How to become a Pharmacist in America ?

Pharmacist

Are you a pharmacy student dreaming of a rewarding career as pharmacist in the United States?

The USA offers a plethora of opportunities for aspiring pharmacists.

With its world-class education system and high-paying jobs, the country is a top destination for international students.

This article will guide you through the steps to pursue a pharmacy degree in the USA.

Eligibility Criteria for a Pharmacy Degree in the USA

To be eligible for a pharmacy degree in the USA, you must meet the following criteria:

  • Bachelor’s Degree: A four-year bachelor’s degree in a science-related field such as biology, chemistry, engineering, or mathematics is required.
  • GPA: A minimum GPA of 3.0 or higher is typically expected.
  • GRE Score: A good score on the Graduate Record Examination (GRE) is often required.
  • Language Proficiency: Strong English language skills are essential. You’ll need to take either the TOEFL or IELTS exam.

The Doctor of Pharmacy (Pharm D) Degree

The Pharm D degree is the professional degree required to practice pharmacy in the USA.

Here’s a breakdown of the process:

  • PCAT: Consider taking the Pharmacy College Admission Test (PCAT) to improve your chances of admission.
  • Pharm D Program: Enroll in a Pharm D program at an accredited US pharmacy school.
  • Curriculum: The Pharm D curriculum covers a wide range of subjects, including pharmacology, medicinal chemistry, pharmacokinetics, and pharmacy practice.
  • Experiential Training: Gain practical experience through internships and rotations in various pharmacy settings.

Licensing and Certification

To practice as a pharmacist in the USA, you must obtain a license from the state where you intend to work.

This typically involves passing two exams:

  • North American Pharmacist Licensure Exam (NAPLEX): This exam assesses your knowledge of pharmacy practice.
  • Multistate Pharmacy Jurisprudence Examination (MPJE): This exam tests your knowledge of pharmacy law.

High-Paying Career Opportunities

Pharmacists in the USA enjoy excellent job prospects and competitive salaries.

According to the US Bureau of Labor Statistics, the average annual salary for a pharmacist is $134,790. The highest-paid 10% of pharmacists earn over $168,650 per year.

By following these steps and meeting the necessary requirements, you can embark on a fulfilling career as a pharmacist in the USA.

  1. Can I work as a pharmacist in the USA with a foreign pharmacy degree?

    While it’s possible to work as a pharmacist in the USA with a foreign pharmacy degree, you’ll need to complete additional education and licensing requirements.

  2. What are the top pharmacy schools in the USA?

    Some of the top pharmacy schools in the USA include the University of California, San Francisco (UCSF), Purdue University, and the University of Michigan.

  3. How long does it take to complete a Pharm D degree?

    A Pharm D degree typically takes four years to complete.

Pharmacy degree USA, Pharm D program, US pharmacy license, Pharmacist salary USA, Study pharmacy abroad, Best pharmacy schools USA, Pharmacist job in America, Pharmacist job in USA,

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DCA Telangana crackdown on illegal Medical Practices

DCA Telangana

In a recent crackdown on illegal medical practices, the Drug Control Administration Telangana (DCA Telangana) conducted a raid on an unlicensed clinic, Anjali Clinic, located in Beerappagadda, Uppal Khalsa Village, Medchal-Malkajgiri District.

The clinic’s owner, Banothu Srinu, was found to be practicing medicine without the necessary qualifications.

During the raid, DCA Telangana officials discovered a concerning stockpile of 17 different types of medicines, including antibiotics, steroids, antifungal drugs, analgesics, and others.

These medications were being stored and dispensed without a valid drug license.

The seized drugs, valued at Rs 20,500, included potent antibiotics like Ceftriaxone and Amoxycillin.

Unregulated Medicine

The indiscriminate sale of antibiotics by unqualified individuals poses a serious threat to public health.

It can lead to the development of antimicrobial resistance, making common infections difficult to treat.

Additionally, the misuse of steroids can have severe consequences, including immune system suppression, hormonal imbalances, muscle and bone weakness, cardiovascular problems, and psychological issues.

Legal Action Imminent

The Drugs Inspectorate has taken samples of the seized medicines for further analysis.

Once the investigation is complete, appropriate legal action will be taken against all individuals involved in this illegal operation.

Warning to Suppliers

The DCA Telangana has also issued a stern warning to wholesalers and dealers who supply medicines to unqualified individuals.

Such suppliers could face penalties under the Drugs and Cosmetics Act.

Key Takeaways

  • Unlicensed medical practice is a serious public health concern.
  • The indiscriminate sale of antibiotics and steroids can lead to severe health consequences.
  • It is crucial to seek medical care from qualified healthcare professionals.
  • Report any suspicious medical practices to the authorities.

By raising awareness about the dangers of unregulated medicine and the importance of seeking care from qualified healthcare professionals, we can work together to protect public health.

  1. What are the risks of using medicines prescribed by unqualified individuals?

    Unqualified individuals may misdiagnose conditions, leading to incorrect treatment.
    They may prescribe inappropriate medications or dosages, increasing the risk of adverse effects.
    They may not be aware of drug interactions, which can lead to serious complications.

  2. How can I protect myself from quack doctors?

    Always verify the qualifications of healthcare providers.
    Be cautious of clinics that offer unrealistic promises or miracle cures.
    Consult with multiple healthcare providers to get a second opinion.
    Report any suspicions of illegal medical practices to the appropriate authorities.

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Drug alert: 3,270 samples declared as NSQ in 2023-24

Drug alert

Drug alert: The Indian pharmaceutical industry is a global leader, supplying affordable and essential medicines worldwide.

However, maintaining the highest standards of drug quality is crucial for public health.

This article explores recent government initiatives aimed at strengthening drug safety regulations in India.

Combating Substandard and Spurious Drugs

A recent drug alert report revealed that between April 2023 and March 2024, of the 1,06,150 drug samples tested, 3,270 found not of standard quality (NSQ), a concerning number (2,988) fell short of the required quality standards.

Additionally, 282 samples were identified as spurious or adulterated, posing a significant health risk.

The Ministry of Health and Family Welfare (MoHFW) is actively addressing this issue.

With respect to the above drug alert, Minister of State for Health Anupriya Patel highlighted several key steps:

Risk-Based Inspections:

Launched in December 2022, the Central Drugs Standard Control Organisation (CDSCO) in collaboration with State Drugs Controllers, has initiated a program of risk-based inspections of drug manufacturing facilities.

This prioritizes inspections based on factors such as the number of non-compliant drugs produced by a firm, past complaints, and the criticality of the manufactured products.

Enforcement Measures:

Based on inspection findings, over 400 actions have been taken against non-compliant manufacturers.

These include issuance of show-cause notices, production stoppages, license suspensions or cancellations.

Strengthened Licensing Procedures:

The Drugs and Cosmetics Rules of 1945 have been amended to mandate joint inspections by central and state government drug inspectors before granting a manufacturing license.

In conclusion, The Indian government’s commitment to robust drug quality control measures is evident in these recent initiatives.

By prioritizing risk-based inspections, enforcing stricter regulations, and enhancing licensing procedures, these steps aim to safeguard public health and trust in Indian-made pharmaceuticals.

How can I check if a specific drug is of standard quality?

The CDSCO website (cdsco.gov.in) regularly uploads a list of drugs declared “not of standard quality” or “spurious, misbranded, or adulterated” by Central Drugs Testing Laboratories.

What happens if a drug is found to be substandard or spurious?

Licensing authorities take action under the Drugs and Cosmetics Act 1940 and its rules. This may include prosecution in court.

How can I report a suspected substandard or spurious drug?

You can report such cases to your nearest drug inspector or through the CDSCO website.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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Key Notes on Revised Schedule M: Point No. 1 – Pharmaceutical Quality System

Pharmaceutical Quality System

Key considerations for Point No. 1 – Pharmaceutical Quality System (PQS) compliance under revised Schedule M are outlined below.

Pharmaceutical manufacturers must adhere to these guidelines to ensure Good Manufacturing Practice (GMP) and produce high-quality drugs.

Quality Assurance:

  • Assume responsibility for product quality and safety.
  • Ensure compliance with licensing requirements.
  • Implement a robust PQS, incorporating GMP and QRM.
  • Secure senior management commitment and staff involvement.

Quality Management:

  • Establish a comprehensive quality management system.
  • Consider all factors influencing product quality, including design and development.
  • Apply GMP throughout the product lifecycle.
  • Adequately resource and maintain the PQS.

Product Quality System:

  • Ensure consistent product delivery through effective system design and improvement.
  • Manage product and process knowledge throughout the lifecycle.
  • Design and develop products in compliance with GMP and other relevant GXPs such as those of Good Laboratory Practice (GLP) and Good Clinical Practices.
  • Clearly define and document production and quality control operations.
  • Specify managerial responsibilities in job descriptions.
  • Control starting materials, intermediate products, and bulk products.
  • Implement robust finished product processing and checking procedures.
  • Ensure authorized person certification before product release.
  • Manage outsourced activities effectively.
  • Maintain product quality during storage, distribution, and handling.
  • Conduct regular self-inspection and quality audits.
  • Monitor products and processes for continuous improvement.
  • Evaluate and approve planned changes before implementation.
  • Review product quality regularly to identify improvement opportunities.
  • Establish and maintain a state of control through effective monitoring and control systems.
  • Implement appropriate quality improvements.
  • Implement a QRM system.
  • Report, investigate, and record deviations, suspected product defects, and other problems.
  • Take corrective and preventive actions to address root causes.

Management Review:

  • Conduct periodic management reviews to identify improvement opportunities.
  • Involve senior management in these reviews.
  • Conduct reviews at least annually, unless justified otherwise.

Documentation:

  • Define and document the PQS.
  • Establish a quality manual or equivalent documentation.
  • Include a description of the quality management system and management responsibilities.

Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana


Also read next article: Key Notes on Revised Schedule M: Point No. 2 – Quality Risk Management

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USFDA issues OAI Classification after inspection to Granules India

USFDA

Granules India, a leading pharmaceutical company, has recently faced a setback in its US operations. The US Food and Drug Administration (USFDA) has issued an Official Action Indicated (OAI) classification for its Gagillapur facility in Hyderabad, Telangana.

This follows an inspection conducted earlier in September that resulted in six Form 483 observations.

What is an OAI?

An OAI is a serious regulatory action issued by the USFDA that indicates potential violations of US drug laws.

It often precedes warning letters or other enforcement actions.

Granules India’s Response

In response to the OAI, Granules India has taken the following steps:

  • Detailed Response: The company has submitted comprehensive responses to the six observations raised by the USFDA.
  • Comprehensive Evaluation: Granules India has initiated a thorough evaluation of its Gagillapur facility to identify and address any potential compliance gaps.
  • External Expert Consultation: The company is seeking guidance from external subject matter experts to enhance its quality and compliance standards.

Impact on Granules India

While the OAI could potentially impact the company’s US operations, Granules India remains optimistic about resolving the issues and regaining compliance.

The company’s proactive approach and commitment to quality and safety are expected to mitigate the impact of this regulatory action.

Key Takeaways

  • Granules India’s Gagillapur facility has received an OAI from the USFDA.
  • The OAI was issued following an inspection that resulted in six Form 483 observations.
  • Granules India is taking proactive steps to address the USFDA’s concerns.
  • The company’s future US operations may be impacted by this regulatory action.
  1. What is a Form 483?

    A Form 483 is a document issued by the USFDA to detail objectionable conditions observed during an inspection.

  2. What is the significance of an OAI?

    An OAI indicates that the USFDA has identified serious violations and may take further enforcement actions.

  3. How might this affect Granules India’s stock price?

    Regulatory actions like OAIs can negatively impact a company’s stock price. However, the extent of the impact depends on various factors, including the severity of the violations and the company’s respons

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MSMEs Commit to Revised Schedule M for Drug Quality

Revised Schedule M

The Indian pharmaceutical industry, particularly Micro, Small, and Medium Enterprises (MSMEs), is actively embracing the Revised Schedule M guidelines.

This proactive approach aims to elevate the quality standards of domestic drug manufacturing to international levels.

Key Focus Areas for Indian Pharma MSMEs

Indian pharma MSMEs are focusing on several key areas to implement the Revised Schedule M:

  • Robust Pharmaceutical Quality System (PQS): Establishing a comprehensive PQS is essential to ensure consistent product quality.
  • Quality Risk Management (QRM): Implementing QRM helps identify, assess, and control potential quality risks.
  • Product Quality Reviews (PQR): Conducting regular PQRs enables continuous improvement in product quality.
  • Computerized Storage Systems: Adopting advanced computerized systems for drug storage enhances efficiency and traceability.

CDSCO-IDMA Workshop Highlights the Path Forward

A recent workshop organized by the Central Drugs Standard Control Organization (CDSCO) in collaboration with the Food and Drug Control Administration (FDCA), Gujarat, and the Indian Drug Manufacturers Association (IDMA) shed light on the industry’s commitment to regulatory compliance.

Key Takeaways from the Workshop:

  • Vendor Validation and Audit: Ensuring that suppliers adhere to stringent quality standards is crucial.
  • Best Practices for GMP Compliance: Industry experts shared insights on effective strategies to meet GMP requirements.
  • Alignment with Regulatory Framework: Understanding and complying with the latest regulatory guidelines is essential.

Revised Schedule M: A Catalyst for Global Recognition

The Revised Schedule M mandates several key changes, including:

  • Comprehensive Validation Processes: Rigorous validation of equipment and processes is necessary to ensure product quality and consistency.
  • Enhanced Supply Chain Quality: Stricter controls on the supply chain will help maintain product integrity.

A Collaborative Effort for a Brighter Future

Dr. H.G. Koshia, Commissioner of Gujarat FDCA, emphasized the importance of industry-regulatory collaboration.

He highlighted that such initiatives are crucial to drive the Indian pharmaceutical industry towards global excellence.

By embracing these changes, Indian pharma MSMEs can position themselves as reliable suppliers of high-quality drugs to the global market.

  1. What is Revised Schedule M?

    Revised Schedule M is a set of guidelines for Good Manufacturing Practices (GMP) in India. It outlines the quality standards that pharmaceutical manufacturers must adhere to.

  2. Why is Revised Schedule M important?

    Revised Schedule M is essential for ensuring the quality, safety, and efficacy of drugs manufactured in India. It also helps India align with international regulatory standards.

  3. How can Indian pharma MSMEs implement Revised Schedule M?

    Indian pharma MSMEs can implement Revised Schedule M by focusing on key areas such as PQS, QRM, PQR, and computerized storage systems. They should also collaborate with regulatory authorities and industry experts to stay updated on the latest guidelines and best practices.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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Key Notes on Revised Schedule M: Must read

Revised Schedule M

To ensure the production of high-quality drugs, pharmaceutical manufacturers must adhere to 20 key points outlined in the Main Principles for Good Manufacturing Practices (GMP) in revised schedule M.

We’ve created concise notes from the revised schedule M for each point to guide manufacturers in maintaining GMP standards.

Click the below links to read more:

1. Pharmaceutical Quality System

Key Notes on Revised Schedule M: Point No. 1 – Pharmaceutical Quality System

2. Quality Risk Management

Key Notes on Revised Schedule M: Point No. 2 – Quality Risk Management

3. Good Manufacturing Practice (GMP)

Key Notes on Revised Schedule M: Point No. 3 – Good Manufacturing Practice (GMP)

4. Sanitation and Hygiene

Key Notes on Revised Schedule M: Point No. 4 – Sanitation and Hygiene

5. Qualification and validation

Key Notes on Revised Schedule M: Point No. 5 – Qualification and validation


Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana


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CDSCO Panel approval granted for Anti Cancer Drug Pertuzumab

CDSCO Panel

A Major Breakthrough in Cancer Treatment: Intas Pharmaceuticals has recently received a significant approval from the CDSCO Panel i.e. Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the anti-cancer drug Pertuzumab.

This approval is a major step forward in the fight against HER2-positive metastatic breast cancer.

Understanding Pertuzumab

Pertuzumab is a monoclonal antibody, a type of protein that targets specific cells. In the case of HER2-positive breast cancer, Pertuzumab works by targeting the HER2 protein, which can lead to uncontrolled cell growth.

By inhibiting the HER2 protein, Pertuzumab can help slow down or stop the growth of cancer cells.

Key Points about the Approval from CDSCO Panel:

  • Conditional Approval: The CDSCO Panel approval is subject to the condition that Intas Pharmaceuticals conducts Phase IV clinical trials in India.
  • Phase IV Trial Requirement: The company must submit the protocol for the Phase IV trial within three months of receiving marketing authorization.
  • Indication: The drug is approved for the treatment of HER2-positive metastatic breast cancer.

What Does This Mean for Patients?

This CDSCO panel approval brings hope to patients with HER2-positive metastatic breast cancer.

Pertuzumab, when used in combination with other treatments, has shown promising results in improving patient outcomes.

However, it’s important to consult with a healthcare professional to determine if Pertuzumab is the right treatment option for you.

The Future of Cancer Treatment

The CDSCO panel approval of Pertuzumab by Intas Pharmaceuticals is a significant milestone in the field of oncology.

It highlights the growing focus on targeted therapies and personalized medicine.

As research continues to advance, we can expect to see more innovative treatments emerging to improve the lives of cancer patients.

  1. What is HER2-positive breast cancer?

    HER2-positive breast cancer is a type of breast cancer that has too much of a protein called HER2. This excess HER2 protein can cause cancer cells to grow and divide more quickly.

  2. How does Pertuzumab work?

    Pertuzumab targets the HER2 protein and blocks its ability to signal other cells. This helps to slow down or stop the growth of cancer cells.

  3. What are the potential side effects of Pertuzumab?

    Common side effects of Pertuzumab include fatigue, diarrhea, and rash. More serious side effects are less common but can occur. It’s important to discuss potential side effects with your healthcare provider.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.

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India drops Anti Dumping probe on Mono Ethylene Glycol

Anti Dumping

In a significant development for the Indian chemical industry, the Directorate General of Trade Remedies (DGTR) has officially terminated its anti dumping investigation into imports of Mono Ethylene Glycol (MEG) originating from Kuwait, Saudi Arabia, and the United States.

This decision comes after a series of legal challenges and a reevaluation of market conditions.

What is MEG?

MEG, a crucial raw material in various industries, including plastics, textiles, and antifreeze, has been at the center of this trade dispute.

It’s particularly vital for the production of Polyethylene Terephthalate (PET), a widely used plastic for packaging, particularly in the pharmaceutical sector.

The Anti Dumping Probe

The investigation was initiated in June 2021 based on a complaint filed by India Glycols Limited (IGL) and Reliance Industries Limited (RIL).

The domestic industry alleged that dumped imports of MEG from the specified countries were causing significant harm to their business.

The Reversal

However, after a detailed investigation and subsequent legal challenges, the DGTR reached a different conclusion.

In October 2022, the authority determined that the domestic industry was not suffering material injury and recommended against imposing anti dumping duties.

A key turning point came in September 2024 when Reliance Industries, one of the original complainants, withdrew its application, citing outdated data and changing market dynamics.

This move triggered the termination of the investigation under the provisions of the Anti Dumping Rules.

Implications for the Indian Industry

The termination of the anti dumping investigation is likely to have positive implications for the Indian chemical industry.

By removing trade barriers and promoting fair competition, the decision could lead to:

  • Lower Input Costs: Reduced import duties on MEG can lower production costs for domestic industries.
  • Increased Competitiveness: A level playing field can help Indian manufacturers compete more effectively in both domestic and international markets.
  • Stimulated Economic Growth: The chemical industry, a major contributor to India’s economy, could benefit from increased investment and job creation.
  1. What is MEG used for?

    MEG is a key ingredient in the production of polyester fibers, PET resins, and antifreeze.

  2. Why was the anti dumping investigation initiated?

    Domestic producers alleged that dumped imports of MEG were causing significant injury to their businesses.

  3. What factors led to the termination of the investigation?

    The DGTR’s reevaluation of market conditions and the withdrawal of the complaint by Reliance Industries were key factors.

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Kerala Drug Control Department Goes Digital: A New Era of Efficiency

Digital

The Kerala Drug Control Department is gearing up for a digital transformation that promises to revolutionize its operations.

The health department is actively integrating digital technologies into its remaining service areas, aiming to enhance efficiency and streamline processes.

Training Program for a Digital Future

To support this digital initiative, the health department recently organized a training program for drug regulatory officers.

Led by Health Secretary Rajan Khobragade, the program focused on introducing innovative ideas to strengthen the department’s capabilities.

Digital Services: A Boon for the Healthcare Sector

The department has already made significant strides in digitizing its services.

Online services are now available for:

  • Drug sale licenses
  • Manufacturing licenses
  • Medical device manufacturing licenses
  • Sale registration

By further integrating digital technologies, the department aims to:

  • Improve efficiency
  • Enhance service capacity
  • Accelerate service delivery

C-DIT Partners to Digitize More Services

The department has partnered with the Centre for Development of Imaging Technology (C-DIT) to develop software solutions for digitizing two more critical service areas:

  • Allotment of medicines to Recognised Medical Institutions (RMIs): This will streamline the process of providing essential medications to palliative care units and other RMIs across Kerala.
  • Permit to blood storage centres: The online application and permit issuance process will simplify operations for blood storage centers.

A Brighter Future for Kerala’s Healthcare Sector

The upcoming digital initiatives are expected to bring numerous benefits to the healthcare sector:

  • Faster processing times: Online applications and approvals will significantly reduce processing time.
  • Improved accessibility: Remote access to services will enhance accessibility for stakeholders.
  • Enhanced transparency: Digital records will improve transparency and accountability.
  • Cost reduction: Reduced paperwork and streamlined processes will lead to cost savings.

Looking Ahead

The Kerala Drug Control Department’s commitment to digital transformation signals a promising future for the state’s healthcare sector.

With continued innovation and technological advancements, the department is poised to deliver efficient, transparent, and patient-centric services.

By embracing digital technologies, the Kerala Drug Control Department is setting a new standard for drug regulation in India.

When will the allotment of medicines to RMIs be digitized?

The department aims to digitize this service within the next two months.

How will the digitization of blood storage center permits benefit healthcare providers?

It will streamline the application and approval process, reducing the time and effort required to obtain permits.

What is the goal of the training programs for drug regulatory officers?

The training programs aim to equip officers with the necessary skills to effectively implement digital technologies and improve service delivery.

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