WEBVTT Kind: captions Language: en 00:00:13.110 --> 00:00:16.360 . Welcome back to lecture 4 for the course Current 00:00:16.360 --> 00:00:22.910 Regulatory Requirement for Conducting Trial in India. In the lecture 4 Drug and Cosmetic 00:00:22.910 --> 00:00:29.390 Act and Rules there under we are going to see the objective of Drug and Cosmetic Act 00:00:29.390 --> 00:00:35.680 1940 and those their under 1945. Then the different chapters available in this 00:00:35.680 --> 00:00:43.140 act, then rules pertains to new drug and clinical trial, different schedules available in the 00:00:43.140 --> 00:00:49.460 rules that is from schedule A to schedule Y. Then you will be familiar with the drug 00:00:49.460 --> 00:00:56.080 testing laboratories . So, what will we learn in lecture 4? 00:00:56.080 --> 00:01:01.440 As I have said in this lecture we are going to see the objective of drug and cosmetic 00:01:01.440 --> 00:01:07.190 act. The different chapter that is chapter from first to five we will see in detail, 00:01:07.190 --> 00:01:11.280 then the different forms required for the permission of the clinical trial and other 00:01:11.280 --> 00:01:20.100 forms, then different schedules and the different drug testing laboratories . So, this is the 00:01:20.100 --> 00:01:28.970 drug and cosmetic act, it is available on our web or website that is www dot cdsco dot 00:01:28.970 --> 00:01:35.780 gov dot in . The act is exercised by government of India 00:01:35.780 --> 00:01:43.060 Ministry of Health and Family Welfare. The act is available as I have said as a web version 00:01:43.060 --> 00:01:52.840 and it is amended up to 31st December 2016. So, let us see the objective of the Drug and 00:01:52.840 --> 00:02:00.189 Cosmetic Act and rules their under. The Drug and Cosmetic Act was passed on 10th 00:02:00.189 --> 00:02:09.090 April 1940 with the main object to import, manufacture to regulate import, manufacture, 00:02:09.090 --> 00:02:16.810 sale and distribution of drug and cosmetic. Cosmetic has been added letter on, how does 00:02:16.810 --> 00:02:22.489 the act do it. The drugs are available in market by two ways 00:02:22.489 --> 00:02:30.570 either by import or by the manufacture and it reaches to the patients through sale or 00:02:30.570 --> 00:02:38.660 distribution. So, it is very important to regulate the manufacture, import, sale and 00:02:38.660 --> 00:02:47.340 distribution of this drug to reach the authenticated standard drug to the patients. The act regulate 00:02:47.340 --> 00:02:53.760 the import of drug in India so, that no sub standard or spurious drug will enter into 00:02:53.760 --> 00:03:02.050 our country. And, the act does it by issuing the import license to the importer and registration 00:03:02.050 --> 00:03:09.360 certificate after satisfying that the drug where it is manufactured is in compliance 00:03:09.360 --> 00:03:14.350 with the schedule M or good manufacturing practices. 00:03:14.350 --> 00:03:22.390 The act prohibits the manufacture of sub standard or spurious drug in the country. See the manufacturing 00:03:22.390 --> 00:03:29.680 is also given the manufacturing license and before giving the manufacturing license, the 00:03:29.680 --> 00:03:37.840 applicant has to apply to the licensing authority either state or the centre. The drug inspector 00:03:37.840 --> 00:03:43.530 in this regard then verify the compliance of these applicant whether it is a complaint 00:03:43.530 --> 00:03:51.470 with the good manufacturing practice or not. And, after the satisfaction then they submit 00:03:51.470 --> 00:03:59.090 itsreport and verification of the report, it confirms that the facility provided for 00:03:59.090 --> 00:04:04.810 the manufacturing of the drug are compliance with the schedule M and good manufacturing. 00:04:04.810 --> 00:04:11.750 And, after that the manufacturing license is issued by the state licensing authority. 00:04:11.750 --> 00:04:18.069 The act provides for the control over the sale and distribution of drug by only trained 00:04:18.069 --> 00:04:26.550 and qualified persons. As I have said the drugs are reaching to the patient either sale 00:04:26.550 --> 00:04:34.729 or by distribution. To control this sale and distribution the act provides control over 00:04:34.729 --> 00:04:41.520 the sale and distribution by resting it to the qualified person. The person who is selling 00:04:41.520 --> 00:04:48.310 or distributing this drug required to be having a qualification of pharmacy. The facility 00:04:48.310 --> 00:04:55.050 provided for sale and storage of the drug should be adequate and as per the norms of 00:04:55.050 --> 00:05:01.909 the Drug and Cosmetic Act; qualified pharmacists, then proper storage facility should be there 00:05:01.909 --> 00:05:07.909 then only we can be ensure that the correct drug is reaching to the patient. 00:05:07.909 --> 00:05:15.729 The act also provide for the control over the manufacture sale and distribution of some 00:05:15.729 --> 00:05:22.759 other types of drug that is we call traditional drug: Ayurvedic, Sidha, Unani and homeopathic 00:05:22.759 --> 00:05:29.939 drugs. So, in this presently we are not regulating the sale of ayurvedic drugs, but why regulating 00:05:29.939 --> 00:05:36.379 the manufacturing of this ayurvedic drug; however, the homeopathic drug for its sale 00:05:36.379 --> 00:05:42.470 it require license . Certain provision of the act regulate the 00:05:42.470 --> 00:05:49.419 import, manufactures, sale and distribution of cosmetics. So, we have seen the drug is 00:05:49.419 --> 00:05:56.469 for the both drug and the cosmetics. So, it is the duty of the regulator to ensure the 00:05:56.469 --> 00:06:04.259 safety and quality of cosmetics also. So, whatever the cosmetic available in the market 00:06:04.259 --> 00:06:11.860 for its manufacturing it required to take prior license. And, if that facility provided 00:06:11.860 --> 00:06:17.589 for manufacturing is in compliance with the norms then the manufacturing permission can 00:06:17.589 --> 00:06:25.309 be given; same is for the import of the cosmetics. In this case the applicant has to apply to 00:06:25.309 --> 00:06:30.520 the licensing authority then they will get a registration certificate, after verifying 00:06:30.520 --> 00:06:35.749 the data submitted permission can be granted . 00:06:35.749 --> 00:06:43.179 To have regular inspection of licensed premises by drug inspector; so, after giving the manufacturing 00:06:43.179 --> 00:06:50.250 permission to have the routine checkup of the quality of the drug and the compliance 00:06:50.250 --> 00:06:57.969 of the premises whether it is as per schedule M or not; there is a provision for the routine 00:06:57.969 --> 00:07:02.629 inspection. The state licensing authority drug inspectors and the central licensing 00:07:02.629 --> 00:07:08.629 authority drug inspector they are routinely checking of the compliance. Even after the 00:07:08.629 --> 00:07:16.740 batch is in market there is a provision to withdraw the samples of the availableproduct. 00:07:16.740 --> 00:07:25.599 And, these samples can be sent to the testing for the for its equality and after satisfying 00:07:25.599 --> 00:07:32.660 result then that can be sold. To have the control over the standard of drug 00:07:32.660 --> 00:07:38.819 and cosmetic taking sample and analyzing them at appropriate laboratories . So, this laboratory 00:07:38.819 --> 00:07:45.550 what are these laboratory, we will see in ournextslide; to provide special provision 00:07:45.550 --> 00:07:52.249 to regulate the preparation, standardization and storage of biological and special products. 00:07:52.249 --> 00:07:58.509 So, act is provided with the special provision for the biological; biological products like 00:07:58.509 --> 00:08:04.710 vaccines, blood, blood products. These are very sensitive product and permission for 00:08:04.710 --> 00:08:10.949 which is given through the central licensing authority and the specific rules and regulations 00:08:10.949 --> 00:08:18.239 are there in this act and rules. To prescribe the manner of labeling and packaging 00:08:18.239 --> 00:08:25.429 of the various classes of drug and cosmetic so, the act is provided with the labeling 00:08:25.429 --> 00:08:33.690 and packaging of the various classes of the drug. So, it means the what should be the 00:08:33.690 --> 00:08:40.870 content on the label that is also given in the rules and the act. Say for example, what 00:08:40.870 --> 00:08:46.589 is what is the manufacturing date, what should be the its expiry date and what should be 00:08:46.589 --> 00:08:52.379 its storage condition. The name of the ingredient, the composition of ingredient that should 00:08:52.379 --> 00:08:59.089 available on the label of this marketed drugs and it is mentioned under the drug and cosmetic 00:08:59.089 --> 00:09:05.629 rule that is rule 92, 93 and other rules. Now, let us see what is this Drug and Cosmetic 00:09:05.629 --> 00:09:10.839 Act and rules; we have seen the objective now we will see the content. 00:09:10.839 --> 00:09:16.079 So, the we can say that Drug and Cosmetic Act and rule we can divide it into two part. 00:09:16.079 --> 00:09:25.360 The first part is the Drug and Cosmetic Act, the act is having 6 chapters and two schedules. 00:09:25.360 --> 00:09:31.990 The this two6 chapters are from chapter first to chapter 5 including chapter 4 A. We will 00:09:31.990 --> 00:09:40.301 see in detail about this chapter in our subsequent slides. Part II of the act is Drug and Cosmetic 00:09:40.301 --> 00:09:48.930 Rules and this rule for the sake of convenience again divided into 19 parts. The part 10 A 00:09:48.930 --> 00:09:56.680 is specifically for import or manufacture of new drug for conducting clinical trials 00:09:56.680 --> 00:10:04.190 or for marketing. At present there are 174 rules followed by 00:10:04.190 --> 00:10:11.129 schedule and the schedules are from A to schedules Y. We have seen in our previous lecture schedule 00:10:11.129 --> 00:10:19.019 Y, it is a for requirement and guideline for permission to import and or manufacture of 00:10:19.019 --> 00:10:26.430 new drug for sale or to undertake clinical trials. All these clinical trials, new drug, 00:10:26.430 --> 00:10:32.680 then manufacture import, the definition, what it mean by we have already seen in our previous 00:10:32.680 --> 00:10:38.470 slides; so, coming to the next slide . So, the chapters available in the Drug and 00:10:38.470 --> 00:10:46.139 Cosmetic Act 1940; first chapter is the introductory chapter. It is introduction and the definitions. 00:10:46.139 --> 00:10:53.850 So, in this chapter the short title then extent and commencement of the act is given, different 00:10:53.850 --> 00:10:58.670 types of definition what we have seen in our lecture 1 that is definition of Ayurvedic, 00:10:58.670 --> 00:11:06.720 Sidha and Unani. Definition of drug section 3 B, then definition of cosmetic, what is 00:11:06.720 --> 00:11:12.430 means by board that is GTAV board, government analyst, what is I mean by inspector, what 00:11:12.430 --> 00:11:17.660 is mean by import, manufacturing and some other definitions are given in this chapter 00:11:17.660 --> 00:11:23.430 first. Chapter second is related to the DTAB and 00:11:23.430 --> 00:11:32.561 DCC DTAB is Drug Technical Advisory Board, DCC is a Drug Consultative Committee. This 00:11:32.561 --> 00:11:40.220 committees are provided in the act to provide the technical guidance in any matter related 00:11:40.220 --> 00:11:47.980 there of the drugs, DCC committee is also there. So, in this committee ensures the uniform 00:11:47.980 --> 00:11:55.829 implementation of Drug and Cosmetic Act and rules there under across the country. The 00:11:55.829 --> 00:12:01.620 detail composition, function, then who should be the chairman of the committee and what 00:12:01.620 --> 00:12:06.889 are the other members of this committee and the frequency of their meeting that everything 00:12:06.889 --> 00:12:15.180 is given in this chapter. Chapter III is of import of drug and cosmetic. 00:12:15.180 --> 00:12:21.240 So, in this chapter standards of quality; what is mean by standard of quality, what 00:12:21.240 --> 00:12:28.490 is mean by miss branded, what is mean by spurious drug, then what is mean by adulterated drug 00:12:28.490 --> 00:12:36.490 everything is about given in this chapter. All the definitions and the if somebody manufactures 00:12:36.490 --> 00:12:43.449 such typeimport such type ofmiss branded, spurious drug what should be the penalties, 00:12:43.449 --> 00:12:51.250 what should be the punishment that is also given in this chapter. Chapter IV is related 00:12:51.250 --> 00:12:55.829 to the standard of chapter IV standard of this miss banded, adulterated, spuriousand 00:12:55.829 --> 00:13:04.860 this chapter is for the manufacturing. The previous chapter is for the import and this 00:13:04.860 --> 00:13:10.370 chapter is for the manufacture, sale and distribution of drug and cosmetic. 00:13:10.370 --> 00:13:16.920 So, here also the standard of quality for the manufacturing what is means by the miss 00:13:16.920 --> 00:13:23.420 branded, what is mean by adulterated drug, what is spurious drug and all this definition 00:13:23.420 --> 00:13:30.759 for in related to the manufacturing has been given. The definitions of all these spurious 00:13:30.759 --> 00:13:38.449 drug also given in this chapter. Then the power of inspector, then procedure of sampling, 00:13:38.449 --> 00:13:44.579 then the procedure for government analyst, then penalties, of offences for the manufacturing 00:13:44.579 --> 00:13:49.690 the sub standard drugs all these things are given in this chapter. 00:13:49.690 --> 00:13:57.130 Chapter IV A that is related to the traditional system of medicine: Ayurvedic, Siddha and 00:13:57.130 --> 00:14:04.399 Unani drug. So, the manufacturing, sale, distribution how it has to be regulated, who has to manufacture 00:14:04.399 --> 00:14:10.160 which schedule, which forms are required for the application that everything regarding 00:14:10.160 --> 00:14:16.879 Ayurvedic, Siddha and Unani system has been given in this chapter IV A. Chapter V is a 00:14:16.879 --> 00:14:24.910 miscellaneous chapter, in this chapter whatever is not covered in earlier up to IV A chapter 00:14:24.910 --> 00:14:31.589 is given in this chapter like a special course, then power of the government to give the direction 00:14:31.589 --> 00:14:37.279 and some other provisions given in this chapter. Coming to the next slide that is rules related 00:14:37.279 --> 00:14:43.740 to new drugs and clinical trials. We have seen what are the rules which were related 00:14:43.740 --> 00:14:50.740 to the clinical trial and new drug in our previous lecture; so, we will see these rules 00:14:50.740 --> 00:14:58.899 in detail one by one . Rule 122 DA this rule is for application for 00:14:58.899 --> 00:15:05.110 permission to conduct clinical trial for new drug or investigational new drug. Definition 00:15:05.110 --> 00:15:12.089 of both of these that is IND and new drug we have seen in our lecture first . So, in 00:15:12.089 --> 00:15:21.899 this rule it is also mention that the no clinical trial for new drug whether for clinical investigation 00:15:21.899 --> 00:15:29.259 that is for medical device or any clinical experiment by any institution shall be conducted 00:15:29.259 --> 00:15:36.950 except under and in accordance with the permission in writing by the licensing authority defined 00:15:36.950 --> 00:15:43.820 in clause B of rule 21 . It means as per this rules the clinical trial 00:15:43.820 --> 00:15:49.939 is required prior permission from the licensing authority which is defined in clause B of 00:15:49.939 --> 00:15:57.720 rule 21 which is a DCJ or CDSCO. Then further in this rule it is given how to apply for 00:15:57.720 --> 00:16:03.699 the new drug permission, how to apply for the clinical trial phase 1, phase 2 and phase 00:16:03.699 --> 00:16:11.149 3 also for the phase 4. And, what is what is the different different fees required, 00:16:11.149 --> 00:16:17.009 what are the different forms required, in which pro-forma it has to be given that everything 00:16:17.009 --> 00:16:23.410 about the application, about the application for permission to conduct the clinical trial 00:16:23.410 --> 00:16:29.389 and new drug given in this rules . We have seen in our first lecture that academic 00:16:29.389 --> 00:16:36.459 that is for the research purpose does not require any regulatory permission . So, that 00:16:36.459 --> 00:16:43.100 also mention in this rule only, then we have seen the definitions of clinical trials GCT 00:16:43.100 --> 00:16:52.029 and DNCA; this is also given in this rule 122 DA under the heading explanation. The 00:16:52.029 --> 00:17:00.029 next tool that is a rule 122 DB is related to the suspension or cancellation of permission 00:17:00.029 --> 00:17:09.579 or approval. So, whatever the permissions given if the licensing authority found that 00:17:09.579 --> 00:17:16.320 the permission which is given with certain condition has not been complied by the importer 00:17:16.320 --> 00:17:24.130 or manufacturer under this part; then the licensing authority after giving him a show 00:17:24.130 --> 00:17:33.039 cause notice may suspend or cancel that permission as per this rule 122 DB . 00:17:33.039 --> 00:17:41.020 The next rule that is 122 DC, it is related to the appeal . So, if the permission has 00:17:41.020 --> 00:17:49.600 been cancelled for the manufacturing or for the import then that applicant can again apply 00:17:49.600 --> 00:17:56.610 or appeal to the central government within a 60 days. And, the central government if 00:17:56.610 --> 00:18:04.330 find the justification has been given properly then the central government can decision take 00:18:04.330 --> 00:18:13.870 a decision as it as it deem fit . The next rule that is rule 122 DAB, it is 00:18:13.870 --> 00:18:21.600 related to the compensation in case of injury or death the clinical trial. This rule has 00:18:21.600 --> 00:18:33.830 been added in 2013 by the GSR 53. So, in this rule the clauses regarding the compensation 00:18:33.830 --> 00:18:40.050 how to give the compensation, in which cases the compensation has to be given whether the 00:18:40.050 --> 00:18:45.690 compensation is in the form of the free medical management. Or, whether it is a in form of 00:18:45.690 --> 00:18:53.730 the financial assistance and whether that injury or SAE is related to theclinical trial 00:18:53.730 --> 00:19:02.580 or not, how to ascertain it that is given in this rule. How to relate this injury or 00:19:02.580 --> 00:19:08.740 SAE and when we can say that the injury or SAE is related to the clinical trials, the 00:19:08.740 --> 00:19:15.860 process reasons are also given in these rules. This possible reasons like a failure to comply 00:19:15.860 --> 00:19:24.270 with the protocol. Then the failure of the failure of the investigational 00:19:24.270 --> 00:19:32.410 drug likewise the reasons are given if these reasons are there then the sponsor has to 00:19:32.410 --> 00:19:41.029 give the compensation to the subjects. Rule 122 DAC it is related to the permission to 00:19:41.029 --> 00:19:47.990 clinical trial. This rule has also been inserted in the drug and cosmetic rules in 2013 vide 00:19:47.990 --> 00:19:56.990 GSR 63 . So, this is a to give the permission in which cases the licensing authority can 00:19:56.990 --> 00:20:03.380 give the permission to conduct clinical trial. The applicant has to apply to the central 00:20:03.380 --> 00:20:09.910 licensing authority in a prescribed uh format and along with the along with the documents 00:20:09.910 --> 00:20:14.670 . This documents after verifying if the data 00:20:14.670 --> 00:20:22.390 found adequate and licensing authority satisfied the data given are adequate then the licensing 00:20:22.390 --> 00:20:29.120 authority can issue a clinical trial, permission to conduct phase 1, phase 2 or phase 3 with 00:20:29.120 --> 00:20:38.330 for that drug. This permissions can be given with the condition and that applicant has 00:20:38.330 --> 00:20:45.110 to follow this conditions of the permissions. The conditions like clinical trial to be conducted 00:20:45.110 --> 00:20:51.549 as per approval and as per the schedule Y guidelines as per the GCP guidelines. 00:20:51.549 --> 00:20:59.810 The condition like ethics committee approval is required for prior approval before initiation 00:20:59.810 --> 00:21:06.419 of the any clinical trial. Then registration of CTRI that is clinical trial has to be registered 00:21:06.419 --> 00:21:12.140 on the site Clinical Trial Registry of India that is also mentioned in the condition. Then 00:21:12.140 --> 00:21:18.700 regarding SAE reporting the ethics committee and the sponsor will report the SAE, if occur 00:21:18.700 --> 00:21:24.910 within a particular time to the licensing authority that condition also stipulated there. 00:21:24.910 --> 00:21:31.360 Then regarding the compensation clause, that in case of injury or death the sponsor will 00:21:31.360 --> 00:21:38.620 be entitled to provide the detailed compensation that is also given there. 00:21:38.620 --> 00:21:47.360 Rule 122 DD this rule is related to the registration of ethics committee and it has been introduce 00:21:47.360 --> 00:21:56.970 in the drug and cosmetic rules in 2013 vide GSR 72. As per this rule the no ethics committee, 00:21:56.970 --> 00:22:05.940 if it is not registered cannot review or approve the protocol for the regulatory purpose . So, 00:22:05.940 --> 00:22:11.820 application for ethics committee, registration how to apply, where to apply it is given under 00:22:11.820 --> 00:22:19.260 this rules; the license licensing authority after satisfying that the documents submitted 00:22:19.260 --> 00:22:28.450 by the applicant are are well formed then can give the permission of the registration. 00:22:28.450 --> 00:22:35.909 Also in case in case of SAE the opinion has to be forwarded by the ethics committee that 00:22:35.909 --> 00:22:44.440 is also stipulated there and the registration of this ethics committee is valid for 3 years. 00:22:44.440 --> 00:22:51.149 The amendment has been made to this rule 122 DAB and this is regarding the clarification 00:22:51.149 --> 00:22:59.260 on the criteria for eligibility of compensation, this is given in 2015 . Coming to the next 00:22:59.260 --> 00:23:09.649 slide the different forms related to the new drug and clinical trials. So, form 44 it is 00:23:09.649 --> 00:23:16.309 the most important form because, it is application for grant of permission to import or manufacture 00:23:16.309 --> 00:23:22.809 a new drug to undertake a clinical trial. So, the applicant has to apply in the form 00:23:22.809 --> 00:23:28.360 44 pro-forma given under the rules of this act. 00:23:28.360 --> 00:23:37.840 In this form the applicant has to submit the name of the form who is applying then the 00:23:37.840 --> 00:23:44.350 particulars of new drug that its dose, dosage forms, strength, name of the drug, centre 00:23:44.350 --> 00:23:51.090 national name. Then the regulatory status of the drug whether this drug is withdrawn 00:23:51.090 --> 00:23:56.480 from some country whether it is prohibited in any other country in the reason there off 00:23:56.480 --> 00:24:01.490 or if it is approved in country or it is a market in that country in that regulatory 00:24:01.490 --> 00:24:07.220 status to be given in this form. Then about the marketing information, then 00:24:07.220 --> 00:24:11.820 proposed a draft label, what should be the draft label, what indication they are going 00:24:11.820 --> 00:24:18.450 to give on this label of the drug and the monograph and other things also given in this 00:24:18.450 --> 00:24:24.090 in this form; in this form it is also given that data required to be submitted should 00:24:24.090 --> 00:24:29.649 be as per schedule Y. So, we are going to see the schedule Y and what is the data requirement 00:24:29.649 --> 00:24:37.389 in detail in our next slide, then form 45 it is permission to import finish formulation 00:24:37.389 --> 00:24:42.769 of a new drug. So, if somebody want to import new drug then 00:24:42.769 --> 00:24:48.840 he has to apply in form 45 and if it is a new drug again it will require first clinical 00:24:48.840 --> 00:24:55.750 trials. So, in this form again the name of company, then detail of drug like name, dosage 00:24:55.750 --> 00:25:03.110 form, dosage from, strength indication of the drug which is to be imported that is given 00:25:03.110 --> 00:25:09.149 in this form. Condition of permissions are also given in this permission and these conditions 00:25:09.149 --> 00:25:15.250 are regarding that the applicant will follow the specification of the drug what he has 00:25:15.250 --> 00:25:20.570 submitted. Then the labeling condition, what are the draft is approved that label will 00:25:20.570 --> 00:25:26.330 be there on the final package. And, also the warning if any that applicant 00:25:26.330 --> 00:25:34.669 has to be given on the label that is also given; warning like to be sold by retail prescription 00:25:34.669 --> 00:25:42.159 of gynecologist, diabetologist or whatever the approved by the licensing authority that 00:25:42.159 --> 00:25:52.250 warning is also has to be written by the applicant. Form 45 A is permission to import raw material 00:25:52.250 --> 00:25:57.900 that is a bulk drug in ingredient. So, above form was the for the formulation and this 00:25:57.900 --> 00:26:03.549 form is for the raw material. So, for this also the conditions have been 00:26:03.549 --> 00:26:09.690 mentioned in the form, the condition of permission to confirm to the specification. So, whatever 00:26:09.690 --> 00:26:16.210 the specification approved by licensing authority, the applicant while manufacturing or while 00:26:16.210 --> 00:26:23.889 importing that drug has to follow that specification that condition is stipulated there. Even though 00:26:23.889 --> 00:26:29.970 this permission has been given for the raw material, it does not mean that the formulation 00:26:29.970 --> 00:26:36.289 he can import or manufacture. He has to take a separate approval for the formulation, for 00:26:36.289 --> 00:26:44.260 import or the manufacture of these drugs . The next form that is form 46, it is permission 00:26:44.260 --> 00:26:51.470 approval for manufacture of new drug formulation . So, again in this forms the details of the 00:26:51.470 --> 00:26:57.840 company, detail of the drug with respect to name dosage form, composition has to be given. 00:26:57.840 --> 00:27:02.980 Condition of permissions are given that the applicant will follow the specification, labeling 00:27:02.980 --> 00:27:08.430 rules and the warning if any stipulated in the condition of the permission that he will 00:27:08.430 --> 00:27:14.570 follow, that will given in this form. Then form 46 A is a permission approval for 00:27:14.570 --> 00:27:21.279 manufacture of raw material. It is also the same that the permission for the manufacture 00:27:21.279 --> 00:27:27.260 what we have seen in the permission for the import of the raw material. There are some 00:27:27.260 --> 00:27:32.960 conditions given that the applicant will follow the specification and he will take the separate 00:27:32.960 --> 00:27:39.429 approval for its manufacturing of the formulation; coming to the next slides. 00:27:39.429 --> 00:27:46.450 Now, what I have said that the rules contain the schedules that schedules are from the 00:27:46.450 --> 00:27:52.539 schedule A to schedule Y. So, we will see this schedules in detail what you what are 00:27:52.539 --> 00:27:58.000 these schedules. Schedule first is the pro-forma of the forms . So, what the forms we have 00:27:58.000 --> 00:28:07.380 seen above that is form 44, form 45, form 46, 46 A, 45 A and many other forms are given 00:28:07.380 --> 00:28:15.399 in this schedule A. Form from from first to the form up to the form 50 with different 00:28:15.399 --> 00:28:22.649 sub form that is form 40 A 46 A 46 B likewise the forms of all the pro-forma is given in 00:28:22.649 --> 00:28:28.750 this schedule A, schedule B is related to the fees . 00:28:28.750 --> 00:28:35.480 So, what is the fees requirement for the testing of this drug it is given in the schedule B. 00:28:35.480 --> 00:28:41.639 For example, if somebody want to conduct a pyrogen test than required fees 500 rupees, 00:28:41.639 --> 00:28:47.790 if it is a for biography of antibiotic than 400 rupees fees. If somebody want to test 00:28:47.790 --> 00:28:54.830 or the test requirement is for the potential testing of DPT or DT vaccine then then the 00:28:54.830 --> 00:29:01.799 fees charged by this laboratories are 2700. So, many of the testing fees and for each 00:29:01.799 --> 00:29:05.389 test an analysis is given in this schedule B . 00:29:05.389 --> 00:29:12.509 Schedule C and schedule C 1 these are related to the import, manufactures, sale distribution 00:29:12.509 --> 00:29:20.669 of some biological products. The biological products like a sera, vaccine, toxine, antigen, 00:29:20.669 --> 00:29:30.470 insulin, fish liver and other other the formulation which are to be administered apparently. Schedule 00:29:30.470 --> 00:29:39.800 D is for import of substances not intended for medicinal use; some of the substances 00:29:39.800 --> 00:29:45.850 which are not for medicinal use does not require the permission from licensing authority . So, 00:29:45.850 --> 00:29:52.330 which are the substances which do not require permission from licensing authority for its 00:29:52.330 --> 00:30:02.380 input is given in this schedule. The substances like oats, then lactose, than cereals, pepper, 00:30:02.380 --> 00:30:08.080 gingers. So, all these which are not require the permission is given in this schedule D 00:30:08.080 --> 00:30:11.600 . Schedule D I and D II is a related to the 00:30:11.600 --> 00:30:19.690 information required to submit along with application for import and registration certification, 00:30:19.690 --> 00:30:25.350 while applying for the permission to import or have the registration certificate from 00:30:25.350 --> 00:30:30.929 licensing authority what data the applicant has to be submitted, what are the particulars, 00:30:30.929 --> 00:30:37.070 how it has to be submitted, what is the fees that everything is given in schedule D I and 00:30:37.070 --> 00:30:44.169 D II. Schedule E earlier it was there now it has been omitted and schedule E 1 has been 00:30:44.169 --> 00:30:51.200 inserted. The schedule E 1 consists of list of poisonous substances under ayurvedic systems. 00:30:51.200 --> 00:30:57.179 So, whatever the poisonous substances mentioned in the ayurvedic system that has been given 00:30:57.179 --> 00:31:04.740 in schedule E 1. And, this poisonous substances like sarpvish, then hartala, then arka all 00:31:04.740 --> 00:31:10.860 this substances whatever mentioned that is given in this schedule E 1 . 00:31:10.860 --> 00:31:19.029 Schedule F is requirement for the functioning and operation of the blood bank . So, blood 00:31:19.029 --> 00:31:24.029 bankblood product comes under the biological product and the Drug and Cosmetic Act has 00:31:24.029 --> 00:31:30.100 been provided to give some provisions; how to operate the blood bank, what should be 00:31:30.100 --> 00:31:35.990 the norms, what should be the specification of the blood, blood products, what is the 00:31:35.990 --> 00:31:43.049 area requirement for the blood donation and for the blood collection that all is given 00:31:43.049 --> 00:31:49.919 in the schedule F. Schedule F 1 is vaccine antisera, schedule 00:31:49.919 --> 00:31:56.870 F 2 standards for surgical dressing, schedule F 3 standard for umbilical tape, schedule 00:31:56.870 --> 00:32:05.179 FF is for standard for ophthalmic preparations, schedule G is list of medicines required medical 00:32:05.179 --> 00:32:13.750 supervision. So, those those those the substances are medicines which require special supervision 00:32:13.750 --> 00:32:22.179 by the by the medicinal practitioner that the list of these drugs have been given in 00:32:22.179 --> 00:32:29.850 the schedule G. The medicines like bleomycin, then insulin and other medicines the list 00:32:29.850 --> 00:32:35.960 is given in this schedule G. The next schedule that is schedule H, it is 00:32:35.960 --> 00:32:45.059 a prescription drug, the retailer has to sold the drug with the prescription only . So, 00:32:45.059 --> 00:32:50.210 these types of drug what are these which can only be sold by the prescription, the list 00:32:50.210 --> 00:32:58.690 of these drugs has been given in this schedule H. The drug like acyclo acyclovir then the 00:32:58.690 --> 00:33:05.629 bimatoprost, dosetocs scril, enalapril this drug which require the special supervision 00:33:05.629 --> 00:33:14.289 and to be prescribed by the doctor or RMPmention under the Drug and Cosmetic Act; the list 00:33:14.289 --> 00:33:22.130 of such drug is given in this schedule . Schedule H 1 is also prescription drug and 00:33:22.130 --> 00:33:30.720 this is related to the prescription of antibiotic medicines. In this schedules the drug like 00:33:30.720 --> 00:33:38.669 alprazolam, then safexin, diafarm, isoniazid and other drugs these are mentioned in the 00:33:38.669 --> 00:33:44.389 schedules. Schedule I is omitted one, then schedule J is the schedule for whichapplicant 00:33:44.389 --> 00:33:52.840 cannot claim to prevent this diseases through the list of the diseases like a , cancer, 00:33:52.840 --> 00:34:00.070 then malaria and other things AIDS. All these diseases which the applicant or medicine cannot 00:34:00.070 --> 00:34:06.740 claim that this drug can be cured or prevented or treated by this drugs. The list of such 00:34:06.740 --> 00:34:09.620 diseases and elements are given in schedule J . 00:34:09.620 --> 00:34:16.700 Let us see schedule K, schedule K is the drug exempted from provision that are applicable 00:34:16.700 --> 00:34:23.220 to manufacture. For the manufacturing the certain provisions has to be exempted for 00:34:23.220 --> 00:34:30.650 special type of drugs. So, what are this provision and which type of the drug like a quinine 00:34:30.650 --> 00:34:37.190 another anti malarial drug then antacid preparation. So, some of the provision of the manufacturing 00:34:37.190 --> 00:34:43.910 has been relaxed and are exempted to give while giving the permission. So, this is given 00:34:43.910 --> 00:34:49.670 in the schedule K. Schedule L 1 is a good laboratory practices, 00:34:49.670 --> 00:34:56.630 the practices to be applied in the laboratory are given in schedule L 1. Schedule M is a 00:34:56.630 --> 00:35:04.790 good manufacturing practices . So, this schedules again divided into schedule M 1, M II and 00:35:04.790 --> 00:35:11.390 M III, the good manufacturing practices for the manufacturing of homeopathic drug is given 00:35:11.390 --> 00:35:19.960 in schedule M 1. For the manufacturing of cosmetic it is given in M II and for the medical 00:35:19.960 --> 00:35:27.120 device it is given in M III, that is QMS for notified medical devices and in vitro diagnostics. 00:35:27.120 --> 00:35:35.390 Schedule N is the minimum requirement of equipment in pharmacy that what are the equipment minimum 00:35:35.390 --> 00:35:42.590 equipment the pharmacy should have that all equipment has been mentioned in schedule N. 00:35:42.590 --> 00:35:50.140 schedule O is standard for the disinfectant fluids all the standards which is required 00:35:50.140 --> 00:35:55.920 to be followed by the manufacturer of a disinfectant has been given in the schedule. Schedule P 00:35:55.920 --> 00:36:00.520 is life period of a drug that is a shelf life of the drug, what should be the shelf life 00:36:00.520 --> 00:36:07.150 of a particular drug. The list of this drug along with its storage and along with its 00:36:07.150 --> 00:36:10.620 shelf life has been mentioned in this schedule P. 00:36:10.620 --> 00:36:17.890 Schedule P 1 is the package size of drug for example, you can say the amoxicillin is the 00:36:17.890 --> 00:36:23.990 storage condition and the shelf life as given is 36 months. For the penicillin tablet it 00:36:23.990 --> 00:36:32.410 is given 18 months. And, in schedule P 1 package size of the drug like albendazole to be packed 00:36:32.410 --> 00:36:39.240 in 10 ml or the or the piperazine granules to be packed in 5 gram size or if it is cereals 00:36:39.240 --> 00:36:45.300 it should be a 30 ml. So, all this the pack size and the shelf life is given in schedule 00:36:45.300 --> 00:36:51.710 P; coming to the next slide . Schedule Q is related to the dyes, color, 00:36:51.710 --> 00:36:58.380 pigment permitted to be used in a cosmetics. So, as we have said that the cosmetics is 00:36:58.380 --> 00:37:04.810 also regulated . So, whatever the colors, pigments and the dyes used in cosmetic color 00:37:04.810 --> 00:37:10.630 like like a sunset yellow, tartrazine in all these are given in part I and part II. Part 00:37:10.630 --> 00:37:16.520 II is the specially for the colour dyes used in the soap and part I is for the cosmetics, 00:37:16.520 --> 00:37:23.410 then schedule R is for the standard for condoms. The how it should be the condom the standards 00:37:23.410 --> 00:37:29.760 are given in this schedule. Schedule S is standard for cosmetic, the standard to be 00:37:29.760 --> 00:37:36.200 followed by the manufacturer or importer in case of the cosmetic is given in the schedule. 00:37:36.200 --> 00:37:43.210 Schedule T is related to the GMP for ayurvedic medicine. So, in schedule M we have seen it 00:37:43.210 --> 00:37:49.360 is GMP for the routine normal drugs, then GMP for homeopathic, GMP for medical device 00:37:49.360 --> 00:37:56.290 and cosmetic only remaining is the GMP for the ayurvedic. So, what the practice are to 00:37:56.290 --> 00:38:02.430 be followed for manufacturing of ayurvedic medicine is given under the schedule T . 00:38:02.430 --> 00:38:10.210 Schedule U is related to the record for manufacturing of manufacturing raw material in drugs. So, 00:38:10.210 --> 00:38:17.980 what are record the applicant has to be maintained and has to be shown while the inspection that 00:38:17.980 --> 00:38:24.160 the least of these records are given in the schedule U. Schedule V is a standard for patent 00:38:24.160 --> 00:38:31.440 and prosperity medicines. Scheduled W it was the list of drugs to be sold with the generator 00:38:31.440 --> 00:38:37.310 and it has been omitted now. Schedule X is narcotic and psychotropic drugs. 00:38:37.310 --> 00:38:42.710 So, in this schedule whatever the narcotic and psychotropic drug which requires special 00:38:42.710 --> 00:38:48.540 attentions are given in the schedules. The drugs like amphetamine, barbital, ketamine 00:38:48.540 --> 00:38:54.850 that can be misused so all these drugs are given in this schedule. Schedule Y we have 00:38:54.850 --> 00:39:01.180 seen many time and it is more related to the our course that is the related to the clinical 00:39:01.180 --> 00:39:06.410 trials. So, it is the schedule Y is for the requirement and guideline for permission to 00:39:06.410 --> 00:39:14.260 import drugs, manufacture of drug of new drug for sale or to undertaker clinical trials 00:39:14.260 --> 00:39:21.730 . We will see this schedule in detail in our subsequent lectures; coming to the next slide 00:39:21.730 --> 00:39:28.200 the different drug testing laboratories . So, where this all the product mention in 00:39:28.200 --> 00:39:34.340 our different schedules and the categories of the product can be tested, the list is 00:39:34.340 --> 00:39:42.500 also given here. The Central Drug Laboratory that is CDL at Kolkata is responsible for 00:39:42.500 --> 00:39:49.190 the testing of new drugs, samples send by the court and the drug inspector as we have 00:39:49.190 --> 00:39:54.990 seen the drug withdraw the sample for its testing analysis; they can send the sample 00:39:54.990 --> 00:39:59.890 to the CDL Kolkata . Then the survey sample and the preparation 00:39:59.890 --> 00:40:06.700 of the standard, this is the responsibility of central drug laboratory Kolkata. Central 00:40:06.700 --> 00:40:12.940 drug laboratory is also available at Kasauli and this laboratory is particularly involved 00:40:12.940 --> 00:40:20.580 in the testing and analysis of the biological product that is a vaccine, sera, OPV testing 00:40:20.580 --> 00:40:25.660 . So, whatever the samples related to the vaccine, sera and other biological product 00:40:25.660 --> 00:40:32.860 has to be sent and are tested by the central drug laboratory at Kasauli. 00:40:32.860 --> 00:40:39.030 Then another laboratory that is for the veterinary medicines that is Indian Veterinary Research 00:40:39.030 --> 00:40:46.080 Institute IVRI it is at Izzatnagar. This is involved in testing of veterinary vaccines, 00:40:46.080 --> 00:40:51.930 veterinary drugs. So, whatever the veterinary vaccine and the drug that can be tested here 00:40:51.930 --> 00:41:00.880 at Izzatnagar; the national institute of biological which is at Noida is mainly involved in testing 00:41:00.880 --> 00:41:07.941 of in vitro diagnostic kits, that is local and imported both that kits privates permission 00:41:07.941 --> 00:41:12.360 has to be undergo testing at this laboratory . 00:41:12.360 --> 00:41:21.200 Central Drug Testing Laboratory that is CDTL is at Mumbai and Chennai . So, this drug testing 00:41:21.200 --> 00:41:27.660 laboratories are also involved in testing of the samples send by the drug inspector. 00:41:27.660 --> 00:41:35.040 And, all the new drugs and all the routine survey sample can be tested for that particular 00:41:35.040 --> 00:41:40.910 zone in this laboratory; let us say for this special biological products such as vaccine 00:41:40.910 --> 00:41:49.290 and another. Regional drug testing laboratories at Guwahati, Chandigarh and Indore; so, this 00:41:49.290 --> 00:41:56.630 laboratory has also been created to test this drugsample sent by the inspectors and sent 00:41:56.630 --> 00:42:03.340 by the server samples or any other customer also can send the sample to this laboratoryfor 00:42:03.340 --> 00:42:07.900 that particular zone. In the Indian pharmacopoeia commission it 00:42:07.900 --> 00:42:15.490 is the laboratory at Ghaziabad and this laboratory is mainly involved in preparation of drug 00:42:15.490 --> 00:42:23.430 monograph and then its standard. The pharmacovigilance centre is also available this is the coordination 00:42:23.430 --> 00:42:32.121 centre and publication of IP is also the responsibility of the Indian pharmacopoeia commission. Coming 00:42:32.121 --> 00:42:38.410 to the next slide so,what we have seen this where the central drug testing laboratory, 00:42:38.410 --> 00:42:43.730 the central government send the sample to this laboratories. Now, let us see the state 00:42:43.730 --> 00:42:49.990 drug laboratories . So, every state has a laboratory for the testing 00:42:49.990 --> 00:42:57.620 and analysis of the drug cosmetics manufacturer of sold in that particular area. So, few of 00:42:57.620 --> 00:43:01.980 the few of the states they are not having their own laboratory, they can send the sample 00:43:01.980 --> 00:43:07.060 to the central government laboratory. Few of the state they are having many laboratories 00:43:07.060 --> 00:43:14.600 to test the samples and the drug samples which are taken by their inspector. Sample send 00:43:14.600 --> 00:43:20.610 by drug inspectors are analyzed by such laboratory as I have said, then also analyze the drug 00:43:20.610 --> 00:43:24.810 send by any person or purchase on payment of necessary fees . 00:43:24.810 --> 00:43:31.360 So, there is a provision in the act and rules that anyone who is aggrieved by the sample 00:43:31.360 --> 00:43:36.940 or would like to test the quality of the sample he can also send this sample in a particular 00:43:36.940 --> 00:43:43.650 format which is given in our format given in our schedule A what we have seen. He can 00:43:43.650 --> 00:43:49.350 send their sample to these particular laboratories and these laboratories in particular format 00:43:49.350 --> 00:43:57.770 give its result to ensure that the drug is having the quality or not . So, this is all 00:43:57.770 --> 00:44:07.080 about the this lecture . So, what we have seen let us now recap ofthis lecture; so, 00:44:07.080 --> 00:44:14.260 the question for this lecture for you. Laboratory responsible for testing of vaccines, 00:44:14.260 --> 00:44:21.740 sera and biological you have to mention the name of the laboratory and where it is . So, 00:44:21.740 --> 00:44:27.410 it is the central drug laboratory of Kasauli which is involved in testing of vaccines, 00:44:27.410 --> 00:44:35.190 sera, biological and OPV testing's. What rules are related to new drug and clinical trials? 00:44:35.190 --> 00:44:46.250 There are many rules you have to answer; the rules like 122 A, B, DAB, DA, DC, DAC all 00:44:46.250 --> 00:44:48.910 these rules are related to the new drug and clinical trial . 00:44:48.910 --> 00:44:57.020 Under which rule registration of ethics committee is mandatory? The specific rule is given for 00:44:57.020 --> 00:45:06.340 the registration of ethics committee. The rule 122 DD is for the registration of ethics 00:45:06.340 --> 00:45:15.490 committee. What is schedule L 1? We have seen all the schedules, schedule L 1 is a good 00:45:15.490 --> 00:45:23.210 laboratory practices . So, in lecture 4 let us have the recap and summarize it. 00:45:23.210 --> 00:45:30.060 We have learn about the objective and objective of Drug and Cosmetic Act and rules there under. 00:45:30.060 --> 00:45:35.270 The objective is to ensure the quality safety and efficacy of the drugs available in the 00:45:35.270 --> 00:45:41.420 market. Then we have seen the different chapters available in act there are actually 6 chapter, 00:45:41.420 --> 00:45:49.060 but is up to 5 that is including IV A chapter and chapters are having different sections. 00:45:49.060 --> 00:45:55.620 Different schedules to the rule, we have seen the different schedules in the available in 00:45:55.620 --> 00:46:02.600 the rule that is schedule A to schedule Y. Then we have seen the drug testing laboratory 00:46:02.600 --> 00:46:08.580 there are many laboratories at the central level and they are having the specific functions 00:46:08.580 --> 00:46:15.300 related to the biological drugs, then IVD and medical devices. We have also seen the 00:46:15.300 --> 00:46:21.760 different testing laboratories which are available at state level for the testing and analysis 00:46:21.760 --> 00:46:30.800 . So, this is all about this lecture, we will see something others in our next lectures; 00:46:30.800 --> 00:46:35.050 till then bye bye see you and. Thank you .