What are the regulatory requirements for marketing a new drug in India?

In June 2011, CDSCO released Guidance for Industry on Approval of Clinical Trials & New Drugs to specify the general requirements for approval of clinical trial and different categories of new drugs and the procedure for review of technical dossiers of such applications by CDSCO under Rule 122 A, 122B, 122DA, 122DAA,122E and Schedule Y of Drugs and Cosmetics Rules.
The categories are as follows:

• New Chemical Entity (NCE) – developed in India as an IND and not marketed anywhere in world
• NCE approved and marketed in other countries not approved in India
• NCE being developed in other countries and not marketed anywhere in world
• A drug already approved - New claims
• New Indication
• New Dosage Form/ New Route of Administration
• Modified Release Dosage Form
• Fixed Dose Combination
• Already Approved New Drug

The number of study subjects and sites to be involved in the conduct of clinical trial will depend upon the nature and objective of the study.

Phase I clinical trials should usually be carried out by investigators trained in clinical pharmacology and having the necessary facilities to closely observe and monitor the subjects. These may be carried out at one or two centres. At least 2 subjects should be used on each dose. Phase II clinical trials should normally be carried out on 10-12 patients at each dose level. These studies should usually be carried out at 3-4 centres by clinicians specialized on the concerned therapeutic areas and having adequate facilities to perform the necessary investigations for efficacy and safety.

If the drug is already approved/marketed in other countries, phase III data should generally be obtained on at least 100 patients distributed over 3-4 centres primarily to confirm the efficacy and safety of the drug, in Indian patients when used as recommended in the product monograph for the claims made. If the drug is a new drug substance discovered in India and not marketed in any other country, phase III data should be obtained on at least 500 patients distributed over 10-15 centres.

If an ethics committee is being shut down in the middle of an ongoing trial, can the site which has taken approval from that committee transfer to a new committee? in this scenario what are the regulatory guidelines?

Yes. However, you need to have documentation to support this change.

If the site is in an institute, you will need to have an official letter from site administration that 1) the EC has stopped working 2) The site will accept jurisdiction of an external - Institutional Or independent EC. 3) External - Institutional or independent EC should accept the responsibility of the site. 4) You will have to formally approach the new EC, which should review the proposal in their official meeting and give EC approval. 5) You need to notify DCGI office about the change of EC.

No new patients can be recruited till the whole process of EC approval from an external EC is obtained.

In the site is a private clinic, you will need a letter from the EC that it has stopped working and items 2-5 from above.

Please note as per DCGI's current guidelines, the EC has to be from the same location where the site is.

If a pharma company wants to do a phase IV study with more number of subjects with lab tests, but for the same indication, same dosage and age group, then is DCGI approval needed or just a notification to DCGI is enough?

In recent times, DCGI office has noticed that companies are doing phase IV trials with designs similar to phase III studies, which have inclusion/exclusion criteria, objectives, investigations and end points. DCGI has been concerned about safety of subjects in such studies. Hence, DCGI office expects the sponsor to obtain permission for such trials from CDSCO.

Can one sub investigator work for two investigators at different sites for the same study?

Yes. He can work at two different sites. His name should be in the delegation log /FDA 1572 for both the sites.