by Aggarwals Associates | Feb 2, 2023 | General
- PAN Card as a common identifier: PAN Card is to be identified as a common identifier for all digi-system as specified in government agencies.
- MSME:
- Revamped credit guarantee to all the MSMEs that will be applicable from April 1, 2023, with 9000 Crores in the corpus.
- Collateral-free credit of 2 lakh crore to the companies registered under MSME.
- Cost of credit is decreased by about 1 per cent for the companies registered under MSME.
- Employment or Job: Schemes have been launched for employment generation.
- Pradhan Mantri Kausal Vikas Yojana 4.0
- 30 Skill India International Centres will be set up across different states. The centre is established for the skill enhancement of youth for International opportunities.
- Green Hydrogen Mission: The amount of 19700 crores is granted to the National Green Hydrogen Mission. The mission aims to reach 5 million tonnes in hydrogen production capacity by 2030.
- Defence: The budget for the defence department is increased by 5.94 lakhs from 5.25 lakhs. Moreover, 1.62 lakhs crore is granted for the capital expenditure for the purchase of weapons or other essential purchases. The budget for border road organisation is increased by 5000 Crore, whereas Indian Air Force is alloted with 57,137.09 Crore, Indian navy with 52,804 crore , Army with 37,241 crore and the outlay of 23,264 is granted to the defence research development organisation
- Railway: The total outlay of 2.4 lakh crore is granted for boosting affordable regional connectivity and logistics of cargo freights.
- 157 new Nursing colleges have to be established in the core areas.
- National Digital Library for children and adolescents.
- 3 centres for excellence of AI (Artifical Intelligence). The objectives of establishing these centres are to make AI for India and to make AI work for India.
- 100 labs for developing apps using 5G services.
- The outlay of 7000 crores for Phase- 3 e courts
- Central Processing centre is established for ensuring faster response in a company filing.
- Capital Investment: The outlay of 10 crores to capital investment for job creation and crowd in private investment.
- Aviation: Fifty additional airports, helipads, water air drones, and advanced landing grounds have to be established in the upcoming years for the upliftment purpose.
Surbhi Singla
Associate at Aggarwals & Associates, S.A.S Nagar, Mohali
by Aggarwals Associates | Feb 2, 2023 | General
The union budget is presented by the Finance Minster every year on the 1st of February. The budget is presented on the 1st of February to materialise all the necessary things from the new financial year. The union budget is presented by Nirmala Sitharaman in 2023 in virtual mode (Bhahi Khata) form.
The key highlights or crux from union budget 2023 are as follows:
- Schemes and extensions in the budget: Various schemes are launched and in some schemes, the validity and investments are increased.
- The deposit for the monthly income scheme is doubled to 9 lakhs and 15 lakhs in the case of the joint account.
- Mahilla Samman Saving Scheme: The scheme is launched for the upliftment of women and girls in society. According to the scheme, an amount of up to 2 lakhs can be invested in the name of women or girls for the period of 2 years. The interest rate for which is 7.5 per cent and also the partial withdrawal is available for the users.
- Senior Citizen Saving Scheme: The investment limit for the scheme has been increased to 30 lakhs from 15 lakhs.
- Dekho Apna Desh Initiative: The initiative aims to establish 50 new desti unit malls in the state for the promotion of tourism.
- PM Awas Yojana: The budget for this yojana is enhanced by 66% to over 79000 Crore.
- Vivad se Vishwas 2 Scheme- The scheme is launched for easy settlement of commercial disputes bet
- New Tax slab: According to the new tax regime there is a rebate in tax for income up to 7 lahks. In simpler terms, taxpayers whose annual income is up to 7 lakhs are exempted from tax.
- The new tax slabs are as follows:
Up to 3 lakh- 0% tax
3-6 lakhs- 5% tax
6-9 lakhs- 10% tax
9-12 lakhs- 15% tax
12-15 lakhs- 20% tax
More than 15 lakhs – 30% tax
Standard deductions for salaried and individual taxpayers.
The surcharge rate reduced from 37% to 25%.
No exemption on proceeds of insurance policies with premiums more than Rs. 5 lakhs.
by Aggarwals Associates | Jan 30, 2023 | Criminal Lawyers, General
The definition of sexual harassment is well-defined in the POSH Act, It states that “sexual harassment is any unwelcome sexual behavior, whether directly expressed or implied, and includes the case of physical contacts and advances, or sexual favour demanded or requested, or making remarks with sexual overtones, or showing pornography or other offensive material, or acting in an unwelcome sexual manner through physical, verbal, or non-verbal means.
What are the different provisions under PoSh Act?
Conciliation: Conciliation plays an important role in dispute resolution as it is always gives win- win solutions to the parties. It is an effective form of ADR ( Alternative Dispute Resolution) mechanism in which a third party, conciliator helps in resolving the dispute by giving multiple solutions to both of the parties. The matter related to the POSH can be resolved by the method of conciliation but it cannot be resolved on monetary terms.
Interim Relief: The victim can get one of the following interim reliefs in the POSH Act:
Relocation for any of them.
There is a provision of 3 months’ leave for the aggrieved women.
Confidentiality Report
Punishment for false complaint:
The Act consists of provisions for the false complaint to prevent bogus allegations and to protect the interest of employees. The provisions of false complaints are very essential to protect the innocents. The person filing false complaint will be entitled to one of the following punishments:
A written apology letter by the complainant.
The promotion of such a person can be withheld by the company.
The pay rise or increment can be withheld by the company.
Termination of services, etc.
View of Legislation on false complaint related to sexual harrasment at work place
The High Court of Delhi imposed a hefty fine of Rs. 50000 on the petitioner
for filing a false case against the respondent in the case named Anita Suresh
vs Union of India & Others, P (C) 5114/2015. This clearly states that the
legislation is strict for false and misleading complaints.
The legal procedure to file a complaint of sexual harassment?
The victim can complain to the internal committee in the company and then to the complaint committee. Also, the aggrieved person can claim under various other provisions provided under Indian legislation such as sec 354 of IPC (Indian Penal Code)
It is pertinent to mention here that the time period for filing a complaint is three months but can be further extended to three months depending on circumstances. Moreover, if the victim herself is not able to complain she can complain through the appropriate person as provided under the legislation.
What are the different loopholes in the POSH Act?
Gender Biased: The provisions stated in the Act is specifically for female employee that depicts that only women are subjected to sexual harassment. This is the major drawback of the legislation that it is gender biased.
No protection for the informal sector: The legislation does not have specific provisions for the informal sector, this shows that the legislation is biased toward the informal sector as the complaint by this sector is not taken into consideration.
The legislation deals with all the basic provisions such as definition, punishment, and appropriate channels to complain. Also the Acts contains provisions for false complaints that is utmost necessary in this legislation. Every employer should add the provisions for sexual harrasment to ensure healthy environment at work place in their employee manual and also to take initiative for arranging awareness campaign at fixed intervals of time.
Surbhi Singla
Associate at Aggarwals & Associates, S.A.S Nagar, Mohali
by Aggarwals Associates | Jan 24, 2023 | Criminal Lawyers, General, Labour Law Lawyers, MSME, Parliament
The Sexual Harassment of Women at Workplace (Prevention, Prohibition, and Redressal) Act, 2013(herein after referred as PoSH Act) is the first and the only legislation in Indian laws that deal specifically with sexual harassment of Women at the workplace. Though, India has several criminal and civil provisions that are related to sexual harassment and also have prescribed punishment for the same under section 354 of the Indian Penal Code (hereinafter referred to as IPC) which speaks about outraging the modesty of a woman. The defined punishment of which is 1 year of imprisonment or fine or can be both depends on the discretion of the court.
What is Sexual harassment?
The definition of sexual harassment is well-defined in the POSH Act, It states that “sexual harassment is any unwelcome sexual behaviour, whether directly expressed or implied, and includes the case of physical contacts and advances, or sexual favour demanded or requested, or making remarks with sexual overtones, or showing pornography or other offensive material, or acting in an unwelcome sexual manner through physical, verbal, or non-verbal means.
Who is Employee under the PoSH Act?
Section 2(f) “employee” defines any person employed at a workplace on a regular, transitory, ad – hoc basis, or daily salary basis, whether directly or via an agency, including a contractor, for any task, with or without the knowledge of the principal employer, whether for remuneration or not, or working voluntarily or otherwise, whether the terms of employment are express or implied, and entails a co-worker, probationer, a contract worker, trainee.
What are the different objectives of the PoSH Act?
PoSH is an act to protect, prevent and prohibit sexual harassment of women at workplace. The main objective of the PoSH Act is to provide a safe and healthy workplace to each and every employee of any organisation. In addition to this it is essential to give a dignified life to all their female employee. The sexual harassment not only means physical torture but it also includes passing sexual comments, bullying, body shaming, taunting and other minor things by the colleagues and higher authorities.
What are the two main committees constituted under PoSH Act?
The two main committees constituted under PoSH Act for preventing the sexual harassment at work place: Internal and Local Committees.
Internal Committee: It is mandatory for every organisation to set up an internal committee if the company is equipped with more than 10 or more employees. The committee is to be formed under the provisions of the PoSH Act and the quorum of members is to be decided according to the provisions of the legislation. The non-compliance of which will attract a fine of Rs.50,000.
Local committee: A local committee is established in each district for dealing with the matter of sexual harassment in the workplace. Before registering the complaint in the local committee, one should go to the internal committee. The committee is established under Section 5 of the PoSH Act by repealing &the Amendment Act of 2016.
Powers of the committee: With the introduction of two different committees, powers are also specified in the Act. The committee can
- Summon and interrogate the accused person under the oath.
- Can ask for the discovery of documents.
- Any other things that are essential for the case.
The legislation deals with all the basic provisions such as definition, punishment, and appropriate channels to complain for any sort of physical and mental harassment faced by any women at their workplaces and it also assures that the women stays safe.
–Surbhi Singla
Associate at Aggarwals& Associates, S.A.S, Nagar Mohali.
by Aggarwals Associates | Jan 18, 2023 | General
Immigration and human rights are closely related, as the human rights of immigrants and refugees are often at risk during the immigration process. The Universal Declaration of Human Rights, adopted by the United Nations in 1948, guarantees the right to leave any country and the right to seek asylum in other countries. However, in practice, many countries have immigration policies and practices that violate these rights. This can include the detention of immigrants and refugees in inhumane conditions, denial of due process, and discrimination based on race, religion, or national origin. It is important for governments to ensure that their immigration policies and practices comply with international human rights standards and to protect the human rights of all individuals, including immigrants and refugees.
Constitutional provisions for immigrants in India.The Constitution of India does not have specific provisions regarding immigration. However, it does contain several provisions that are relevant to the rights of immigrants and their treatment in India.
Article 14 of the Constitution guarantees the right to equality before the law and prohibits discrimination on the grounds of religion, race, caste, sex, or place of birth. This applies to immigrants as well as Indian citizens.
Article 21 guarantees the right to life and personal liberty, which includes protection against arbitrary arrest and detention. This applies to immigrants as well as Indian citizens, and would require that any detention of immigrants be in accordance with due process of law.
Article 23 prohibits forced labour, which would prohibit the use of immigrants as forced labour.
Article 24 prohibits the employment of children below the age of 14 years in any factory, mine or other hazardous employment.
Article 39(e) & (f) directs the state to make provisions for securing just and humane conditions of work and for maternity relief.
And also, India is also a signatory to several international human rights treaties, such as the International Covenant on Civil and Political Rights and the Convention on the Rights of the Child, which contain provisions that are relevant to the rights of immigrants and refugees.
Remedies for issues in case of violation of Human rights in India
If an immigrant in India believes that their human rights have been violated, they may have several avenues for seeking remedies. Some possible remedies include:
Complaint to the police: If the violation is a criminal matter, such as physical assault or theft, the immigrant can file a complaint with the police.
Complaint to the National Human Rights Commission (NHRC): The NHRC is an independent body established by the Indian government to investigate human rights violations. Immigrants can file a complaint with the NHRC if they believe that their rights have been violated by government officials or agencies.
Legal action: If the violation is a civil matter, such as employment discrimination or denial of housing, the immigrant can take legal action in a civil court.
International remedies: If the immigrant is a refugee or asylum seeker, they may be able to seek remedies through international organizations such as the United Nations High Commissioner for Refugees (UNHCR).
Complaint to the office of State Human Rights Commission(SHRC): Each state in India have their own SHRCs to investigate human rights violation by a government official or non-government actors within the state.
They can also seek help from non-government organizations that work on immigrant rights and provide legal assistance.
-Surbhi Singla
Associate at Aggarwals & Associates, S.A.S Nagar Mohali.
by Aggarwals Associates | Jan 6, 2023 | General, MSME
What are the benefits of registering a company under MSME?
There are multiple advantages of registering the company under MSME some of the common benefits are mentioned below:
Protection against delayed payment: The ministry provides that the buyer has to pay the billed amount within 15 days after receiving the product or service in case the payment is not decided. In addition, the owner of MSME can charge interest on the delayed payment if the payment is delayed by 45 days.
Rebate in Tax: The companies registered under MSME are having multiple benefits in terms of payment. Additionally, the companies are excluded from the audit and inspection.
Discount in patent filing: The ministry of MSME gives a 50% of instant discount at the time of patent filing to promote small-scale industries.
Easy Bank loans are collateral-free and have less interest rate: The companies registered under MSME get collateral-free loans from the bank and also the interest rate on bank loans is very less as compared to other companies.
Worldwide business exposure: The ministry provides every opportunity for the MSME enterprises to connect globally and makes space in the international market. The exhibition, seminars, and all international events can be accessed by the companies registered under the Ministry of MSME.
Discounts on Electricity Bills: The companies registered under MSME are eligible to avail reimbursement for the electricity bill.
No fees for ISO certificate: If the company submits the application for an ISO certificate with the registration certificate of MSME, the certificate will be issued free of cost after fulfilling all the essential conditions.
Reimbursement for technology upgradation: The cost incurred on the installation of clean technology and the audit cost and other expenses will be reimbursed by the Government in order to keep the companies updated on the latest technology.
There are some basic questions that create confusion in the mind of people. Here is answer to all their queries.
Whether the start-up companies are eligible for registration under MSME?
Yes, start-up companies can register themselves under MSME using the UAM (Udyog Aadhar Memorandum) portal.
Whether Pharma Companies are eligible for registration under MSME?
Yes, Pharma companies can register themselves under MSME by following the online registration procedure.
What are the documents that are required for registration purposes?
For registering under MSME one must have a valid Aadhar Card, Pan Card, and GST details are the basic document requirement.
Is it compulsory to obtain GST for registration under MSME?
Yes, GST registration is mandatory for the registration of companies under MSME.
How much cost is required for registering under MSME?
The registration process under MSME is free of cost.
What is the procedure to register under MSME?
The entire procedure of registration is online. One can register himself by submitting basic information and documents on the online portal.
In order to promote micro, small and medium enterprises the Government of India is giving numerous benefits to these companies. Also, the registration of companies under the ministry of micro, small and medium company is free of cost.
Surbhi Singla
Associate at Aggarwals & Associates, S.A.S Nagar, Mohali
by Aggarwals Associates | Jan 4, 2023 | General, MSME
The Government of India is encouraging start-ups and small businesses. In pursuance of this, it has established the Ministry of MSME (Micro, Small & Medium Enterprises). This ministry is regulated by NSIC (National Small Industries Corporation Ltd). The companies can register themselves under the MSME ministry if they fall under the eligibility criteria of same.
What is MSME?
Before going further, one has to study the definitions of Micro Small and Medium Enterprises.
Micro Enterprises: The companies whose investment in plants and machinery is upto one (1) crore and the total turnover does not exceed five (5) crore falls under the category of micro enterprise.
Small Enterprises: Those companies whose investment in plant and machinery is upto ten (10) and the total turnover does not exceed fifty (50) crores fall under the category of small enterprises.
Medium Enterprises: The companies whose investment in plant and machinery is upto fifty (50) crores and the total turnover does not exceed two hundred and fifty (250) crores fall under the category of medium enterprises.
What are the important changes that came after the amendment in 2020?
With the amendment in MSME criteria following things are also changed with respect to MSME:
- Retail and Wholesale businesses are now included in MSME.
- The limit of investment and turnover is increased as mentioned above.Now, the export turnover is not added to the total turnover.
- Now, the depreciation cost is calculated as per the IT (Information Technology) Rules instead or Commercial rates,
- Now, the threshold limits are the same for the manufacturing and service sector as the different limits for the different sector is creating confusion in the mind of people.
What are the different opportunities provided by MSME?
- The MSME provides employment opportunities to workers and unemployed people.
- The MSME provides growth opportunities to small scale businessmen who are not able to grow due to lack of money.
- The MSME provides development opportunities to skilled labours by providing training at regular intervals.
- The MSME provides opportunities to grow in the international market by providing the basic framework and access to international programmes and seminars.
Why MSME is important for the Indian economy?
- MSME contributes in the growth of rural development as it provides employment opportunities in rural areas.
- With the introduction of MSME the export rate of India is increased than before.
- Highest contributors to GDP after agriculture.
- MSME promotes innovations by bringing new ideas into the market which eventually leads to increased competition in the market.
With the growth of MSME, India is moving towards a developed country as MSME is creating employment opportunities and the technology upgradation that eventually supports the national economy and acts as defence from global economic threats.
..Surbhi Singla
Associate at Aggarwals& Associates, S.A.S Nagar, Mohali
by Aggarwals Associates | Dec 20, 2022 | General
Labels and labeling materials are the main sources of information for consumers since they include valuable details on the safe and reliable use of a drug product (such as indications, pharmacologic class, and dose), as well as details about quality. An essential component of the pharmaceutical sector is effective packaging. During storage, selling, delivery, and use, it safeguards the medication. Pharmaceutical items are packaged differently depending on the type of drug since they may interact with one another.Then the process of importing the medicines and medical devices plays a major role in bringing them into the market. For ensuring the proper functioning of medicines and medical devices, it is necessary to comply with the labeling, packaging, and importation requirements provided under the law. The following are the provisional requirements for the process of labeling, packaging and importation of medicines and medical devices, which includes;
- Labeling Provisions and Requirements
For medical devices:As per Section 109-A of the Drugs and Cosmetics rules, 1945 every medical device in practice in India should be labelled according to the Indian standard specifications laid down by the Bureau of Indian Standards and also must be inconsistent with any other rules laid down under this provision. The outer covering of the medical device must be labelled which must contain the following information:
- Name of the device, the manufacturer, and the address of the manufacturing premises.
- Details for identification.
- The correct statement of net quantity in terms of weight
- Medicinal or biological indication.
- The lot no. or batch no. along with the manufacturing no. or license no.
- Warnings or precautions for the usage of such devices.
- Single usage indication.
- Clinical investigation label.
- Indication of using the device as a free sample for medical device.
- In-vitro diagnostics indication.
- Any other symbols as may be recognized by the Indian standard of specifications.
For Medicines: For the purpose of labeling the drugs as per Section 96 of the Drugs and Cosmetics Rules, 1945 it is essential to print the following information on the label of the drug:
- Name of the drugs.
- A correct statement of the net content in terms of weight, measure, volume and number of units.
- The content of the active ingredients.
- Name of the manufacturer and the address of the manufacturing premises.
- A distinctive batch number.
- Packaging Requirements
The proper packaging of medicines and medical products is very much essential to manage all the aspects of quality of the medicines. The following are the packaging requirements:
- Containment of the ingredients.
- Selection of proper packaging material for maintaining stability.
- Protecting the main pharmaceutical product from external factor
- Effective storage must be made while packing.
- Importation Requirements
For the purpose of importation of medicines and medical devices, the following particulars are essential:
- Sale or distribution license obtained by the foreign manufacturers and the local authorized agents.
- Covering Letter.
- Application form
- Copy of import permission
- Authorization letter
- Schedule D (I) and (II), an undertaking duly sealed, signed and stamped by the manufacturer or his authorized agent or the Indian agent.
- Free sale certificate
- Manufacturing License & Market authorization Certificate
- Establishment License
- Inspection or Audit Report
- An Undertaking from the proprietor of the firm (in the case of proprietorship firm)
- An Undertaking from the Board of Directors (BoDs) (in case of a Private Limited Company)
The evidence of the accuracy of scientific content related to the drug can be made only when there is proper compliance with their statutory requirements. There should be strict enforcement of laws related to labeling content and format of prescribed drugs, packaging of such drugs, and other importation regulations for better and safer use of medicines. While for other products these requirements indicate a procedural necessity alone but for pharmaceutical products, these requirements form a crucial element both from the provider as well as user point of view. Hence compliance to these requirements is essential for the labeling, packaging and importation of medicines and medical devices.
-NAGARJUN.S
Intern at Aggarwals & Associates, S.A.S. Nagar, Mohali
by Aggarwals Associates | Dec 16, 2022 | General
BRIEF:
Advertising of pharmaceuticals and medical equipment to consumers is strictly regulated. The “Uniform Code of Pharmaceutical Marketing Practices” (UCPMP) is a set of regulations that the Central Government published in December 2014 to provide advice to the pharmaceutical and medical device industries. These recommendations, however, are not already binding laws and are voluntary.
The government is considering creating a unique regulation called the Uniform Code for Medical Device Marketing Practices (UCMDMP) to regulate the marketing of medical devices. The code hasn’t been finished, though. The UCPMP should be regarded as the official policy for medical device promotion by medical device businesses up until the UCMDMP is formally issued.
ISSUES:
- What are the specific laws that govern the marketing aspects of the materials in the pharma sector and whether is it codified?
- What are the separate marketing requirements for advertising materials, brochures, videos, and slogans in the Indian pharmaceutical sector?
APPLICABLE LAW:
Currently, there is no explicit regulation in India that governs how businesses can advertise and market their products to healthcare professionals (HCPs). Contrarily, the promotion of medications and medical devices to consumers is closely regulated. The “Uniform Code of Pharmaceutical Marketing Practices” (UCPMP) is a set of regulations that the Central Government published in December 2014 to provide advice to the pharmaceutical and medical device industries. These recommendations, however, are not already binding laws and are voluntary.
SOLUTIONS OFFERED:
- For marketing promotional materials
The following information must be given clearly so that the persons qualified to prescribe or supply the promotional material have had sufficient knowledge about that material, which includes: the relevant drug, the name, and address of the holder of the authorization of the drug or the business name and address of the part of the business responsible for the marketing of such drugs.
A statement stating that more information is available upon request; adverse reactions; warnings and precautions for usage; and pertinent contraindications of the product; the date on which the aforementioned material was created or last updated. Advertising in journals and other promotional materials such as mailings cannot be disguised as something else. Promotional content that a pharmaceutical corporation purchase obtains, or arranges for its publication in journals must not resemble editorial content. Regardless of editorial control over the content, any promotional materials appearing in journals whose publication is paid for, secured, or organized by a firm and referencing by brand name any product of that company must comply with (the standards immediately above) as necessary.
Promotional materials must be written and illustrated in a manner that complies with good taste standards, respects the receivers’ profession, and avoids any situations where they might be offensive. In promotional materials, healthcare practitioners’ names or images are not permitted to be utilized. Promotional materials cannot include devices, phrases, or general layouts used by other businesses in a way that could confuse or lead to misinformation. The date of printing or the time of the most recent examination of promotional materials must be provided when appropriate (for instance, in technical and other instructive information). Anything that the general public might interpret as advertising must not be included on postcards, other exposed mailings, envelopes, or wrappers.
- For the purpose of Brochures containing general information
A drug cannot be advertised before receiving the appropriate authority’s marketing approval, which permits its sale or supply. The terms of the marketing approval must be followed when promoting a medicine. Information concerning drugs must be accurate, current, and based on responsible knowledge of current events. Information about drugs must be truthful, objective, fair, and balanced, and it cannot inadvertently or overtly mislead. Information needs to be able to when members of the medical and pharmacy professions, including those who work in the pharmaceutical sector, request evidence under the aforementioned provision, that evidence must be delivered right away.
- For the purpose of samples
No one who is not licensed to prescribe the medicine in question may receive free samples of it. When a medical representative gives out product samples, the sample must be given directly to the person who is qualified to prescribe the product or to the person who has been designated to accept the sample on their behalf. Samples must be given in the following circumstances to a person licensed to prescribe the product: These samples are only given in extraordinary circumstances and are given so that recipients can gain experience working with the product in question. Such sample packets shall only contain the prescribed dosages for the necessary course of treatment for three individuals; the size of each sample pack must not exceed that of the smallest pack currently on the market. Each sample shall be accompanied by a copy of the most recent Product Information (as required by the Drug and Cosmetic Act, 1940) relevant to that product. Each sample shall be marked “free medical sample – not for sale”. The provision of a sample of an antidepressant, hypnotic, sedative, or tranquilizer by a pharmaceutical business is prohibited. The companies will keep records of information like the product name, the doctor’s name, the number of samples delivered, the date of the free samples were distributed to healthcare professionals, etc.
Pharmaceutical industry regulations are subject to frequent change, so it is up to businesses to fully comprehend how these changes affect their marketing strategies when they advertise to the general public. The rules governing promotional materials are intended to protect consumers by ensuring that they receive accurate information that enables them to make wise health decisions and to promote an equitable market in general.
NAGARJUN.S
Intern at Aggarwals & Associates, S.A.S. Nagar, Mohali
by Aggarwals Associates | Dec 15, 2022 | General
1.Quality Agreements
Parties taking part in contracts for manufacturing of pharmaceutical products sign quality agreements. They specify how every party will adhere to the Current Good Manufacturing Practices (CGMPs). The Food and Drug Administration (FDA) enforces CGMPs or current good manufacturing practices. Supplier and vendor quality agreements specify the conditions governing the calibre of supplies or services provided to a pharmaceutical manufacturing facility. The FDA advises parties involved in contract manufacturing to use quality control procedures. This guidance expands on the recommendations and guiding principles for quality risk management provided in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance to highlight important ideas for creating and implementing quality agreements that specify and support contract manufacturing arrangements.
2. License Agreements
License agreements are contracts between two parties, typically a pharmaceutical lab and a medication firm. The lab creates novel medications and files for a patent on them. The lab then issues a pharmaceutical business with a license to manufacture these medications. This is frequently observed in a market where a laboratory lacks the resources necessary to create medications on a wide scale and instead offers a license to bigger pharmaceutical corporations with sufficient resources to accomplish the same.
3.Product Supply Agreement
The product supply agreement is a legal contract between a seller and a purchaser of drugs or other pharmaceutical products. The agreement’s terms and conditions, as well as the consequences of breaking them, are detailed in the contract.
4.R&D Agreements
Pharmaceutical companies enter into cooperative R&D agreements in which the parties agree to collaborate on the innovative work and subsequent commercialization of a drug.
5.Technology-based contracts
Pharmaceutical companies collaborate with Contract Research Organisations (CRO) and other logical, innovative suppliers, such as biochemical plants. They donate the equipment these businesses require for their labs to conduct research or produce medications. The management of clinical preliminary exams is frequently under time pressure, with the passage of time, particularly in the period leading up to the start of a clinical preliminary, playing a crucial role in the worldwide competition. It should be possible to complete the fundamental agreements between the parties involved quickly, effectively, and with substantial content in order to have the option of beginning a clinical preliminary as early as is reasonably possible. As a result, rules would be useful if they were made available to likely legally binding partners during their specific arrangements. This would lead to an improvement in those arrangements. Model contract clauses give examples of explicit legally binding arrangements that frequently repeat in agreements overseeing the lead of clinical preliminary procedures.
Contracts play a fundamental role in every exchange, whether it’s buying goods and services from suppliers, accelerating the development of pharmaceuticals, managing medical professionals or Contract Research Organizations for clinical trials, or bringing in discounters and Pharmacy Benefit Managers on the sell side.
NAGARJUN.S
Intern at Aggarwals & Associates, S.A.S. Nagar, Mohali.
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