To begin a CRO in India refer CDSCO draft Schedule Y1 guidance

We know that D&C Act 1940 states that drugs should be dispensed by a registered pharmacist. However, all Indian sites do not have pharmacists available. Most of the time, dispensing of drugs (oral tablets, strips) are being done by study coordinators (who may or may not be a registered pharmacists). How can one manage this situation?

Indian / ICH GCP does not mandate requirement of a pharmacist at the site. (See below). The person who is assigned the task has to be knowledgeable about the IP as required by the protocol, regulations GCP and GMP.

ICH GCP 4.6.2  - Where allowed/required, the investigator/institution may/should assign some or all of the investigator's/institution’s duties for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution..

4.6.3 - The investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the investigator/institution, should maintain records of the product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and trial subjects. Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.

4.6.4 Indian GCP 3.3.6. Investigational Product(s)

Investigator has the primary responsibility for investigational product(s) accountability at the study site(s). Investigator should maintain records of the product’s delivery to the study site, the inventory at the site, the use by each subject, and the return to the sponsor or the alternative disposal of the unused product(s). These records should include dates, quantities, batch / serial numbers, expiry dates if applicable, and the unique code number assigned to the investigational product packs and study subjects.  Investigator should maintain records that describe that the subjects were provided the dosage specified by the protocol and reconcile all investigational products received from the sponsor. Investigator should ensure that the product(s) are stored under specified conditions and are used only in accordance with the approved protocol.

The investigator should assign some or all of his / her duties for investigational product’s accountability at the study site(s) to his subordinate who is under the supervision of the investigator / institution. The investigator or subordinate should explain the correct use of the product(s) to each subject and should check at intervals appropriate for the study that each subject is following the instructions properly. The person who carries them out should document such periodic checks.

Is there any comprehensive guide for how to start a CRO in India, its regulations?
At present, there is no formal guideline for setting up a CRO. In Jan 2011, CDSCO has issued a draft Schedule Y1 guidance for CRO registration.

Some of the requirements for the CRO are:

Should under the charge of a person who is responsible for the overall activities of the organization

Have competent persons who are thoroughly familiar with the investigational product(s), the protocol, written informed consent forms or other information provided to the subjects, the standard operative procedures by the sponsors, GCP guidelines and other rules applicable to the conduct of clinical trials.

Have adequate resources, qualified and trained staff for oversight of clinical trials.

Trial related duties and functions transferred to and assumed by the CRO specified in writing and properly quantified.

Ensure that the trials are adequately monitored and the trial related responsibilities transferred to it, partially or fully, by the sponsor are discharged effectively and efficiently

Implement quality assurance and quality control as per standard operative procedures designed for the purpose

Maintain complete data, documentations and other related records accurately.

Ensure that the investigator(s) received all documents and trial related supplies needed to conduct the trial properly.

Have education programmes to help its investigators to carry out the research studies as per guidelines and regulations applicable to such trials. Training will include protocol adherence, GCP guidelines, informed consent process, and investigator’s responsibilities for GCP compliance.

All records (written documents, electronics, magnetic or optical records, scans, etc.) such as protocols, approvals from the Central Drugs Standard Control Organization (CDSCO) and ethics committee, investigator(s) particulars, blank consent forms, monitor reports, audit certificates, relevant correspondence, reference ranges, completed and the final reports, shall be maintained.