New Regulations for Global Clinical Trials in India

India’s Central Drugs Standard Control Organization (CDSCO) has recently passed new regulations on global clinical trials. The regulations are based on a meeting held in October 2006, which brought together clinical trial specialists, manufacturers’ associations, and contract research organizations.

In the process of granting permission, clinical trials will be classified into Categories A and B. Category A will consist of trials whose protocols are approved by the US, UK, Switzerland, Australia, Canada, Germany, South Africa, Japan, or the European Medicines Agency. Applications without any such approvals will automatically fall under Category B.

Category A trials will be processed in a streamlined manner. Their existing foreign approval will be accepted for Indian purposes, eliminating the protocol verification process. This will reduce the approval time for this category to 2-4 weeks. Category B applications, in contrast, are expected to take 8-12 weeks for approval as they will require protocol verification. Once an application has been taken up as Category B, it cannot be shifted to Category A afterwards, even if the applicant submits an approval from one of the listed countries.

The CDSCO also issued a draft checklist for filling out a clinical trial application, as many approval delays for global clinical trials arise from incomplete applications. The checklist includes basic information on the product (composition, dosage form, etc.) as well as foreign approvals and status of the trial. Once the checklist is implemented, any incomplete application will be rejected summarily. Applicants will have the option of re-applying for an additional fee.

Another issue the CDSCO addressed during this October 2006 meeting was the categorization of amendments to clinical trial protocol into three groups, as follows:

  • Amendments which require no notification or permission (minor protocol amendments)
  • Amendments which require only notification without permission from the CDSCO (such as additional investigator sites, amended informed consent)
  • Amendments which require permission from the CDSCO before being implemented (major amendments such as change of principal investigator, additional patients to be recruited, etc.)