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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.

Drug manufacturing facility cannot manufacture food products: Central Drugs Regulator
India’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to take action against the drug manufacturers who are also manufacturing nutraceuticals and health supplements in the same facility. Under Indian law, a drug manufacturing facility cannot be used to manufacture food products. Nutraceuticals and health supplements are regulated as food products in India.
Source: bit.ly/4bUWpwg

Methodology to calculate Green Credit against Tree Plantations notified
India’s Ministry of Environment, Climate and Forest Change, has notified the methodology for calculating green credit in respect of tree plantation under Green Credit Rules, 2023 which were notified under The Environment Protection Act, 1986. A person desirous of purchasing green credits will have to make an application to the Administrator. 1 tree planted will be equal to 1 green credit.
Source: bit.ly/3wGJgqo

A person cannot be prosecuted for food related offence under Food Safety Law and Indian Penal Code simultaneously: Supreme Court
The Supreme Court of India has held that, since The Food Safety and Standards Act, 2006 (FSSA) has effect notwithstanding any other law, a food related offence will have to be pursued under FSSA and not under a general law such as the Indian Penal Code, 1860 (IPC).
Source: bit.ly/48whOZJ

Period Safety Update Reports (PSURs) of new drugs will have to be submitted online, physical submissions will not be accepted
The Indian Central Drug Regulator, Central Drugs Standard Control Organization (CDSCO), will accept PSURs of new drugs, subsequent new drugs (SND), fixed dose combinations (FDC), biologicals and veterinary drugs only through online medium from 11th March 2024. A PSUR is required to be submitted for a period of four years after receipt of marketing permission.
Source: bit.ly/3wDqZKE

Indian Government is incentivizing domestic drug manufacturers to develop cost effective treatment for rare health conditions
India’s medical research body, Indian Council of Medical Research (ICMR), has reportedly invited domestic drug companies to develop localized treatments for “priority rare genetic disorders” and has offered assistance in pre-clinical, clinical research and regulatory approvals. The aim for this initiative is to encourage domestic drug companies to develop cost-effective treatments for rare health conditions by offering assistance in clinical research.
Source: bit.ly/4bQQ3y4

Posted on

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.

Drug manufacturing facility cannot manufacture food products: Central Drugs Regulator
India’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to take action against the drug manufacturers who are also manufacturing nutraceuticals and health supplements in the same facility. Under Indian law, a drug manufacturing facility cannot be used to manufacture food products. Nutraceuticals and health supplements are regulated as food products in India.
Source: bit.ly/4bUWpwg

Methodology to calculate Green Credit against Tree Plantations notified
India’s Ministry of Environment, Climate and Forest Change, has notified the methodology for calculating green credit in respect of tree plantation under Green Credit Rules, 2023 which were notified under The Environment Protection Act, 1986. A person desirous of purchasing green credits will have to make an application to the Administrator. 1 tree planted will be equal to 1 green credit.
Source: bit.ly/3wGJgqo

A person cannot be prosecuted for food related offence under Food Safety Law and Indian Penal Code simultaneously: Supreme Court
The Supreme Court of India has held that, since The Food Safety and Standards Act, 2006 (FSSA) has effect notwithstanding any other law, a food related offence will have to be pursued under FSSA and not under a general law such as the Indian Penal Code, 1860 (IPC).
Source: bit.ly/48whOZJ

Period Safety Update Reports (PSURs) of new drugs will have to be submitted online, physical submissions will not be accepted
The Indian Central Drug Regulator, Central Drugs Standard Control Organization (CDSCO), will accept PSURs of new drugs, subsequent new drugs (SND), fixed dose combinations (FDC), biologicals and veterinary drugs only through online medium from 11th March 2024. A PSUR is required to be submitted for a period of four years after receipt of marketing permission.
Source: bit.ly/3wDqZKE

Indian Government is incentivizing domestic drug manufacturers to develop cost effective treatment for rare health conditions
India’s medical research body, Indian Council of Medical Research (ICMR), has reportedly invited domestic drug companies to develop localized treatments for “priority rare genetic disorders” and has offered assistance in pre-clinical, clinical research and regulatory approvals. The aim for this initiative is to encourage domestic drug companies to develop cost-effective treatments for rare health conditions by offering assistance in clinical research.
Source: bit.ly/4bQQ3y4

Posted on

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.

Couples seeking surrogacy will be allowed to use donor gametes only if either partner suffers from a disabling medical condition
India’s Ministry of Health and Family Welfare has notified the Surrogacy (Regulation) Amendment Rules, 2024, which removes the earlier requirement that barred the use of donor gametes for surrogacy. Now, couples intending to opt for surrogacy, can use donor gametes if either spouse is certified by the District Medical Board as having a medical condition which prevents the spouse form contributing the gamete.
Source: bit.ly/3T4Ortd

Antibiotics to be sold in blue cover by medical stores and hospital pharmacies in Kerala
In a first of its kind development, the Health Department of the Government of Kerala has instructed all the hospital pharmacies and medical stores in Ernakulum to sell antibiotics in a blue cover effective immediately. All medical stores have also been directed to display a poster stating that antibiotics will not be given without a doctor’s prescription. This initiative has reportedly been taken to control the use of antibiotics.
Source: bit.ly/3T4OiGb

Insurance companies should cover costs of medical equipment if it forms an integral part of the medical treatment: Consumer Court
India’s Vadodara District Consumer Disputes Redressal Commission has upheld the complaint of a person who was denied insurance coverage for cost of BPAP device for Sleep Apnea treatment post discharge from hospital. As per the consumer court, medical insurance should cover the cost of equipment required for treatment after discharge from the hospital, because it forms integral part of the medical treatment.
Source: bit.ly/3SLOjgJ

Smartwatches and rings should not be used for measuring blood sugar levels for diabetes management: USFDA
The US Food and Drug Administration (USFDA) has warned users that it has not approved any non-invasive smartwatches or rings that use sensors to measure blood sugar levels for diabetes management, and relying on them for blood sugar measurements could have serious implications.
Source: bit.ly/3wt4B6P

New Medical Device Quality Management System Rules published by USFDA
The US Food and Drug Administration (USFDA) has issued a final rule on Quality Management System Regulation (QSMR) for medical devices. The rule intends to reduce regulatory burden on the manufacturers and importers of medical device by enhancing global harmonization in device regulation for Quality Management Systems.
Source: bit.ly/48pxmyy

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TOP 5 HEALTH LAWS & 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.

Indian Government tacitly endorses use of AI in screening patients
India has started a pilot telemedicine project called “Aarogya-Doctor on Wheels”. The unique aspect of the pilot project is that it is leveraging Artificial Intelligence (AI) for screening patients. The patient narrates his illness or complaint in his native language and the AI understands the language and responds to the patient in the same language. Once the patient has been screened, he is referred to a specialist doctor for teleconsultation.
Source: bit.ly/3SISGt8

Code for regulation of marketing practices of medical devices industry will continue to remain in a draft form for some time
The Department related Standing Committee on Chemicals and Fertilizers has stated that draft Uniform Code for Pharmaceutical/Medical Device Marketing Practices (“UCMPMD”) will be finalized once the Supreme Court adjudicates a related writ petition, in which it has been prayed that code for regulation of pharmaceutical marketing practices (UCPMP) be given the status of law.
Source: bit.ly/49J8Mdb

Home based care models should be developed specifically for elderly population: Government Policy Think Tank
Taking note of the fact that there are more than 100 million elderly people in India, India’s apex government think-tank, NITI Ayog, has made case for development of Comprehensive and Integrated Senior Care Package. The package will include all aspects of senior care such as home-based care models, R&D in geriatric care, palliative and end-of-life services, Capacity building healthcare professionals and caregivers, development of assistive devices such as Mobility aids, Personal emergency response systems, Medication reminders, Smart home technology and Hearing and visual aids.
Source: bit.ly/3T5XYjP

Courts should be slow in granting anticipatory bail in narcotic matters, if the quantity is large: Supreme Court
India’s Supreme Court has held that in bail matters pertaining to dealing in illegal Narcotics Drugs and Psychotropic Substances, the Courts should first satisfy itself that accused may not be guilty of the offence alleged and that accused is not likely to commit any offence while on bail.
Source: bit.ly/3uGeCx2

Promotion of prescription drugs by Social Media Influencers in US a cause of concern, but US FDA may not have jurisdiction to regulate them
The US Food and Drug Administration (US FDA) is under scrutiny for its inability to regulate social media influencers engaged in marketing of prescription drugs without providing warnings about risks associated with their use. US FDA is reportedly unsure whether it can or cannot regulate such actions of social media influencers.
Source: bit.ly/3OMCYfj

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TOP 5 HEALTH LAWS & 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.

Central Drug Regulator to have open-door meetings with Industry twice a week
In a first, perhaps anywhere in the world, India’s top officer in the Drug Regulator’s office, the Drugs Controller General of India (DCGI), has announced that there will be walk-in meetings for the industry every Tuesday and Thursday between 5 and 6 pm, where industry can present its problems and suggestions directly before the officer. The move is aimed at improving Ease of Doing Business in India.
Source: bit.ly/48k9MmX

Waiting for Drug Price Regulator to fix retail prices of new drugs before they can be launched will adversely impact industry
An association of pharmaceutical manufacturers has reportedly submitted an appeal before the Drug Price Regulator, National Pharmaceutical Pricing Authority (NPPA), to recall its notice which directs drug manufacturers to delay launch of new drug until the retail prices of those products have been fixed and notified by NPPA. The association has submitted that notice will negatively impact drug manufacturers’ businesses and cause significant losses.
Source: bit.ly/48cUJvf

Regulatory Data Exclusivity on negotiation table between India and Europe during FTA talks
As per media reports, European Free Trade Association has demanded regulatory data exclusivity for drugs during the discussion on proposed Trade and Economic Partnership Agreement. If India accepts the demand, then Indian domestic drug manufacturers will not be able to rely on clinical trial data of innovator drug manufacturer for obtaining regulatory approvals in India, thereby impacting cost and timelines for generic drugs entry in Indian market.
Source: bit.ly/3T01NHe

Insurance Regulator has proposed to increase free-look time for insurance policies from 15 days to 1 month
As part of the recently published draft IRDAI (Protection of Policyholders’ Interests and Allied Matters of Insurers) Regulations, 2024, the Insurance Regulator (IRDAI) has proposed to increase the free-look time for insurance policies from 15 days to 1 month. The free-look time is the time by which a policy holder of an insurance policy can cancel an insurance policy after purchasing it without liability to him.
Source: bit.ly/3T1PcDr

New York City has sued major social media companies for affecting mental health of youth and children
The New York City Mayor has announced that his administration has sued major social media companies on ground that they have intentionally designed platforms to purposefully manipulate and addict children and teens to social media applications.
Source: bit.ly/3OLyZPY

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TOP 5 HEALTH LAWS & 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.

New Departmental Guidelines for sampling of Spurious Drugs, Medical Devices and Cosmetics Published
India’s apex regulatory body for drugs, medical devices and cosmetics, the Central Drugs Standards Control Organization, has published revised sampling guidelines for inspectors to follow in various states. All inspectors are required to collect at least 9 samples of drugs, and 1 sample of cosmetic or medical device in each month. The inspectors are supposed to be alert about feedback received from citizens and doctors in deciding which drugs, cosmetics and medical device brands they ought to sample and test for compliance with laws.
Source: bit.ly/3SDnLym

Social Media companies asked by High Court to handover details of persons who fraudulently operated certain accounts and channels
The Delhi High Court has ordered major social media companies including Facebook and Telegram to disclose identities of users accused of misusing trademark of major venture capital firm to cheat users by soliciting bogus investments. The court has also ordered concerned social media companies to provide details on action they will take to prevent further violation.
Source: bit.ly/3HXkxAP

WhatsApp and emails may be used to send legal notices for demanding unpaid amounts: High Court
The Allahabad High Court has reiterated that notice in cheque bounce case sent by WhatsApp or e-mail will be considered valid notice for the purposes of recovery under The Negotiable Instruments Act, 1881, and it will be presumed to have been dispatched and served on the same day.
Source: bit.ly/48f8Xf6

Popular Party Drugs added to list of Psychotropic Substances
The Indian Government has added popular synthetic party drugs, ADB-BUTINACA, Alpha-PiHP and 3 Methylmethcathinone (3-MMC), to list of psychotropic substances and notified small and commercial quantity of these substances for the purpose of fixing quantum of punishment for unlawful possession. Possessing psychotropic substances without permission or prescription is an offence under Narcotic Drugs and Psychotropic Substances Act, 1985.
Source: bit.ly/48ghuhM

WHO recommends antibiotics which should be exclusively put to human use to reduce chance of antimicrobial resistance
The World Health Organization (WHO) has updated its Medically Important Antimicrobials for Human Use (WHO MIA List), and reclassified antimicrobial drugs on basis of potential impact on human heath to limit the use of identified antimicrobials in other populations such as in plants and animals. The WHO hopes that reducing use of critical antimicrobial drugs in other population will reduce pace of antimicrobial resistance.
Source: bit.ly/49eVll9

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TOP 5 HEALTH LAWS & 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.

Human Rights body to probe sale of drugs with identical brand names in India
The National Human Rights Commission (NHRC) in India has taken suo motu cognizance of a newspaper report which stated that many drugs in India were being sold with identical brand names for treating different medical conditions. NHRC has issued notice to Secretary, Ministry of Health and Family Welfare and Central Drugs Regulator, asking for detailed report within four (04) weeks.
Source: bit.ly/3SB8WfB

India’s Environment Regulator to take action against unregistered recyclers and refurbisher of battery waste
India’s Central Pollution Control Board (CPCB) has issued direction to all State Pollution Control Board (SPCB) and Pollution Control Committees (PCCs) to ensure compliance with Battery Waste Management Rules, 2022 by recyclers and refurbishers of battery waste. CPCB has directed SPCB/PCC to carry out drives identifying informal / illegal battery waste recyclers, and physically verify facilities of existing waste recyclers. All battery waste recyclers and refurbishers are obligated to register under Battery Waste Management Rules, 2022.
Source: bit.ly/3OGJTGI

Difference of manufacturing process will not take away ability of manufacturer of product manufacturer to enforce product patent, if the product is covered by Product-by-Process Patent: High Court
The Delhi High Court of India has held that a product-by-process patent would be enforceable even if the alleged infringement relates to manufacturing of a product using process which is different than the one claimed in patent. The High Court was dealing with a matter relating to manufacture of a compound called Ferric Carboxymaltose (FCM) which was patented by the Innovator. The defendants had raised an argument that they are not covered by the patent because they were following a different process to manufacture FCM. However, the argument was rejected by the High Court.
Source: bit.ly/3OGtr9C

Manufacturers of medical devices who do not wish to disclose name and address of manufacturing facility, may apply for neutral code on central portal
The Indian medical devices regulator, Central Drugs Standard Control Organization (CDSCO) has direct all the manufacturers of medical devices for export purposes to submit the applications for neutral code through online system of medical devices portal only. If a neutral code is declared on the label of package, it does not have to bear the name and address of the manufacturer. The online portal is now functional to accept the applications.
Source: bit.ly/3SWgTxn

Recommendations for COVID legislation received from Law Commission of India
The Law Commission of India has submitted its report titled “A Comprehensive Review of the Epidemic Diseases Act, 1897″ to the Government of India. The commission has recommended either to amend the existing law or enact the new legislation to address the underlying gaps in the Epidemic Diseases Act, 1897. The 1897 was relied on by the Government of India to introduce various controls during the COVID pandemic, including lock downs.
Source: bit.ly/3SWMdMm

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Top 5 Health Laws & 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.

Innovator Pharma Company questions biosimilar trial on ground of non-procurement of comparator drug from authorized sources
A multinational pharmaceutical company has questioned the veracity of a biosimilar drug trial before India’s clinical trial regulator, The Drugs Controller General of India (DCGI), on grounds that the comparator drug, a biologic, was not procured from authorized sources, thereby putting clinical trial subjects at risk and casting shadow over appropriateness of the clinical trial.
Source: bit.ly/49tJmjj

Indian IPR regime well-equipped to handle AI generated works and there is no proposal to amend the law in context of AI generated content: Ministry of Commerce & Industry
India’s Minister of Commerce & Industry, while replying to a question in India’s parliament, has clarified that user of Generative AI should obtain permissions of owner of original copyrighted work processed by Generative AI technology before using the AI generated content for commercial purposes. The Minister further clarified that there is neither any proposal to create any separate right nor to amend the law in the context of AI-generated content.
Source: bit.ly/48cK4R8

Guidelines to distinguish nutraceuticals and drugs which have same or similar composition soon
The Indian Government has reportedly formed a high-level committee to address complaints that products which have identical or similar compositions are being approved as nutraceuticals, drugs or ayurvedic formulations, depending on the regulatory pathway chosen by the manufacturer. Under the current law, nutraceuticals are not permitted to make claims of treatment or cure on the label, however there are reports of non-compliance with this requirement.
Source: bit.ly/49bvaMb

Preparing a list of unvaccinated employees does not amount to violation of privacy: Madras High Court
India’s Madras High Court has held that the action of preparation of list of employees who have not received COVID-19 vaccinations and subsequent circulation of such list amongst employees of company would not amount to violation of privacy. The High Court was hearing a criminal complaint filed by an employee of the Company under Information Technology Act, 2000 on grounds that the Company had breached the said law sharing his personal information as part of list of unvaccinated employees.
Source: bit.ly/42yExmP

Couples seeking surrogacy on medical grounds are able to use donor sperm or egg, in spite of law to the contrary, by approaching a High Court
Following the precedent set by Supreme Court, the Bombay High Court has permitted two couples to use donor eggs for surrogacy owing to medical issues faced by the Couple. The development is important because The Surrogacy (Regulation) Rules, 2022 explicitly prohibits the use of donor gametes for surrogacy. In the past, Karnataka High Court has also granted similar reliefs to a couple facing medical challenges to conceive using own gametes while seeking a surrogate to deliver the baby.
Source: bit.ly/42yczHP

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Daily Health News Wrap – 01 Feb 2024

01 Feb 2024

Important clarifications issued by Central Pollution Control Board w.r.t. Extended Producer Responsibility (EPR) compliances under E-waste Management Rules, 2022.
India’s Central Pollution Control Board (CPCB) has released certain notices and guidance document under E-Waste (Management) Rules, 2022 which have a significant impact on EPR obligations.
Sources: –
FAQ for E-waste: bit.ly/3HHuiCU
Fee Structure for registration for Recyclers: bit.ly/3SpMBkS
Notice for Producers:  bit.ly/48XXFwK
Notice for Recyclers: bit.ly/48XhbJK
Important clarification issued by India’s Central Pollution Control Board (CPCB) under E-waste Management Rules, 2022 (EWM) for the importers of Electrical and Electronic Equipment (EEE) who are not required to comply with Extended Producer Responsibility (EPR) requirements
India’s Central Pollution Control Board has issued a clarification under E-waste Management Rules, 2022 (EWM Rules) identifying importers of Electrical and Electronic Equipment (EEE) who are not required to be registered as Producers under EWM Rules and therefore do not need to fulfil Extended Producer Responsibility (EPR) obligations. Such producers are required to submit certain documents to Customs/Port authorities as a proof of submission of those documents to CPCB.
Source: bit.ly/42kj9Bq
Indian Government extends the deadline for application of quality control order for certain drugs
Indian Central Government has extended the dates of applicability of Quality Control Orders (QCO) of Morpholine, Acetic Acid, Methanol and Aniline to 1st August 2024, 3rd August 2024, 3rd August 2024 and 3rd August 2024 respectively.
Source: bit.ly/48XokK3
Indian Government extends timelines for submission of application under Production Linked Incentive (PLI) scheme
The Department of Pharmaceutical under the Indian Ministry of Chemicals and Fertilizers has extended the timeline for medical device manufacturing companies to submit the application under the Production Linked Incentive (PLI) Scheme till the end of February 2024. The PLI scheme aims to promote domestic manufacturing of class B medical devices.
Source: bit.ly/47Y4UDx
New Guidelines for effective performance of Environment Regulators issued by Supreme Court of India
The Supreme Court of India has recently issued stringent guidelines which ensure the efficient functioning of environmental protection authorities and the enforcement of environmental regulations across the country. The court also upheld the reconstitution of the Central Empowered Committee (CEC), which is tasked with compliance with judicial orders pertaining to environmental conservation.
Source: bit.ly/3SFwscs
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Rounding-off Principles for Drugs and Medical Devices under Drugs (Prices Control) Order, 2013

In this article, we have discussed rounding-off principles that manufacturers and importers of drugs and medical devices should follow while determining the maximum retail price (MRP) of their products.


What is rounding-off?
Rounding-off refers to adjusting a fractional price of a drug or medical device to the nearest rupee, or the nearest paisa, depending on the context.


Why is rounding-off relevant for drugs and medical devices?
The MRP of drugs and medical devices is regulated by a law called the Drugs (Prices Control) Order, 2013 (“DPCO”). If a manufacturer or importer decides to round-off the MRP of a drug or medical device for any reason, for example, pursuant to an increase or decrease in applicable taxes, and the rounding-off is not acceptable as per provisions of DPCO, then it may result in recovery of the overcharged amount from the manufacturer or importer.


What are the principles of rounding-off prescribed under DPCO?
The DPCO itself is, as such, silent on the rounding-off of MRP. However, the authority responsible for enforcement of the DPCO, the National Pharmaceutical Pricing Authority (NPPA), has recognized the fact that rounding-off of MRP is an acceptable market practice [NPPA Minutes, 2016]. It is acceptable to NPPA that rounding-off of MRP is done as per ‘general mathematical practice’.


What is the general mathematical practice of rounding-off?
The general mathematical practice is to round-off the second decimal place of the MRP, depending on the number present at the third decimal. If the number present at the third decimal place is 5 or bigger than 5, then the number present at the second decimal place may be increased by 1. If the number present at the third decimal is less than 5, then the number present at the second decimal place will not change.
Some illustrations:

S No.Actual FigureRounded-off Figure
1.Rs. 123.45/-Rs. 123.45/-
2.Rs. 123.455/-Rs. 123.46/-
3.Rs. 123.456/-Rs. 123.46/-
4.Rs. 123.991/-Rs. 123.99/-
5.Rs. 123.999/-Rs. 124.00/-
6.Rs. 123.001/-Rs. 123.00/-
7.Rs. 123.111/-Rs. 123.11/-


The above understanding was validated by the Delhi High Court in the case of Union of India v Bharat Serums.


Whether rounding-off is permitted for medical devices under Legal Metrology (Packaged Commodities) Rules, 2011?
The MRP of medical devices is regulated by DPCO as well as Legal Metrology (Packaged Commodities) Rules, 2011 (“LMPC Rules”). Until 23.6.2017, the LMPC Rules had a provision to round off the fractional MRP to the nearest rupee. In other words, medical devices were permitted to round-off the fraction of less than fifty paise to the preceding rupees and a fraction of above 50 paise and up to 95 paise to the rounded off to fifty paise.
However, the above provision was omitted from LMPC Rules with effect from 1.1.2018. Therefore, the MRP of medical devices today cannot be rounded off, except in the case of the second decimal place, as described earlier.


Can a manufacturer or importer of medical devices round-off MRP of medical devices to the nearest rupee or 50 paise?
The simple answer is no, especially not after 2018. Before this, it was at least arguable that manufacturers and importers of medical devices could rely on the provisions of LMPC to take a position that they had the flexibility to round-off the MRP to the nearest rupee or 50 paise. The price regulator, NPPA, however, has not accepted this position. Post 2018, there is no basis for manufacturers and importers of medical devices to take such a position since the supporting LMPC provisions are now omitted.
Please note that manufacturers and importers of drugs could never take benefit of the flexibility of rounding-off under LMPC Rules for fixing MRP because LMPC Rules do not apply to drugs.


Conclusion
The flexibility to round-off MRP in the case of drugs and medical devices is available up to the second decimal place only, as per general mathematical practice. Any error in rounding-off for drugs and medical devices can result in significant recovery from manufacturers and importers under the provisions of the Drugs (Prices Control) Order, 2013.