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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 requested state drug regulators to direct manufacturers of Carbimazole formulations to incorporate agranulocytosis as an adverse drug reaction in Prescribing Information Leaflets (PIL) following recommendation by the Subject Expert Committee on Endocrinology and Metabolism.
Source: short-url.org/1pcz1

2. The Central Pollution Control Board (CPCB) has introduced a Common EPR Portal to unify all Extended Producer Responsibility activities under one platform. Through Single Sign-On (SSO), users can access Plastic, E-Waste, Battery, Tyre and Used Oil Management portals, and the EPR Trading Platform with one login. Registration is mandatory, with no additional fee.
Source: short-url.org/1pcz4

3. The Madras High Court has reportedly strongly criticised the practice of imposing non-compete and non-solicitation clauses on doctors in employment contracts, calling such restrictive covenants “unlawful on the face of it” and questioning their enforceability in healthcare settings. The bench indicated it will discourage hospitals from using these clauses, emphasising doctors’ freedom to practice and patient choice.
Source: short-url.org/1pcz6

4. The National Pharmaceutical Pricing Authority has reportedly deferred a decision on creating a separate price ceiling for cementless knee implants. The Multidisciplinary Committee will invite subject experts and manufacturers for detailed deliberations. Until a final determination is made, all companies must continue complying with the existing ceiling prices.
Source: short-url.org/1k7in

5. India’s drug regulator CDSCO is enhancing the online WHO-GMP Certificate of Pharmaceutical Product (CoPP) application via its ONDLS portal, partnering with C-DAC and state authorities to replace manual submissions. The digital shift aims to cut delays, improve transparency, and boost export readiness for Indian pharma manufacturers.
Source: short-url.org/1pcze

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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 has reportedly agreed to reduce tariffs on a broad range of U.S. exports, including medical devices, manufactured goods and chemicals from about 13.5% to zero. Lower tariffs on medical devices from the US would help hospitals and clinics in India to procure advanced equipment more cheaply, improving healthcare delivery and access.
Source: h7.cl/1ow26

2. US FDA has shut down over 200 illegal online pharmacy websites linked to an India-based criminal network. The sites allegedly sold unapproved and counterfeit medicines to U.S. consumers, raising serious public health concerns and highlighting the need for stronger regulation and cross-border cooperation.
Source: h7.cl/1ow29

3. The Indian government is reportedly examining a proposal to mandate pharmaceutical companies to allocate at least 1% of their net profits for free medicines during health emergencies by amending the Drugs Rules, 1945. However, the move faces legal constraints, as CSR spending is governed by the Companies Act, 2013. The central drugs regulator, CDSCO, is reassessing the proposal’s feasibility.
Source: h7.cl/1ow2c

4. The Association of Indian Medical Device Industry (AiMEd) has reportedly opposed any reconsideration or easing of policy restrictions on importing refurbished or pre-owned medical equipment. Association has urged the government to uphold the ban on imports, enforce stricter regulations by emphasizing the strengthening of indigenous innovation like Make in India.
Source: h7.cl/1ow2i

5. A leading fast moving consumer goods manufacturer has filed a suit in the Calcutta High Court, alleging deceptive imitation of its biscuit packaging and trade dress by a rival. The suit seeks injunction against sale and distribution, claiming consumer confusion and unfair competition. The court has taken the matter on record and scheduled further hearing shortly.
Source: h7.cl/1jt71

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

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

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

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

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

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

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Ministry of Health and Family Welfare has constituted a committee to develop a policy governing refurbished medical devices. The committee will examine the scope of refurbished medical devices, methodology to evaluate the safety, performance, and remaining useful life of refurbished medical devices & suggest guidance for waste disposal of such refurbished devices.
Source: h7.cl/1o8qd

2. Indian government has announced a tax holiday until 2047 for foreign companies that provide cloud services globally using data centres located in India. Further, there will be no risk of foreign firms’ global income being taxed in India solely because they use Indian data centres. This move is aimed at attracting long-term investment into India’s digital infrastructure.
Source: h7.cl/1o8qp

3. Indian Government has released first national evidence-based lung cancer treatment and palliation guidelines. It offers 15 recommendations to standardise diagnosis, treatment and palliative care, improve early detection, reduce treatment disparities and ensure consistent, patient-centred care across the country.
Source: h7.cl/1o8qA

4. India’s Ministry of Consumer Affairs issued show-cause notices to major edible oil companies for violating the amended Vegetable Oils Products, Production and Availability (VOPPA) Order, 2025. Companies failed to submit monthly production data and register on official portals. Authorities have warned that continued non-compliance could lead to inspections and confiscation under the Essential Commodities Act, 1955.
Source: h7.cl/1o8qN

5. The United States Food and Drug Administration has launched the PreCheck pilot program to strengthen domestic pharmaceutical manufacturing. The initiative offers early regulatory engagement for new manufacturing facilities, improving predictability, streamlining facility assessments and accelerating readiness to supply medicines for the United States market.
Source: h7.cl/1o8qS

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Karnataka Health Department has proposed introducing QR codes on medicine strips and boxes to help visually impaired patients access key drug information via smartphone scanning under the IMPACT-VIP programme. Details such as dosage, composition, and expiry dates can be accessed, and the proposal may be sent to the Centre for wider implementation.
Source: h7.cl/1o2Wy

2. India’s central drugs regulatory authority (CDSCO) has released a draft guidance outlining regulatory requirements and online procedures for importing in-vitro diagnostic medical devices. The document aims to streamline approvals under Medical Devices Rules, 2017. Comments from stakeholders are invited within 15 days.
Source: h7.cl/1j0Wg

3. The Government of India has in the Union Budget 2026–27 announced measures to position India as a hub for medical tourism, biopharmaceutical manufacturing and traditional medicine. The government will establish five regional medical hubs, expand Ayurveda, Yoga, Unani, Siddha and Homeopathy infrastructure, and strengthen research, manufacturing capacity and employment across the healthcare value chain.
Source: h7.cl/1o2WE

4. The Government of India is planning to amend the Drugs and Cosmetics Act to tighten oversight of pharmaceutical opioids, proposing stricter penalties, higher fines, and enhanced monitoring of manufacturing and sales to curb misuse, diversion, and illegal distribution while strengthening regulatory enforcement.
Source: h7.cl/1j0Wr

5. Indian Pharmacopoeia Commission has issued a formal circular urging all Medical Device Marketing Authorisation Holders (MAHs) to strictly comply with adverse event reporting requirements under the Materiovigilance Programme of India (MvPI). The move is aimed at bolstering patient safety and enhancing the post-market surveillance ecosystem for medical devices across India.
Source: h7.cl/1o2WQ

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The 90 Day Rule: Indian Drug and Medical Device Regulator (CDSCO) tightens query response timelines on applications 

India’s Central Drug and Medical Device Regulator, The Central Drugs Standard Control Organisation (CDSCO), has made it clear that it will reject product applications if the official queries to the applications are not responded within 90 days from the date of receipt of the first official reminder.

Background
On January 16, 2026, CDSCO issued a public notice informing the general public that it has initiated a time-bound reminder and rejection mechanism to ensure timely disposal of the pending applications. As per CDSCO, a large number of product applications across categories such as new drugs, cosmetics, biologics, medical devices and IVDs are pending since 8 to 10 years because of non- submission of responses to queries on product application raised on the official electronic submission portal (SUGAM portal).

In the notice, CDSCO issued a final warning to applicants whose application has been pending for more than two years for want of response to queries and who have received three reminders from CDSCO requesting submission of response to query. If such applicants fail to respond to queries within 30 days from date of public notice i.e. by 14 February 2026, it will result in rejection of the application.

The CDSCO also used the opportunity to inform the public that it has instituted a structured reminder mechanism for queries to applications under which it was going to issue three reminders to applicants in relation to unresponded queries. This structured reminder system and consequences of failing to respond to queries are discussed in the paragraphs below.

CDSCO’s Structured reminder mechanism
Under the structured reminder mechanism, CDSCO has decided that it will issue reminders at fixed intervals to applicants who do not respond to the official queries to an application in the following manner:

  • First Reminder- CDSCO will issue the first reminder if it does not receive response to query. The time-period that CDSCO will wait for response to queries before it issues the first reminder has not been specified.
  • Second reminder – If no response to queries is received within 30 days of first reminder, a second reminder will be issued o.
  • Third reminder – If no response to queries is received within 30 days of second reminder, a third and final reminder will be issued.
  • Disposal Notice – If no response to queries is received within 30 days of issuance of third reminder, CDSCO will issue dispose the application.

Will the disposal of application due to non-response to queries be treated as rejection of the application effectively barring the applicant to make the same application again?
The disposal by CDSCO should not be treated as rejection of the application. This means that the applicant should be able to apply for license again for the same products, even if the application for same products has been rejected before for want of response to queries.

Whether the government fees paid be refunded or reused or adjusted in case of disposal of application of CDSCO on grounds of non-response to queries?
As per the public notice, the government fees paid will not be refunded or reused or adjusted once the underlying application is disposed by CDSCO due to non-receipt of response to queries despite three reminders.

What will happen to product applications that are pending for more than two years?
Where an application has remained pending for over two years, but no queries have been raised by CDSCO, there is currently no clarity on how such cases will be treated. Based on the language and intent of the public notice, such applications should not be disposed, because the structured reminder mechanism gets triggered only when queries raised by CDSCO are not responded to by the applicants.
Where queries have been raised in the application, but the applicant is yet to receive three reminders from CDSCO as described in the structured reminder mechanism, it is unclear what will happen because the public notice does not provide any guidance on this issue. In our view, such applications should not get disposed by CDSCO for want of response since the disposal of application under the structured reminder mechanism can happen only after issuance of three reminders by CDSCO. However, CDSCO is free to follow its own processes and cannot be blamed for disposal of application without notice on the ground that the applicant has not responded to queries and appears to have abandoned the application.

Is it possible to seek extension of the timeline?
It is unclear whether CDSCO will entertain extension of timeline beyond the timeline of 90 days prescribed under the structured reminder mechanism. The Public Notice leaves some flexibility for making an application for extension of timeline. However, the final decision on extension of timeline beyond the 90 day window under the structured reminder mechanism will rest with CDSCO.

Is it possible to partly respond to CDSCO’s queries and respond to remainder of the queries later?
It is unclear whether CDSCO will entertain partial response to queries as sufficient to stop the 90 day clock under its structured reminder mechanism. However, in the event of time-crunch, it may be pragmatic to submit a partial response to queries than to submit no response at all.

What is timeline for CDSCO to issue queries after submission of an application?
CDSCO has not committed to a timeline to review application and issue queries to applicants.

What is the timeline within which an applicant must respond to queries raised on the application to avoid receipt of first reminder from CDSCO?
CDSCO has not indicated any expectation on timeline within which applicants should respond to its queries to avoid receiving the first reminder.

Will State Drug and Medical Device Licensing Authorities also follow structured reminder mechanism and dispose applications due to non-response to queries?
The State Drug and Medical Device Licensing Authorities are not bound to follow the structured reminder mechanism as published by CDSCO in its public notice. For all practical purposes, the structured reminder mechanism should be assumed to be applicable to CDSCO only.

There is a statutory timeline prescribed for processing most product license applications. What happens to the statutory timeline is the impact of query on statutory timeline of processing of an application?
The statutory timelines prescribed for processing drug, medical device or cosmetic license by CDSCO or State Licensing Authority are considered to be suspended upon receipt of queries from the regulatory authority.

Take-away for industry
It may be pragmatic for manufacturers and importers of drugs and medical device manufacturers to respond official queries received to their product applications at the earliest opportunity and in the best possible way, to avoid repeat queries or reminders from CDSCO. It is possible that some queries may require more time to respond than other queries, at which time appropriate regulatory strategy should be formulated to address all queries so as to avoid disposal or rejection of application and consequent loss of valuable time and government fees.

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Food Safety and Standards Authority of India has issued draft amendments to the Food Business Licensing Regulations mandating food manufacturers to keep daily production and raw-material records and to follow FIFO/FEFO storage norms. Retailers and non-manufacturers are exempt. The move strengthens traceability, inventory control, and food safety compliance. Public comments are invited within 30 days of Gazette publication.
Source: h7.cl/1iFOX

2. Madras High Court has ruled that the word “Vapo” is a descriptive and generic term derived from “vapour” and cannot be claimed exclusively by any party, rejecting petitions seeking cancellation of trademarks for “Vaporin” products. The Court held that the rival marks and trade dress are distinct and unlikely to cause consumer confusion.
Source: h7.cl/1nG6S

3. India’s Central Government has amended Uniform Consent Guidelines under the Air and Water Acts to simplify industrial approvals and cut delays. Key changes include consolidated consents covering multiple environmental laws, faster timelines for red-category industries, and Consent to Operate remaining valid until cancelled. Inspections, audits, and cancellation powers remain to ensure environmental compliance.
Source: h7.cl/1iFAP

4. The India–EU free trade agreement is set to eliminate duties on about 90% of European medical devices imported into India, reducing tariffs that earlier went up to 27%. The agreement is expected to lower costs and improve access to advanced technologies, Indian manufacturers are seeking regulatory alignment and mutual recognition to overcome non-tariff barriers.
Source: h7.cl/1iFAU

5. The India–EU Free Trade Agreement is expected to expand opportunities for Indian traditional medicine in Europe. In EU countries where no specific regulations exist, AYUSH practitioners will be allowed to offer services based on their Indian qualifications. The agreement also provides long-term certainty for setting up AYUSH wellness centres and clinics across EU member states.
Source: h7.cl/1iFAX

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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 and Medical Device Regulator, The Central Drugs Standard Control Organisation (CDSCO), has issued a public notice that it will reject applications if the queries to the applications are not responded within 90 days from the date of receipt of the query on its official application portal called SUGAM portal. A time-bound reminder and rejection mechanism for timely disposal of the pending applications has been introduced. Applications pending for two years will now be rejected after 30 days notice if no response is submitted.
Source: h7.cl/1i6LX

2. India’s Ministry of Commerce and Industry has extended the deadline for importers and manufacturers to obtain BIS certification for aluminium utensils and food and beverage cans covered under the Quality Control Order, 2026. The revised timelines are issued in a phase wise manner based on industry category, beginning from 1 October 2026.
Source: h7.cl/1i6L0

3. Several drug companies are cautious about a new fast approval program under the United States Food and Drug Administration. They fear quicker reviews may weaken scientific scrutiny, increase legal risk, and invite court challenges, even as others support faster access to important medicines for patients nationwide safely.
Source: h7.cl/1i6Lg

4. The Maharashtra Public Health Department has launched dedicated menopause clinics in Pune to provide specialised care for women’s physical and mental health needs. Weekly OPDs will be held every Wednesday at government hospitals, offering medical management, counselling, and lifestyle guidance. The initiative aims to address menopause-related health issues across urban and rural areas.
Source: h7.cl/1n5Uw

5. India’s Ministry of Agriculture and Farmers Welfare has announced that the Seed Act, 2026, to introduces a nationwide seed traceability through QR codes, mandate seed company registration, and impose penalties up to ₹30 lakh for substandard seeds, and safeguards the traditional seed systems and strengths transparency.
Source: h7.cl/1i6Lp

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FAQs for subsequent importer license of medical devices in India

On September 15, 2025, the Central Drugs Standards Control Organization (“CDSCO”) which issues import license for medical devices and In-vitro diagnostic medical devices (“IVD”) in India, announced that it had introduced a new regulatory pathway for importers of medical devices which are already approved for marketing in India. Such importers may obtain license as a ‘subsequent importer’ by submitting limited set of information and documents as opposed to the original importers who received the first import license for import of specific medical device in India.
After the announcement, several questions and issues remain arose, which are yet to be addressed by CDSCO. In this article, we have attempted to collate the questions and issues in form of frequently asked questions (FAQs) and address them to the best of our current understanding.
Please note that our answers are based on our good faith understanding of the current law and industry practice and should not be construed as official responses of CDSCO or professional advice.

1. Who qualifies as a “Subsequent Importer”?
Any entity/person who intends to import into India a medical device or IVDS that is already licensed by the CDSCO under the Medical Devices Rules, 2017 (MDR) to be imported into India by another importer, may apply as a subsequent importer.

2. Who cannot be a subsequent importer in India?
Importers of medical devices which are not already licensed to be imported into India, and importers who do not have direct access to foreign manufacturer of the medical device sought to be imported, cannot become subsequent importers in India.

3. Is there a similar regulatory pathway available for subsequent manufacturers of medical devices?
No. Unlike the concept of a subsequent importer, there is no provision that allows an entity in India to act as a subsequent manufacturer. Domestic manufacturers who are desirous of claiming the title of ‘manufacturer’ without manufacturing the medical device may explore the loan license route.

4. Where should applications to obtain a license as a Subsequent Importer be submitted?
The application for obtaining a license as a subsequent importer has to be filed through the CDSCO MD online portal.

5. In which form is the application for obtaining a license as a subsequent importer to be filed?
The application will be submitted in Form MD-14. The license will be issued in Form MD-15.

6. Is the subsequent importer route available to importers of IVDs?
Yes. The subsequent importer route is available to both importers of medical devices and IVD.

7. Is a wholesale drug license prerequisite for applying for a subsequent importer license?
In order to import and sell medical devices in India, the applicant who wishes to obtain subsequent importer license must first obtain wholesale drug License or registration certificate under Form MD-42.

8. Is submission of a fresh Power of Attorney (POA) required for subsequent importer application?
Yes. A fresh POA has to be submitted at the time of application.

9. What is the role of foreign manufacturer in obtaining subsequent importer license?
The person making an application for obtaining a license as subsequent importer has to obtain original documents from foreign manufacturer. The documents include POA, labels, regulatory certificates like free sales certificate, quality management certificate, undertaking etc.

10. Does an applicant have to submit Plant Master File (PMF) and Device Master File (DMF) for obtaining subsequent importer license?
No. There is no requirement to submit the actual PMF and DMF. However, the foreign manufacturer is required to submit an undertaking confirming that there have been no major changes to the PMF and DMF of the previously approved device since its primary submission and approval.

11. Is it mandatory for the subsequent import license holder to comply with the labelling requirements prescribed under MDR?
Yes. The subsequent importer has the mandatory obligation to comply with the labelling requirements prescribed under the rules.

12. Is a separate government fee payable for obtaining a subsequent importer license?
Yes. The applicant is required to pay both manufacturing site fee and product fee to obtain a fresh license as a subsequent importer.

13. What are the timelines for obtaining a subsequent importer license?
The Medical Devices Rules, 2017 do not prescribe specific timelines for obtaining a subsequent importer licence. The typical timelines to obtain an import license under Form MD-14 is nine months from the date of application. In practice, the timeline for obtaining a subsequent importer license may be similar or shorter than the primary import license, since the approval relies on the primary import licence already granted for the same device.

14. What is the validity of a subsequent importer license?
There is no clarity on it. However, in our view, the license for the applied device should be valid in perpetuity as long as the primary license stands.

15. Will the subsequent importer license remain valid if the primary import license is suspended or cancelled?
There is no clarity on it. However, in our view, if the primary import licence is suspended or cancelled due to issue with the medical device or foreign manufacturer, all subsequent importer licences linked to that device should be suspended or cancelled.

16. Does the applicant have to submit predicate analysis document for obtaining a subsequent importer license?
No. There is no requirement to submit the predicate analysis document at the time of application because the license as a subsequent importer is issued based on an already approved license.

17. Can a subsequent importer file an application for addition of models for the already approved device?
There is no clarity on it. However, in our view, the licensee should be able to add models.

18. What is the process to renew the subsequent importer license?
The license issued in Form MD-15 is valid in perpetuity. However, the subsequent impoter is required to pay the retention fee every 5 years from the date of its issuance in order to retain the license.

19. Can a person obtain a subsequent importer license for brand names different from those approved under the primary import license?
No. The subsequent import license can be issued only under the brand names approved in the primary license.

20. Does a subsequent importer have the responsibility to report the adverse events?
Yes. The subsequent importer has to report every adverse event to the authorities.

21. Does the subsequent importer have to comply with BIS standards?
Yes. All medical devices imported and sold in India shall conform to the standards laid down by the BIS, which are periodically notified by the Ministry of Health and Family Welfare (the Ministry). Where no such relevant standard of any medical device has been laid down either by BIS or by the Ministry, such device shall conform to the standards laid down by the International Organisation for Standardisation (ISO) or the International ElectroTechnical Commission (IEC), or by any other pharmacopeial standards. In case none of the above-mentioned standards exists, the device shall conform to the validated manufacturer’s standards.

22. Does subsequent importer have to fulfil the obligations prescribed under Drugs Price Control Order, 2013 (DPCO)?
Yes. The licensee has to comply with the obligations of declaring Maximum Retail Price (MRP) on the package of the device if the device is sold in retail packages. The licensee has to ensure that the MRP of the device is less than the prescribed price ceiling, where applicable, or does not increase beyond 10% in any 12-month period.

23. Is it mandatory for a subsequent importer to obtain IPDMS registration with National Pharmaceutical Pricing Authority (NPPA) under DPCO?
Yes. The licensee has to mandatorily obtain registration on IPDMS portal and file mandatory forms prescribed under DPCO.

24. Does the subsequent importer obliged to comply with Legal metrology (prepackaged commodities) rules, 2011 (LMPC Rules)?
Yes. The licensee has to obtain a registration under LMPC Rules and comply with the labelling requirements prescribed under the rules.

25. Is the subsequent importer required to fulfil the obligations under Plastic, E-waste and Battery Waste Management Rules?
Yes. The subsequent importer must comply with the Plastic, E-waste, and Battery Waste Management Rules where applicable. If the approved device is an electronic medical device, or it is an electronic medical device containing battery, and is imported with plastic packaging material, the importer must obtain the required Extended Producer Responsibility (EPR) registrations under the respective rules and fulfil all associated compliance obligations.

26. Can a subsequent importer transfer its license and rights to the third party?
No. The license issued in Form MD-15 is non-transferable.

27. Can an entity become a subsequent importer for Class A Non-sterile Non-measuring (NSNM) medical device?
No. The fresh registration under Class A NSNM category has to be obtained.

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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.