#Drug licence application process

[regulatorysolutionsindia]

Demystifying CDSCO Test License for Medical Devices in India

In India, if you want to make or bring in small amounts of medical devices for certain purposes, you need to follow specific rules outlined in Chapters IV and V of the Medical Device Rules (MDR) 2017. These rules allow companies to do important things like clinical testing, evaluations, or training without needing full manufacturing or import licenses. Let’s take a closer look at what’s involved in getting a test license for medical devices, who’s eligible, and why it’s important.

Who Can Get a Test License?

If you’re a company planning to import or make small quantities of medical devices for testing, evaluation, demonstration, or training, you’ll need a test license approved by the Central Drugs Standard Control Organization (CDSCO). But remember, if you want to do these things for commercial reasons, you’ll need a different kind of license i.e. manufacturing license or import license.

How to Apply for a Test License:

Create an Account: First, you’ll need to make an account on the NSWS portal and register.

Fill Out the Forms: Then, fill out the right form — MD-16 for import or MD-12 for manufacturing — and submit it.

Upload Documents: You’ll have to upload various documents that CDSCO requires.

Pay the Fee: There’s a fee you have to pay along with your application.

Wait for Approval: CDSCO will review your application and, if everything looks good, they’ll issue your test license.

What Documents Do You Need?

You’ll need to provide a brief description of your medical device, explain why you need to make or bring in a certain amount, show that you have quality certifications, and more. It’s essential to have all the necessary paperwork in order.

How Much Does It Cost?

The fee depends on whether you’re making or importing the device. For manufacturing, it’s INR 500 per device, and for importing, it’s USD 100 per device.

How Long Does It Last?

Your test license will be valid for three years from the date it’s issued. But be careful — if you break the rules, your license could get canceled.

What Are the Benefits?

Getting a test license isn’t just about following the rules; it can help your business in many ways. It lets you innovate while sticking to the rules, test your products before launching them, and train your staff before starting full-scale production.

Why Choose RSI?

If you need help navigating the process of getting a test licence, Regulatory Solutions India (RSI) is here for you. They’re experts in helping companies with all aspects of the process, from filling out forms to making sure you meet all the requirements.

[ezfastmedicalcards]

How Does a Medical Marijuana Program Work?

 Medical Marijuana Program

Cannabis has become a hot topic in recent years because of its purported medical benefits. A medical marijuana program in several jurisdictions and nations allows patients to use cannabis for therapeutic purposes. Patients, carers, healthcare providers, and policymakers must understand these programs. A detailed overview: 

1. Laws and regulations 

A medical marijuana program starts with state or federal legislation. These laws govern medical cannabis cultivation, distribution, and usage. We then create regulations for farmers, dispensaries, healthcare professionals, patient registration, and product testing. Medical cannabis legislation generally entails significant arguments and considerations of legal, ethical, and medical ramifications. 

2. Criteria for Qualification 

At Ezfastmedicalcard, patients must meet certain medical requirements to enroll in most medicinal marijuana programs. Chronic pain, cancer, epilepsy, MS, PTSD, Crohn's disease, glaucoma, and others are examples. Usually, patients need a doctor's recommendation to use cannabis for treatment. New scientific and medical research updates the qualifying criteria list. 

3. Registering Patients 

After a referral, patients must register with the state's medicinal marijuana programme. An application form, evidence of residency, and a healthcare provider's recommendation are usually required for registration. Patients acquire a medicinal marijuana card to buy cannabis from licenced dispensaries after approval. The Ezfastmedicalcard registration process ensures that only approved patients can obtain medical cannabis and maintains transparency and regulation. 

4. Cannabis Access 

Patients in medicinal marijuana programmes get their cannabis from licenced dispensaries. These shops buy cannabis from licenced farmers and producers and ensure safety, quality, and compliance. Patients can buy cannabis flowers, edibles, tinctures, extracts, and topical creams based on their tastes and medicinal needs. Patients receive information and guidance from dispensaries to make educated treatment decisions. 

5. Dosing and Administration 

Physicians help patients determine medical cannabis dosage and delivery. Based on the patient's condition, symptoms, and tolerance, they may prescribe strains, products, and ingestion techniques. Patients should follow their doctor's advice and start with minimal doses to assess their cannabis response. Physicians may also evaluate patients for side effects and drug interactions and change treatment approaches. 

6. Monitoring/Evaluation 

Medical marijuana programs often track patient results and assess cannabis efficacy and safety. This may include tracking symptom alleviation, side effects, drug adherence, and quality of life. To improve outcomes, doctors may change treatment regimens depending on patient input and clinical observations. To ensure compliance with standards and laws, regulatory organizations may audit and inspect dispensaries and cultivation facilities. 

7. Lawful Protections 

Safeguarding patients, caretakers, and medical professionals is the goal of the medical marijuana program. A few examples of these rights are exemptions from discrimination in employment, housing, and child custody, as well as exemptions from the possession and use of cannabis for medical purposes. Participants are required to educate themselves on the medical marijuana regulations that govern their state to prevent any potential legal difficulties. Drug laws for medical purposes strike a balance between patient access, public safety, and regulation. 

Conclusion 

Ezfastmedicalcard medical marijuana programs allow individuals to use cannabis for various ailments. To promote safe, effective, and equitable medical cannabis access, these programs build legal frameworks, regulate production and distribution, and educate and support patients. As cannabis legalization evolves, stakeholders must collaborate and research to improve medicinal marijuana programs for patients worldwide.

[kosmodermaclinicbangalore]

Botox Injections: Treatment, Recovery & Side Effects | Kosmoderma

The desire to look young and beautiful is eternal. With this desire as a guiding light, several treatments have been developed in the cosmetic and beauty industry. Botox is one such prominent treatment method used to battle the signs of ageing. It is a non-surgical way to get rid of wrinkles and fine lines. If you are thinking about getting Botox to refresh your look and go back in time, you should be aware of the side effects, recuperation time, and treatment methods. We will explore all aspects of Botox in this extensive post, including how it functions and what to anticipate before, during, and after the surgery.

Understanding Botox- What Is Botox And How Does It Work?

“Botox” is a brand name for a neurotoxin, botulinum toxin. This neurotoxin is produced by the Clostridium bacteria. It is a diluted and refined version of the toxin that is suitable for both medical and cosmetic applications. The U.S. Food and Drug Administration (FDA) has approved Botox for a number of medicinal and cosmetic uses.

Botox works by temporarily paralysing or relaxing particular muscles in the treated area. In order to stop muscle contractions, it works by obstructing the impulses that travel from neurons to muscles. A smoother, more youthful appearance is achieved when the targeted muscles are relaxed, which reduces the visibility of fine lines and wrinkles in the skin layer above.

Dynamic wrinkles are the main focus area of treatment with Botox. These are the result of long-term, repetitive facial motions. Crow’s feet, forehead lines, and frown lines are common examples of these.

The Botox Treatment Process

Botox is a minimally invasive, quick procedure that is often referred to as the ‘lunch-break job’. It is usually done at the doctor’s clinic, and you can go back home or to work immediately after.

Consultation

Make an appointment for a consultation with a licenced healthcare provider, such as a plastic surgeon or dermatologist, prior to receiving Botox treatments. The doctor will examine your skin, talk to you about your issues, and decide if Botox is the best course of action for you at this visit. Together with giving you an estimate of the number of units required for your therapy, they will also go over the possible dangers and advantages.

Preparation

Botox injections require very little preparation. To lower your chance of bruising in the days before your appointment, you might be told to abstain from alcohol and blood thinners. During the consultation, let your provider know about any allergies, prescription drugs, or underlying medical issues.

The Injection Procedure

Getting a Botox injection is a quick and painless process. The Botox solution will be injected straight into the targeted muscles by the practitioner using a tiny needle. The particular area being treated and the severity of the wrinkles will determine how much Botox is administered and how many injections are necessary. The procedure takes about 15 to 30 minutes, depending on the size of the area being treated. The common areas treated by Botox include the following-

Forehead lines, the horizontal lines on your forehead

Glabellar lines, the vertical lines between your eyebrows

Crow’s feet, lines that radiate from the corners of your eyes

Bunny lines, lines on the side of your nose

Smile lines, the wrinkles that appear when you smile

Neck bands, line on your neck

Post-Injection Procedure

After the injection, you can usually get back to your regular activities right away. Botox treatments require very little to no downtime. But for a few hours following the injections, you should refrain from massaging the treated area, lying down, or engaging in strenuous exercise.

The Recovery Period

Recovering from Botox treatment is uneventful. The downtime is minimal. However, you need to keep in mind certain things, which will be explained to you once the procedure is complete.

Immediate Effects

The results of Botox treatment are immediate. You will be able to see visible changes almost immediately after the procedure. However, it will take about two weeks for the full effects to be visible.

Results And Maintenance

The results of Botox treatment are immediate. You will be able to see visible changes almost immediately after the procedure. However, it will take about two weeks for the full effects to be visible.

However, these results are not permanent. They usually last three or four months, after which wrinkles may emerge and muscular function gradually resumes. Make routine Botox visits if you want to keep the desired effects. Some people discover that the effects last longer over time, enabling them to go between treatments for extended periods of time.

Botox injections can occasionally have unexpected side effects, such as a frozen or unnatural appearance. Usually, an untrained professional or over-injection causes this. It emphasises how crucial it is to select a licenced and experienced practitioner.

Possible Side-Effects Of Botox Treatment

Though rare, there are some potential side effects that will be explained to you at the start of the procedure. These side effects are minimal and usually subside on their own in a couple of days. You may experience the following-

Mild redness, which resolves in a couple of hours

Bruising, which may take a few days to subside. This can be well-concealed with make-up

Swelling around the treated area, which subsides in a day or two

Tenderness in the treated area

Mild headache which resolves in a couple of hours

Drooping eyelids can happen in rare cases where the toxin migrates to adjacent areas. This usually resolves in a few days

Less common complications include infections, allergic reactions and ptosis (a persistent eye droop). These complications necessitate medical intervention.

The Right Candidate For Botox Treatment

Botox is safe and ideal for anyone seeking relief from wrinkles, fine lines and other signs of ageing. You are an ideal candidate if-

You are between 18 to 65 years of age

Have realistic expectations from the treatment

Do not have allergies to botulinum toxin

Are in general good health

Botox is not for you if you are pregnant, breastfeeding or if you have any medical condition that contradicts the use of the toxin.

A thorough assessment with a qualified medical practitioner will help determine your eligibility for Botox.

Botox injections, which provide a quick and efficient means of reducing wrinkles and giving the illusion of younger skin, have completely transformed the field of non-surgical cosmetic operations. Botox has gained popularity as a treatment for people looking to revitalise their appearance because of its short recovery period and low risk.

It is important to know about the procedure, recuperation time, and any side effects before getting Botox. The first and most crucial step in guaranteeing a positive and secure Botox experience is selecting a trained and experienced practitioner. You may confidently enjoy the benefits of Botox, knowing that you are taking the required steps to attain a rejuvenated and more youthful appearance by adhering to post-treatment protocols and being informed of potential problems.

[maasantoshi]

Passport Agents near Wagle estate, Thane

In the bustling vicinity of Wagle Estate, Thane stands as a beacon of reliability and efficiency in passport and documentation services - Jai Maa Santoshi Passport Consultancy. With two decades of unwavering commitment, this seasoned establishment has become synonymous with hassle-free passport solutions and other essential business documentation services.

Jai Maa Santoshi Passport Consultancy is a trusted partner for individuals seeking a seamless passport application and renewal process. The company's expertise extends to the Tatkal passport renewal in Thane, ensuring a swift and efficient renewal process for those needing urgent passport services. The experienced team at Jai Maa Santoshi Passport Consultancy is well-versed in the intricacies of the Tatkal passport process, providing clients with peace of mind during time-sensitive situations.

Beyond passport services, Jai Maa Santoshi Passport Consultancy extends its proficiency to diverse business documentation needs. GST Consultancy Services in Thane West is one of the notable offerings, catering to businesses seeking expert guidance in navigating the complexities of Goods and Services Tax. The consultancy's adept professionals ensure that businesses comply with GST regulations, fostering a smooth and compliant financial environment.

Another vital service Jai Maa Santoshi Passport Consultancy provides is Food and Drug License Renewal. As businesses in the food and pharmaceutical sectors know, renewing licences is crucial to maintaining legal compliance. The consultancy simplifies this process, ensuring businesses can focus on their core operations while complying with regulatory requirements.

The mention of Tatkal passport in Thane Fresh Reissue Passport Tatkal underscores the consultancy's dedication to providing comprehensive passport solutions. Clients can rely on Jai Maa Santoshi Passport Consultancy for a swift and efficient process, whether a fresh passport application or a re-issue under the Tatkal category.

What sets Jai Maa Santoshi Passport Consultancy apart is its two decades of experience, making it a seasoned passport and documentation service player. The wealth of knowledge amassed over the years enables the consultancy to navigate the intricacies of passport applications, renewals, and other documentation services with unparalleled expertise.

In conclusion, Jai Maa Santoshi Passport Consultancy in Thane is more than just a service provider; it is a reliable partner for individuals and businesses. With a commitment to simplicity, efficiency, and two decades of experience, the consultancy is a beacon for those navigating the complex world of passport and business documentation services. Trust Jai Maa Santoshi Passport Consultancy for a journey about reaching your destination and enjoying a smooth ride.

[dueranconsultancy]

How to Apply For a Drug Licence Online with Dueranconsultancy

Dueranconsultancy is a leading provider of drug license consulting services in India. We can help you with every step of the online application process, from preparing the required documents to submitting your application and tracking its status. To learn more about how Dueranconsultancy can help you apply for a drug license online, please visit our website or contact us today

[professionalutilities1]

Drug License Registration in India at Glance - Process, Documents Required

For any Individual/Corporate/Partnership Firms etc., it is mandatory to obtain a valid Drug Licence from concerned State Authorities (Drugs Control Department). The provisions for this have been made in the Drugs and Cosmetic Act 1940 and Rules 1945 applicable in India.

Conditions for obtaining Drug License in India

Minimum Area & Height of Premises

Storage Facility

Pharmacist / Competent / Technical Staffs

Commercial Premises

Location Based License

Location Based License

Importer of Drugs or Cosmetics

Drug License Registration process in India ( General Instruction)

Login ID and Password

Online Application

Upload Documents

Physical Inspection

Approval/Rejection

Change in constitution

Separate Password for Pharmacists

*If you want to know about EPR Registration_ click here

[budandtender]

Navigating the Complexities of Hemp Cultivation Licensing in the UK

Introduction

The United Kingdom has long been a proponent of strict regulations when it comes to the cultivation and use of cannabis plants. While these restrictions have primarily focused on high-THC strains responsible for psychoactive effects, they also extend to hemp – a low-THC variety of cannabis known for its myriad industrial applications and non-intoxicating nature. As a result, anyone seeking to grow even a single hemp plant must first secure a licence from the government.

In this article, we will explore the various aspects of licensing for hemp cultivation in the UK, including the reasons behind these stringent regulations, the specific uses for which licences may be granted, and the importance of adhering to licensing conditions to ensure compliance with UK law.

The Purpose of Licensing for Hemp Cultivation

At the heart of the UK's regulatory regime surrounding hemp cultivation is the desire to prevent the misuse of controlled cannabinoids, such as THC. By imposing strict licensing requirements, the government can better regulate the production of hemp and its derivatives, ensuring that any products derived from hemp are safe for consumers and compliant with UK CBD laws.

Licences for Specific Uses

Licences for hemp cultivation in the UK are only granted for specific uses, such as the production of hemp fibre or the extraction of seeds. Hemp fibre has a wide range of industrial applications, including the creation of textiles, paper, and eco-friendly building materials like hempcrete. Meanwhile, hemp seeds can be pressed to extract their oil, which is used in food, cosmetics, and various health products.

These specific-use licences help to ensure that hemp is grown for legitimate purposes and not for the production of illicit drugs or other controlled substances.

Stipulations and Restrictions

Hemp cultivation licences come with a number of stringent stipulations, most notably the restriction on using certain parts of the plant. Licence holders are only permitted to use the seeds and mature stalk (fibre) of the hemp plant, while the flowering tops – which contain higher concentrations of controlled cannabinoids like THC – are off-limits.

This restriction is in place to minimise the risk of licence holders diverting controlled substances into the illicit market or producing products with unsafe levels of cannabinoids. Additionally, licence holders must adhere to a number of other conditions, such as maintaining accurate records of their cultivation activities and submitting to regular inspections by government officials.

The Importance of Adherence to Licensing Conditions

It is crucial for anyone involved in hemp cultivation to strictly adhere to the conditions of their licence, as failure to do so can result in severe penalties, including the revocation of the licence, fines, and even imprisonment. By operating within the bounds of the law, hemp cultivators can help to maintain the integrity of the industry and ensure that hemp-derived products remain safe and compliant with UK regulations.

Challenges and Opportunities for Hemp Cultivators in the UK

Despite the strict regulatory environment, there are still numerous opportunities for hemp cultivators in the UK. The growing demand for sustainable and eco-friendly products has led to increased interest in hemp-based materials, while the burgeoning CBD market offers significant potential for those able to navigate the complexities of the licensing process.

However, prospective hemp cultivators must also contend with a number of challenges, such as the difficulty of securing a licence and the need to source low-THC cannabis strains that meet the government's stringent requirements. Moreover, cultivators must invest in the necessary infrastructure and equipment to process hemp plants in accordance with the specific uses outlined in their licence.

Conclusion

In conclusion, the licensing regime for hemp cultivation in the UK is undeniably complex and restrictive, reflecting the government's commitment to preventing the misuse of controlled cannabinoids and ensuring the safety of hemp-derived products. However, for those able to navigate these complexities and secure a licence, the opportunities for growth and innovation within the hemp industry are vast. By adhering to the conditions of their licence and operating within the bounds of the law, hemp cultivators can contribute to the development of a sustainable and responsible sector that meets the needs of consumers while remaining compliant with UK regulations.

[midlandmed]

New Guidance for Firearms Licence

New guidance for firearms licencing was brought into effect in November 2021 for England and Wales and later in January 2022 for Scotland. This means that anyone applying for a firearms/shotgun licence must now provide a completed medical proforma, along with their application to the licensing department.

This form needs to be completed and signed by a GP or another GMC-registered doctor. The GP will check the applicants’ medical records to ensure there is no previous or current medical history that would deem them unsuitable to have a firearm. If using a private medical facility, the GP will request the applicants’ full medical records from their local GP surgery. Without a signed medical proforma, the applicant will not be granted a firearms licence. It’s usually possible for either the applicant or doctor to provide the medical proforma to the licencing department.

Once a firearms licence is granted, the police will contact the applicant’s GP to get them to place a firearms market on their medical record. This is very important as it informs GPs that they may need to notify the police should the patient’s health deteriorate in a way that would deem them no longer safe to have a firearm. There is, however, currently no requirement for a GP to monitor a patient who has a firearm certificate.

The introduction of a medical assessment for a firearms licence has been brought into to help protect the public by ensuring that no one of a vulnerable nature or with certain medical conditions is allowed to be in the procession of a firearm. Medical conditions that may prevent someone from being granted a licence include depression or anxiety, dementia, bipolar/psychotic illness, a neurological condition, alcohol or drug abuse and post-traumatic stress disorder. This list, however, is not exhaustive and GPs may also consider the impact or any other mental or physical conditions.

Although it is the GPs responsibility to check medical records and sign the medical proforma, the decision to grant the licence lies with the police.

Gun laws in the UK were already very strict, with applicants for a firearms licence being subject to an extensive number of background checks and a home visit from the police. Furthermore, two credible referees for a fireman and one for a shotgun are required before a license can be issued. The introduction of a medical is seen as an important step forward to tighten up laws on gun ownership in the UK even further. This is paramount in taking even further steps to ensure firearms do not fall into the hands of the wrong people and that the public continue to be safe guarded against gun crime.

Fortunately, because of strict gun laws, shootings are rare in the UK. Unfortunately, the same can’t be said about America where gun crime is quite common due to the relaxed nature of gun ownership in this country. In 2021, for example, Americans were killed by guns at the highest rate in 30 years.  

See firearms and gun medical in Nottingham, Peterborough, Northampton and Leicester and private medicals in Peterborough.

[suprameds]

Which is the best online medical store in India?

Suprameds is one of the best online medical stores in India. You can utilise this online medical store for all of your health needs. We are working to simplify the healthcare process for you.

History of Supracyn Pharma, one of the top pharmaceutical firms in India, started its journey in 2014. Under third-party licences, we buy medications from producers who are WHO Certified. Leading pharmaceutical professionals and titans of industry closely monitor the production of our medicines.

Our Tale:

What we offer

We provide accurate, authoritative & trustworthy information on medicines and help people use their medicines effectively and safely. We started our Pharma Company in Hyderabad.

The overall journey

By providing high-quality care at reasonable costs, we have opened up health care to millions of people.

Primary Values 

to become a renowned pharmaceutical company with goods that are affordable, high-quality, and easily accessible. Wherever our clients are, we attend to their needs.

Mission

 to be able to deliver innovative, high-quality pharmaceutical goods at reasonable prices to improve patients' lives everywhere. 

Why Do Customers Choose Us Over Other Online Medical Stores?

You can pay at a discount using our platform's lucrative offers to pay online and with a variety of payment wallets. As an alternative, you can decide to pay in cash when the things are delivered to your door. We take care of all of your pharmaceutical requirements and make it easy for you to order medications online. We only put you in touch with licenced diagnostic labs and retail pharmacies that are registered. We make the internet ordering process simple and guarantee that healthcare is affordable for everyone.

Access medical and health information:

Our health specialists have carefully prepared, verified, and confirmed the medical material that Suprameds provides. Our experts handpick the best and most trustworthy literature on drugs, ailments, diagnostic procedures, Ayurveda, and over-the-counter drugs.

EASY ONLINE MEDICINE ORDERS AT SUPRAMEDS 

Why do we say that we are the best online medical supply store? Because ordering medications online doesn't have to be difficult; rather, it should be simple. We SUPRAMEDS make sure of that. All that is required is:

Browse our extensive selection of items.

Place items in your shopping cart and finish the payment. Voila!

Your order will soon be delivered.

Is it safe to order medicines online?

Absolutely! For their authenticity and quality, all of the medications and items supplied through our site are rigorously examined. In order to make sure that only the best items are provided to you, our crew adheres to strict safety regulations when delivering the medications.

Boom in Online Medicine Orders after Covid: 

More people than ever are doing online orders as a result of the COVID-19 outbreak. For instance, people have recently started purchasing food, electronics, and medicines that are delivered to their doorsteps in a couple of hours. Online pharmacies offer a number of additional benefits when purchasing prescriptions online, making them a wonderful alternative to strolling to your neighbourhood pharmacy right now.

You have the convenience of obtaining drug deliveries from online pharmacies while remaining comfortable and private in your own home. You may download these applications to your device, add items to your cart, and complete a purchase because the majority offer a large variety of healthcare products. With a few clicks and perhaps some online savings, real medications can be delivered to your home in a matter of minutes.

[mishraji645]

The Union Health Ministry has relieved the import of active pharmaceutical ingredients of the peptide hormone Oxytocin to our country to manufacture formulations for exporting. On April 24, 2018, the Government put restrictions on oxytocin formulation manufacture for domestic use to only public use and restricted the oxytocin import and its formulations to the country.

[godollyfan]

Government Approves American Standard Test Method (ASTM) As Product Standards For Medical Devices

The union health ministry has published a draft notification vide no. GSR 98 E dt 5.2.2021 on Medical Devices Amendment rules 2021 to involve American Standard Test Method (ASTM) in standards of product for all medical devices to increase the competency of indigenous medical devices internationally.

According to the draft rule, all these rules might be called the Medical Devices (Amendment) Rules 2021. All these rules will come into force on the date when they are finally published in the official gazette. In the medical device rules 2017, in rule 7, in sub-rule 2, after the words, letters, and bracket" the international electro technical commission ," the words, letter, and bracket or "American standard test method" will  be inserted.

The following draft of specific rules for amending MDR 2017 is done while exercising the powers given by subsection 1 of section 12 and subsection 1 of section 33 of the Drugs and Cosmetics Act,1940. In consultation with the Drugs technical advisory board, it was published to inform every person who is likely to be impacted. Notice is given to all that the said draft rule will be considered on or after 45 days from the date on which the Gazette of India consisting of these draft rules is published.

The central government considers the timeframe specified above. All kinds of objections and suggestions should be addressed to the undersecretary, union health ministry, Government of India. Drugs Technical Advisory Board, after complete deliberation, approved the proposal and suggested these required amendments in the MDR-2017.

It has been suggested since all developed countries possess their own certification needs. So, Indian Medical device manufacturers will be required to meet the needs of countries where they export. According to rule 7 of MDR 2017, the medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of BIS Act, 1985 or might be notified by the Union health Ministry frequently.

If the standards have not been specified under sub-rule one and sub-rule 2, the device shall be confirmed to the validated manufacturer's standards. This is as per the medical device regulation in India. Because ASTM is accepted at the international level, it was proposed to include ASTM in the sub-rule 2 of rule 70 of MDR 2017.

DTAB was apprised that the Union health ministry notified the MDR 2017 on January 31, 2017, under the provision of the Drugs and Cosmetics Act, 1940.

 Use To Know More Information, Visit - Cosmetic import license | Vaccine Import Registration India

[themedicalstate]

COVID-19 vaccines

Traditional vaccine development can take 15 years or more, starting with a lengthy discovery phase in which vaccines are designed and exploratory preclinical experiments are conducted. This is usually followed by a phase in which more formal preclinical experiments and toxicology studies are performed and in which production processes are developed. During this process an investigational new drug (IND) application is filed and the vaccine candidate then enters phase I, II and III trials. If, when phase III trials are completed, the predetermined end points have been met, a biologics licence application (BLA) is filed, reviewed by regulatory agencies and finally the vaccine is licensed. After that point, large-scale production begins. 

Vaccine development for SARS-CoV-2 followed an accelerated timeline. Because of knowledge gained from the initial development of vaccines for SARS-CoV and MERS-CoV, the discovery phase was omitted. Existing processes were adopted, and phase I/II trials were started. Phase III trials were initiated after the interim analysis of phase I/II results, with several clinical trial stages running in parallel. In the meantime, vaccine producers started the large-scale production of several vaccine candidates, at risk. 

Source: Florian Krammer (SARS-CoV-2 vaccines in development). Nature 586, 516–527 (2020). https://doi.org/10.1038/s41586-020-2798-3.

[meneatyoghurt]

Oh yeah I forgot I started doing this to try and work out when TK’s addiction issues might have started. So, this is all based on actual information about the NYFD, but I think it’s much more likely that the show has used a huge chunk of artistic license and handwaved away the technical stuff, so this may all be useless. Er...I did this backwards.

26 - TK’s age now (in 2020? His birthday is in December, but I’m not sure if that’s his 7th or 8th birthday in 2001...maybe 8th because if he’s 26 now, maybe he turns 27 at the end of 2020, making his birthday December 1993)

24 - Latest possible time he could have been actively taking pills (based on his word in episode 1 - he says it’s been years, so at least two) - maybe a bit earlier since his relapse was a good six months ago or something. So like...2017 or 2018.

21 - Earliest he could have qualified as a firefighter in NYC - December 2014

19 (and a half) - Earliest he could have started his 18-months of training to become a firefighter and qualify age 21 (I think you can start training before then?) - summer 2013

17 - Earliest he could have started the application process - 2010/2011

Other things TK would have needed to be a firefighter: high school diploma, 15 college credits, driver’s licence, drug testing, medical and psychological evaluation and background check, and to pass the written exam (which is only held once every four years or so) and physical tests. After the written exam, you get put on a list and called up based on demand for firefighters - you get priority for some things, like being an NYC resident (also for being the child of a firefighter who died in 9/11 but I didn’t see any mention of firefighters who survived...) Apparently it can take two to four years before you can be asked to complete your training. It’s super competitive.

Apparently, the last test was 2017 (TK was 23/24). So if they’re being accurate, the previous one would have been 2013, when TK was 19 or 20, so really the earliest one he could have taken. So based on this info, if he got lucky and started training at 21, finished by 22-23, he would only have been fully qualified for three or four years. although doing on-the-job training before that. Unless he started his training at 23 or 24 but that would mean he’s barely been qualified for long. Of course, this is a drama, so the likelihood that they’re being really accurate on timelines is slim.

This article has some info about the NYFD policy on drug use, including a case of a man who tested positive for a painkiller which seems relevant (although it was apparently a one-time thing). Keep in mind that it’s not impossible that TK was actively using during either training or working as it is possible to hide it, but you have to be prepared because they do carry out random tests. He could have been caught using while on the job although if they wanted to be accurate, he likely would have been fired pre-2018. Unless Owen was capable of pulling some strings.

So basically, this has cleared nothing up! Hope that helps!

TLDR: Basically, when the hell did TK have time to develop an addiction and then get clean? I am coming around to people’s theory that it was when he was a teen, even though my initial idea was that he was injured on the job and it started from there. Edit: also, an additional note that I wonder whether episode 1 was his first overdose/SA because Owen says he promised it would never happen again, but he could have just been talking about using in general.

[itsallabouteveworld]

In India, there are two legislations (Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945) that govern the import of drugs. The main authority responsible is the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.

[dat-town]

No Speed Limit | Chapter 3

Summary: Some people live to race while others race to live. When an uptown girl’s and street racer’s worlds collide, their lives are bound to change. For the better or worse, it’s hard to tell. In-between rivalry and unwanted sparks, there’s definitely a bumpy road ahead (with no speed limit).

Words: 2.6k

Chapter index

Hanbin knew that if he told anyone about having a hot girl over at his apartment and not doing anything beside throwing a pillow at her, most people would think he had gone nuts or started whispering about him playing for the other team. So he didn't tell anyone and apparently Soyeon didn't either because it had been weeks and there were no rumours about this little lie. Oh well they didn't even have to lie, just not correct the wrong assumptions. Bobby had been adamant at first trying to get those juicy details out of him but Hanbin wasn't a big talker anyway, so it didn't really surprised his circle that he didn't go around telling everyone that he got laid. Which he didn't.

He had bigger problems than that.

He groaned when the next blow send him to the floor clutching onto his stomach that ached from the hit it took repeatedly. His palms were scratched, proofs of the rough asphalt’s marks on his skin as he pushed himself up spitting blood onto the dirt. He got one more kick in his side and only then when he collapsed onto the floor with his pride stepped on did Giriboy told the other guys to stop and let him be. The exactor crouched down next to him and patted his bruised cheeks like a parent would do with a disobedient child.

“Look Kim… how many times do I have to tell you that we take deadlines seriously? Big boss won't be so forgiving every fucking time just because you're a mediocre driver and he wins whenever he bets on you. You owe him money, he wants that back, it's that simple,” he explains so helpfully one would think he really wanted Hanbin to get rid of the debt he wasn't even responsible for. Having a shitty family background and parents who overdosed on drugs is enough to chase him into it. Because of course they owed a large sum of money to their dealer who now kept coming at Hanbin to get it back.

“Two more month. Just two more,” he whispered almost too weak to be even heard. Giriboy leaned annoyingly close to his face to make out the next mumbled words, his vicious smile appearing right in front of Hanbin's hazy vision. “A big competition is coming up.”

One of the biggest actually and he planed to get out of here if he won. From that money, he could not only pay off the debt, but get rid of that shitty apartment and actually do something with his life. He didn't have big dreams, all he wanted was a simple life without dealers breathing down on his neck and a bunch of strangers attacking him in dark alleys on his way to the convenience store. He wanted nothing more than a few friends and a car to drive. Was it really that much to ask for?

“A big competition, huh?” the exactor spit on him and let out a mocking laugh that hurt almost as much as the punches. “I heard you had money to buy new car components but not to pay us?”

Hanbin just gritted his teeth willing himself not to throw back any insult return before they really beat him to half-dead. He needed his car to get money, so of course he needed to spend money on his car, so that it could be in its best shape.

“If we gave you two months you wouldn't even be able to pay the interest,” Giriboy clicked his tongue while he sat back on his heels. He pretended to think out loud giving him more time to suffer, to feel miserable and humiliated that his life is basically in the hands of a tyrant. “You get one month and if you don't pay back the whole amount interest included then we will meet again and we won't be so kind.”

The driver just grunted as he acknowledged the new offer and let out a breath when the footsteps started to fade away in the distance. He wasn't sure how long he stayed there lying on the hard ground that was cold even after the scorching heat of summer Sun that shone on it all day. It took him quite some time to gather enough strength to get up, standing to his wobbly feet and crawl back home, the beer and bread he wanted to buy long forgotten.

“Shit bro, they got your good this time,” Bobby grimaced when he saw his best friend's swollen cheeks and split lips next morning. The car repair shop where they both and a few more from their crew worked was busy even in early morning. The others only greeted him nonchalantly or hissed at seeing his beat up face. Two of the girls in the corner whispered about something while keeping their eyes on their duo.

“You should see my ribcage. It looks like some fucked up, rotten eggplant,” Hanbin shrugged and threw his bag onto the floor next to the stall he usually worked at. Among them there was not much privacy or anything to be shy about, so he quickly got out of his shirt and kicked off his pants to put on his mechanic uniform instead. He was in the middle of putting his arms in it when Bobby grabbed the hem of his undershirt and pulled it up to see the expressionist painting blooming on his chest and stomach.

“Fuck. That's not good,” he mumbled letting go of the material. Genuine worry flashed in his eyes as he watched Hanbin get into the uniform properly. “What are you gonna do about it?”

“I dunno. Participate in more races maybe?” Hanbin sighed. Even after taking painkillers he had a tough night, he could barely think, not to make plans about how to get the money as fast as he could. A month of small races and working here he knew wouldn't cover it all, especially now that the boss increased the interest on it.

“What about a job that pays more?” Yuna walked over to them followed by Haesoo closely. The sisters were the only female addition of their small crew but they could take apart a car and put it back together like it was nobody's business.

Hanbin knew the two of them just wanted to help, this entire community was their safe haven, like a chosen family that supportive each member but he knew the usual requirements for well-paid jobs and without any kind of certificate he had no chance.

“I'm a high school dropout. Where they would take me?”

“I actually know the perfect job for you,” Haesoo exclaimed with enthusiasm which Bobby was watching warily but Hanbin didn't notice any of it. “A friend of one of our cousins works for this super rich family and they need a new chauffeur.”

“You mean personal driver?”

“I guess.” the girl shrugged tapping her chin while thinking. “I don't know exact details but I can get info for you about the pay and the application process. It's what you like and know how to do, right? To drive, so...”

“Yeah, thanks Haesoo. That would be cool if you could get a number for me,” Hanbin nodded, hastily agreeing because what was the worst thing that could happen? They reject him and then what? It wouldn't have mattered. But it was worth a try, especially since the girl was right: driving was the activity he enjoyed most in this world and it came to him the easiest, so getting paid for doing that seemed almost too good.

To get the job was actually easier than he thought. After he got the contact info and talked with some assistant of the family, he had to submitted a copy of his driver licence and a paper to prove his clean record. Then he was called in for a test drive with eleven other applicants and he finally met the owner of the voice from the calls' other end. Both his manners and driving skills were tested but according to him, it went well. Pretty well in fact because two days later he got the job. He was sent an elegant uniform and a contract to sign, then he was called in to start working from Monday.

“Oh man I never thought I would live the day to see you in a tuxedo,” Bobby snorted when he saw him fully dressed in his shiny new black and white uniform that morning. It was a famous brand, a high quality suit, so Hanbin had no reason to complain yet he missed his less rigid clothes. It felt like he was tucked in some kind of prison of clothes wearing this well ironed shirt and pants.

“Are you envious?” Hanbin croaked a brow at his friend jokingly while fixing his cuff links.

“Well chicks dig guys in tuxedos, so… In your shoes, I would be careful with the old man's wife,” Bobby joked and quite a few of the others present joined the laughter. Hanbin just shook his head. He didn't care about wives committing adultery or daughters drooling at his sight. He was in it for money and the money only. He didn't even care what kind of family he had to drive for as long as they had money, it was enough for him.

“Or get yourself a sugar mommy,” Jinhwan yelled from his place and laughter erupted again at the eldest's stupid joke.

Hanbin checked the time on his watch and knew he should go soon if he wanted to be on time on his first day of work. But before he could move an inch, Yuna stepped in from of him with a shy smile and blush on her cheeks.

“Your bruises heal nicely,” she commented quietly as she take out a cotton pad from her makeup bag and leaned closer to apply some foundation and powder over the fading marks on Hanbin's face.

The boy inhaled sharply as the girl ever so slowly worked on the perfect outcome. He waited patiently because without her help he probably wouldn't have gotten his job anyway if he showed up at the interview like the ragged thug he really was. After she was satisfied with the result, Yuna pulled back examining his features before her eyes settled on his lips.

“Oh your lips healed already,” she remarked poking on the not anymore sore spot on the boy's mouth playfully. Well, it has already been a week since the incident, so luckily all the bruised and wounded areas got better and less painful.

“Yeah. Thanks Yuna,” Hanbin smiled as grateful as he could. He was indeed lucky to have the whole crew having his back for this.

“Don't mention it,” the girl shrugged and walked away just as fast as she came.

Not much later Hanbin was off to go too, so he bid his quick goodbyes and got into his car. As he drove off the suburb shop, all his friends hollered after him and Bobby even joked that he shouldn't forget where he came from once he got together with crazy rich chick. From the outskirts of the city the more he approached the downtown worn one-storey houses were changed to tall apartments with barely any place between them and when he left the busy part of the city behind, the Gangnam luxury welcomed him. His car was clearly out of place and he got a few looks while turning into the driveway of a smaller palace-like house at one corner. After identifying himself, the security guard told him to park in front the garage that had four identical black Audis in it. Woah, they sure were on a different level.

“Good morning, Mr. Kim. Please follow me inside. The family wishes to meet you,” the assistant he met the other time greeted him as soon as he got out of the car.

He tried not to stare too much while he looked around in the fancy house as he was led into the living room. There sit a couple in their 40s in elegant clothes and serious expressions on their faces.

“Mr. Jeon, Mrs. Jeon, let me introduce you the newest addition to our staff. Mr. Kim will be the personal driver of Miss Jeon from now on,” the assistant introduced them and Hanbin didn't forget to bow deeply in front of his new employers.

“I hope he will deal with her better than the earlier ones,” the woman muttered and it peaked the boy's interest. How bad that girl could have been to chase away his previous drivers? He sure hoped she wouldn't be some annoying twelve-year-old with an obsession about idols because he might not take that too well either.

“Welcome, Mr. Kim. I hope you will ensure my daughter's safety and make sure she follows her schedule,” Mr. Jeon reached for his hand and shook on it firmly.

“I will try my best, sir,” Hanbin nodded and started to get slightly nervous from all this big fuss around the whole situation. Not to mention that the man in front of him looked strangely familiar but he couldn't tell from where.

“This is the car key. You will get it every morning here and have to hand it in after your working hours. And this is your work phone. Make sure to be always available. It has every number in it you need and you get Miss Jeon's schedule texted to you the day before. You can find today's in the calendar app already,” the assistant handed him the two items but before he could check what's his exact job for today, footsteps echoed on the staircase closeby.

“Soyeon, your new driver is here. Don't you dare sneak out!” Mrs. Jeon raised her voice and when Hanbin lifted his head to see who caused this stir in the motion, his jaw almost dropped. “And how many times do I have to tell you not to dress like that in university?”

Hanbin's mind barely recognized all the complaints the woman made as his eyes got fixed on the slim figure ascending the stairs. The girl wore leather pants with crop top and a jacket thrown over her shoulders. She flipped her long, black hair with such elegance only their kind had as her gaze lazily settled on the small crowd in the living room.

Her sharp gaze met Hanbin's only for a moment but he could tell she recognized him, too. There was a moment hesitation in her movements before her perfect mask was back on.

“I don't have time to get changed. I'm out,” she turned her back to them and walked in confident strides towards the garage. She had the same fire in her that burnt when her brother lost that stupid bet. That was actually quite impressive.

“Good luck, Mr. Kim,” the politician - oh of course, how could he not recognize him? - ushered the driver to go after her and it was the first time since he got the job that Hanbin actually thought he will need luck to deal with it.

Because now he got to drive around the girl who was offered to him as a prize, the girl he thought he would never see again, the girl who had been on his mind more times than he would like to admit.