Download the lists of NSQ drugs given below: We have provided the list of "not of standard quality" (NSQ) drugs declared by various drug testing laboratories in India.

Picture: Pixabay

Lists of NSQ drugs

2022

May 2022: Download the list of NSQ samples, click below link:

Drug-Alert-List-May-2022

April 2022: Download the list of NSQ samples (Revised), click below link:

Drug-Alert-list-April-2022-Revised

April 2022: Download the list of NSQ samples, click below link:

Drug-Alert-list-April-2022

March 2022: Download the list of NSQ samples, click below link:

Drug-Alert-list-March-2022

February 2022: Download the list of NSQ samples, click below link:

Drug-Alert-List-February-2022

January 2022: Download the list of NSQ samples, click below link:

Drug-Alert-List-January-2022

2021

December 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-December-2021

November 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-November-2021

October 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-October-2021

September 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-September-2021

August 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-August-2021

July 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-July-2021

June 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-June-2021

May 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-May-2021

April 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-April-2021

March 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-March-2021

February 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-February-2021

January 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-January-2021

2020

December 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-December-2020

November 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-November-2020

October 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-October-2020

September 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-September-2020

August 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-August-2020

July 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-July-2020

June 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-June-2020

May 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-May-2020

April 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-April-2020

March 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-March-2020

February 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-February-2020

January 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-January-2020

2019

December 2019: Download the list of NSQ samples, click below link:

Drug-Alert-List-December-2019

November 2019: Download the list of NSQ samples, click below link:

Drug-Alert-List-November-2019

October 2019: Download the list of NSQ samples, click below link:

Drug-Alert-List-October-2019

Source of Drug alert lists: CDSCO website

Commercial Testing Laboratories

Govt Laboratories

List of Laboratory instruments

Latest Notifications: Testing Laboratories

Licensing procedure for manufacturing of Drugs

Procedure to obtain license for manufacturing of Cosmetics

Procedure to obtain license for manufacturing of Homoeopathic Medicines

Procedure to obtain license for manufacturing of Medical Devices

Procedure to obtain License to Manufacture drugs for testing and analysis purposes

Procedure to obtain license for Blood Centre (Blood Bank)

Procedure to obtain license for Commercial Testing Laboratories

Procedure to obtain license for Medical Store / Pharmacy

How to start Jan Aushadhi Store: Procedure

Click to read other articles of the Author
https://thehealthmaster.com/2022/06/26/drug-alert-nsq-drugs-lists/

Download the lists of NSQ drugs given below: We have provided the list of "not of standard quality" (NSQ) drugs declared by various drug testing laboratories in India.

Picture: Pixabay

Lists of NSQ drugs

2022

May 2022: Download the list of NSQ samples, click below link:

Drug-Alert-List-May-2022

April 2022: Download the list of NSQ samples (Revised), click below link:

Drug-Alert-list-April-2022-Revised

April 2022: Download the list of NSQ samples, click below link:

Drug-Alert-list-April-2022

March 2022: Download the list of NSQ samples, click below link:

Drug-Alert-list-March-2022

February 2022: Download the list of NSQ samples, click below link:

Drug-Alert-List-February-2022

January 2022: Download the list of NSQ samples, click below link:

Drug-Alert-List-January-2022

2021

December 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-December-2021

November 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-November-2021

October 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-October-2021

September 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-September-2021

August 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-August-2021

July 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-July-2021

June 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-June-2021

May 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-May-2021

April 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-April-2021

March 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-March-2021

February 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-February-2021

January 2021: Download the list of NSQ samples, click below link:

Drug-Alert-List-January-2021

2020

December 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-December-2020

November 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-November-2020

October 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-October-2020

September 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-September-2020

August 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-August-2020

July 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-July-2020

June 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-June-2020

May 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-May-2020

April 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-April-2020

March 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-March-2020

February 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-February-2020

January 2020: Download the list of NSQ samples, click below link:

Drug-Alert-List-January-2020

2019

December 2019: Download the list of NSQ samples, click below link:

Drug-Alert-List-December-2019

November 2019: Download the list of NSQ samples, click below link:

Drug-Alert-List-November-2019

October 2019: Download the list of NSQ samples, click below link:

Drug-Alert-List-October-2019

Source of Drug alert lists: CDSCO website

Commercial Testing Laboratories

Govt Laboratories

List of Laboratory instruments

Latest Notifications: Testing Laboratories

Licensing procedure for manufacturing of Drugs

Procedure to obtain license for manufacturing of Cosmetics

Procedure to obtain license for manufacturing of Homoeopathic Medicines

Procedure to obtain license for manufacturing of Medical Devices

Procedure to obtain License to Manufacture drugs for testing and analysis purposes

Procedure to obtain license for Blood Centre (Blood Bank)

Procedure to obtain license for Commercial Testing Laboratories

Procedure to obtain license for Medical Store / Pharmacy

How to start Jan Aushadhi Store: Procedure
https://thehealthmaster.com/drug-alert-nsq-drugs-lists/

CDSCO issues alert on batches of peripheral stent from US-based Cordis

https://thehealthmaster.com/2022/06/29/cdsco-issues-alert-on-batches-of-peripheral-stent-from-us-based-cordis/

Govt Job: For M.Pharm, M.S Pharm to work in SERB Project, NIPER

https://thehealthmaster.com/?p=38885

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DCGI approves India’s first mRNA vaccine against C-19

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Govt in talks with UAE to recognise Indian Pharmacopoeia

https://thehealthmaster.com/?p=38878

15 quick Skincare facts we must know

15 quick Skincare facts we must know

https://thehealthmaster.com/?p=38819

In a bid to increase its efforts towards recognition and acceptance of IP in foreign countries, the Indian Pharmacopoeia Commission (IPC) has submitted proposals to various countries through the Ministry of Health and Family Welfare, Ministry of Commerce and Industry, and Ministry of External Affairs, according to a statement by IPC.

The statement said that it is a matter of delight to share that pursuant to sincere efforts and guidance provided by the Union Minister of Health and Family Welfare to get IP recognised in foreign countries, IP has been accepted as a book of standards in a total of four countries, with details as appended below:

Click for more articles on IPC - Indian Pharmacopoeia Commisssion

Afghanistan: IP has been recognised formally by the National Department of Regulation of Medicines and Health Products of the Ministry of Public Health of the Islamic Republic of Afghanistan and will also be used based on the requirements of reputable pharmacopoeia in the laboratory of medicines and health products quality. A new beginning has been made as Afghanistan has become the first country to recognise the IP.

Ghana: IP is considered an approved reference when its monograph compares with the monographs in recognised pharmacopoeias in the Fourth Schedule of the Public Health Act.

 Nepal: IP is recognised as the book of standards in Drugs Category Rules 1986 of Nepal. As per the list of pharmacopoeia or encyclopedia related to the category of drugs under Schedule 1 (related to Rule 5) of the Drugs Category Rules 1986, “Pharmacopoeia of India” published by the Ministry of Health of the Government of India has been included in Sr. No. 3.

Mauritius: In order to include IP in the standards of pharmaceuticals authorised in Mauritius, Section 2 of the Pharmacy Act 1983 has been amended through Section 50 of the legal supplement published in August 2020 and in the definition of “specified standards” of Section 2 of the Pharmacy Act, the word “or European” has been deleted and replaced with the words “European or Indian.”

Accordingly, the amended section reads as “specified standards," which means such standards are specified in the British, French, US, European, or Indian Pharmacopoeia, the statement added.

Efforts are on to add more countries to the list and stakeholders are encouraged to take advantage of this recognition, the statement stated.

In addition to it, with a view to further strengthening the standards of drugs in India, IPC is releasing a new, 9th edition of IP (IP 2022) on July 1st, 2022.

Mansukh Mandaviya, Minister of Health and Family Welfare, will be releasing the new edition. The event will be hosted at Vigyan Bhawan, Maulana Azad Road, as per another statement by IPC.

The statement said that the publication of the 9th edition of IP will make a big contribution to improving and ensuring the quality of medicines and the overall strengthening of the regulation of the drug in India, said the statement.

To mark the occasion of the publication and release of the IP 2022 on 1st July, IPC is also organising a one-day scientific conference on the theme of ‘Addressing Medicine Quality for Future.’

Since the main users of IP are from the pharma industry, the target audience for the conference will be leading pharma companies, pharma MSMEs, regulatory authorities, industry bodies like IDMA, BDMA, IPA, etc, and academia, the statement concluded.

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This commonly used drug is linked to risk of high BP

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Govt to monitor sale of these 11 Drugs from being misused

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Download the lists of NSQ drugs given below: 

https://thehealthmaster.com/?p=38750

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Report of Govt Analyst and CDL must give factual data (Part-2)

Continued from …… Report of Govt Analyst and CDL must give factual data (Part-1)

But where the opinion is not supported by any factual data, the Court cannot test the opinion of the Government Analyst and can not accept it blindly. The liberty of the people cannot be taken away from them on such evidence which cannot be tested. It is, therefore, necessary that the procedure laid down in The Drugs and Cosmetics Act, 1940, should be strictly followed and where this procedure has not been followed the report of the Government Analyst cannot be treated as conclusive evidence.

Under Section 25(4) of the Act, the Central Drugs Laboratory, Calcutta, is the final authority. If a conflict of opinion about the quality of the sample had arisen during the normal course the trial Court will send a sample to the Central Drugs Laboratory, Calcutta, to decide the question and then the opinion of the Central Drugs Laboratory would be treated as conclusive evidence of the facts stated in its report.

It has to be noted that the test report from the Central drug Laboratory directly without being it is tested by the state drug laboratory will not be final. Meaning thereby that the sample has to be sent to the Government Analyst for testing as a first authority and thereafter only the sample can be sent to the CDL, Calcutta.

Picture: Pixabay

It is, therefore, obvious that if the report of the Central Drugs Laboratory is to be held to be the final word regarding the quality of the sample, the accused be given the chance of rebutting the report. In the special circumstances of this case the opinion of the Central Drugs Laboratory, therefore, cannot be treated as the final authority and it can be treated only as of the report of a Government Analyst.

What happened when the report of the Government Analyst or CDL, is in an abridgment and does not give detail of the test. The question, therefore, arises whether this abridgment amounts to an infringement of any basic right given to the citizens under the Constitution of India. Article 21 of the Constitution of India states that no person shall be deprived of his life or personal liberty except according to the procedure established by law.

It cannot be denied that one of the basic natural rights possessed by an accused person is that he should have an opportunity to defend himself against the charge leveled against him. If any enactment contains any such procedure which takes away the basic right to defend then it must be held to be ultra vires of the Constitution. According to Article 13 of the Constitution of India, all laws which are inconsistent with the rights given to the citizens are void to the extent of such inconsistency.

It is, therefore, to be determined whether Section 25(4) of the Act is inconsistent with Article 21 or not. Is it against an established procedure of law, when it makes the opinion of the Government Analyst final and gives no opportunity to an accused person to challenge that opinion by cross-examining the Government Analyst.

That this provision has been made for the sake of convenience and saving of expenditure can be well understood, but these reasons cannot take away the right of an accused person to defend himself. The Court has to see whether any alternative procedure of defence is open to an accused person or not. The basic right of an accused to defend himself is protected and the provisions of Section 25 of the Act, therefore, are intra-vires of the Constitution.

Click here to read more articles of the Author

The procedure mentioned should be strictly followed and if reliance is to be placed upon the conclusive nature of the evidence of the Analyst, it should be procured only in the manner mentioned in Section 25 of the Drugs Act. The basic rights can be abridged only in the manner prescribed and in no other manner.

In the end, it goes to say that if there is a material discrepancy as to factual data in the report it follows that the accused may seek to cross-examine the analyst. Even the report of CDL which does not contain the data as required under Form 2 of the Act is not conclusive and can be termed as defective.

Under such circumstances the conclusiveness of the report of CDL, Calcutta can be challenged and can be rebutted by various means depending upon the circumstances of the case.

Disclaimer:The opinion of the author is personal and based upon his understanding. The author is an Advocate practicing before Supreme Court and Delhi High Court.

Commercial Testing Laboratories

Govt Laboratories

List of Laboratory instruments
https://thehealthmaster.com/2021/08/02/report-of-govt-analyst-and-cdl-must-give-factual-data-part-2/

Report of Govt Analyst and CDL must give factual data (Part-2)

Continued from …… Report of Govt Analyst and CDL must give factual data (Part-1)

But where the opinion is not supported by any factual data, the Court cannot test the opinion of the Government Analyst and can not accept it blindly. The liberty of the people cannot be taken away from them on such evidence which cannot be tested. It is, therefore, necessary that the procedure laid down in The Drugs and Cosmetics Act, 1940, should be strictly followed and where this procedure has not been followed the report of the Government Analyst cannot be treated as conclusive evidence.

Under Section 25(4) of the Act, the Central Drugs Laboratory, Calcutta, is the final authority. If a conflict of opinion about the quality of the sample had arisen during the normal course the trial Court will send a sample to the Central Drugs Laboratory, Calcutta, to decide the question and then the opinion of the Central Drugs Laboratory would be treated as conclusive evidence of the facts stated in its report.

It has to be noted that the test report from the Central drug Laboratory directly without being it is tested by the state drug laboratory will not be final. Meaning thereby that the sample has to be sent to the Government Analyst for testing as a first authority and thereafter only the sample can be sent to the CDL, Calcutta.

Picture: Pixabay

It is, therefore, obvious that if the report of the Central Drugs Laboratory is to be held to be the final word regarding the quality of the sample, the accused be given the chance of rebutting the report. In the special circumstances of this case the opinion of the Central Drugs Laboratory, therefore, cannot be treated as the final authority and it can be treated only as of the report of a Government Analyst.

What happened when the report of the Government Analyst or CDL, is in an abridgment and does not give detail of the test. The question, therefore, arises whether this abridgment amounts to an infringement of any basic right given to the citizens under the Constitution of India. Article 21 of the Constitution of India states that no person shall be deprived of his life or personal liberty except according to the procedure established by law.

It cannot be denied that one of the basic natural rights possessed by an accused person is that he should have an opportunity to defend himself against the charge leveled against him. If any enactment contains any such procedure which takes away the basic right to defend then it must be held to be ultra vires of the Constitution. According to Article 13 of the Constitution of India, all laws which are inconsistent with the rights given to the citizens are void to the extent of such inconsistency.

It is, therefore, to be determined whether Section 25(4) of the Act is inconsistent with Article 21 or not. Is it against an established procedure of law, when it makes the opinion of the Government Analyst final and gives no opportunity to an accused person to challenge that opinion by cross-examining the Government Analyst.

That this provision has been made for the sake of convenience and saving of expenditure can be well understood, but these reasons cannot take away the right of an accused person to defend himself. The Court has to see whether any alternative procedure of defence is open to an accused person or not. The basic right of an accused to defend himself is protected and the provisions of Section 25 of the Act, therefore, are intra-vires of the Constitution.

Click here to read more articles of the Author

The procedure mentioned should be strictly followed and if reliance is to be placed upon the conclusive nature of the evidence of the Analyst, it should be procured only in the manner mentioned in Section 25 of the Drugs Act. The basic rights can be abridged only in the manner prescribed and in no other manner.

In the end, it goes to say that if there is a material discrepancy as to factual data in the report it follows that the accused may seek to cross-examine the analyst. Even the report of CDL which does not contain the data as required under Form 2 of the Act is not conclusive and can be termed as defective.

Under such circumstances the conclusiveness of the report of CDL, Calcutta can be challenged and can be rebutted by various means depending upon the circumstances of the case.

Disclaimer:The opinion of the author is personal and based upon his understanding. The author is an Advocate practicing before Supreme Court and Delhi High Court.

Commercial Testing Laboratories

Govt Laboratories

List of Laboratory instruments
https://thehealthmaster.com/2021/08/02/report-of-govt-analyst-and-cdl-must-give-factual-data-part-2/

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Drug Alert: NSQ Drugs Lists

Download the lists of NSQ drugs given below: 

https://thehealthmaster.com/?p=38750

Govt Job: For Pharmacy Professionals at (PCI) Pharmacy Council of India | Salary upto Rs 1,00,000 pm

Apply online, link is given below:

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मध्यम आयु वर्ग के लोग, जो कम से कम 10 सेकंड के लिए एक पैर पर नहीं खड़े हो सकते हैं, उनमें एक दशक के भीतर मरने का ख़तरा अधिक होता है।

यह अध्ययन हाल ही में ब्रिटिश जर्नल ऑफ स्पोर्ट्स मेडिसिन में प्रकाशित हुआ है।

शोधकर्ताओं ने पाया कि सरल संतुलन परीक्षण में जो वॉलंटियर्स संघर्ष कर रहे थे, उनकी अगले 10 सालों में मरने की संभावना 84% बढ़ जाती है, उन लोगों की तुलना जो बिना किसी सपोर्ट के एक पैर पर खड़े हो सके थे।

Healthy life

परिणाम ब्राजील में 50 वर्ष से अधिक उम्र के 1,702 लोगों के बीच फिटनेस और स्वास्थ्य के अध्ययन से सामने आया, जो 2009 में शुरू हुआ था।

स्टडी के प्रतिभागियों को एक पैर उठाने को कहा गया और उसे दूसरे पैर के पीछे रखने के लिए कहा गया था, वो भी बिना जमीन को छुए, अपने हाथों को अपने साइड में रखते हुए और आगे की ओर देखते हुए।

इसे करने के लिए उन्हें तीन प्रयासों की अनुमति दी गई थी। पांच में से एक व्यक्ति परीक्षण में विफल रहा, इनमें वे लोग शामिल थे, जिनकी या तो उम्र ज़्यादा थी या वे बीमार थे।

आप कितनी देर और कितनी अच्छी तरह से अपने शरीर को बैलेंस कर पाते हैं, इससे आपकी सेहत का पता लगाया जा सकता है।

इस शोध से पहले हुई एक स्टडी से पता चला था कि वे लोग जो एक पैर पर 10 सेकंड के लिए नहीं खड़े हो पाते हैं, उनमें स्ट्रोक से मौत का ख़तरा बढ़ जाता है।

इसके लिए यूके, अमेरिका, ऑस्ट्रेलिया, फिनलैंड और ब्राजील के एक्सपर्ट्स ने 12 साल तक एक रिसर्च की, जिसमें खुलासा हुआ कि मध्यम आयु वर्ग और बुजुर्ग लोग जो 10 सेंकड के लिए एक पैर पर संतुलन नहीं बना पाते हैं, उनमें अगले 10 सालों में मौत का जोखिम बढ़ जाता है।

लोग इस तरह का संतुलन आमतौर पर 60 साल की उम्र से पहले तक आराम से कर लेते हैं, हालांकि, इस उम्र के बाद उनके लिए संतुलन करना मुश्किल होता चला जाता है।

Disclaimer: लेख में उल्लिखित सलाह और सुझाव सिर्फ सामान्य सूचना के उद्देश्य के लिए हैं और इन्हें पेशेवर चिकित्सा सलाह के रूप में नहीं लिया जाना चाहिए। कोई भी सवाल या परेशानी हो तो हमेशा अपने डॉक्टर से सलाह लें।

Medicine: दवाओं को कैसे पता चलता है कि शरीर में कहां जाना है – Must read

How do drugs know where to go in the body ?

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Skincare: 6 best Clays used in Skincare

Topical steroid: Types, uses, side effects and treatment, revealed by doctors

Eat Right: Building a strong stomach for better immunity

Which is better for the skin and hair: Collagen or Biotin ?

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Getting headaches for 8 or more days a month ? Beware

Negative calorie foods खाने से वजन होता है कम ? Let’s know the source
https://thehealthmaster.com/2022/06/24/test-%e0%a4%af%e0%a4%b9-%e0%a4%9f%e0%a5%87%e0%a4%b8%e0%a5%8d%e0%a4%9f-%e0%a4%ac%e0%a4%a4%e0%a4%be%e0%a4%8f%e0%a4%97%e0%a4%be-%e0%a4%95%e0%a4%bf%e0%a4%a4%e0%a4%a8%e0%a5%87-%e0%a4%b8%e0%a4%be%e0%a4%b2/

Drug Alert: NSQ Drugs Lists

Download the lists of NSQ drugs given below: 

https://thehealthmaster.com/?p=38750

USFDA approves Pneumococcal Vaccine for children

https://thehealthmaster.com/?p=38741

Govt Job: For Pharmacy Professionals at (PCI) Pharmacy Council of India | Salary upto Rs 1,00,000 pm

Apply online, link is given below:

https://thehealthmaster.com/?p=38743

Blood Centre / Bank - How to obtain license

Click below links:

DCGI-Notice-dt-03-06-2022-Advisory-for-registration-of-Blood-Centres-on-E-rakhtkosh

Blood Centre (Bank) – requirements at a glance

FAQs – on Blood Bank / Centre (Part-1)

FAQs – on Blood Bank / Centre (Part-2)

FAQs – on Blood Bank / Centre (Part-3)

FAQs on Legal Metrology & Blood Bags

FAQs – on Blood Bags and its Testing

Pharmacopoeial status of Blood and its components

How to obtain manufacturing license for Blood Centre / Bank

Documents required for obtaining Blood Centre

For obtaining manufacturing license for Blood Centre, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Documents-required-for-obtaining-Blood-Centre

Procedure for obtaining license

Procedure for obtaining manufacturing license for Blood Centre. Download the pdf file for more detail and prepare the documents accordingly.

Procedure-for-obtaining-Blood-Centre

Form and fee

List of Forms
& Fee for obtaining the said license is provided below. Download the pdf
file and prepare the Form accordingly and submit the required fee.

Form-and-fee-for-Blood-Centre

Form-27C

Download the
below pdf files for various Forms which suits your requirement

Form-27C

Click for all other application forms

Submit your
application (Online and / or hard copy) to DCGI and State Drugs Controller / Licensing
Authority of your area after completing all the required documents.

Note: Requirements
of some of documents and procedure for submission of application may vary from
State to State

License conditions

Conditions of licenses is to be maintained after obtaining the required Blood Centre. Download the pdf file for ready reference.

License-conditions-for-Blood-Centre

License renewal fee: Procedure

Procedure for
submission of license renewal fee. Download the pdf file for more detail and
prepare the documents accordingly.

Procedure-for-License-renewal-fee

Requirements for running a Blood Centre

Part X-B

Requirements for the collection, storage, processing and distribution of Whole Human Blood, Human Blood Components by Blood Banks / centres and manufcature of blood products are mentioned in “part X B of drugs and cosmetics act 1940 and rules framed thereunder. For more details click below:

Requirements-for-running-a-Blood-Bank-Part-X-B

Part XII-B

Requirements for the functioning and operation of a blood Centre and / or for preparation of blood components are mentioned in “part XII B of drugs and cosmetics act 1940 and rules framed thereunder. For more details click below:

Requirements-for-running-a-Blood-Centre - Part XII B

List of emergency Equipment / Items / Drugs to be kept in the Blood Centre / Bank:

(i) Oxygen cylinder with mask, gauge and pressure regulator. (ii) 5 per cent Glucose or Normal Saline. (iii) Disposable sterile syringes and needles of various sizes. (iv) Disposable sterile I.V. infusion sets. (v) Ampoules of Adrenaline, Noradrenaline, Mephentin, Betamethasone or Dexamethasone, Metoclorpropamide injections. (vi) Aspirin.

Deferment of blood donation

Blood donation cannot be done in the conditions mentioned below for the period mentioned in the table below:

CONDITIONSPERIOD OF DEFERMENTAbortions6 monthsHistory of Blood6 monthsSurgery12 months Typhoid12 months after recoveryHistory of Malaria and duly treated 2 months (endemic) 3 years (non endemic area)Tattoo6 monthsBreast feeding12 months after deliveryImmunization (Cholera, Typhoid, Diphtheria, Tetanus, Plague, Gammaglobulin)15 days  Rabies vaccination1 year after vaccinationHistory of Hepatitis in family or close contact12 monthsImmunoglobulin12 months

These persons should not donate blood

No person shall donate blood and no blood bank shall draw blood from a person, suffering from any of the diseases mentioned below, namely:

(a) Cancer (b) Heart disease (c) Abnormal bleeding tendencies (d) Unexplained weight loss (e) Diabetes-controlled on insulin (f) Hepatitis infection (g) Chronic nephritis (h) Signs and symptoms, suggestive of AIDS (i ) Liver diseases (j) Tuberculosis (k) Polycythemia Vera. (l) Asthma (m) Epilepsy (n) Leprosy (o) Schizophrenia (p) Endocrine disorders

Important notifications

2020

GSR-166 (E) dated 11-03-20 regarding – Blood Bank / Blood Centre, Qualification of Doctor and technical staff etc.

GSR-166-E-11-03-20-Blood-Bank-Blood-Centre

Central Govt. has issued notification dated 03-04-2017 regarding Blood Transfer to another Blood Bank and Blood donation Camps. Click below for the said notification:

2017

GSR-No.-328-E-dt-03-04-2017-Blood-Transfer-to-another-Blood-Bank-and-Blood-donation-Camps

GSR 733 (E) dt 21-12-2005 Blood bank run by Govt, Red Cross, Hospitals, Charitable trust or Voluntary Organization approved by Blood Transfusion Council

2005

GSR-733-E-dt-21-12-2005-Blood-bank-run-by-Govt-Red-Cross-Hospitals-Cheritable-trust-or-Voluntary-Organization-approved-by-Blood-Transfusion-Council

2002

GSR 600 (E) dt 27-08-2002 regarding In-Vitro Blood grouping Sera and In-Vitro Diagnostic Devices for HIV, HbsAg and HCV

GSR-600-E-dt-27-08-2002-regarding-In-Vitro-Blood-grouping-Sera-and-In-Vitro-Diagnostic-DEvices-for-HIV-HbsAg-and-HCV

2001

GSR 40 (E) Dt 29-01-2001 Regarding Blood Bank – Blood donation, Testing, Records labels, Plasma etc.

GSR-40-E-Dt-29-01-2001-Regarding-Blood-Bank-Blood-donation-Testing-Records-labels-Plasma-etc.

FAQs on Cord Blood Banking

ICMR – FAQs on Cord Blood Banking, clccik below link

ICMR-FAQs-on-Cord-Blood-Banking

List of Blood Centres / Banks in India

List of Licensed Blood Centres / Banks in India as on Feb 2015

List-of-Licensed-Blood-Centres-Banks-in-India-as-on-Feb-2015

NBTC Guidelines

National Blood Transfusion Council (NBTC) has issued some guidelines regarding Blood banks / centres. (These guideline shave been taken from NBTC website) Click below links to read or download:

2018

NBTC-25-06-2018-Letter-reg-Guidelines-on-Processing-Charges-for-Blood-and-Blood-Components

Revised-Manpower-norms-for-Blood-Banks-2018

2017

NBTC-11-10-2017-Letter-Guidelines-for-blood-donor-selection-referral

2015

NBTC-28-10-2015-Regarding-surplus-plasma

NBTC-28-10-2015-Guidelines-on-bulk-transfer-of-blood

NBTC-28-10-2015-Guidelines-on-exchange-of-Surplus-Plasma-with-Indigenous-Fractionators

NBTC-21-09-2015-Norms-for-set-up-of-New-Blood-Banks-and-NOC-from-SBTC

NBTC-21-09-2015-Guidelines-for-issuance-of-NOC-for-new-blood-bank-renewal-of-licence-criteria-s-for-Designation-blood-banks-as-RBTC

2014

NBTC-24-06-2014-Letter-about-change-in-the-definition-of-voluntary-blood-donation

NBTC-12-02-2014-Guidlines-on-uniform-processing-charges-for-blood-and-blood-components

NACO Guidelines

National AIDS Control Organisation has issued Blood Bank / Centre Guidelines, Standards for Blood Banks / Centres and Blood Bank / Centre Policy. To read or download click below links:

Blood-Bank-guidelines-BY-NACO-12-02-2014

Standards-for-Blood-Banks-and-Blood-Transfusion-Services-NACO-2007

National-Blood-Policy-2007

Notifications - Blood Bank / Centre

Bombay Blood Group

Your Guide to Preventing and Treating Blood Clots

Adequate and safe blood transfusion for all: Article

Why India needs more blood donors: Article

Blood Centre: Precautions and safety to be observed during blood transfusion

Blood Bank / Centre: Difference Between SDP and RDP

Click for more articles on Blood Centre / Bank

Click for more articles of the Author
https://thehealthmaster.com/2021/09/18/procedure-to-obtain-license-for-blood-centre-blood-bank/

Blood Bank / Centre - How to obtain license

Click below links:

DCGI-Notice-dt-03-06-2022-Advisory-for-registration-of-Blood-Centres-on-E-rakhtkosh

Blood Centre (Bank) – requirements at a glance

FAQs – on Blood Bank / Centre (Part-1)

FAQs – on Blood Bank / Centre (Part-2)

FAQs – on Blood Bank / Centre (Part-3)

FAQs on Legal Metrology & Blood Bags

FAQs – on Blood Bags and its Testing

Pharmacopoeial status of Blood and its components

How to obtain manufacturing license for Blood Bank / Centre

Documents required for obtaining Blood Centre

For obtaining manufacturing license for Blood Centre, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Documents-required-for-obtaining-Blood-Centre

Procedure for obtaining license

Procedure for obtaining manufacturing license for Blood Centre. Download the pdf file for more detail and prepare the documents accordingly.

Procedure-for-obtaining-Blood-Centre

Form and fee

List of Forms
& Fee for obtaining the said license is provided below. Download the pdf
file and prepare the Form accordingly and submit the required fee.

Form-and-fee-for-Blood-Centre

Form-27C

Download the
below pdf files for various Forms which suits your requirement

Form-27C

Click for all other application forms

Submit your
application (Online and / or hard copy) to DCGI and State Drugs Controller / Licensing
Authority of your area after completing all the required documents.

Note: Requirements
of some of documents and procedure for submission of application may vary from
State to State

License conditions

Conditions of licenses is to be maintained after obtaining the required Blood Centre. Download the pdf file for ready reference.

License-conditions-for-Blood-Centre

License renewal fee: Procedure

Procedure for
submission of license renewal fee. Download the pdf file for more detail and
prepare the documents accordingly.

Procedure-for-License-renewal-fee

Requirements for running a Blood Centre

Part X-B

Requirements for the collection, storage, processing and distribution of Whole Human Blood, Human Blood Components by Blood Banks / centres and manufcature of blood products are mentioned in “part X B of drugs and cosmetics act 1940 and rules framed thereunder. For more details click below:

Requirements-for-running-a-Blood-Bank-Part-X-B

Part XII-B

Requirements for the functioning and operation of a blood Centre and / or for preparation of blood components are mentioned in “part XII B of drugs and cosmetics act 1940 and rules framed thereunder. For more details click below:

Requirements-for-running-a-Blood-Centre - Part XII B

List of emergency Equipment / Items / Drugs to be kept in the Blood Centre / Bank:

(i) Oxygen cylinder with mask, gauge and pressure regulator. (ii) 5 per cent Glucose or Normal Saline. (iii) Disposable sterile syringes and needles of various sizes. (iv) Disposable sterile I.V. infusion sets. (v) Ampoules of Adrenaline, Noradrenaline, Mephentin, Betamethasone or Dexamethasone, Metoclorpropamide injections. (vi) Aspirin.

Deferment of blood donation

Blood donation cannot be done in the conditions mentioned below for the period mentioned in the table below:

CONDITIONSPERIOD OF DEFERMENTAbortions6 monthsHistory of Blood6 monthsSurgery12 months Typhoid12 months after recoveryHistory of Malaria and duly treated 2 months (endemic) 3 years (non endemic area)Tattoo6 monthsBreast feeding12 months after deliveryImmunization (Cholera, Typhoid, Diphtheria, Tetanus, Plague, Gammaglobulin)15 days  Rabies vaccination1 year after vaccinationHistory of Hepatitis in family or close contact12 monthsImmunoglobulin12 months

These persons should not donate blood

No person shall donate blood and no blood bank shall draw blood from a person, suffering from any of the diseases mentioned below, namely:

(a) Cancer (b) Heart disease (c) Abnormal bleeding tendencies (d) Unexplained weight loss (e) Diabetes-controlled on insulin (f) Hepatitis infection (g) Chronic nephritis (h) Signs and symptoms, suggestive of AIDS (i ) Liver diseases (j) Tuberculosis (k) Polycythemia Vera. (l) Asthma (m) Epilepsy (n) Leprosy (o) Schizophrenia (p) Endocrine disorders

Important notifications

2020

GSR-166 (E) dated 11-03-20 regarding – Blood Bank / Blood Centre, Qualification of Doctor and technical staff etc.

GSR-166-E-11-03-20-Blood-Bank-Blood-Centre

Central Govt. has issued notification dated 03-04-2017 regarding Blood Transfer to another Blood Bank and Blood donation Camps. Click below for the said notification:

2017

GSR-No.-328-E-dt-03-04-2017-Blood-Transfer-to-another-Blood-Bank-and-Blood-donation-Camps

GSR 733 (E) dt 21-12-2005 Blood bank run by Govt, Red Cross, Hospitals, Charitable trust or Voluntary Organization approved by Blood Transfusion Council

2005

GSR-733-E-dt-21-12-2005-Blood-bank-run-by-Govt-Red-Cross-Hospitals-Cheritable-trust-or-Voluntary-Organization-approved-by-Blood-Transfusion-Council

2002

GSR 600 (E) dt 27-08-2002 regarding In-Vitro Blood grouping Sera and In-Vitro Diagnostic Devices for HIV, HbsAg and HCV

GSR-600-E-dt-27-08-2002-regarding-In-Vitro-Blood-grouping-Sera-and-In-Vitro-Diagnostic-DEvices-for-HIV-HbsAg-and-HCV

2001

GSR 40 (E) Dt 29-01-2001 Regarding Blood Bank – Blood donation, Testing, Records labels, Plasma etc.

GSR-40-E-Dt-29-01-2001-Regarding-Blood-Bank-Blood-donation-Testing-Records-labels-Plasma-etc.

FAQs on Cord Blood Banking

ICMR – FAQs on Cord Blood Banking, clccik below link

ICMR-FAQs-on-Cord-Blood-Banking

List of Blood Centres / Banks in India

List of Licensed Blood Centres / Banks in India as on Feb 2015

List-of-Licensed-Blood-Centres-Banks-in-India-as-on-Feb-2015

NBTC Guidelines

National Blood Transfusion Council (NBTC) has issued some guidelines regarding Blood banks / centres. (These guideline shave been taken from NBTC website) Click below links to read or download:

2018

NBTC-25-06-2018-Letter-reg-Guidelines-on-Processing-Charges-for-Blood-and-Blood-Components

Revised-Manpower-norms-for-Blood-Banks-2018

2017

NBTC-11-10-2017-Letter-Guidelines-for-blood-donor-selection-referral

2015

NBTC-28-10-2015-Regarding-surplus-plasma

NBTC-28-10-2015-Guidelines-on-bulk-transfer-of-blood

NBTC-28-10-2015-Guidelines-on-exchange-of-Surplus-Plasma-with-Indigenous-Fractionators

NBTC-21-09-2015-Norms-for-set-up-of-New-Blood-Banks-and-NOC-from-SBTC

NBTC-21-09-2015-Guidelines-for-issuance-of-NOC-for-new-blood-bank-renewal-of-licence-criteria-s-for-Designation-blood-banks-as-RBTC

2014

NBTC-24-06-2014-Letter-about-change-in-the-definition-of-voluntary-blood-donation

NBTC-12-02-2014-Guidlines-on-uniform-processing-charges-for-blood-and-blood-components

NACO Guidelines

National AIDS Control Organisation has issued Blood Bank / Centre Guidelines, Standards for Blood Banks / Centres and Blood Bank / Centre Policy. To read or download click below links:

Blood Bank guidelines by NACO 2014, Click below link to download:

Blood-Bank-guidelines-BY-NACO-12-02-2014

Standards for Blood Banks and Blood Transfusion Services NACO 2007

Standards-for-Blood-Banks-and-Blood-Transfusion-Services-NACO-2007

National Blood Policy, 2007, Click the below link to download:

National-Blood-Policy-2007

Bombay Blood Group

Your Guide to Preventing and Treating Blood Clots

Adequate and safe blood transfusion for all: Article

Why India needs more blood donors: Article

Blood Centre: Precautions and safety to be observed during blood transfusion

Blood Bank / Centre: Difference Between SDP and RDP

Notifications - Blood Bank / Centre

Click for more articles on Blood Centre / Bank
https://thehealthmaster.com/drugs/manufacturing-licenses/blood-bank-centre/

New Delhi: For a major part of north India, air pollution is a menacing issue, and last year, during the winter season, pollution led to a health emergency in Delhi-NCR.

Ambient air pollution, specifically PM 2.5, is reportedly associated with cardiovascular disease risk.

However, evidence linking PM 2.5 and blood pressure is largely from cross-sectional studies and from settings with a lower concentration of PM 2.5, with exposures not accounting for myriad time-varying and other factors such as the built environment.

But, a first-of-a-kind study in Delhi, has shown epidemiological evidence, for short and long-term effects of ambient PM 2.5 exposure on elevated blood pressure(BP) and hypertension.

The research was published in the American Heart Association's flagship journal Circulation. According to this research, data strongly supports a temporal association between high levels of ambient air pollution, higher systolic BP, and incident hypertension.

The world is facing an unprecedented threat from COVID-19. Many countries have resorted to following advices issued by the World Health Organization (WHO) regarding physical distancing measures as one of the ways to reduce disease transmission.

Register Now One of the authors and lead investigators of the project, Dr. Dorairaj Prabhakaran, vice president, research and policy at the Public Health Foundation India said:

"In India, there is very little or no evidence linking the exposure of ambient particulate matter (PM2.5), as a marker of air pollution with hypertension."

"This is a first-of-a-kind study in the Indian context which shows epidemiological evidence, for short and long-term effects of ambient PM2.5 exposure on elevated BP and hypertension."

The study was conducted by Indian scientists at the Centre for Chronic Disease Control and PHFI in collaboration with the Harvard T.H. Chan School of Public Health on a locally recruited representative population.

Click for more articles on Blood Pressure

It presents strong evidence of the harmful effects of PM2.5 exposures on cardiovascular diseases (CVDs) in India.

"The findings have shown that both short and long-term exposure to air pollution contributed to higher BP and increased risk of hypertension, especially in certain sections of the population (obese individuals)," added Prabhakaran

The research suggests there are significant benefits of controlling air pollution in reducing a major risk factor for cardiovascular deaths, the leading contributor to deaths in the country.

Pharma Manufacturing systems are highly variable with each system having different levels of interdependence and variability.

These factors increase the unpredictability of the system making it increasingly difficult to predict the behavior.

"Till we reach the safe levels of air quality, people with high risk of arrhythmias, worsening heart failure or stroke such as those with severe heart failure should be specially protected by avoiding exposure to high levels of outdoor PM2.5 by not going out on these days or through the use of protective N95 masks if feasible," said one of the researchers.

The participants in the project were studied for seven years. "The longitudinal range of seven years, over which the participants have been followed, also ensures that we are observing consistent long-term patterns and lends significant weight to the findings compared with cross-sectional studies of intermittent episodes of high pollution and BP that may skew the findings," said the research.

The authors investigated the association between PM2.5, a marker of air pollution with blood pressure and incident hypertension in Delhi, carried out in a cohort of 5,300 individuals, and included annual questionnaire surveys and alternate year biological sample collection.

Blood pressure was assessed longitudinally at three-time points within the cohort over the seven-year period.

"There are various mechanistic pathways through which acute and chronic exposure to air pollutants can increase BP, including an imbalance in the autonomic nervous system, activation of the sympathetic nervous system, generation and release of proinflammatory mediators, and direct influence on the vascular endothelium," said the study.
https://thehealthmaster.com/2020/08/31/higher-bp-hypertension-due-to-exposure-to-air-pollution-study/

With the increased focus on digital transformation, pharma companies in India are prioritising data security, finds a Deloitte Touche Tohmatsu India LLP (Deloitte India) and Data Security Council of India (DSCI) report, “Indian pharma takes digital leap – what does it mean for cybersecurity?”

The report further says ransomware attacks and IP and data theft were the top cybersecurity concerns for the sector, both in India and globally.

DSCI and Deloitte conducted more than 25 expert discussions between August 2021 and March 2022, where leading pharma companies and industry experts, both global and in India, shared their views on the pulse of the sector and the rising focus on cybersecurity.

Click for more articles on Pharma Companies

Commenting on the report findings, Gaurav Shukla, Partner and Leader, Cyber, Deloitte India, said, “With proper regulatory support, collaboration and ecosystem development, the pharmaceutical sector is ready to become a “world pharmacy.”

Now is the perfect time to harness the power of technology and digital transformation to drive this growth and enable Indian pharma to set a new paradigm in the global arena.

To be able to scale this digital vision and create trust globally, the pharma sector must recognise cybersecurity as a key lever, working towards bolstering security around data, Operational Technologies (OT), and across the supply chain.

This ability to utilise cybersecurity as a key enabler for business and digital transformation can help pharma organisations make the transition from a leader to a trusted leader.”

For leading pharma companies, cybersecurity investments have increased by a minimum of 25 to 30 per cent between 2019 and 2021.

The pandemic and the rising number of targetted attacks have prompted certain pharma companies to double their cybersecurity investments over the past 18 months.

As part of the cybersecurity strategy, along with data protection and resilience, identity and access management, OT security, offensive security capabilities, and better threat detection and response are some focus areas for pharma companies in India.

Furthermore, 70 per cent of the leading pharma companies highlighted their focus on a zero-trust approach with the need for a clear roadmap over the next two years, around network, data and access.

Rama Vedashree, CEO, Data Security Council of India, said, “The pandemic catapulted the Indian pharma sector from a drug manufacturer to one of the leading global pharma solution providers through novel drug R&D, high-end production, personalised healthcare, driven by digital transformation.

The DSCI–Deloitte joint report underpins the rapid transformation and opportunities lying ahead of the pharma sector, and the way it affects their cybersecurity posture.

While Production Linked Incentive (PLI) schemes and government support will encourage more niche manufacturers and research-led organisations, the focus on cybersecurity adoption and effectively managing cyber risks will enable business transformation and establish market leaders in this sector.”

For organisations who have made significant investments in the past two years, their future investments are likely to stabilise, mostly focussed on better third-party management, enhanced monitoring, optimisation through automation and outsourcing, and security around digital transformation and new-tech adoption.

The report lists down certain cybersecurity considerations for pharma companies.

It includes better cyber preparedness, cyber due diligence in M&As, along with having cyber insurance. Apart from a zero-trust approach, adopting a security-by-design, resilient-by-design and safety-by-design approach has also been recommended.

Strengthening the supply chain and OT security, enhancing monitoring and awareness and empowering CISO to effectively manage cyber risks across functions are also some considerations for pharma companies in India.

USFDA issues 6 observations to Glenmark Baddi Facility

New technology for safer Blood Transfusions at NCI Jhajjar

Haryana became the first state in the country to issue Drug Manufacturing Licenses online: HM

Govt notifies Surrogacy (Regulation) Rules for Surrogacy Clinics

UAFDA approves first Alopecia Drug that restores Hair Growth

Govt told to decide affordable price of Cancer Drug

Govt told to decide affordable price of Cancer Drug

Now TDS On Free Physician Samples

High Court to PCI: Open its portal for Pharmacy Colleges to submit application

Latest Notifications regarding Pharmaceuticals
https://thehealthmaster.com/2022/06/25/data-security-a-priority-for-pharma-companies-in-india/

USFDA issues 6 observations to Glenmark Baddi Facility

https://thehealthmaster.com/?p=38696

Data security a priority for Pharma Companies in India

https://thehealthmaster.com/?p=38676