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.
by Aggarwals Associates | Dec 14, 2022 | General
Registration of medicines and medical devices is an indispensable requirement for the manufacturing and usage of medicines and medical devices in India. The proper identification of the medicines and providing the requirements for their safe use are the main goals of drug registration. Enforcement measures and proper guidelines can be instituted upon the manufacturers and users of these drugs and devices only when there is a statutory obligation behind it to do so. The rules and guidelines specified under these Acts play a major role in the proper use of consumption of drugs and medical devices.
Laws governing Medicines in India:
- Drugs and Cosmetics Act, 1940: The Drugs and Cosmetics Act, of 1940 regulates the import, manufacture, and distribution of drugs as well as medical devices in India. The primary objective of the enactment of the Drugs and Cosmetics Act, of 1940 is to ensure that the drugs and cosmetics sold in India are safe, effective, and conform to state quality standards.
- Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954: The legislative intent in devising the Drugs and Magic Remedies (Objectionable Advertisements) Act is to control the advertising of drugs in India. It prohibits advertisements of drugs and remedies that claim to have magical properties and indulging in such advertisements of drugs is claimed to be an offense under this Act.
- Pharmacy Act, 1940 (Rules by the Pharmacy Council of India): The Pharmacy Act was brought in to regulate the profession of pharmacy and to constitute pharmacy councils. For the purpose of registering as a pharmacist under the Pharmacy Act, the country’s pharmacy education is regulated. Regulation of Pharmacy Practice and maintaining pharmacy as a profession is the core objective of this Act.
- Guidelines under Central Drug Standard Control Organisation (CDSCO): Under the Drugs and Cosmetics Act, CDSCO is answerable for the approval of New Drugs, Conduct of Clinical Trials, laying down the requirements for Drugs, manage over the high-satisfactory of imported Drugs, and coordinating the sports of State Drug Control Organizations with the aid of using imparting professional recommendation on the way to result in the uniformity within side the enforcement of the Drugs and Cosmetics Act.
CDSCO together with kingdom regulators is mutually answerable for providing licenses of positive specialized classes of important Drugs which include blood and blood products, I. V. Fluids, Vaccine, and Sera.
Laws Governing Medical Devices in India:
- Drugs and Cosmetics Act, 1940
The statute framing the rules for manufacturing medical devices is the Drugs and Cosmetics Act, 1940. The notification of devices through this Act is very much essential to carry out their usage.
- Medical Devices Rules, 2017
The Licensing Application process for medical devices in India is being carried out by these rules and it is applicable to in-vitro diagnostic medical devices. The latest amendment to these rules were brought in 2020.
Process involved in the registration of medicines in India
- Submission of Documents: To prevent persons from abusing or misusing such products, access to medications and drugs must be controlled and restricted. As a result, the Pharmaceuticals and Cosmetics Act of 1940 makes it mandatory for all pharmacists, distributors, retailers, producers, sellers, dealers, and importers of drugs, cosmetics, and Ayurveda, Siddha, and Unani drugs to get drug licenses. These licenses are issued in the form of certificates. The following documents must be enhanced for the purpose of registering the medicines in India, which includes;
- MOA and AOA
- ID proof of the partner/director/promoter
- Copy of ownership documents of properties along with site plan of the premises for manufacturing of the medicines.
- Copy of board resolution permitting the grant of license.
- Proof that storage capacity is available, including cold storage, a refrigerator, etc.
- Copy of challan as evidence of fee deposit
- Affidavit regarding the firm and its owner, partners, and directors not being convicted.
- Cover letter with the name of the applicant
- Declaration form
- Applicant’s qualification certificate
- Approval from DCGI: Once after submitting all the necessary documents, the verification would be done by the Drug Controller General of India. If the DCGI is satisfied, then the approval certificate will be issued.
Process involved in the registration of medical devices in India
- Submission of Documents: Before submitting the application for registration, it is necessary to check whether the product requires registration and an authorized Indian agent must be appointed. The following particulars must be provided for registering medical devices in India which includes;
- The application form as specified under form 40 of the drugs and cosmetics rules, 1945 must be submitted along with the Power of Attorney, Schedule D(0), ISO 13485 Certificate, Full Quality Assurance Certificate, CE Design Certificate Declaration of Conformity, Free Sale Certificate, Certificate of Marketability from GHTF countries and other Regulatory Approvals, PMS report, Plant Master File and Device Master File.
- Registration certificate as specified under form 41.
- Importing license as specified under form 10.
- ISO Certification: It is mandatory for all medical device manufacturers to get the ISO certification from the National Accreditation Board for Certification Bodies (NABCB) or the International Accreditation Forum (IAF) to the manufacturer of medical devices which is based on the quality management system of the medical device.
This sets out the entire process behind the entry of medicine and medical device into the market and its functioning which is a significant guide for all the users and the associated persons involved in it. Hence, proper statutory enforcement has to be given to the procedural aspects for building up the healthy pharmaceutical sector.
NAGARJUN.S
Intern at Aggarwals & Associates, S.A.S. Nagar, Mohali
by Aggarwals Associates | Dec 12, 2022 | General
Before setting up a business in the market, founder must go through the legalities in the business with respect to legal documents that would be beneficial to the business. For any start-up company NDA (Non disclosure statement) plays a key role as it will reduce the chances of future disputes that can lead to legal disputes and eventually cause loss to the company. It is recommended that a NDA should be prepared by a legal attorney or in the guidance of legal attorney for inclusion of all the important clauses.
What is included in NDA?
NDA stands for non disclosure agreement. Confidential information can be protected by signing a NDA, as it comprises of clauses that says that the person signing the agreement cannot share company’s private information with the third person. NDA can be signed with various people in the company such as:
- Founding members
- Employees
- Other high rank officials in the company that have access to confidential information.
What are the clauses that must be added in the Non disclosure agreement?
- Definition Clause: This is the most important clause in the NDA as this agreement has relevance without the definite meaning of confidential information. The definition makes the criteria easy to analyse that what information is included in confidential and not to be shared for both the parties.
- The Parties: The agreement must include the parties’ clause to eliminate the confusion in coming future i.e. the receiving party and the disclosing party to whom it is essential to share confidential information in the due course of business.
- Time period: The clause should precisely define the time period for the execution of agreement and the after time execution. For example the agreement is enforceable for one month and any information can’t be disclosed for further 1 year.
- Use of shared information: If some confidential information is shared with the concerned person for the business transaction then the use of that information must be limited to the business only and the criteria must be explained in this particular clause.
- Consequences for breach: The consequences for breach of agreement should be enlisted in the agreement itself to avoid any hassle in the future.
- Jurisdiction: If some issues arises in the future between both the parties then the jurisdiction clauses comes into the picture. The clause define specific place where the matter would be referred if any consequences arises.
- Legal Fees: The agreement should be clear regarding the fee if any dispute arises in the future.
- Remedies: The possible remedies that can be accepted in case of breach of agreement must be stated in the NDA agreement.
Importance of signing NDA with Co founders
- Protection of Information: Preparing NDA will ensure the protection of relevant information in the company, which is the key source of development and success in the company. Moreover, IP rights can also be protected by signing Non disclosure agreement with co founders.
- Decreases the risk of competition: There is always a chance that the founders get separate in future and results in creation of competition as they are well acquainted with the company’s information. Therefore, to protect the company from the competition in the market a non disclosure agreement must be signed between the co founders.
- Ensures Security: The security of the company can be protected by signing a non disclosure agreement, as the agreement will ensure that all the crucial information will remain in the safe hands and not transferred to third party.
- Create enforceability in case of breach of agreement: As the agreement is a legal document that is enforceable by law makes it more relevant and create accountability. The agreement helps the company to deal with the legal consequences that may arise in the future.
In order to save company’s confidential information, their IP rights and other relevant data NDA agreement must be well drafted and signed before commencing the business irrespective of the relation with the founding team. Most of the companies are not aware about the legal framework and documentation before establishing company and ends up in early winding up of the company. Therefore, it is the basic requirement to know about the legalities and related documents before establishing any business.
-Surbhi Singla
-Associate at Aggarwals & Associates, S.A.S Nagar Mohali
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