28.08.2023 11879

Шрея Чакраборти — студентка второго курса Индийского института социального обеспечения и управления бизнесом (IISWBM) в Калькутте, она получает MBA в области финансов. Сейчас она проходит двухмесячную летнюю стажировку в Московском государственном лингвистическом университете и в рамках соглашения с Союзом журналистов России прошла практику в Medagro.ru и подготовила цикл статей об особенностях фармацевтического рынка Индии. Сегодня мы представляем вашему вниманию вторую из них.

По состоянию на середину августа в Индии насчитывалось в общей сложности почти 119 тыс. аптек. Их могут открывать только фармацевты. Предварительно необходимо зарегистрироваться в Государственном аптечном совете в соответствии с Законом о фармации 1948 года. Пакет документов включает сертификат об образовании, документ, удостоверяющий личность, и другие.

Помещения будущей аптеки должно соответствовать нормам Закона о лекарствах и косметических средствах. Они должны быть достаточно просторными, оснащены складскими помещениями. Заявка на получение лицензии на розничную продажу лекарств подается в Государственный департамент по контролю за лекарствами или Государственное управление по контролю за продуктами питания и лекарствами. К ней необходимо приложить документы, подтверждающие ваше право собственности или договор аренды, планировку и регистрационные данные аптеки. Власти проведут проверку и убедятся, что помещение соответствует всем требованиям.

В Индии лекарства могут продаваться в аптеках зарегистрированными фармацевтами или под наблюдением зарегистрированного фармацевта.

Рецептурные препараты могут отпускаться только по рецепту зарегистрированного практикующего врача. Фармацевты должны гарантировать, что рецепты являются настоящими и правильно оформленными. Сотрудники аптек та кже, как и их российские коллеги, ведут учет рецептов и хранят журналы учета, чтобы при необходимости предоставить их контролирующим органам.

Фармацевты должны информировать покупателей о дозировке лекарств, о потенциальных побочных эффектах и взаимодействиях с другими препаратами, а также обеспечивать надлежащую маркировку препаратов. 

Следом за многими развитыми странами Индия переходит на электронные рецепты. Их преимущества очевидны, а технические проблемы, сопряженные с внедрением, типичны, независимо от региона: сбои программного обеспечения, проблемы с подключением, невысокий уровень грамотности как пациентов, так и врачей и фармацевтов. Внедрение систем электронных рецептов влечет за собой рост затрат аптечных организаций на программное обеспечение, обучение персонала и аппаратное обеспечение. Много вопросов возникает по поводу конфиденциальности данных пациентов и потенциальной возможности взлома электронных записей и неправомочного использования украденных данных. Если система выйдет из строя, то получить препарат человеку станет проблематично.

Как и в нашей стране, фармацевты официально не относятся к системе здравоохранения, и их роль в терапевтическом процессе часто недооценивается. Знакомы им и такие проблемы, характерные для российской аптечной розницы, как зарегулированность отрасли, различные толкования положений закона в разных штатах, большая рабочая нагрузка, дефицит персонала и высокие риски профессионального выгорания, растущая конкуренция с онлайн-аптеками.

На розничном фармацевтическом рынке Индии весьма распространены контрафактные лекарства, и онлайн-аптеки вносят в это огромный вклад. Правоохранительные органы регулярно проводят рейды с целью выявления такой продукции. Фармацевты должны проявлять бдительность, чтобы гарантировать, что они отпускают легальные и безопасные медикаменты. Индия сотрудничает с международными организациями в борьбе с поддельными лекарствами, поскольку это глобальная проблема.

Из других вызовов, с которыми сталкивается фармацевтическая розница: работники аптек не всегда могут самостоятельно принимать решения об уходе за пациентами, о корректировке лекарств или рекомендациях по терапии, что может снижать их эффективность. Фармспециалисты Индии убеждены, что их более комплексная интеграция в систему здравоохранения могла бы улучшить результаты лечения пациентов.

Уровень престижа профессии фармацевта в разных регионах, местностях может быть разным. В сельской местности их, как правило, больше уважают и ценят за то, что они “заменяют” врача, обладают специализированными знаниями о лекарствах, лекарственном взаимодействии и обеспечении безопасности пациентов. 

От редакции: При этом, как и в России, дефицит фармспециалистов в сельских территориях в Индии велик. В июле один из муниципалитетов даже принял закон, который разрешал открывать аптеку человеку без фармобразования, но Государственный аптечный совет назвал этот нормативный акт незаконным, поскольку он входит в противоречие с Законом о фармации и положениями Надлежащей аптечной практики.

Статья 42 Закона об аптеках гласит, что “никто, кроме зарегистрированного фармацевта, не может составлять, готовить, смешивать или отпускать какие-либо лекарства по рецепту практикующего врача”, а тот, кто нарушает это правило, подлежит наказанию на срок шесть месяцев или штраф не более 1 тыс. рупий или и то, и другое.

Зарплата фармацевтов в Индии зависит от местности, где расположена аптека, и стажа специалиста. Фармацевт с 5–9-летним профессиональным опытом получает в переводе на рубли среднюю общую зарплату в размере 35 тыс., а обладатель 10-19-летнего стажа — 39,5 тыс. руб., более опытные коллеги (20 лет и более) могу рассчитывать на 47,6 тыс. руб. Заработная плата в Нью-Дели в среднем выше на 16,1%. Города с самыми низкими доходами — Хайдарабад, Андхра-Прадеш (на 15,4% меньше) и Ченнаи, Тамилнад (на 0,9% меньше).

RESEARCH ON RETAIL PHARMACEUTICAL INDUSTRYOF INDIA

There are total of 118943 pharmacies in India as of August 12, 2023. They can be opened by registered pharmacists or individuals who hold a degreeor diploma in pharmacy and are registered with the respective State Pharmacy Council.

Here is a general outline of the procedure to open a pharmacy in India:

1. Educational Qualification: You need to have a degree or diploma in pharmacy from a recognized institution. This is a requirement for obtaining a license to open a pharmacy.
2. Registration: You need to registerwith the StatePharmacy Council underthe Pharmacy Act, 1948. This involves submitting your educational certificates, proof of identity, and other required documents.
3. Location: Choosea suitable locationfor your pharmacy. It should complywith the guidelines of the Drug and Cosmetic Act and Rules. The premises must have adequate space, storage, and facilities as specified.
4. Infrastructure: The pharmacy musthave proper storagefacilities for drugs and medicines, as well as a dispensing area, counter, and necessary equipment.
5. License Application: Apply for a retail drug license from the State Drugs ControlDepartment or the State Food and Drug Administration. You'llneed to submit various documentssuch as proof of ownership/tenancy, layout plan of the premises, and your pharmacy registration details.
6. Pharmacist: You, as an owner, should be a registered pharmacist. Additionally, you may need to hire a registered pharmacist to ensurecompliance with regulations.
7. Inspection: After submitting the application the authorities will conduct an inspection ofyour pharmacy premises to ensure it meets the required standards.
8. License Issuance: Once the inspection is successful and all requirements are met, you will receivea retail drug license from the regulatory authorities.
9. Compliance: It's important to comply with the Drug and CosmeticAct and Rules,maintain properrecord-keeping, and follow ethicalpractices in dispensing medicines.

In India, drugs and medicinescan be sold in pharmacies by registered pharmacists or under the supervision of a registered pharmacist. The procedure for selling drugsand medicines in Indian pharmacies involves the following steps:

1. Pharmacist Registration: The person responsible for managing the pharmacy must be a registered pharmacist with the respective StatePharmacy Council under the PharmacyAct, 1948. This individual is responsible for ensuring the proper storage,dispensing, and sale of drugs and medicines.
2. Licensing: The pharmacy itselfmust obtain a retail drug license from the StateDrugs Control Department or the State Food and Drug Administration. This license allows the pharmacyto legally selldrugs and medicines.
3. Storage and Dispensing: The pharmacy must adhere to the guidelines of the Drug and Cosmetic Act and Rules regarding the proper storageand dispensing of drugs. Medicinesmust be storedin appropriate conditions to maintain their efficacy and safety.
4. Prescription Requirement: Prescription drugscan only be dispensed with a validprescription from a registered medical practitioner. Pharmacists must ensure that prescriptions are genuine, accurate, and legally valid.
5. Record Keeping: Pharmacists are required to maintain accuraterecords of the drugs and medicines stocked and sold, along with prescription details.These records must be kept for a specifiedperiod and made available for inspection by regulatory authorities when required.
6. Dispensing Guidelines: Pharmacists must follow proper dispensing guidelines, including providing appropriate dosage instructions, informing customers aboutpotential side effectsand interactions, and ensuring the medicines are properly labelled.
7. Ethical Practices: Pharmacies are expected to adhere to ethical practices, maintain patientconfidentiality, and provideaccurate information aboutmedicines.

Also there are some problemsor struggle to get well recognition as a pharmacist in India like Lack of Recognition: Pharmacists often struggle to gain recognition as crucial membersof the healthcare system. Their role in patientcare and medication management is sometimes underestimated.

1. Regulatory Issues: Ambiguities in regulations and varying interpretations across states can create challengesfor pharmacists, affecting their ability to operate smoothly and consistently.
2. Workload and Staffing: Many pharmacies operate with limited staff, leading to high workload and stress for pharmacists. Thiscan impact the quality of patient careand lead to errors.
3. Counterfeit Medicines: The prevalence of counterfeit medicines in the marketposes a significant challenge. Pharmacists must be vigilant to ensure they dispense authentic and safe medications.
4. Online Pharmacy Competition: The rise of online pharmacies presents competition for brick-and-mortar establishments. Pharmacists may need to adapt to technological advancements and offer added value to customers.
5. Limited Clinical Services: Due to a focus on dispensing, pharmacists often have limited opportunities to provide clinicalservices like medication therapy management, which could improvepatient outcomes.
6. Professional Autonomy: Pharmacists might not always have the autonomyto make decisionsabout patient care, medication adjustments, or therapy recommendations, which could hindertheir effectiveness.
7. Continuing Education: Keeping up with the evolvingfield of pharmacyrequires continuous  learning,but accessing quality education and training opportunities can be challenging for some pharmacists.
8. Low Awareness: Patients and the generalpublic might not fully understand the role of pharmacists in healthcare, leadingto underutilization of their expertise.

Compensation and Recognition: Compensation for pharmacists can vary, and their contributions to patient care might not always be adequately recognized in terms of remuneration.

Healthcare System Integration: Integrating pharmacists more comprehensively into the healthcare system could improve patientoutcomes, but challenges related to regulations, policies, and infrastructure need to be addressed.

It's worth noting that these challenges can vary in severity depending on factors such as location, type of pharmacy, and individual circumstances. Efforts are being made by regulatory bodies, professional associations, and stakeholders to address these issues and enhance the role of pharmacists in India's healthcare system.

The level of prestigeassociated with being a pharmacist can vary based on factorssuch as cultural norms, societal perceptions, and individual perspectives. In many societies, pharmacists are respectedhealthcare professionals who play a crucial role in ensuringthe safe and effectiveuse of medications. They are often seen as experts in medication therapyand are valued for their contributions to patient care.

Some reasons pharmacists are considered prestigious:

1. Medical Expertise: Pharmacists possess specialized knowledge about medications, drug interactions, and patient safety, making them trusted advisors in healthcare settings.
2. Patient Interaction: Pharmacists have direct interactions with patients, counseling them on medication usage, potential side effects, and proper administration.
3. Healthcare Team Collaboration: Pharmacists work closely with physicians, nurses,and other healthcare providers to optimize patient care and medication management.
4. Ethical Responsibilities: Pharmacists are responsible for ensuring that patients receivethe correct medications and dosages, which contributes to patient safetyand well-being.
5. Regulatory Role: Pharmacists play a regulatory role in dispensing prescription medications and ensuring theyare used appropriately.

In many places,pharmacists are highly regarded for their expertise and contributions to patient care,but the extentof their prestigemay vary.

India has facedchallenges with illegal pharmacies and the sale of counterfeit or substandard medications. The prevalence of illegal pharmacies can vary over time and across regions.The Indian government has taken severalmeasures to addressthis issue:

1. Regulation and Licensing: The government has established regulatory bodies like the Central Drugs Standard ControlOrganization (CDSCO) to regulate the sale and distribution of pharmaceuticals. Licensedpharmacies are requiredto follow certainstandards and guidelines.
2. Crackdowns: Law enforcement agencies periodically conduct raids and crackdowns on unlicensed and illegal pharmacies. These efforts aim to shut down operations that violate pharmaceutical regulations.
3. Online PharmacyRegulation: The government has been workingto regulate online pharmacies as well, as the rise of e-commerce has also broughtchallenges related to the sale of counterfeit or substandard medications online.
4. Awareness Campaigns: The government, along with pharmaceutical associations, NGOs, and other stakeholders, often conducts awareness campaigns to educatethe public about the risks of purchasing medications from unlicensed or illegal sources.
5. Strengthening Regulations: Efforts are made to strengthen existingregulations and to create a more robust framework to oversee the pharmaceutical sector and ensure the quality and safety of medications.
6. Collaboration with International Organizations: India collaborates with international organizations to combat counterfeit medications, as this is a globalchallenge.

Thereare some violations in this industry. Typical violations in the pharmaceutical industryin India can includeissues related to quality control, manufacturing standards, drug safety, mislabelling, and improper documentation. To prevent these violations, regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) enforce strict guidelines and regulations. They conduct inspections, audits, and monitoradherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices(GLP). Regular training, quality assurance processes, and stringent documentation are also key measures taken by the industry to preventviolations and ensure patient safety.

In another way, illegal drugs can be a significant problem for countries. The illicit drug trade can lead to a range of negative social,economic, and health-related consequences. Some of the issuesassociated with illegaldrugs include:

1. Public HealthImpact: Illegal drugs can have severe healthconsequences, including addiction, overdose, and the spread of infectious diseaseslike HIV and hepatitis throughshared needles.
2. Crime and Violence: The illegaldrug trade is often associated with organized crime, violence, and gang activities, leading to safety concerns for communities.
3. Economic Burden: The costs of law enforcement efforts, healthcare for drug-related issues,and lost productivity due to drug abuse can place a strain on a country's economy.
4. Social Disruption: Drug abuse can lead to family breakdowns, job loss, homelessness, and other socialproblems that strainsocial services and communities.
5. Undermining Development: The illicitdrug trade can divert resources away from legitimate economicactivities and development efforts, hindering a country's progress.
6. Corruption: The drug tradecan lead to corruption within law enforcement agenciesand other government institutions.

Governments around the world oftenimplement various strategies to address the issue of illegaldrugs, including law enforcement efforts to disrupt supplychains, public education campaigns to deter drug use, and efforts to provide treatment and support for individuals struggling with addiction. The approach can vary from country to countrybased on cultural, legal, and societalfactors.

Thereis also digitalization in pharmaceutical industryalso. One exampleis Electronic Prescribing.

Electronic prescribing, also known as e-prescribing, is the process of generating and transmitting prescription orders for medications electronically, instead of using traditional paperprescriptions. It involves healthcare providers using computersystems, software, or mobile applications to createand send prescription information directly to pharmacies.

Advantages of electronic prescribing:

1. Accuracy: E-prescribing reduces the likelihood of errors that can occurduring manual transcription of paper prescriptions.
2. Efficiency: It saves time for both healthcare providers and pharmacists, as prescriptions can be transmitted instantly, reducing wait times.
3. Legibility: Handwriting-related errors are eliminated, enhancing patient safety.
4. PatientConvenience: Prescriptions can be sent directly to pharmacies, makingit easier for patients to pick up their medications.
5. Drug Interaction Checks: E-prescribing systemsoften include checksfor potential drug interactions, alerting healthcare providers to possible adverse effects.

Disadvantages of electronic prescribing:

1. Technical Issues: System downtimes, softwareglitches, or connectivity problems can hinderthe process and lead to delays.
2. Cost: Implementation of e-prescribing systems can involveinitial costs for software, training, and hardware.
3. Privacyand Security: Concerns about patient data privacy and the potential for electronic recordsto be hacked or misused.
4. User Familiarity: Healthcare providers and pharmacists needto be comfortable with the technology, which can be a learning curvefor some.
5. Dependency on Technology: If the systemgoes down, it can disruptthe prescription processand patient care.

Overall,electronic prescribing can be very useful as it helps improve the accuracy, efficiency, and safety of prescription processes. However, its effectiveness depends on proper implementation, user training, and robust technical infrastructure. The advantages often outweighthe disadvantages, particularly as the healthcare industry continues to adopt and adapt to digital solutions.

Shreya Chakraborty

Sources of information:

1. https://www.pci.nic.in/
2. Ссылка

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