Aug 19, 2012 | Patent
Purple Book, brought out on September 9, 2014, by the FDA consolidates list of licensed biological products including biosimilar and their interchangeable biological products. This compendium guides pharmacists in implementing pharmacovigilance in biological products and its biosimilars. Biological products and biosimilars are FDA approved that are primarily governed under Public Health Services Act. For the FDA approval, a Biologics License Application (BLA) can be filed under sub-sections of Section 351(a) and 351(k) of PHSA. An application filed under Section 351(a) for biologics and innovator biologics should submit all requisite information supporting its safety and effectiveness. This section 351(a) application is also referred as a standalone application for its non-reliance placed on other biologic products. A BLA filed under Section 351(k) for biologics license should submit information that confirms the manufacturer’s claim that the biosimilarity of the product is based on data to animal studies, clinical studies and analytical studies. Thus, the primary purpose of the Purple Book is to enable cross-checking as to whether a licensed biological product under Section 351(k) is biosimilar to or interchangeable with the reference product and to provide information pertaining the exclusivity of such reference product. Thus, the Purple Book lists all the biological products licensed under Section 351(a) and lists correspondingly, all the licensed biosimilar and interchangeable products of the reference product.
Purple Book originally accommodated two separate lists:
- Biologics approved by FDA’s Centre for Drug Evaluation and Research
- Biologics approved by FDA’s Centre of Biologic Evaluation and Research
The aforementioned lists have been replaced and discontinued after FDA releasing a single, searchable, online database, Purple Book Database, storing all the information about FDA approved / licensed biological products. This planned transitioning to online database is a step forward for ensuring improved transparency and accessibility for patients, industry users and other stakeholders. The information of the biologic product listed in Purple Book include:
- BLA tracking number
- Product Name
- Biologic product’s non-proprietary name
- If a biological product is a biosimilar or interchangeable one
- Application number
- Approval date
- Biosimilar information
- Date of licensure
- Date of first licensure- this indicates whether the biological product qualifies for reference product exclusivity and the expiration date to such exclusivity if applicable.
- Expiration date of Reference product exclusivity (12 yrs)- This exclusivity period disallows FDA from approving a 351(k) application until the exclusivity period of reference product is expired in 12 years from its first licensure.
Biologics Price Competition and Innovation Act, 2009
BPCI Act of 2009 amended the PHSA Act to create an abbreviated approval pathway for biosimilars or interchangeable biological products, which is comparable to the one created through Hatch-Waxman Amendments for ANDA applications under FD&C Act for the Orange Book. BPCI Act requires the BLA applicant to submit evidences supporting the claim that the biological drug is biosimilar to reference product. Evidences should show that the drug has same dosage, same route of administration and same strength as the reference biological product, and additionally, exhibits no clinically meaningful differences in terms of its purity, safety and potency from the reference product. Now for the designation of interchangeability, the BLA applicant must provide requisite information to demonstrate bisoimilarity as well as to show that the biological product has same clinical result as its correspondent reference drug when administered to the patient. Moreover, it is essential to demonstrate that a biological product when administered to a patient more than once, the risks associated in terms of its safety and diminished efficacy upon alternating or switching the reference product with the biological product, should not be greater than the risks associated when administering the reference product alone.[1] Section 351(i)(3) of the PHS Act implicates that once a biological product has received the designation of interchangeability, it can be in official capacity be substituted for the reference product with no intervention from the public health care provider. [2]
PURPLE BOOK CONTINUITY ACT, 2020
Patent Listing in Purple Book
Since its time of outset, Purple Book limited itself in providing information on a biological product’s labeling of being a biosimilar or its interchangeability to a reference biological product, and accommodated no listing of patents for such biological products. However, with the recent enactment of Purple Book Continuity Act (PBCA), FDA has for the first time imposed the requirement of patent listing of approved biological products as well as FDA regulatory exclusivity information. This transparency of patent information facilitates the biosimilar developers in getting hold of the patent information before the patent dance itself. Patent dance is a procedural concept formulated under the legislation of Biologics Price Competition and Innovation Act, intended to create an opportunistic space for patent dispute resolution between biosimilar applicant and biologic license holder, thus facilitating for a less elaborative approval route for biosimilar applicants. The preliminary step that needed to be furthered for the patent dance is the disclosure of such patent information that could otherwise possibly result in infringement by the biosimilar applicant, as per Section 1(3)(a) of the BPCI Act. As per the new law, a window period of 30 days is provided for the biologic license holders to share the disclosed patent information and its expiry dates to FDA which would later be incorporated in Purple Book.
Section 325 of the Consolidation Appropriations Act has specifically recognized for biological product patent transparency which upon preliminary concordance with the Public Health Service Act, has given FDA a period of 180 days from the date of enactment of the Purple Book Database. Moreover, FDA is required to update the list within 30 days after its first publication to include newly licensed products. In regards to the patent information that has been already subjected to the disclosure during the patent dance, requires the reference product sponsor to submit such list of patents and its corresponding expiry dates before FDA, within 30 days after such disclosure to the biosimilar applicant. [3]When the exclusivity of the biologic product has been duly determined or established by the Secretary of FDA, the product would be accordingly fitted into the Purple Book.
Implications of the Patent Information Requirement in Purple Book
With the new law creating an attic for the incorporation of patent information alongside with other details of the biologic product, it is essential to understand its implications on a biosmilar applicant. As mentioned before, patent information gets incorporated in the Purple Book database only upon following a standardized disclosure of the same by the biologic license holder to the section 351 (k) applicant during patent dance. This implies that only subsequent applicants can have an effective perusal of the patent information mentioned in the Purple Book and little impact on the first applicant. It is imperative to understand that this patent information provided and updated in Purple Book is not holistic at its preliminary view since it is totally dependent on the extent of disclosure engaged in by the license holder during the patent dance. hence, when a subsequent applicant peruse through the provided patent information in Purple Book, the possibility of the applicant getting ambushed by the license holder with its unidentified patent information still lies ahead.
Exclusivity Information
Under the new legislation, FDA is required to codify all the regulatory exclusivities for biological products including any attached pediatric exclusivities.[4] Initially the list did not identify periods of orphan exclusivities of the biological products and their expiration dates, which are usually listed in Orphan Designated and/or Approved Products.[5] However, the revised Purple Book database has listed information on orphan exclusivities as well. [6]
CONCLUSION
Though biosimilar and interchangeable products are not as dominant in market place as the generic drugs in pharmaceutical sector, it is prospectively expected that the marketing of biological products will potentially increase. Even the enactment of Purple Continuity act can be viewed as a step taken towards this potential shift in pharmaceutical market. The confidentiality shield that once protected the patent information of the products are partially lifted with the new listing requirement under the Act. Essentially, this compendium is facilitated for the pharmacists in comprehending the nature of the biological product and its administration in patients, and to implement pharamacovigilance on the biological products.
Author: Vaishnavi Suresh, Symbiosis Law School, Pune
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[1] The “Deemed To Be a License” Provision of the BPCI Act Questions and Answers Guidance for Industry, https://www.fda.gov/media/135838/download
[2] Public Health Services Act, Section 351(i)(3)
[3] Consolidated Appropriations Act, Section 325 (a)(A)(iii).
[4] FDA/CDER SBIA CHRONICLES, November 18th, 2014, https://www.fda.gov/media/90150/download.
[5] Designating an Orphan Product: Drugs and Biological Products, https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products
[6]Purple Book Database of Licensed Biological Products, https://purplebooksearch.fda.gov/downloads
Aug 19, 2012 | General, Trademark
Paytm is an Indian e-commerce platform primarily dealing with digital payments. In 2016, PayPal, an US-based international digital payment company accused Paytm of trademark infringement. PayPal issued a Notice of Opposition in Paytm’s trademark registration application under Class 38. With its presence in over 190 countries and having the competency to transact in over 100 currencies, PayPal has become one of the world’s largest online payment services.
After demonetization was implemented in India, there was a massive amount of increase in subscribers of Paytm. Paytm had 300 million registered users by August 2018. This figure compares with 520 million Alipay users and 237 million PayPal users around the same time. On average, one in five Indians had already started useing Paytm.
Paytm filed its application for trademark in 2012. However, it was advertised in the Trademark Journal (No. 1754) on July 18, 2016 only. Section 21 of the Trademark Act, 1999, enables any person to oppose a trademark by filing Form TM-5 within 3 months of the advertisement of such mark in the TM Journal, with a maximum extension of another month. PayPal filed its Notice of Opposition on November 18, 2016, with the Indian trademark office.
Contentions of PayPal (Plaintiff)
PayPal alleged that Paytm’s logo was “deceptively and confusingly similar” to its own. PayPal alleged that Paytm had “adopted the two-tone blue colour scheme” of its registered trademark logo. Also, the two brands start with the word “Pay” and has same nature of business existing in the same market, thus confusing consumers at a glance.
According to PayPal, Paytm has violated the following provisions:
- Section 9(2)(a) of the Trademarks Act, 1999, provides deception or confusion as an absolute ground for refusal of a trademark registration,
- Section 11 of the Act provides for similarity with an ‘earlier trademark’ as relative ground for refusal of a trademark registration,
- Section 11(2) states that usage of the similar trademark would be inimical to the distinctive character of its trademark, and
- Section 11(3) as it would amount to passing off.
- Paytm is precluded from relying on Section 11(4) of the Act which allows the applicant to seek the consent of the earlier trademark holder.
- Section 11(10) as there is an element of bad faith involved.
- Section 18 as it disallows the registrar from registering trademarks where there is no honesty involved, with the original proprietor being the owner of the trademark.
On the contrary, Paytm has declined to comment on the allegations.
Analysis
It is not appropriate for PayPal to claim exclusivity over a generic word like “Pay”. Delhi Hing Court has decided in a case that generic word like “Today” cannot be claimed to be exclusive by any of the news company groups.[1]
In India, the trademark law protects colors to the extent the colors or combination of colors confer a distinctive characteristic upon a product or service. Schedule 10 of the Trademarks Act deals with use of colors:
- A trademark may be limited wholly or in part to any combination of colors and any such limitation shall be taken into consideration by the tribunal having to decide on the distinctive character of the trademark.
- As far as a trademark is registered without limitation of color, it shall be deemed to be registered for all colors.
Here, the two-tone blue color in question, is not identical but they are similar.
Then, it has to be considered whether the whole package – name, font, and colors – used by Paytm and PayPal are similar enough for consumers, with average mind in India, to be misled into buying or choosing the other product.
As a matter of fact, ordinary consumers like fruit or vegetable vendors, taxi drivers, regular workers, small hotel owners, use and hear the word “Paytm” every day of their life, and they may not even know about the existence of PayPal. PayPal’s existence in the Indian market is limited generally to eBay shoppers, freelancers and IT software developers that are exposed to global economy much more than the ordinary consumers, which implies that if PayPal and/or Paytm were to conduct a survey, it would likely result strongly in favor of Paytm.
Order of the TM Registrar
The opponent, i.e., PayPal has withdrawn their opposition to the registration of Paytm’s trademark via a letter dated 25.06.2021. The order of the TM Registrar dated 12.07.2022, states that since PayPal withdrew their opposition, Paytm was successful in registering its trademark under class 38 in India.
Author: P.I. Shivamirthika.
Reference:
Mugdha variyar ‘Shades of brand envy in Paypal’s row with Paytm’ Economic Times (2016) available at https://economictimes.indiatimes.com/small-biz/startups/shades-of-brand-envy-in-paypals-row-with-paytm/articleshow/56057299.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst
Priyanka Pani, ‘Paytm has copied our logo: PayPal’ (2018) available at https://www.thehindubusinessline.com/info-tech/paytm-has-copied-our-logo-paypal/article64325546.ece
‘PayPal and Paytm Trademark Dispute’ (2016) Banana IP Counsels available at https://www.bananaip.com/ip-news-center/paypal-paytm-trademark-dispute/
Vasundhara Majithia, “The PayMark Battle: Whose Blue is it Anyway?” 2017 available at https://spicyip.com/2017/01/the-paymark-battle-whose-blue-is-it-anyway.html
Rahul Vijh, “PayPal Accuses Paytm of Trademark Infringement in India” (2017) available at https://www.ipwatchdog.com/2017/01/02/paypal-accuses-paytm-trademark-infringement-india/id=75995/
Samden Sherpa, “PayPal VS Paytm: Find Out What the Dispute is All About” (2016) avaible at- https://www.gizbot.com/apps/news/paypal-vs-paytm-find-what-the-dispute-is-all-about-036920.html
Arvind Panagariya, “Digital Revolution, Financial Infrastructure and Entrepreneurship: The Case of India” (November 18, 2019), SIPA’s Entrepreneurship & Policy Initiative Working Paper Series, 2019 available at http://dx.doi.org/10.2139/ssrn.3493341
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[1] Living Media India Ltd. & Anr. vs Alpha Dealcom Pvt. Ltd. & Ors.
Jul 7, 2012 | Indian Patents Act 1970, Patent
One of the prime stages in the process of getting a patent is publication of the patent application in official journal of the patent office. Publication of the application, in India, happens after expiry of 18 months from the date of filing patent application or from the priority date, whichever is earlier. The publication of application happens on its own without any specific request made by the applicant. The date of publication is very crucial because on this date, the patent application is published by the patent office and from this date, the invention forms part of the prior art.
If the applicant wants application to be published before expiry of 18 months, he/she must request for publication of the application before expiry of 18 months by making request in a prescribed manner for “Early Publication”. It is important to note here that provisional application is never published, and it is only the complete specification, which gets published. The advantages and disadvantages of early publication of the application are as below:
Withdrawal of application
Upon publication of the application, the invention forms the part of prior art. However, Indian patent law gives a chance to the applicant to withdraw application within 15 months from the date of filing and such withdrawal makes sure that confidentiality of the invention is maintained. In such a case, the inventor can further work on the invention and file the patent application again. If the applicant has opted for early publication, he loses the chance to withdraw the application.
Pre-grant opposition
The pre-grant opposition can be filed by any person, upon publication of the application and anytime before grant of the patent provided examination fee has been paid. Thereby, early publication certainly gives more time for the opponents for pre-grant opposition
Rights and Privileges of the patent holder
On and from the date of publication of application for the patent and until grant of the patent, the applicant has rights and privileges of the patent holder as if the patent for the invention has been granted to him on the date of publication, provided that the applicant shall not be entitled to institute any proceedings for infringement until the patent is granted. Moreover, in case of any infringement, the applicant can claim damages from the date of publication. Here, the applicant gets the advantages if he opts for early publication.
Infringement proceedings
No suit or other proceedings shall be commenced or prosecuted in respect of an infringement committed before date of publication of the application, meaning that publication of the application is critical to initiate any suit or any other proceeding.
Expedited Examination
As per the recent amendments and the provision of the Expedited Examination for certain categories of applicants, the early publication to be filed by the applicant to seek the benefit of Expediated Examination.
The period within which the Controller shall refer the application and specification and other documents to the examiner in respect of the applications where the request for examination has been received shall ordinarily be one month from the date of its publication or one month from the date of the request for examination whichever is later. Hence, it may be conclude that early publication of the application for a patent has certain advantages as well as disadvantages which shall be taken into account depending upon the circumstances and preferences of the applicant.
Author: Bindu Sharma
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May 23, 2012 | Contracts, General
An employer-employee relationship is established, and the terms and conditions of employment are laid out in a legally binding contract known as an employment agreement. Although the Shops & Establishment Acts (“S&E Acts”) of a few Indian states, including Karnataka, mandate that an employer shall issue an appointment letter, neither the employment agreements nor the issuance of appointment letters is expressly required by the labour laws. Typically, employers will write employment/appointment letters and complete employment contracts that explicitly state the terms and conditions of the employment. Important clauses of an Employment Agreement are as below:
- Roles and Responsibilities
It is important to make sure that the employer and the employee are on the same page with regard to what is expected from the employee. All the roles and responsibilities of the employees shall be expressly defined by the employer and clearly written in the employment agreement.
- Non-Disclosure and Confidentiality of the information
Employment Agreement typically includes a confidentiality clause to protect the employer’s proprietary information from the employee disclosure to or dissemination to third parties without authorization. An employee is required by this clause to take precautions to ensure that the information of the employer is kept confidential and is not disclosed to others, unless doing so is required by applicable law. This provision safeguards the employer’s proprietary and confidential information and prohibits the employee from disclosing such information to any third party. These conditions might also stipulate that employee’s hand over all of their employer’s confidential documents and information when their employment ends.
A prohibition was imposed by the Delhi High Court in Burlington Home Shopping Pvt. Ltd. vs. Rajnish Chibber on the use of the client/customer list on any business, including the mail order business, which was included in the petitioner’s database.[1]
The defendant in Diljeet Titus v. Mr. Alfred A. Adebare and Others was an employee of the plaintiff’s company. The plaintiff’s client list and important confidential business information, including several proprietary drafts, were taken by the defendant after he was fired from his position as an attorney. The defendant argued that because he worked on the specific data while employed, he was the owner of the data and had copyright over it. The Delhi High Court rejected the defendant’s argument and determined that the plaintiff owned the information, which was unlawfully taken from the plaintiff, and which the defendant was prohibited from using. It should be noted that while the defendant was prohibited from using such confidential information, the Delhi High Court did not prevent the defendant from offering a comparable service.[2]
Penalties for confidentiality breaches and unauthorized disclosure are provided by the provisions of the Indian Penal Code, 1860, and the Information Technology Act, 2000. With regard to the employee’s breach of confidentiality and disclosure, employers may also pursue remedies under Sections 66 (hacking), 43 (damaging computer systems), 65 (tampering with computer source documents), and 66E (punishment for violation of privacy policy) of the Information Technology Act, 2000.
- Non-Solicitation
To prevent current or former employees from engaging in any business activities that would be against the interests of the employer, non-solicitation clause is often incorporated into employment agreements. This clause limits and forbids employees from interacting with coworkers or clients/customers of the employer for personal gain, either while they are employed or after they leave their positions. This provision is included to safeguard the employer’s commercial interests.
In the case of Embee Software Private Limited vs. Samir Kumar Shaw the Calcutta High Court ruled that “acts of soliciting committed by former employees take such active form that it induces the customers of the former employer to break their contract with the former employer and enter into a contract with the former employee, or prevents other persons from entering into contracts with the former employer, cannot be permitted”.[3]
- Non-Compete
In an employment contract, a non-compete clause is included to ensure that employees are prohibited from starting competing businesses both while they are employed and after their employment has ended. According to Section 27 of the Indian Contracts Act of 1872, “Every agreement by which anyone is restrained from exercising a lawful profession, trade or business of any kind, is to that extent void.” Additionally, every citizen of India has the freedom to engage in any profession, trade, or business, according to Article 19 (g) of the Indian Constitution. However, employers typically include this provision in employment contracts to safeguard the company’s trade secrets and confidential information. The question of how restrictions can be imposed on employees after their employment has ended arises because it is widely accepted that employees may be prohibited from starting businesses or engaging in activities that compete with the company’s operations while they are still employed.
The CEO of the company, Mr. Kumar Apurva, was prohibited by the court in Kumar Apurva v. Valuefirst Digital Media Pvt. Ltd. from engaging in any activity that is in competition with the company as well as from soliciting, interfering with, disturbing, or attempting to disturb the relationship between the company or subsidiary and third parties, including any customers or suppliers of the company or subsidiary.[4]
In Ozone Spa Pvt. Ltd. vs. Pure Fitness & Ors., the court barred the defendants from starting, operating, or establishing any rival businesses in any location that is within 4 kilometers of the plaintiff’s premises. However, Section 27 states that all agreements restricting the practice of any profession are void if they are made with the intent to defraud, mislead, or cause irreparable harm to the employer, trade, or business. Therefore, reasonable restrictions are allowed and do not invalidate the contract.[5]
As a result, the employers typically impose reasonable limitations on this clause to ensure the protection of both the company’s and the employee’s interests.
- Term and Termination
The nature of the establishment, its location, and the category of employees, are all relevant considerations when it comes to India’s labor laws regarding termination. The Industrial Disputes Act of 1947 governs the dismissal of employees, and the S&E Acts of the relevant states govern the dismissal of non-employees. The length of the notice period to be given upon termination of employment and the severance payments that would be due to an employee upon termination are set forth in the state-specific S&E Acts.
By tendering his or her resignation, an employee may voluntarily end the Agreement. The clause specifically states the conditions and obligations that must be met by both the employer and the employee upon termination, as well as the length of notice that the employee must provide upon termination. A breach of the terms of the agreement, a false representation, fraud, misconduct, a failure to perform obligations and duties, among other things, may be grounds for such a termination of employment. A domestic investigation using natural justice principles should be conducted before any such termination. The employer will be required to complete a full and final settlement by paying the employee all statutory and contractual obligations.
Conclusion
Given the foregoing, it is advised that employment agreements be made between the employer and the employee and contain clauses outlining the terms and conditions of employment, both for the duration of employment as well as after termination of employment. The roles and responsibilities of the employees are outlined in employment agreements, giving the employees a clear understanding of what is expected of him or her both during the employment relationship and after it has ended. Most importantly, an employment agreement protects the company by including provisions like confidentiality, non-compete, and non-solicitation. These restrictive covenants are crucial in protecting against unauthorized information disclosure, the solicitation of existing employees, and clients, and the establishment of any rival businesses that might harm the employer’s business. Typically, employers will give probationary employees an appointment letter to cover the duration of their employment, and once they are hired permanently, they will enter into an employment agreement with them.
REFERENCES:
[1] 61 (1995) DLT 6.
[2] 2006 (32) PTC 609 (Del).
[3] 2012(3)CHN250.
[4] 2015 SCC Online Del 8360.
[5] 2015 222 DLT 372.
Author: Adyasha Das, Symbiosis Law School, Hyderabad
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Mar 9, 2012 | General, Patent
The National Dairy Research Institute (NDRI), a deemed university and a flagship institute of the Indian Council of Agricultural Research (IARI), has created low-cholesterol ghee that has been scientifically evaluated and contains up to 85 percent less cholesterol than traditional desi ghee. The unique technology, created by NDRI’s Dairy Chemistry Division, employs processing technology rather than chemicals, ensuring that the quality and taste of the finished product are identical to the original, with no additional manufacturing costs. Importantly, the procedure adheres to FSSAI requirements.
The NDRI has inked a Memorandum of Understanding with Vaishal Patliputra Dugdh Utpadak Sahkari Sangh Ltd Patna, also known as Patna Dairy Project, to launch the product in Bihar. The Patna Dairy Project has been given access to the technology for a low charge of Rs. 6 lakhs, with no time constraints.
This product is likely to appeal to India’s large health-conscious population. As a result, the NDRI is contacting Haryana and Punjab to see if this product can be made available in these states as well. The substance is safe for cardiac patients, but it can also be consumed by healthy people with no negative side effects.
PRODUCT THAT HAS BEEN SCIENTIFICALLY TESTED
This variation, which is a scientifically verified product, had a lot of potential in the cooperative sector.
This was the first time that technology created five years ago, had been transferred to a milk cooperative society.
“NDRI and Vaishal Patliputra Dugdh Utpadak Sahkari Sangh Ltd Patna, also known as Patna Dairy Project, inked a memorandum of understanding. The product will be launched by Bihar dairy officials, and it is a big dairy brand in the state “Srivastava stated.
NDRI is a famous research institute of the Indian Council of Agricultural Research and is a deemed university (ICAR). According to Srivastava, the low-cholesterol technology was given to a private dairy firm in 2011-12 with exclusive rights for five years.
“Following the completion of the contract, NDRI has chosen to make the technology available to the general public. The technology may be obtained for a minimal charge of Rs. 6 lakh, with no time limit”
“It’s a simple technology that adds no further costs to the production,”
GOOD FOR CARDIOVASCULAR PROBLEMS PEOPLE
Even though low-cholesterol ghee is highly advised for persons with cardiovascular problems, he claims that healthy people can consume it without harming their health.
Srivastava said he will meet with Vita authorities in Haryana, Verka officials in Punjab, and other cooperative dairy officials shortly to convince them to embrace the revolutionary method. “The cooperative sector should abandon traditional techniques in order to get into the massive diet-conscious market. For the new ghee to conquer the market, the cooperative should focus on smaller communities as well “he stated Srivastava said that the ghee made with the technique met all of the Food Safety Standards Authority of India’s (FSSAI) criteria and tasted and looked like regular ghee.
Cholesterol is a fatty substance that can lead to heart disease. Although cholesterol is produced in the body, the majority of it comes from the foods we eat. Cholesterol levels are high in fat-containing foods, such as egg yolk, red meat, and high-fat dairy products. High-density lipoproteins (HDL) (“good cholesterol”) and low-density lipoproteins (LDL) (“bad cholesterol”) are the two forms of cholesterol. Because of lipid accumulation in the arteries, too much LDL cholesterol causes obstruction. This is especially problematic when it comes to the heart’s coronary arteries, which can lead to heart attacks. HDL cholesterol is healthy for the heart because it eliminates cholesterol from the blood vessels.
It’s critical to understand the specific quantities of cholesterol in diets so that high-cholesterol foods can be avoided. As a result, the FSSAI has stipulated, in accordance with the Food Safety and Standards (Packaging and Labeling) Regulations, 2011, that complete nutritional information, including cholesterol (in mg) in relevant food items, must be clearly labeled on the packet so that consumers can make an informed decision based on their needs.
Conclusion
The National Dairy Research Institute (NDRI) here has decided to encourage milk cooperative societies in Haryana and Punjab to launch similar products to meet the demand of the health-conscious section of the society, just a day after transferring technology for low-cholesterol ghee to a Bihar-based co-operative dairy.
Author: Pratik Maitra, Symbiosis Law School, Hyderabad
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