A meeting was held on 17th October, 2006 at IDMA office Mumbai to discuss Matters  relating to Global Clinical Trials.  As agreed upon the following drafts are placed below for comments:

 

1.      Minutes of the meeting held on 17th October at IDMA Office, Mumbai

2.      Checklist for filing Global Clinical Trial Applications

3.      Categorization of approval of protocol amendments

 

The comments if any should reach the Drugs Controller General (India) office on or before 10th November, 2006.  The same would be finalized by 22nd November, 2006.

 

 

MINUTES OF THE MEETING ON  MATTERS RELATING TO GLOBAL CLINICAL TRIALS HELD ON 17TH OCTOBER 2006 AT IDMA OFFICE -  MUMBAI

 

The Drugs Controller General (India) has welcomed all the participants representing Manufacturer Associations like IDMA, OPPI, IPA, CROs and Individual Specialists in the field of Clinical Trials.

 

Opening Remarks:

 

The Drugs Controller General (I) thanked all the participants for spending their valuable time and attending the meeting and IDMA for providing their Conference Hall and explained the objective of the meeting.

 

He stated that his office is receiving  increasing number of applications for conducting global clinical trials,  as India is becoming a hub for global clinical trials because of its inherent strengths.  To ensure that the Indian entrepreneurs grab this opportunity he wanted to have a debate on various issues relating - from applicaiton to grant of permission to global clinical trials.  He emphasised the concern of Indian regulatory authorities regarding subject safety in global clinical trials. He further explained that due to lack of clarity some of the applications received are incomplete and lot of avoidable correspondence is being carried out.  He delibrated with the participants on all the issues to arrive at a basic checklist and details of annexures and information to be furnished for approval of global clinical trials.  He also put this opportunity to inform various deficiencies which are usually observed in applications leading to avoidable correspondence. After prolonged debate the following decisions were taken :

 

1.         For the purpose of granting permission, the clinical trials are classified into Category A and Category B , Category A will include those clinial trials whose protocols are approved by some of the recognised and developed countries  The committee has agreed following countries under the Category A; viz.  USA, UK, Switzerland, Australia, Canada, Germany, South Africa, Japan, EMEA.    In this cases the permission will be granted accepting the approval of protocols by the countries mentioned above.  And the time frame suggested for such clearances based on the current load of 20 applicatons per month is 2 – 4 weeks and the members are agreed that such  time frame will help them to meet the global time lines.

 

2.         All the other applications which are not covered under Category A  will fall  under category B. They will take more time as the adequacy of the protocol have to be verified  to protect the subjects.   The approximate time for this is excepted to be  8 – 12 weeks. It was clarified that once an application is considered under Cateogry B it will not be shifted to Cateogry A even though the applicant produces an approval from the developed countries mentioned above the protocols.

 

3.                  It was agreed upon by IDMA, OPPI,  Reliance Life Sciences,  Quintiles will upgrade the existing check list followed by Office of the DCG (I) and submit to DCG (I) by 25th October 2006.

4.                  As a part of the data to be submitted for each phase of clinical trial, it was agreed upon to accept summarized information in investigatior’s broucher duly supported by an affidavit declaring the information furnished in the summarise affidavit are based on the facts.

5.                  The summarised information shall include information with respect to safety and efficacy of these drugs.

6.                  As regarding Phase I Clinical Trial, DCG (I) has  clarified the Government Policy that Phase I trials are permitted to those molecules which are discovered in  India.

7.                  He also stated that the repeat Phase I can also be permitted to the company.

8.                  As regarding request for permitting Phase I studies on repeat dose limiting to the total dose maximum to single dose,  same will be examined in consultation with experts and decison will be taken on the basis of discussions.

9.                  As regarding Phase IV trials if the drug is permitted for marketing into India, it will be permitted and will be considered as “Category A” and in case if the drug is not permitted it will be kept under Category B for complete examination.

10.              DCG (I) also opnioned to find out and prepare a list in consultation with experts indications for which Phase IV clincial trials should not be permitted.

11.              DCG (I) re-emphasised that incomplete applications are one of the major reasons for delay in clearances and stated that once  the checklist and information to be furnished  is finalised, any application not complying with the requirements will stand rejected and no correspendence will be entertained.  The applicant has to re-apply with necessary fees etc. as per rules and he will get his chance based on the receipt of the application on second time.

12.              As regarding protocol amendments,  it was agreed upon after deliberations to categorise the amendments into three categories : a. Those amendments which do not require any infomation or permission b. Those amendements which require to be infomed but need not wait for permission. c. Those amendments which require prior permission before implementation of the amendments. Dr. Menon of Novartis India, Brijesh Regal of Apothecaries and Smt. Swati Srivastava of CDSCO will prepare a list of amendments and their categorisation.

13.              DCG (I) desired that the CROs  carrying out the global clinical trials should  submit Half Yearly returns on the status of Clinical Trials which were permitted by him as per standard format and  communicated through the website.

14.              DCG (I) also informed that all permissions granted will be registered and maintained for the purpose by DCG (I)

15.              After deliberations it was agreed upon that  the CROs while submitting  serious adverse events will also provide a proof from the sponsorer to have intimated the respective regulatory bodies with whom they are filing the data.

16.              The DCG (I) suggested to simplify the procedure of issuing NOC for test license, clinical trial and export of serum samples in one permission letter as against the current practice of three permission letters. He desired that the time of  application for global Clinical Trial should also include applications for test license and if they propose to send any of the samples abroad for test and analysis,  those information shall also be given along with the application.

17.              As regarding destruction of drugs imported by manufacturer for the purpose fo Clinical trials shall be carried out by the CROs / Sponsorer and the certificate to the extent shall be furnished along with the returns they are going to file half-yearly.

18.              The members present in the meeting desired that audit should be initiated of the investigators and the ethical committees. DCG (I) has agreed to the suggestion and said to workout for the same.

19.              DCG (I) also wanted to know the views of the participating members  about need for self regulators as well as regulations from the regulatory authoritieis.  All the participating members have expressed their need for regulation of organisation carrying out Clinical Trials by the regulatory mechanism.

In his closing remarks the DCG (I) once again thanked  all the members for their inputs and he said that he would strive to see the decisions would be implemented at the earliest.

 

Checklist For Filing Global Clinical Trial Applications

                                                                                                            CATEGORY      A/B

 

1.      Name of the Company/ CRO

2.      Authorization letter from the Sponsor

3.      Name of the Drug

4.      Objective of the Study

5.      Phase of Study

6.      Names of Participating Countries Centers

7.      Total no. of  patients to be enrolled globally

8.      No. of centers to be included in India

9.      No. of patients to be included in India

10.  Regulatory/ IRB approvals from participating countries

11.  Status of the study in other countries

12.  Serious adverse event from other participating countries if reported

13.  Affidavit from the sponsor that the study has not been withdrawn from any country and in case of withdrawal of study the same would be communicated to the DCG (I) office at the earliest

14.  Data Submitted

a)        Chemical and Pharmaceutical data

i) Generic name and chemical name

ii)Dosage form

iii)Composition

 

 

 

b)        Animal Pharmacological Data

c)        Animal Toxicology data

d)                                Clinical data

i) Phase I

ii) Phase II

iii) Phase III

iv)  Phase IV

e)        Rationale for selecting the proposed dose in the trial

f)          Regulatory status of the drug in other countries (Names of countries where the drug is approved  along with international package insert or where IND application is filed)

15.       Documents Submitted

a)        Form 44 and Treasury chalan

b)        Form 12 and Treasury chalan

c)        Details of Biological samples to be exported

d)        Protocol and Informed consent form

e)        Case Report form

f)          Investigator’s Brochure duly supported by an affidavit that the summarized information submitted  is based on facts

g)        Undertakings by the Investigators

h)         Ethics committee approvals ( if any)

 

PROTOCOL AMMENDMENTS

 

a. Those amendments which do not require any information or permission

 

i)          Administrative and Logistic changes

ii)         Minor protocol amendments and additional safety assessments  in case the institutional ethical committee has already approved these changes

 

 

 b. Those amendments which require to be informed but need not wait for permission

 

i)          Additional Investigator sites

ii)         Amended Investigators Brochure, amended informed consent

 

 

c. Those amendments which require prior permission before implementation of the amendments.

 

 

i)          Change of Principal Investigator

ii)         Additional Patients to be recruited

iii)         Major changes in protocol with respect to study design, dose and treatment options