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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 Drug Controller General of India (DCGI) has directed all State and UT Drug Controllers to regularly sample kumkum and colour powders at religious sites for testing for synthetic ingredients due to public health concerns. Kumkum is regulated as a cosmetic in Indian law and must meet BIS standards covering heavy metal limits, microbial safety, prescribed testing methods, and mandatory packaging and labelling requirements.
Source: h7.cl/1nnwz

2. India’s Ministry of Agriculture & Farmers Welfare has released the draft Pesticides Management Bill, 2025 to replace the Insecticides Act, 1968. The farmer-centric bill proposes stronger regulation of spurious pesticides, higher penalties, digital processes, mandatory lab accreditation, and promotion of biopesticides and indigenous manufacturing. Stakeholders can submit comments in the prescribed format by 4 February 2026.
Source: h7.cl/1inPA

3. The Tea Board of India has issued revised guidelines for registration of manufacturers of flavoured tea, reaffirming that every factory manufacturing flavoured tea must be registered as a bonafide manufacturer with the Tea Board. This makes the registration process for flavoured tea manufacturers clearer and more structured.
Source: h7.cl/1nnx8

4. The European Parliament has approved measures to strengthen EU supply of essential medicines by reducing dependence on non-EU countries. The proposals support domestic manufacturing through strategic projects, priority funding, EU-favoured procurement, joint purchasing, and coordinated stockpiles to prevent shortages of critical medicines such as antibiotics, insulin and vaccines.
Source: h7.cl/1nnwI

5. India’s Central Drug regulator has given approval to manufacture and sell a generic version of Ozempic (semaglutide) for diabetes, ahead of its patent expiry in March 2026. The company plans to launch 12 million injectable pens in the first year and partner locally for distribution. The company is also awaiting similar approval for the obesity drug Wegovy.
Source: h7.cl/1nnwM

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

On September 03, 2025, The Goods & Services Tax Council has announced the reduction in Goods and Services Tax (GST) rates for medicines. The reduced GST rates will come into effect on September 22, 2025. In this article, we have answered frequently asked questions (FAQs) about compliance associated with the reduction in GST rates for medicines (other than ayurveda and homeopathy medicines).

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

GST reduction and its impact on existing stock

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

Yes. The reduced GST rates will apply to all the stock of medicines already present in the market on or after September 22, 2025, irrespective of the fact that it was manufactured, imported or packed prior to September 22, 2025.

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

2. Is it possible to retain same MRP on medicines present in the market after reducing GST?

No. While it is generally permissible to increase MRP of medicines by up to 10% in India if they are not essential medicines (i.e. if they are not scheduled formulations under DPCO), doing so for stock of medicines which were manufactured or imported prior to September 22, 2025 may tantamount to denying trade and customers the benefit of reduction of GST, which is not permissible under India’s GST laws and is generally regarded as unlawful ‘profiteering’.
 
Compliances to be undertaken on account of reduction in GST rate

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

Manufacturers and importers of medicines should circulate a revised price list of medicines manufactured or imported or marketed by the company in Form V of DPCO to wholesale and retail dealers, State Drug Controllers, National Pharmaceutical Pricing Authority (NPPA) and Department of Pharmaceuticals (DoP), indicating revised GST rates and the revised MRP effective from September 22, 2025. The revised price list may be circulated through any suitable communication channel, including WhatsApp and email.

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

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

  • Submit the revised price list in Form V of DPCO on the IPDMS portal of NPPA, on or before October 6, 2025.
  • File Form II of DPCO to report a decrease in MRP on IPDMS Portal of NPPA, on or before October 6, 2025, applicable only if the medicine is part of list of scheduled formulations under DPCO.

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

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

No. It is not mandatory to declare reduced MRP on the label of medicines available with wholesale and retail dealers which are manufactured in India or imported into India before September 22, 2025.

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

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

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

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

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

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

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

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

Please note that the re-labelling to reflect reduced MRP on account of reduction in GST is subject to conditions which are discussed in response to Q. 8 and Q.9 below.

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

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

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

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

Assuming the manufacturer or importer has complied with the mandatory requirements outlined in response to Q. 3, 7 and 8, the manufacturers and importers of medicines may declare reduced MRP on pack of medicines by stamping or affixing stickers or by printing.
Compliances applicable to wholesale and retail dealers

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

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

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

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

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

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

    Penalties for non-compliance

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

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

    The failure to submit Form V on the IPDMS portal on or before October 6, 2025 will constitute a violation of DPCO and may lead to penal action under the Essential Commodities Act, 1955 including fine and imprisonment.

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

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

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

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

    The re-labelling of a medicine may be legally construed as manufacture of medicine under The Drugs and Cosmetics Act, 1940 (D&C Act), and such manufacturing activity requires a license from the Licensing Authority under D&C Act. The Licensing Authority in case of manufacturing of medicines in India is the respective State Licensing Authority i.e. SLA (for example – State Drug Control Department, State Food and Drug Administration). Such a license is require from SLA irrespective of whether the drug is manufactured in India or imported into India,

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

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

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    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 Directorate General of Foreign Trade (DGFT) has launched an online module for filing the Annual Remission of Duties and Taxes on Exported Products (RoDTEP) Return (ARR), aimed at streamlining the process for pharma exporters. The module is available on the DGFT Portal and simplifies ARR filing, eliminating the need for physical documents.
    Source: bit.ly/4hxQShu

    2. India’s Parliamentary Standing Committee on Chemicals and Fertilisers has urged the Centre to actively implement recommendations from the Standing Forum on Medical Device Association, focusing on streamlining logistics and transitioning to licensing all types of medical devices.
    Source: bit.ly/40XAnp8

    3. The Directorate General of Foreign Trade (DGFT) has withdrawn the Track and Trace System for pharmaceutical exports under the Foreign Trade Policy (FTP), which required barcoding on primary packaging. The withdrawal is attributed to the implementation of the Ministry of Health & Family Welfare’s (MoH&FW) own barcode/QR code system, along with the fact that most export destinations have their own traceability systems.
    Source: bit.ly/4aQDzqc

    4. India’s Finance Minister has announced that 36 life-saving drugs, including cancer treatments, will be exempted from basic customs duty. Additionally, 37 more medicines will also benefit from this exemption. Furthermore, 6 life-saving medicines will be added to a list with a concessional 5% customs duty. The GST rate on cancer drugs like Trastuzumab, Osimertinib, and Durvalumab has been reduced from 12% to 5%. A new 13 Patient Assistance Programme has also been introduced.
    Source: bit.ly/40UODPz

    5. India’s Finance Minister in its 2025-26 Union Budget, announced that gig workers will be included in the Pradhan Mantri Jan Arogya Yojana (PMJAY) health insurance scheme. This will provide healthcare coverage to nearly 10 million online platform workers, offering financial protection to a sector that previously lacked structured benefits.
    Source: bit.ly/4gmQwsN

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    TOP 5 HEALTH LAWS AND POLICY UPDATES

    Dear Reader, 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. A Missouri State Court has directed a multinational healthcare company to pay $495 million in damages over its specialised formula for premature infants which caused a girl to develop dangerous bowel disease. The Court ordered that the company did not warn doctors about infants receiving formula, having a greater risk of Necrotizing Enterocolitis (NEC) compared to infants who are breast-fed or given donor milk or human milk-derived formula
    Source: bit.ly/46rTKb1

    2. India’s Karnataka State Assembly has brought in a new bill which penalises any person found guilty of causing “intentional insult” to a doctor directly, on social media or using unauthorised audio or video. The penalty includes a jail term up to three months or a fine of ten thousand rupees. Intentional insult includes use of words, figures or gestures with an intent to insult, humiliate, disgrace, annoy or abuse a medical service personnel.
    Source: bit.ly/4d0momi

    3. India’s Kerala High Court has ordered that the Kerala Medical Association (“KMA”) is liable to pay Goods and Services Tax (GST) on the supply of goods and services to its members. KMA contended that it does not need to pay GST as it is registered as “charitable association” but the High Court held that KMA is liable to pay GST as 90% of its activities are non-charitable.
    Source: bit.ly/3WF5x2G

    4. Multinational Pharmaceutical Companies have requested the Indian Government to keep the free access medicines, provided under Patient Assistance Programme (“PAP”), outside the scope of Trade Margin Rationalisation (“TMR”). According to Pharma companies, medicines are made accessible and affordable through PAP and bringing them under the purview of TMR will impact their price and patients will end up paying more.
    Source: bit.ly/3ykeaGu

    5. Indian Government has built a health claims gateway, National Health Claims Exchange (NHCX), which aims to streamline and standardize health insurance claim processing, enhancing efficiency in the insurance industry. NHCX serves as a gateway for exchanging health claim information among insurers, third-party auditors, healthcare providers, beneficiaries, and other relevant entities and ensures interoperability, machine-readability, auditability, and verifiability, making the information exchange accurate and trustworthy.
    Source: bit.ly/3WEmom2

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    Ethical marketing and promotion of medicines

    Time and again, the pharmaceutical industry has been accused of indulging in unethical practices concerning the marketing of medicines around the world.  These unethical marketing practices are, in fact, a major area of concern for the Government as well as patient groups. Amongst all unethical practices, the one that attracts the highest amount of scrutiny is the (questionable) interaction between pharmaceutical companies and healthcare practitioners (HCPs).

    India is no exception. The Draft Pharmaceutical Policy, 2017 published by the Government itself makes a note that unethical practices employed by pharma companies are an area of major concern and that Doctors are lured to recommend a particular brand through all expenses paid trips often disguised as ‘educational conventions’. Unfortunately, the cost of such trips and other incentives gets added to the overhead cost of marketing of the medicine and is ultimately passed on to the patients.

    There is no law at present that regulates the promotion and marketing of drugs (including medical devices) by companies before HCPs. Interactions between pharma companies and HCPs are regulated, at best, by way of restrictions cast on HCPs through their respective professional and ethical guidelines. For example, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 regulate the professional and ethical conduct of doctors practising modern medicine and prohibits doctors from accepting any kind of freebies (including travel and accommodation) from pharma and allied healthcare industry. Unfortunately, the principal legislation that regulates the pharma industry i.e. The Drugs and Cosmetics Act, 1940 does not say what pharma companies can and cannot say, or give or cannot give, to HCPs.

    It is true that there are consumer protection legislations in India such as the Consumer Protection Act, 1986 (now the Consumer Protection Act, 2019) and the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 and Rules, 1955 but these legislations regulate misleading advertisements, not unethical industry-HCP interaction.

    It is, perhaps, not right to say that the government has turned a blind eye to this problem. In fact, in light of the increasing number of complaints of unethical practices adopted by pharma companies, the Department of Pharmaceuticals had introduced the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) back in 2011 (later revised in 2014). The intent behind UCPMP code was to guide the pharma industry in its interaction with HCPs. However, the voluntary nature of UCPMP has relegated its own status to that of a “non-binding guideline”.

    However, not all is lost. There is no dearth of pharma companies who are proudly ethical in their dealings with HCPs. In fact, most pharma MNCs have put in place exhaustive internal guidelines and robust internal systems which guide interactions of their medical representatives/marketing personnel with HCPs.  Interestingly, HCPs also seem to value such ethical behaviour. It is obvious that, at the end of the day, a HCP will prescribe medicines from only those pharma companies whose quality he or she trusts.

    It is quite likely that the Indian government may decide to give legal teeth to UCPMP and make it binding. After all, the UCPMP is the nearest Indian equivalent to the US Physicians Payment Sunshine Act that we have. Interestingly, the enforcement of the Sunshine Act by US Authorities have resulted in hundreds of millions of dollars in fines for some pharma companies.

    There is no doubt that making UCPMP into a law would certainly help to curb the rampant quid-pro-quo arrangements that exist today between pharma companies and HCPs. More so, those companies which currently engage in unethical practices will be forced to re-evaluate their sales and marketing strategies and become compliant, or else they will have to face legal consequences.  

    In the meanwhile, at least those companies who have achieved leadership positions in India’s pharma industry may lead by example and assume voluntary responsibility to follow UCPMP in text and spirit. The pharma industry associations would also do much good if they could adopt the UCPMP and direct their members to ensure compliance with the provisions of UCPMP at all costs. Such proactiveness will go a long way in instilling a sense of confidence amongst the Government and patients groups. And if that happens, needless to say,  the heavily regulated industry that is pharma industry will have one less regulation to worry about.

    The views are personal.

    Anil Upadhyay