The Department-Related Parliamentary Standing Committee for the Ministry of Health and Family Welfare has sought the Centre to submit the response from the five states, including Maharashtra and Uttar Pradesh, among others, on the proposed project proposals for strengthening their state drug regulatory systems.

The Committee, in the latest report on the action taken by the Ministry on its recommendations from the previous report, said that it is of the considered view that vibrant, dynamic, strengthened drug testing laboratories are concomitantly efficient and effective drug regulatory mechanisms to avert the prevalence of sub-standard drugs.

"Therefore, the Ministry should instruct and guide the state governments to strengthen their state drug regulatory systems,” it said.

Click for more on State FDAs

“Moreover, the Committee wants to be informed of the response of the following states' governments to the Ministry’s perusal for submitting the project proposals matching the indicative amount of each state.":

- Maharashtra,
- Uttar Pradesh,
- Bihar,
- Tamil Nadu,
- Karnataka

"Understandably, the Ministry will continue to monitor optimal utilization of funds earmarked for the scheme,” it added.

In the previous report, the Committee took into account the lack of adequate drug control infrastructure and drug testing facilities across the States.

“The Committee strongly believes that for the development of a vibrant drug manufacturing industry, issues related to the supply of poor quality drugs need to be resolved."

"It is an established fact that Strengthening of state drug regulatory system is the keystone for addressing the issues of substandard drugs,” it said in the previous report.

It also noted the plea of the Ministry that the lack of proposals from states for strengthening state drug regulatory systems has been one of the primary reasons for underutilization under the Scheme.

The nonsubmission of proposals from states especially, States with a higher allocation of the indicative amount, is not tenable.

It is then recommended that states, especially Maharashtra, Uttar Pradesh, Bihar, Tamil Nadu, and Karnataka, may be persuaded to submit project proposals matching the indicative amount.

The Ministry may also follow up with all the states and make efforts to set up a sufficient number of laboratories The Committee emphasized the need for cooperation between the States and the Union government to establish a vibrant, dynamic, and effective drug regulatory regime.

In response to this previous report, the Ministry responded that it has been making concerted efforts to implement the Scheme of Strengthening of the State Drug Regulatory System with all the states/UTs for signing the Memorandum of Understanding under the scheme and submitting project proposals for release of grant-in-aid.

All the states/UTs which have received Grants-in-Aid have also been requested to furnish Utilization Certificates (USs) and detailed progress reports of the projects undertaken through a number of virtual meetings and repeated communications.

Up to March 31, 2022, a Grant-in-Aid of Rs. 642.18 crores has been released to the states/UTs. This scheme has paved the way for the setting up of 17 new drug testing labs and the renovation/upgradation of 26 existing ones, as well as the setting up of 48 new offices for drug controllers and the upgradation of 27 existing similar offices.

In line with the recommendations of the Committee, the states of Maharashtra, Uttar Pradesh, Bihar, Tamil Nadu, and Karnataka are being persuaded to submit the project proposals matching their indicative amount, said the Ministry. Further, all the other states/UTs are also being requested to set up a sufficient number of drug testing laboratories to meet their requirements, it added.

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To practice mindfulness for daily well-being and work performance, a person should sleep for extra 29 minutes each night, suggested a recent study.

Mindfulness is achieved by purposefully bringing an individual’s awareness and attention to experiences occurring in the present moment without forming an opinion.

Unlike previous studies, new research published in Sleep Health looked at how multiple dimensions of nightly sleep impact daily mindfulness, rather than just focusing on sleep quality or duration.

The study led by the University of South Florida found better sleep improves next-day mindfulness, which in turn, reduces sleepiness during the day.

The research focused on nurses, the largest group of healthcare professionals whose need for optimal sleep and mindful attention is particularly high.

Sleep problems are common in this population due to long shifts, lack of situational control, and close proximity to life-threatening health conditions.

Their optimal sleep health and mindful attention are particularly important as they work on the front lines of the pandemic.

“One can be awake and alert but not necessarily mindful. Similarly, one can be tired or in low arousal but still be mindful, "said lead author Soomi Lee, assistant professor of aging studies at USF.

“Mindful attention is beyond just being awake. "It indicates attentional control and self-regulation that facilitates sensitivity and adaptive adjustment to environmental and internal cues, which are essential when providing mindful care to patients and effectively dealing with stressful situations,” added Lee.

Lee and her colleagues from USF and Moffitt Cancer Center followed 61 nurses for two weeks and examined multiple characteristics of sleep health.

They found that nurses’ mindful attention was greater than their usual after-nights with greater sleep sufficiency, better sleep quality, lower efficiency, and longer sleep duration (an extra half-hour longer).

Daily mindful attention contributed to less sleepiness. Those with greater mindful attention were also 66% less likely to experience symptoms of insomnia during the two-week study period.

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Researchers came to these conclusions by using a variety of tools to measure how much participants were mindful of each daily moment and how their mental states were impacted by sleep.

Participants were prompted to answer daily mindfulness and sleepiness questions three times a day for two weeks using the smartphone application, RealLife Exp.

Daily mindfulness was measured by the Mindful Attention Awareness Scale, which asked questions such as, “I was doing something automatically, without being aware of what I was doing,” and “I was finding it difficult to stay focused on what was happening.”

Participants also wore an Actiwatch Spectrum device for the same two weeks that measured wrist movement activity to quantify sleep and wake patterns.

Findings from this study provide insight into developing a behavioral health intervention strategy for a broader array of healthcare workers who need better sleep and mindful attention.

Given the association between mindful attention and better patient care, improving sleep in this population may provide important benefits to patient health outcomes as well.
https://thehealthmaster.com/2020/10/19/29-minutes-extra-sleep-for-well-being-study/

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Apply online, the link is given below: 

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Changing the Regulations for Class A Medical Devices and its Impact

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The Govt. of India issued a draft notification GSR 710(E) on September 20th, 2022, and gave just 7 days’ time to the industry to respond, thus making it clear to the stakeholders that this will be soon finalized without much change to its shape and size.

Download notification No. GSR 710(E) on September 20th, 2022

I would like to draw the attention of the medical devices industry to some of the points that the industry and the authorities must ponder about the impact these changed regulations will have on the market.

This draft notification is issued almost at the fag end of the expiry of mandatory registration as per GSR 102(E) dated February 11, 2020, and the effective date is October 1, 2022.

Download notification No. GSR 102(E) on February 11, 2020

The license will be applicable and many of the medical device manufacturers and importers have already submitted the applications after paying the due fee as per the Second Schedule of GSR 78(E) dated January 31, 2017.

Download notification No. GSR 78(E) on January 31, 2017

Out of these many medical devices, manufacturers have already been audited by the Central Drugs Standard Control Organisation (CDSCO) approved notified bodies after paying the fee as prescribed by the CDSCO for the auditing.

And many have already been issued the licenses as well by the State Licensing Authorities.

So what is going to be for them as they have already shelled out the money for them?

Many of medical device companies may feel cheated as they have done the complete exercise, followed all the compliances, and have either received their approval or are just due to getting it in a few days.

Click for more on Medical Devices

This is the same as students who studied well throughout the year and were ready for their final exams, and all of a sudden the examinations were scrapped and all declared passed.

The students, who didn’t touch their books for the complete year, also got the same passing marks as it’s for the whole of the Class.

This notification GSR 710(E) is probably to help the people who were sleeping to date and were not abiding by the regulations introduced by this CDSCO office, which were in line with many developing and developed countries in the world to have regulations in place to improve public health by avoiding sub-standard medical devices in the market.

As we all know that there are many medical devices available in the Indian market manufactured by unsolicited manufacturers running their show from a single shabby room in many areas unfit for even living and these medical device land in many hospitals easily as they save on cost but not on human lives.

Click for more on CDSCO

So, we must ask a question ourselves, Why aren’t we compromising on human health and pushing the public at large to a substandard medical device?

One technical point to be brought to the notice of all is that the registration number issued by the CDSCO portal has been creating a lot of confusion in the market because of a lack of awareness.

As many of the hospitals used to demand either Form MD-15 for imported items and MD-05 or MD-06 or MD-09 or MD-10 for a domestically manufactured non-regulated medical device wherein either a registration no. issued by the CDSCO was either available or just a Screenshot of submission of registration under MDR 2020 under GSR 102(E).

This became very difficult for the medical device manufacturers/importers to explain to the Hospitals/Tendering Authorities about the non-availability of issuance of any certificate or any letter/mail from authorities for such registrations.

This would request the authorities to kindly maintain a uniform system of issuing licenses to all medical devices across the board.

In my opinion, these changed regulations may help the industry towards a short-term gain, but this will result in a long-term loss to the health of the medical device industry and humans.

I request the readers to do some introspection and turn the tables toward the proper regulations to have a healthy environment and a level playing field in the global market.

By: Dr. B. N. NagpalThe author is CEO at M N Solutions, Medical Device Regulatory Consulting. Email: solutions.mn@gmail.com

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HYDERABAD:  I’m Lutf Khan from St Mary’s College, Yousufguda. The lockdown introduced me to my new "me."

I must confess that bingeing on a lot of junk food and sugar in my college life and the sedentary life during the lockdown took my weight to 106 kg.

I couldn’t have imagined my life being worse than this when carrying my own weight became difficult for me.

I wasn’t prepared to continue living in this body. I kept browsing the internet the big moment occurred when I came across Dr. Eric Berg’s YouTube Channel. 

I kept following his plans, which were basically intermittent fasting, which increases the HGH in your body and boosts your metabolism, and a keto diet, which makes you burn your body fat rather than burning carbohydrates.

One Meal A Day

I combined these two and started doing OMAD, which is One Meal A Day! When I started doing OMAD, I started seeing a drastic change in my weight, I started to lose weight and now I knew I could nurture my dream and passion for acting and filmmaking. 

I work out once a day and this comprises 40 minutes of cardio and 20 of mild weight training in my home in Banjara Hills.

My current weight is 72 kg. I lost 34 kg in three months after lockdown. I had no coach, but I followed Dr. Eric Berg and Beer Biceps on YouTube. 

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I am much more energetic and feel great inside out. There are some facts that we all should know about beyond Keto and intermittent fasting.

The plan that I took up helps in insulin resistance – because of eating sugar and too many carbohydrates frequently, the insulin spikes up which completely stops your weight and slows down your metabolism.

Secondly, we must drink plenty of water, which helps to detox our bodies! Next is to eat protein-rich foods which help us feel full for a longer period of time, satiating our hunger pangs.

It is important for us to maintain a caloric count. This is what I started eating and shall continue to do so - two egg whites, chicken breast, green vegetables, and whole wheat chapatis.

In keto, your total carb intake should be less than 50 grams! My mantra: Stay healthy, stay awesome.  

by Arthi Sreenath

A Hyderabadi collegian tells us how he followed Dr Eric Berg and Beer Biceps from YouTube and some common sense weight loss tips to be where he is today(As told to Arthi Sreenath)
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प्राकृतिक चिकित्सा: स्वस्थ रहने के लिए क्यों है जरूरी

व्यस्तता के दौर में लोगों की अनियमित जीवनशैली के कारण कई प्रकार की बीमारियां घेर रही हैं. इन सभी प्रकार की बीमारियों के इलाज के लिए कई दवाइयां (Medicines) उपलब्ध हैं, लेकिन दवाइयों के कई नुकसान भी हैं.

ऐसे में शरीर के लिए सही इलाज है प्राकृतिक चिकित्सा (Naturopathy). प्राकृतिक चिकित्सा से तात्पर्य है, प्रकृति के साथ रहकर शरीर को स्वस्थ रखना. आयुर्वेद (Ayurveda) के अनुसार, सूर्योदय से पहले उठना, हमारे शरीर और मन के लिए अच्छा होता है क्योंकि सुबह शुद्ध वायु और सूर्य की धीमी रोशनी से मन मस्तिष्क ऊर्जा से भर जाते हैं.

सूर्य की रोशनी से विटामिन-डी (Vitamin-D) की भी पूर्ति होती है, जो शरीर की हड्डियों के लिए बहुत जरूरी है.

आजकल लोग शारीरिक मेहनत कम करते हैं और लगातार कंप्यूटर व मोबाइल में लगे रहते हैं.

इस वजह से आंखों पर भी बुरा असर पड़ता है, साथ ही मानसिक थकान महसूस होती है, ‌इसलिए जरूरी है कि हम प्राकृतिक चिकित्सा को अपनाएं. आइए जानते हैं प्राकृतिक चिकित्सा के बारे में.

समय पर भोजन करना

स्वास्थ्य के लिए आवश्यक है कि सही समय पर भोजन किया जाए, लेकिन ऐसा नहीं करने से पाचन तंत्र खराब हो जाता है.

यह सुनिश्चित करना चाहिए कि सुबह जल्दी उठकर स्नान करके सुबह 9:00 बजे तक नाश्ता करें, उसके बाद दिन में 12:00 बजे के बाद मध्यान्ह भोजन और सूर्यास्त से पहले भोजन करने से शरीर स्वस्थ रहेगा.

इसके अलावा अपने भोजन में पर्याप्त रूप से सभी प्रकार के विटामिन्स और अन्य आवश्यक तत्वों को शामिल करें.

नेचुरोपैथी के इलाज में उपवास का महत्व

अनुशासित दिनचर्या से शरीर को स्वस्थ रखा जा सकता है. उपवास का भी शरीर के लिए काफी महत्व है. इससे शरीर के अंगों को आराम मिलता है.

हफ्ते में एक से दो बार उपवास करना शरीर के लिए अच्छा होता है. उपवास के दौरान फलाहार या जूस लें तो पाचन जल्दी से हो जाता है. उपवास में ऐसी चीजें बिल्कुल भी न खाएं, जिन्हें पचाने में मुश्किल हो.

फाइबर से भरपूर आहार है लाभकारी

लोग फाइबर युक्त चीजों का सेवन कम कर रहे हैं. इस वजह से पाचन कमजोर होने लगता है. डॉ. मेधावी अग्रवाल के अनुसार, फाइबर युक्त आहार लेने से पेट से संबंधित रोगों से बचा जा सकता है.

इसके लिए अपने आहार में जौ, बाजरा, मक्का और चना जरूर शामिल करने चाहिए, क्योंकि इनमें काफी मात्रा में फाइबर होता है.

यह भी कोशिश करें कि सब्जियों को छिलके सहित खाएं क्योंकि छिलकों में काफी मात्रा में विटामिन और प्रोटीन पाया जाता है. इसके अलावा छिलके वाली दालें भी फायदेमंद होती हैं.

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घर का भोजन ही लाभकारी

प्राकृतिक चिकित्सा में घर के भोजन को ही फायदेमंद माना जाता है क्योंकि घर के भोजन में किसी भी प्रकार की मिलावट नहीं होती है.

घर का भोजन बनाते समय साफ-सफाई का भी ख्याल रखा जाता है. घर के भोजन में सभी प्रकार के पोषक तत्व भी मौजूद होते हैं.

डॉ. मेधावी अग्रवाल के अनुसार, फास्ट फूड और जंक फूड में पोषक तत्व नहीं होते हैं. इनमें काफी मात्रा में वसा होती है, जो हृदय के लिए काफी नुकसानदायक हैं.

प्राकृतिक चिकित्सा में रखें इन बातों का ध्यान

-एक बार में एक ही तरह का फल खाना चाहिए. अलग अलग फल एक बार में न खाएं.-गाजर के जूस के साथ आंवला काफी लाभकारी होता है.-यदि रोज नियमित रूप से उबले हुए टमाटर खाएंगे तो कैंसर नहीं होगा.-अपने खाने में हल्दी, दालचीनी, काली मिर्च आदि का सेवन जरूर करना चाहिए.

अस्वीकरण : इस लेख में दी गयी जानकारी कुछ खास स्वास्थ्य स्थितियों और उनके संभावित उपचार के संबंध में शैक्षणिक उद्देश्यों के लिए है। यह किसी योग्य और लाइसेंस प्राप्त चिकित्सक द्वारा दी जाने वाली स्वास्थ्य सेवा, जांच, निदान और इलाज का विकल्प नहीं है। यदि आप, आपका बच्चा या कोई करीबी ऐसी किसी स्वास्थ्य समस्या का सामना कर रहा है, जिसके बारे में यहां बताया गया है तो जल्द से जल्द डॉक्टर से संपर्क करें। यहां पर दी गयी जानकारी का उपयोग किसी भी स्वास्थ्य संबंधी समस्या या बीमारी के निदान या उपचार के लिए बिना विशेषज्ञ की सलाह के ना करें। यदि आप ऐसा करते हैं तो ऐसी स्थिति में आपको होने वाले किसी भी तरह से संभावित नुकसान के लिए The Health Master जिम्मेदार नहीं होगा।
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Pharmacists - The Doctors behind the screens

The distribution of medicines should always take place under the observation of a pharmacist.

To ensure that the correct medicines were given to the concerned and also to ensure the overall health of the people of India, the top leaders of our country drafted a rule called the "Pharmacist Rule' in 1948, which was then passed by our Parliament.

But over the course of time, the rule was only partially implemented, which led to the pharmacists facing a lack of job opportunities and a financial crisis.

Because of the increasing financial burden, a lot of them were unable to even set up a pharmacy, so they resorted to renting out their certificates.

Clcik for more on Pharmacy Act and Regulations

Pharmacist: A Major contributor

Pharmacists are the major contributors to ensuring the good health of the general public in the long run.

Over the past few years, new medicines have been developed and manufactured by pharmacists to combat new diseases and health complications.

They have been working nonstop to tackle issues like C-19 and other major health concerns.

The Indian pharmaceutical industry has kept pace with its foreign competitors by finding new medicines for major health ailments, which is highly appreciable.

A lot of essential factors, such as preparation of medicines, their quality and other associated parameters, proper ways of medical storage, and informing patients regarding medicine dosage and when to take them and their effects if taken wrongly, fall under a pharmacist's role.

Pharmacist: A bridge between a doctor and a patient

A pharmacist primarily acts as a bridge between a doctor and a patient. Identifying the issues and diseases of a patient is the job of a doctor.

The quantity of medicine to take, timings, and other major factors are conveyed to the patient by the pharmacist.

When you look at the bigger picture, the pharmacist is the doctor behind the screen.

In emergency cases, if the main doctor is not present, the pharmacist can take over in primary health care centers and conduct the preliminary diagnosis.

The Shankarrao Chavan parliamentary sub-committee addressed the above issue in parliament and spoke about the acceptance of pharmacists in the primary health center.

In 2017, the Ministry of Health and Family Welfare and the National Rural Health Mission reiterated the importance of pharmacists.

They said that they should be trained and sent across all rural and urban areas to help and support people.

State of pharmacies in hospitals

Jaisukh Lal Hathi, Justice Lentin, and Bajaj lent their hands to help and improve the state of pharmacies in hospitals.

A study group was formed under the leadership of Ajith Prasad Jain. They recommended in 1966 that even in small hospitals, a minimum of three pharmacists be present.

If the desired final results have to be achieved, the pharmacist definitely has to be involved, as only the pharmacist knows which medicine is for which disease and how they react.

Pharmacists can also look into the medicines prescribed by the doctor and suggest any changes if needed.

Importance of pharmacists

Over the course of time, we have forgotten the importance of pharmacists, and that has led to medical distribution being all over the place.

This has in turn given rise to a lot of health issues and complications.

The dosage of medicines is something that is primarily known only to a pharmacist. Countries like Germany, France, Britain, Italy, and other European and Arab countries like Saudi Arabia have always placed pharmacists on a higher pedestal than other countries.

In such countries, the doctor decides on the medicine and the pharmacist takes care of the duration and dosage of the medicine.

But in our country, it is completely different. Pharmacists and doctors have no connection. It is of paramount importance that medical distribution happens primarily under the supervision of a pharmacist.

Government hospitals, public health care centers, district health care centers, and village health care centers all have pharmaceutical positions that need to be filled.

Any vacancies should be looked into and immediately filled with the right people. Also, interest-free loan opportunities can be looked into to help pharmacists set up their own pharmacies.

A little encouragement and support go a really long way.

I wish all my fellow pharmacists across the globe a happy pharmacist's day.

By G. Koteshwar RaoThe author is:National president, DCO INDIA DRUGS CONTROL WELFARE ASSOCIATION. President: Indian Pharmacy Graduates Association (IPGA), Telangana,Chairman: Pallavi Memorial Trust, Hyderabad

DISCLAIMER: The views expressed are solely of the author and TheHealthMaster.com does not necessarily subscribe to it. TheHealthMaster.com shall not be responsible for any damage caused to any person / organization directly or indirectly.

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