hi students I'm dr. Badrinath I am handling the subject of regulator efforts and in this video we will see the CDSCO okay and if I put the I here it becomes a disco disco okay so don't think that it is a disco or disco dance it is a very powerful organization It makes us to do disco. Highly powerful organization in India. Highly powerful organization in India.
And this is a official symbol of CDSCO. Official symbol of CDSCO. Now we will see this abbreviation appeared in number of competitive examination.
What is CDSCO? Central Drugs Standard Control Organization. CDSCO, basically it is an organization. Keep in your mind.
See the last word, organization. See the first word, it is centrally located. Centrally means it is located in Delhi. That's why it is a central organization.
What is the main job? It controls. See here, control. What it controls? Drugs standard.
It controls the drug standards. This was important bit appeared in question paper. In one question paper they gave CDSCO as a central drug standardization control organization.
Most of the students they thought it is correct and they kept. But it went wrong. Not standardization. Standard control organization. And it works under the Directorate General.
He is the King, Directorate General of Health Services. In short time, it is called DGHS. Okay. And he is an exceptional member in PCI also, Pharmacy Council of India. That is another part.
Okay. Directorate, he is the King, he is the boss, everything is under the control of him, Directorate General of Health Services. Okay.
And it works under Ministry of Health and Family Welfare. Ministry of, under the Ministry of Health and Family Welfare. This is also important bit where it works.
Under Health Department, Health Ministry, Family Ministry, Children and Family Ministry or Health and Family Welfare like that, they will confuse in the examination. All the options whatever they give, it will be confusing to you. From there, you have to pick up the correct words. It belongs to the Government of India. It is a purely government organization.
It is located in the FDA bound, Food and Drug Administration. Ito, Kotla roads, New Delhi. It is a basic thing.
See our boss now. I will make this video in September 2020. Drex, Controller General of India. At present now he is Dr. V.G. Somani.
you can see the photo also and WHO declares to the CDSCO as a functional NRA not NRI NRI means non-residential Indian okay don't write as a NRI NRA NRA means national regulatory authority authority okay so now it is authority also this this is organization but it is authority also declared by the who who declared whether Yeah. CDSCO, we will see why it formed actually. What basis, what makes the government to form it.
People are saying that, aarogyam na janma hakku. Okay? Aarogyam na janma hakku and that is your government responsibility to safeguard my health. Like that, the people are saying that. And it is a rights given by the, our constitution also.
So, constitution say that, it is a safe to, government job is to safeguard the public health, our people's health. So, government says that, yes, my job is to safeguard your health and thus I allocated this job to the health ministry. That is health and family welfare.
Health ministry says that, yes, for this purpose I constituted the DISCO, not disco, okay? DISCO that is C-D-S-C-O. Yes, CDSCO said that yes, my job and objective is to safeguard the public health. So that is the main objective of the, to safeguard the public health, whatever it may be. Okay and any condition you make the rules or break the rules and finally what you have to do is CDSCO to safeguard the public health.
That is the main important key point. It is a prestigious Indian regulatory agency or regulatory authority also. We can call it as agency or it is called as an organization or it is an authority and works under the Indian government Ministry of Health and Family Health departments. And vision and mission. See the vision to protect and promote the public health in India.
Just like a RRR movie, here you can see that PPP, protect, see here, protect, promotes public health. PPP, it is a disco. What is a disco vision is PPP.
To safeguard and enhance the public health, safeguard, just like a guard, watchman, we will keep watchmen or guard to safeguard. Like that, this is also to safeguard and enhance the public health by assuring the safety, efficacy, quality. So, if it gives the assurance of the quality, safety, efficacy of all the medicines which is manufacturing in India, automatically the public health will be good. So, if you keep watching on the outlets of this all the products, whatever is there in the market, if you keep watching, keep watching by the CDSCO, automatically entire formulations will be good and all the people who are all using that, it will be good.
CDSCO is Drug Control General of India. See the structure and mainly headquarter is headquarter, new drugs, CLAA, imports, DTAB, DCC. These are some of the important functional bodies under the... There are functional categories under the headquarter and the zonal offices.
Zonal offices are four are there. Headquarter is only one. It is located at Delhi and zonal offices are there. Just like a east, west, south, north like that some zonal offices are there. Four offices are there.
Four. One, two, three, four. Zone. And what is the main job of this is GMP Addict.
You know that GMP is a good manufacturing addict. So whatever it may be, all the journal offices main job is it go and search the site where you are. Either you are following the GMP, current good manufacturing, CGMP and all it. And it coordination is also important job with the states, this journal offices.
So journal offices is different. State offices are different. Keep in your mind.
Central offices are different. Below is the zonal offices, under that state offices will be there. CDSCO is having its branches in all the states.
Sub zonal offices, it is a two. GMPRD, its coordination with states and port office, it is located in port means just like import and export. Either airport or ship port, whatever it may be, all the ports. Port offices and laboratories it is having. Six laboratories are there which are running by the CDS CVO.
Testing of drug samples, validation of test protocols. If you want to do tests of any drug, you have to prepare a protocol that protocol must be monitored by the laboratories running by the CDS CVO. Structure at a state level.
See the state level. All the states are having a branch of CDSCO. Keep in your mind. State drugs control organization. It is called as.
And it consists of drugs controller or drugs commissioner. Sometimes it is also called and drug testing laboratory. First here we will see this follow. Deputy drugs controller, drugs inspector and supporting staff.
Keep in your mind and under whom, under whom drugs inspector will work. Deputy drugs controller is a very important and powerful person. Deputy drugs controller works under drug controller of the state. So, drug inspector is almost third category in the state level. Third category.
Drug testing laboratories are there. It consists of government analysts. It is one of the crazy jobs also just like drug inspector and drug government analyst also a crazy job.
So here they will do in drug testing laboratories. All these laboratories are run by CDSCO. CDSCO analysts, supporting staff.
That's the common. Total number of drug inspectors around India, it is a data, 1000. And total number of drug manufacturers is 10,000. And 5 lakh total number of sales premises are 5. 5 lakhs.
And functions of disco. Functions is approval of new drugs and clinical trials. Very important. All the functions are very important. What is the main job, what it does and all.
Approval of new drug. If you brought any new drug and you are doing any clinical trial, there must be approval by the DISCO. And import registration and licensing.
Imports of drugs, registration and you have to get a license for that. License approving of blood banks. See here, blood banks, LVPs, large volume parenterals, vaccines or DNA. products like our corona vaccine is also cdsco is giving approval for the clinical trials of corona vaccine nobody should give in india only cdsco is having a authority to do a clinical trials on corona virus and clas scheme some medical devices also medical devices most of the students they do not know that these medical devices comes under the CDSCO.
Amendment to the drugs and cosmetics act and rules. It has powerful capacity CDSCO. It can change, it can tear the pages of DNCO or it can add some pages or some points to the drugs and cosmetics act. It's a powerful body, it's a disco. Banning of drugs and cosmetics.
In certain cases, it's all watching the public and watching all the medicines. If there are any contraindications or drug-drug interactions and it makes a problem in the people, definitely those drugs will be recalled and it will be banned completely. Just like a nemucelide.
Nemucelide is one of the most of the students, they do not know that nemucelide is a... One of the important painkiller, okay, and it was banned by the CDSCO. And CDSCO having a power to ban the combinations also, different combos.
You can go on website of DISCO and see that list of various medicines or combos which are banned by them. Grants of test license, personal license, NOCs for export, no objection certificate for exporting. either through ship or airports testing of new drugs if you want to do test you can do it oversight and market surveillance through the inspectorate of central over and above the state authority yeah this is one of the online now things which is available in the websites of disco sugam online licensing Application submission online. See it is also doing online because all nowadays nobody is doing a hard copy and making a books and tearing the books and binding the book and sending it. No, only online.
Everything is online. Sugam is one of the important online licensing system. It's a name given by the disco. Application submission. Track status of application, you can track it.
And grant of permission or approval of licensing. And finally, amendments. If you want to change the amendments, it does.
Functions of state licensing authority. So far what we saw in the previous video, it is a central. Now you can see the state functional, all these you can be noted down. Licensing of manufacturing site for drugs-induced API, active pharmaceutical ingredients and finished formulations, anything, either formulation or API.
The site which is manufacturing, that site must be approved and licensed by the state CDSCO, state disco. I told them they will make us to do a disco. When you want to start it, you have to start a disco. Licensing of establishing for sale or distribution of drugs.
It gives the licenses and establishments. Approval of a drug testing laboratories. If you want to open the drug testing laboratory, we must have approval.
Maintenance of quality of drugs and cosmetics also. Marketing in the country. Investigations and. a prosecution of various legal provisions recall of substandard drugs in the market if is there any substandard drugs entire stock whatever is there is there in medical shop also they'll recall it they'll recall the way approval of clinical trials imports and manufacturing of new drugs and some numbers also you can see here requirements and guidelines you know schedule why dedicatedly for the clinical trials Rule number 122A and corresponding numbers here you can see permission to improve the new drug, permission to manufacturing of new drug, definition of clinical trials, definition of new drugs, everything will be there in that. Corresponding number and approval of IND.
IND means Investigational New Drug. It is a new drug only but still it is under the investigation. That's why it is called a IND. IND means India. So it is not India here, IND.
It is investigational new drug. So IND applicant, CDSCO headquarters, you have to apply. If you have any doubt or developing a new drug, just you have to apply on CDSCO headquarters.
Examination by the new drug division, detailed review by IND committee and recommendation to DJI, Drug Control General of India. And finally he will give the approval and here you can see the timelines, phase 1, 30 days, 45 days and phase 3 is 60 days. It is the timelines and this is very important.
And import registration and see here I made a video on what is the investigation new drug new chemical entity Investigational new drug and when you have to do a preclinical trial and when you have to do a clinical trial, when it is called NDA, new drug application. That and all I made a separate video and go and see my channel. In that I have all mentioned what is difference between all these things. Because most of the people, even though they went industry, they were unable to find the differences and all. For them I made and for students also, those regulatory students and M Pharmacy students.
okay it is very very important import registration and the licensing how they have to do manufacturing site and products are required to be registered issue of import license 1010 year and various rules registration certificate yeah central licensing system here to see though you start with manufacturer manufacturer state Lacey will approach the state licensing authority next there will be a joint inspection by the state and central inspector examination on the report license okay prepared by the state licensing authority and finally CLEA approval and the grant of the license for biological larger volume parentals LVPs large volume parentals blood bank and bread products some medical devices you have to follow this Global clinical trials permission is required from CDSCO. If you want to do it globally, globally I mean you want to do a clinical trial for your drug in other countries, then you have a, you should have a control of CDSCO also. Even though you are doing a clinical trials in other country, you must take a permission from CF because your drug is manufacturing in India.
Permission is required from CDSCO for conducting a global clinical trials in a country phase So for approximately 500 permissions have been granted since 2003. National Pharmacovigilance Program. See here, already told no, NPAC, it is a national level and it is a journal. See ZPC.
Here I abbreviated what is NPAC, National Pharmacovigilance Advisory Committee, Maine. Under that journal will work. North East, South West, zonal. Then RPC.
RPC means here you can see Regional Pharmacovigilance Centers. RPC, Regional, Zonal, National. N, North, East, South, West.
And PPC. PPC means periparyl, just like a periparyl blood vessel. Periparyl Pharmacovigilance Center. side by side very very small small small small will be there so this is entire structure pyramid structure you can see the pyramid if you do a meditation and a pyramid you will get all you can secure the powers that is a power of pyramid right and collaborations having a with the US FDA Brazil South Africa and so many countries it is having a collaborations clinical trial inspections various sites okay good clinical practice just like a gmp good manufacturing practice if you are doing a clinical trials you have to glp good laboratory practice glp or gc good clinical practice the first it is a history the first it's not much important for you and see here it is a cds co fda billing In the Delhi, which is located in the Delhi, right? And it is an inauguration of, see here the Pranab Mukherjee.
Recently he expired the Pranab Mukherjee. And Bharat Ratnawardi also and he's worked as a president, ex-president of India. He is inaugurating this building. And here you can see the Ram Dass.
He's a Tamil Nadu health, he worked as a central health minister. During that time only, there was an inauguration of this building. This is some of the important photos.
I will stop here. It completes the video. Thank you very much. This is one of the very important concepts that you have to keep in your mind. Repeat the video, rewind the video and you can watch all my videos.
You can see all my videos in my channel playlist.