Introduction 

This article deals with the Clinical Trial Amendments in India. India is a country with a vast population, highly skilled personnel and regulations in place to conduct clinical research. The Drug Controller General (DCGI) is an official part of the CDSCO who regulates and gives the final authority for the approval of clinical trials in India. They are responsible for the approval of licenses under categories such as blood and blood products, IV Fluids, Sera and Vaccines in India. DCGI also is responsible for setting standards in India for Manufacturing, Sales, Import and Distribution of Drugs in India. Clinical Trial Amendments was introduced in June 2020. These Clinical Trial Amendments was introduced as a Draft Notice for a short period of time. ALSO READ : Why Invest In India

Prerequisites for Conducting a Clinical Trial in India 

There are several prerequisites for conducting a clinical trial in India. The rules and regulations have undergone several changes in the previous years and come under the Clinical Trial Amendments. All responsible parties have to register clinical trial requests and the summary to clinicaltrials.gov. This law applies to drugs, biological and device products and has been effective since September 27th, 2007. The parties wishing to conduct a clinical trial in India have to first do the following steps

  1. Notify and get an approval from the DCGI
  2. Approval from Ethics Committee 
  3. Registration on an online portal of the Indian Council of Medical Research (ICMR) 

The ethics committee must grant a separate approval in the areas where the study is planned. An Ethics Committee usually grants permission at separate sites for the conduction of clinical trials. Clinical trials are generally institutions and hospitals and the Institutional Ethics Committee have to get their license renewed every 3 years. 

Clinical Trials of Medical Devices in India 

The Medical Devices are controlled by the Drug and Cosmetic Act and Rules. The ICMR is the soul body responsible for the coordination of clinical research in India. To conduct a clinical trial in India, the Medical Device must have an approval from any of the GHTF countries such as USA, Australia, Japan, Canada and European Union. There are several data which is to be submitted to conduct a trial in India – 

  1. Biocompatibility Studies, Protocols followed, Test conducted for establishing Biocompatibilty and results.
  2. Design Analysis Data 

Once the trial is registered, data is expected to be collected regularly and the import and export of the samples can be done without prior approval from any government agency. 

Phases and Documentation Requirement of Conducting Clinical Trials in India 

The clinical trial in India is conducted in four stages in India – Phase I, Phase II, Phase III, Phase IV. ALSO READ : Clinical Trials in India: Document Requirements

  1. Phase I – Conducted by investigators trained in Clinical Pharmacology and can be carried out in two centres wherein at least 2 patients must be given a single dose. 
  2. Phase II – It is conducted in three to four centres and 10-12 patients will be administered each dose by clinicians specialised in these therapeutic areas. 
  3. Phase III – If the drug has been approved in other countries, the phase III data must be recorded for about 100 patients distributed over 3-4 centres. If the product does not have approvals in other countries, then data for about 500 patients in 10-15 centres must be available. 
  4. Phase IV – The complete details of the non-clinical safety data needed for the previous stages must be submitted to enter Phase IV clinical trials. The permission for conducting these trails is generally given in phases depending on the data collected from the earlier stages. 

The rules and regulations has undergone changes and come under the Clinical Trial Amendments in India.

Clinical Trial Amendments

The CDSCO has amended a few rules of the New Drugs and Clinical Trial Rules, 2019 as New Drugs and Clinical Trials (……Amendment) Rules, 2020. This draft came into power on 20th June, 2020. The following are the amendments to be incorporated- 

1. Section 96 A : Import of Unapproved Drug

A hospital or practitioner can import new drugs for the use of patients suffering from severe diseases, which has not been permitted into the country, but under Phase – III clinical trials anywhere in the world by applying in the Medical Superintendent of the hospital or Head of the medical institution. 

2. Section 96C : Import License will be Issues under Several Conditions

  • The license will be  displayed in the premises of the hospital where the drug is being used
  • The licensee will have to store the drug under proper storage conditions
  • The drug imported is exclusively used for compassionate use
  • The record of usage of these drugs must be available at all times
  • The Hospital/Institution must submit a quarterly report of the units in stock and sold units and units destroyed. 
  • If the drug is damaged or expired, the same has to be destroyed and a recording of the same should be available.

3. Section 96CA : Suspension/Cancellation of License 

If the importer fails to comply with the rules, the Central Licencing Authority after giving a notice may suspend or cancel the license for a period or wholly. 

4. Section 96D : Application to Manufacture New Drug for Compassionate use

If the hospital/medical institute wants to manufacture these new drugs, they have to follow the following rules – 

  • The manufacturer has to obtain a letter in writing from the patient and make an application the the Ethics Committee for approval to manufacture such a drug
  • After obtaining approval from the EC, the manufacturer has to get the permission from the Central Licencing Authority to manufacture the drug.
  • The consent forms from the patient has to be specified in Form CT-30
  • The application is accompanied by the following details:
    • Reasons to manufacture the new drug over the available therapeutic options.
    • How the patient was selected 
    • Method of drug delivery 
    • Manufacturing facility information
    • CMC information of the drug
    • Pharmacology, Toxicology and Clinical Procedure Information

5. Section 96E : Approval to Manufacture New Drug: 

If all the information provided is correct, after scrutiny of information and documents obtained, approval for manufacturing the drug will be given. The quantity of a single new drug should not exceed more than 100 doses. However in exceptional cases, more quantities will be allowed. 

6. Section 96F :  Permission Condition 

The permission granted is subject to the following conditions – 

  • Validity of the certificate is 1 years from the date of approval
  • The patient has to be under supervision by the Central Licencing Authority
  • The manufacturer can only sell to places mentioned in the permission letter
  • Storage of the drugs must be as per the rules
  • Status of the units sold, destroyed and not used must be submitted as a quarterly report.
  •  The registered pharmacist has to maintain all the necessary information about the patients the drug is sold to.
  • If the drug is damaged or expired, the same has to be destroyed and a recording of the same should be available.
  • The Central Licencing Authority must be informed in the occurrence of any Adverse Event. 

7. Section 96G :  Inspection of Manufacturing Site 

Central and State Authorised personnel are allowed to enter the manufacturing site without prior notice to inspect the manufacturing, storage and supplying conditions of the new drug.,

Morulaa’s Expertise in the Indian Market

Morulaa HealthTech as successful consultants for the Indian Market have delivered high level professionalism and quality towards our clients. Contact Harshita Gupta for additional consultation or information on Registration, Importation, Clinical Trial Information, Commericialisation of your Medical Device in India. 


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