and it ought to meet the minimum requirements for promotional material within UCMPMD. 

Claims of safety of medical device: The UCMPMD states that the words ‘safe’ or ‘safety’ should not be used without qualification and that the medical device industry should not categorically state that a medical device has no adverse consequences. 

Use of brand names: The UCMPMD states that brand names of medical devices should not be used for comparison unless prior consent of the owner of the brand name has been obtained.  

Brand Reminders: UCMPMD allows the medical device industry to provide brand reminders to the HCPs, which ought to be limited in terms of its use in healthcare settings only and should not have independent commercial value for the HCP. Some of the permitted brand reminders are: books, calendars, diaries, journals (including e-journals), dummy device models etc. The value of a brand reminder must not exceed ₹1,000 per item. There is no annual limit on the number of such reminders that can be given to HCPs. 

Use of names and photographs of HCPs: The UCMPMD restricts the medical device industry from using names and photographs of HCPs in promotional material.  

Changes in employment agreement of sales representatives: The UCMPMD states that the employment agreement between the medical device industry and sales representatives who interact with HCPs personally (also referred to as medical representatives) should contain a clause that requires them to know that the HCPs are required to ensure compliance with UCMPMD. 

Engagement of marketing agencies: Any external agency hired to support the medical device industry for promotion, marketing and sales of medical devices ought to have sound working knowledge and must comply with all provisions of the UCMPMD.  

Provision of Free Samples or Evaluation Products: The medical device industry may provide free evaluation samples of medical devices to qualified HCPs. The free samples distributed by companies cannot exceed 2% of their annual domestic sales. These samples must be provided in reasonable quantities, and the industry is required to maintain detailed records of all samples distributed, including date, quantity, value, etc. for at least five years. Additionally, all evaluation samples must be clearly labelled as ‘Evaluation Sample – Not for Sale’ or with a declaration conveying the same meaning. 

Provision of Demo Products: The medical device industry may provide demo products to HCPs. The industry is required to maintain detailed records of the quantity and value of the device, date of supply to HCP, date of receipt from HCP etc. for at least five years. Demo products are not intended for use on the patients. They may be used by HCPs for patient awareness and education. 

Is UCMPMD enforceable as a law? 

India’s Supreme Court has affirmed that for any circular, order, notification or similar direction issued by any governmental department to be considered enforceable, it has to be issued under the scheme of existing legislation. 

The UCMPMD is neither a legislation nor has it been issued under the scheme of any existing legislation. Therefore, it should not be considered enforceable as a law in India. In other words, no government department or authority including the DoP should be able to take any direct action for an alleged breach of the UCMPMD, if an importer, manufacturer or marketer of medical devices is unable to comply with UCMPMD. 

Is giving the Self-Declaration mandatory? What are the consequences of not giving the self-declaration? 

Since UCMPMD is not a law, there should not be any adverse legal consequence for not giving the self-declaration. 

However, if an entity is part of a medical device industry association, then the association may suspend or expel the entity from the association for failing to submit the undertaking. 

The association and DoP may also take other steps, such as reprimanding the entity and requiring a full apology to be published. 

If the self-declaration is submitted, but the entity fails to comply with UCMPMD, then what happens? 

In general, whether the entity gives the self-declaration (undertaking) or not, the consequences of non-compliance with UCMPMD will not change. These consequences are: 

  1. Suspension or expulsion of the entity from the concerned pharmaceutical or medical device association of which the entity is a member; 
  2. Reprimand of the entity; 
  3. Requiring the entity to publish a full apology; 
  4. Requiring the entity to issue a corrective statement; 
  5. Requiring the entity to recover any sums or articles given or received in contravention of the UCMPMD; 
  6. Recommending the matter of breach to the concerned governmental body having appropriate jurisdiction. 

Can action be taken under S. 405 of the Companies Act, 2013 against a medical device company for failure to disclose marketing expenditures? 

Section 405 of the Companies Act, 2013 applies to such orders that are notified in Official Gazette.  The UCMPMD is not an order notified in the Official Gazette. Further, any action taken under the Companies Act can be for companies regarding matters which are strictly covered under the provisions of the Companies Act and therefore, there should not be any legal consequence of failing to disclose marketing expenditure as required by DoP under UCMPMD. 

Conclusion 

The UCMPMD has brought much-needed clarity on several issues that had become a pain point for the industry when the DoP had extended the application of the pharmaceutical marketing code (UCPMP) to the medical device industry. While the UCMPMD is far from perfect, the medical device industry will prefer it than being subject to the promotion and marketing standards of the pharmaceutical industry, which sometimes results in absurdity.  

The UCMPMD is expected to undergo changes with time, however until then, it remains the official guidance on standards of interaction between HCPs and the medical device industry in India. Unfortunately, the question mark over its legality and legal enforceability may discourage the medical device industry from adopting it in full, especially on contentious issues such as paying for travel and accommodation of HCPs who accept the invite to attend internal product training and therapy awareness programs. 

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Self-Declaration under the UCPMP 2024: Should One Submit

In March 2024, Department of Pharmaceuticals (“DoP”) published a guidance titled ‘The Uniform Code for Pharmaceutical Marketing Practices, 2024’ (“UCPMP”) which lays down the standards for interaction between pharmaceutical and medical device industry and  healthcare practitioners. The UCPMP 2024 replaced a similar 2015 guidance.

More recently, the DoP has issued a Standing Order which implores importers, manufacturers and marketers of drugs and medical devices to submit a self-declaration signed by the seniormost executive of the organization promising compliance with UCPMP. If the entity is a member of an industry association, then the self-declaration has to be submitted to the industry association, and if not, then to the DoP at the email address: dop.ucpmp@gov.in.

In this article, we have examined whether there is any legal requirement for importers, manufacturers and marketers of pharmaceuticals and medical devices to provide self-declaration under UCPMP. We have also examined the consequence of providing the self-declaration and ramification of not providing such self-declaration.

Background to UCPMP Self-Declaration

The UCPMP itself has language which gives the DoP the ability to issue Standing Orders to introduce new guidelines which should be read as if they are part of UCPMP.

Through the Standing Order On 28th May 2024The DoP introduced a new self-declaration requirement in addition to the self-declaration requirement already existing under UCPMP 2024. The UCPMP had a self-declaration expectation under which the seniormost executive of the organization had to declare that the organization had complied with the UCPMP in the financial year (April – March) that had elapsed. The new self-declaration requirement, which was introduced by the Standing Order, now expects the senior executive to undertake that the organization will comply with UCPMP in the ongoing/ upcoming financial year.

Is UCPMP enforceable as a law?

India’s Supreme Court has affirmed that for any circular, order, notification or similar direction issued by any governmental department to be considered enforceable, it has to be issued under the scheme of an existing  legislation.

The UCPMP is neither a legislation nor has it  been issued under the scheme of any existing legislation. Therefore, it should not be considered enforceable as a law in India. In other words, no government department or authority including the DoP should be able to take any action if an importer, manufacturer or marketer of pharmaceuticals or medical devices is unable to comply with UCPMP.

Is a Standing Order issued under UCPMP enforceable as law?

India’s Supreme Court has held that standing orders issued in exercise of administrative powers of any department are only enforceable if such Standing Order(s) are based on powers granted under a parent statute. As indicated in paragraphs above, the UCPMP is not a law. Therefore, a Standing Order issued in pursuance of UCPMP should not be treated as enforceable by law.

Is giving the Self-Declaration mandatory? What are the consequences of not giving the self-declaration?

Since UCPMP is not law and Standing Order issued through it which expects submission of the Self-Declaration is not legally enforceable, there should not be any adverse legal consequence of not giving the self-declaration.

However, if an entity is part of a pharmaceutical or medical device industry association, then the association may suspend or expel the entity from the association for failing to submit the undertaking.

The association and DoP may also take other steps, such as reprimand the entity and require a full apology to be published, however such a step would be disproportional and therefore improbable.

If the self-declaration is submitted, but the entity fails to comply with UCPMP, then what happens?

In general, whether the entity gives the self-declaration (undertaking) or not, the consequences of non-compliance of UCPMP will not change. These consequences are:

  1. Suspension or expulsion of the entity from the concerned pharmaceutical or medical device association of which the entity is member;
  2. Reprimand of the entity;
  3. Requiring the entity to a full apology to be published;
  4. Requiring the entity to issue a corrective statement;
  5. Requiring the entity to recover any sums or articles given or received in contravention of the UCPMP;
  6. Recommending the matter of breach to concerned governmental body having appropriate jurisdiction.

However, if the undertaking is given, and there is a non-compliance of UCPMP, there may be serious consequences.

Consequences of non-compliance with UCPMP after submission of self-declaration

Under India’s penal codes, it is punishable to give a declaration which the person knows is or believes to be false, or does not believe to be true, which is received by an authority as evidence of a fact.

The language of the self-declaration states that the entity shall provide “all required assistance to authorities for the enforcement” of UCPMP.

In the event of any inquiry into non-compliance of UCPMP, if the entity does not co-operate with DoP or panel of auditors appointed by UCPMP, there is a possibility that the DoP may initiate criminal prosecution on grounds of providing a false undertaking that the entity will assist in the enforcement of the UCPMP.

Similarly, if it is established that the entity has breached UCPMP, then DoP may initiate criminal prosecution on grounds of providing false undertaking that the entity shall comply with the UCPMP.

The chance of such prosecution succeeding in trial is not guaranteed however, due to a strong technical defence that exists with every entity who has given the self-undertaking: which is that the undertaking was given without knowledge or belief that it would be treated as ‘evidence of fact’. However, the possibility of a different outcome cannot be completely ruled out.

Tax Consequence of providing the self-undertaking under UCPMP

The Supreme Court has ruled in Apex Laboratories Pvt. Ltd. v Deputy Commissioner of Income Tax (2022) 7 SCC 98 that any expense incurred by an entity in the pharmaceutical or medical device industry, in the course of its dealings with Doctors, that results in an violation of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, in the hands of Doctors, will be an expense impermissible for deduction under Sec. 37(1) of the Income Tax Act, 1961.

The Supreme Court, however, has not ruled that any expense incurred in its dealings with Doctors by an entity in  pharmaceutical or medical device industry which may be in violation of the UCPMP will also be an expense impermissible for deduction under Sec. 37(1) of the Income Tax Act, 1961.

The recent amendment to Sec. 37(1) of the Income Tax Act, 1961 which has given “guidelines” the status of law such that any expense incurred in violation of “guidelines” would also be an expense impermissible for deduction, would not extend to UCPMP even though it is a “guideline”, because the scope of the term “guidelines” under this provision may include only those guidelines which apply to the receiving party of any expense sought to be deducted under Sec. 37(1), in the current fact scenario: Doctors. By implication, it would not cover any other guideline such as UCPMP which may apply to the pharmaceutical and medical device industry.

Therefore, the current position of law is that an expense incurred in violation of the UCPMP will be inadmissible for deduction only when the violation also results in a violation of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, or any other law or guideline. However, if the self-declaration is given by an entity then it may vitiate defences available in proceedings before the tax authorities.

Conclusion

It is clear that UCPMP is not law and therefore non-submission of self-declaration \by itself should not result in any legal action.

In fact, submission of the self-undertaking may invite more serious repercussions as opposed to non-submission of the self-undertaking. Therefore, the importers, manufacturers and marketers of pharmaceuticals and medical devices should adopt a cautious approach to submitting the self-undertaking under UCPMP.

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Can cooking oil be lawfully reused in India? An analysis of law and recent KFC case

Under Indian law, it is not unlawful to reuse cooking oil, provided certain conditions and thresholds are not crossed by food businesses. In this article, we will examine the thresholds and conditions associated with reusing cooking oil. We will also examine the Madras High Court order which protected a fast-food chain outlet against arbitrary action of suspension of license for reusing cooking oil.

Thresholds and Conditions for Reuse of Cooking Oil

The Food Safety and Standards Authority of India (FSSAI) is the regulatory body responsible for quality of food for consumers. It regulates the use and reuse of cooking oil and issues directions from time to time.

The FSSAI has recommended that “re-heating and reuse of oil should be avoided as far as possible”. It has further recommended that cooking oil should be reheated a maximum of three times, and that ideally it should be heated only once. However, these recommendations are for guidance only are not binding on food businesses.

The only legal restriction on reusing vegetable cooking oil is that the Total Polar Compounds (TPC) developed in cooking oil due to reheating cannot exceed 25%[1]. According to FSSAI, any cooking oil whose TPC content is more than 25% is unsafe for human consumption and is thereby prohibited for use.

In order to keep a check on TPC content in reused vegetable cooking oil, FSSAI has directed that food businesses using 50 litres or more of cooking oil per day to maintain records detailing oil usage, including type, quantity used and discarded, and disposal date. Such food businesses are required to dispose the used cooking oil (UCO) only to FSSAI-approved aggregators or collection agencies.[2]

Adding fresh cooking oil to used cooking oil

In 2019, FSSAI directed food businesses to ensure that used cooking oil should not be topped with fresh cooking oil.[3]

Legal consequences of reusing cooking oil

Any violation of the 25% TPC threshold limit may result in suspension or cancellation of food license[4], as well as imprisonment or fine.[5]

Madras High Court’s intervention in unlawful suspension of license for reusing cooking oil

In Thoothukudi, Tamil Nadu, the FSSAI through Tamil Nadu Food Safety and Drug Administration Department (“Department”) suspended (i.e. temporarily cancelled) the license of one Kentucky Fried Chicken (“KFC”) outlet on grounds that it was reusing cooking oil and was adding a filtration agent, namely Magnesium Silicate Synthetic (“MSS”), to the cooking oil.

KFC challenged the suspension before the Madras High Court. On review, the High Court found that prima facie Magnesium Silicate Synthetic (MSS) does not appear to be a banned substance. On the contrary, it is an approved filtration agent. The Court further observed that there is no legal bar on reusing cooking oil.

For these reasons, and also on account of the fact that the Department did not follow due process before suspending the license, the Court passed an interim order staying the suspension of license and allowed the KFC outlet to resume operations.

Can Magnesium Silicate Synthetic (MSS) be added to reused cooking oil?

Magnesium Silicate Synthetic is a food additive that is primarily used as an anticaking agent and as a carrier for flavours in different food items. The Food Safety and Standards (Food Products Standards and Food Additives) Regulation, 2011 limits the use of anti-caking agents in such cases where its use is specifically permitted.[6] Synthetic Magnesium Silicate (or Magnesium Silicate Synthetic) is recognized an additive that may be used as clarifying agents or filtration aid in edible oils[7] and therefore may be lawfully used as a filtration aid in cooking oil.

Conclusion

The controversy surrounding reuse of cooking oil by restaurants seem to be manufactured, since the law surrounding reuse of cooking oil is very clear – vegetable cooking oils may be reheated and reused so long as the TPC content in the cooking oil does not exceed 25%. It is, however, recommended that cooking oil should not be reheated more than three times, though following such recommendation is not a legal requirement.

 

[1] The Food Safety and Standards (Licensing and Registration of Food Businesses) First Amendment Regulations, 2017, available at: https://www.fssai.gov.in/upload/uploadfiles/files/Gazette_Notification_Quality_Vegetable_Oil_03_11_2017.pdf  and Section 2.3.15(8) of FSS (Prohibition and Restriction on Sales) Regulations, 2011, available at: 61f381c576d16SOP_Cooking_Oil_28_01_2022.pdf (fssai.gov.in)

[2] Direction under Section 16(5) of the FSS Act regarding disposal and collection of Used Cooking Oil, available at:  5c6271f25d447Direction_Reused_Cooking_Oil_07_02_2019.pdf (fssai.gov.in)

[3] Direction under Section 16(5) of the FSS Act regarding disposal and collection of Used Cooking Oil, available at: 5c6271f25d447Direction_Reused_Cooking_Oil_07_02_2019.pdf (fssai.gov.in)

[4] Regulation 2.1.8 (4) of the Food Safety and Standards(Licensing and Registration of Food Businesses) Regulations, 2011, available at: https://www.fssai.gov.in/upload/uploadfiles/files/Licensing_Regulations.pdf

[5] Section 55, 57 and 59 of the Food Safety and Security Act, 2006 (“Act”), and Section 274, 275 of the Bharatiya Nyaya Sanhita, 2023.

[6] 3.1.7: Anticaking Agents: 1) Restriction on use of anticaking agents. No anticaking agents shall be used in any food except where the use of anticaking agents is specifically permitted. [Page 430, Part III, Section 4, the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations of 2011].

[7]Direction under Section 16(5) of the FSS Act regarding compliance w.r.t. Processing Aids under Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations of 2011, available at:  https://fssai.gov.in/upload/advisories/2024/03/65f2d680c053cApproved%20direction%20under%20Section%2016_5%20regarding%20compliance%20w.r.t.%20Processing%20Aids%20under%20FSS_FPS&FA_Regulations_2011.pdf

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Medical Fitness Certificate for Food Handlers: How to ensure compliance with this Mandatory License Condition?

All Food Business Operators (FBOs) in India must maintain a record of annual medical examination of all food handler(s) engaged by the FBO. This is a mandatory condition of the food license. The Food Safety Officer checks the record of medical examination at the time of inspection, and any shortcoming in the record-keeping may result in suspension or cancellation of license.

In this article, we will discuss key considerations for ensuring full compliance with the requirement of maintaining records of medical examinations of food handlers.

Who is a food handler?

A food handler is any person who directly handles packaged or unpackaged food, food equipment, utensils, or food contact surfaces, and is therefore expected to comply with food hygiene requirements.

Personal hygiene and sanitary requirements applicable to FBOs

In addition to the requirement of a medical examination of food handlers, all FBOs have to ensure that no person, whether handling food or not, who may be suffering from any disease or illness that is likely to be transmitted through food is allowed to enter any area where the food is handled, i.e., where the food is packaged or unpackaged, where food equipment and utensils are stored, where food contact surfaces exist, or where food is cooked or manufactured.

In addition to the above general requirement, FBOs who are involved in high-risk food businesses such as meat and dairy have additional personal hygiene and cleanliness requirements, which are discussed below.

Meat

FBOs who deal in meat must ensure that any person who comes into contact with meat in the course of his or her work must be medically examined prior to such person being engaged. FBOs who run meat shops must ensure that any person who handles meat is medically examined annually, and the medical examination includes an examination of the sputum and chest X-ray for tuberculosis. The medical examination should also include stool tests for parasitic infections (protozoal and helminthic) transmitted through ingestion, as well as for enteropathogenic bacteria such as Escherichia coli, Salmonella, Shigella species, and Vibrio cholera.

Dairy

FBOs who manufacture, process, store, or sell milk and milk products are required to ensure that the persons employed for handling raw materials or dairy products have, before joining, submitted a medical certificate that states that there is no medical impediment to working in the specific capacity or role that the person is going to be employed by the FBO.

Mandatory vaccination of workers working in food factory    

If the FBO is a manufacturer, processor, and packer who operates a factory, then all workers working in the factory ought to be compulsorily vaccinated against an enteric group of diseases as per the recommended schedule of vaccination. Enteric groups of disease are infections caused by viruses and bacteria that enter the body through the mouth or intestinal system, primarily as a result of eating, drinking, and digesting contaminated food or liquids. Cholera, typhoid fever, Salmonella, or E. coli are some common enteric diseases. A record of the vaccination of all factory workers is required to be maintained, which may be inspected at the time of inspection. The decision regarding the scope of vaccination, i.e., which enteric diseases are to be covered by vaccination, is taken by the registered medical practitioner according to the list declared by the concerned municipal corporation of the area.

Format of Medical Fitness Certificate 

After the medical examination of food handlers, a medical fitness certificate in the prescribed format must be issued by a registered medical practitioner. It must contain the signature and seal of the registered medical practitioner. The medical fitness certificate should indicate that the registered medical practitioner has undertaken a physical examination, an eye test, and a skin examination, as well as any other tests required to confirm any communicable or infectious disease that the person is suspected to be suffering as observed during the clinical examination, if applicable. It should also indicate that “based on the medical examination, he/she is found free from any infectious or communicable diseases, and the person is fit to work in the food establishment.”

Discretionary Powers of Food Safety Officer vis-à-vis ordering medical examination of workers

If a Food Safety Officer, during an inspection, believes that the food handler is suffering from any infectious disease, he may ask for a medical examination of that person, and on such examination, if he finds out that person is suffering from an infectious disease, he has the authority to prohibit employees suffering from infectious diseases from participating in food handling activities and ensure strict adherence to health and safety.

Penalty for non-compliance

Failure to comply with these regulations can result in penalties of up to two lakh rupees and potential license cancellation under Section 58 of the Food Safety and Standards Act, 2006.

Conclusion 

All FBOs should sensitize themselves to the legal requirements of annual medical examination of staff, mandatory vaccination of workers working in food factories, and general hygiene and sanitary requirements applicable to all persons handling food or operating in an area where food is handled. Failure to meet these requirements of food laws may result in a heavy monetary fine and suspension or cancellation of the license.

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India’s Food Regulator FSSAI Introduces Instant License and Registration for Food Businesses with Some Exceptions

India’s Food Regulator Introduces Instant License and Registration for Food Businesses with Some Exceptions_1

India’s central food regulator, the Food Safety and Standards Authority of India (FSSAI), has made a policy decision to issue instant registrations and licenses to food businesses in India. The instant registration or license will be valid for one year and may be renewed in a regular course.

Background

All food businesses in India require either a registration or license to operate. Whether a food business will require a registration or license depends on (a) the scale of the business (b) the nature of the business and (c) the number of States in India in which the business will operate. A registration will be typically granted by the State-level Food Regulators, and license may be granted either by State-level or Central Food Regulator (FSSAI).

As per current timelines prescribed in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, the food regulators may take anywhere between seven days and a month to grant a registration, and up to two months to grant a license. These timelines are sometimes compounded if, during the pre-registration / pre-license inspection, the inspector directs the applicant to make improvements before the registration/license may be granted.

Tatkal (Instant) System of Food License

To improve the ease of doing business for businesses, the FSSAI has streamlined the process for granting license such that the registration/license for food businesses could be made available instantly without inspection. Of course, the registered/licensed food business will be subject to future inspection and requirements to comply with inspection related improvements.

The said ‘Tatkal’ (instant) license facility will be made available to the following categories of food businesses: importers, wholesalers, distributors, retailers, transporters, non-atmospheric-controlled storage providers, food vending agencies, direct sellers, merchant exporters, petty retailers such as snack and tea shops, and mobile food vendors (hawkers).

However, this Tatkal registration or license will not be issued to food business operators dealing in milk, meat, and fish. Also, the applicant should not have had their registration or license suspended or cancelled in the prior three months before the date of application.

Before applying, every food business should thoroughly evaluate their application. Providing incorrect information regarding the Kind of Business or failing to meet eligibility requirements can result in fines of up to Rs. 10 lakhs.

Conclusion

The decision to issue tatkal (instant) registrations and licenses is a very pragmatic step taken by the Indian Government to improve the ease of doing business for food business operators. The facility will be initially available only for individuals who own food businesses (proprietors) and be rolled out in Assam, Delhi, Gujarat, Jammu & Kashmir, and Kerala. It is expected to be eventually extended to partnerships/registered firms and be available to businesses in other States and Union Territories as well.