PMS primarily is a surveillance of safety of new drug

If there is an SAE occurrence in a BE study, should the DCGI reporting be done separately by both the sponsor and the investigator or can a single report go to DCGI?
Nanda Kumari
There is a change in reporting after the Compensation Rules were released in Jan 13. The investigator and sponsor have to send separate reports of SAEs to DCGI office, Expert committee, Ethics committee and Head of the institution.

What are the PMS requirements in India? Number of cases for PMS? Can we ask for PMS waiver?
Ashish Chavda
For all new drugs approved by CDSCO, PMS is mandatory. No waiver is possible. There is no fixed number recommended in CDSCO documents. However, as the primary objective of such studies is surveillance of safety, NDAC has been asking the companies to conduct phase IV in statistically significant number for common conditions. For common conditions the NDAC has been asking for trial in 200-1000 patients, depending upon the indication. For rare diseases, the number could be small e.g. 25-50.

Is there a need to submit PSURs for subsequent new drugs in India?
Ashish Chavda
PSUR applies to all new drugs approved by CDSCO for all new drugs and subsequent drugs approved by DCGI office.

What is difference between PMS and Phase 4? Is there is need to get EC permission for PMS/Phase 4?  
Prafulla Pawar
Phase 4 includes all post marketing studies.

• PMS is one type of Phase IV study to obtain additional information about the risks and benefits resulting from long term usage of drug. PMS primarily is a surveillance of safety of new drug.
• Another type of Phase IV study is that is designed to evaluate the marketed drug in specifically designed studies, which have inclusion/exclusion criteria, objectives and end points. The drug is used for the labeled indication in these studies
• Another type of Phase IV study involves evaluation of the drug for a new indication of a marketed drug,
• For Phase 4, EC permission is essential. In addition, you also need DCGI approval.

In drug trial, if a site does not have Ethics Committee in their hospital as well as in same city, then can we get EC permission from DCGI registered Ethics Committee from different nearby city?
Prafulla Pawar
No. this is not acceptable as the DCGI guidelines mandate that EC should be from local area.

What are the clinical trial requirements, if a granthokt ayurvedic formulation (skin ointment) need to be marketed?
Dr Varun Mishra
'Ayurvedic, Siddha or Unani drug' includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of [disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of [Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the first Schedule;]

This means that granthokt ayurvedic formulation (skin ointment) should have been prepared as per the formulae described in, the authoritative books of Ayurvedic system

listed in Drugs & Cosmetic Act. The link contains the list (http://www.fda-mah.com/ legalproayurved1.aspx).

In 2008, Dept of Ayush released guidelines for evaluation of Ayurvedic drugs. As per these guidelines, The granthokt ayurvedic formulation will fall in Category I. If the indication for granthokt ayurvedic formulation is as per authoritative books, no clinical trials are needed. However, if the indication is new, clinical trials are required. Phase of trial would be II or III depending on what literature is available.

In Mar 2013, Dept of Ayush released GCP guidelines for clinical trials in  Ayurvedic, Siddha or Unani medicines.