The Central Drug Standard Control Organisation (CDSCO) is pushing for a new set of guidelines seeking to produce additional documents for import of limited quantities of drugs from overseas for clinical trial needs. This has become necessary to regulate import of large quantities of drugs by certain organizations under the guise of clinical trial activities.

The proposed guidelines for import of large quantities of drugs for clinical trials stipulate additional documents such as intend letters from the overseas partners engaged in the specific project and justification and utilisation break up of the proposed quantities of drugs to be imported. The additional documents should be submitted along with applications for Form-11 licence for such large quantity of drug imports for clinical research.

CDSCO's move comes in the wake of it realising that in many recent cases the manufacturers, Clinical Research Organisations (CROs) and other importers are submitting applications for the import of large quantities of bulk drug and formulations which do not comply with the provisions of Rule-33. Provision of granting licence in Form-11 to import drugs for examination, test or analysis, made under Rule-33 in Drugs and Cosmetics Rules-1945, entitles that a small quantity of drug which is otherwise not allowed under Section-10 can be licensed for import.

The regulatory authority comments that there is no provision as such to define the term 'small quantity' under this rule. "However, to facilitate the research and development activities on pharmaceutical products and contract research facilities to boost up the scientific and technological activities in this knowledge based industry, it is decided that import of apparently large quantities of drugs should be justified with test parameters, batch sizes, no. of batches, categories of batches etc. vis-à-vis official monographs, official guidelines only," explains a document released by a drug regulatory official on behalf of the Drug Controller General of India (DCGI).

With the new guideline, the applicant for imports of large quantity of drugs for testing should submit additional documents for justification of import and utilization break-up of the proposed quantities of drug with reference to the detailed test parameters, batch-manufacturing plan, in accordance with the regulatory needs specified by the drug regulatory of the country where the study data would be submitted.

Documents to assert the bona fide use of the imported drug also includes indent letter from overseas partners delivering the specific job assignments to the Indian applicant firm for the claimed quantities of drug. However, the focus of the new guideline is only on drugs for human use undergoing systemic circulation and not applicable for import of diagnostic kits, veterinary drugs, medical devices, and drugs of biological origin.

The guideline further adds that the import quantity of narcotic drug and psychotropic substances which falls under the NDPS Act, 1985 should be justified with necessary approvals from competent authorities including Central Bureau of Narcotics, Gwalior along with the additional documents mentioned earlier.

At present, the applicants for Form-11 licence are sought to submit information for justification and utilization break-up, detailing the test parameters as against quantities of the drugs, batch manufacturing plan and the receipt from the bank for the payment of requisite fees by way of TR-6 Challan. The application in form-12, for the purpose, should be countersigned by the head of the institution conducting the research project or the proprietor of the research firm carrying out the project.