India’s Central Drugs Standard Control Organisation (CDSCO) wants to tighten up conditions for the import of larger quantities of drugs for use in clinical trials.

The CDSCO has issued a proposed guideline that calls for additional documentation and evidence when contract research organisations (CROs) or other companies/institutions apply to import “appreciably large” volumes of drugs.

Under Rule 33 of the 1945 Drugs and Cosmetics Regulations, small quantities of drugs may be imported into India for “examination, test or analysis” by means of a Form 11 licence.

However, the regulations do not specify what “small quantities” are, and recently there have been a number of cases of manufacturers, CROs and other importers “submitting applications for the import of reasonably large quantities of active pharmaceutical ingredients and/or drug formulations which do not comply with the provisions of Rule 33”, , the CDSCO notes.

In future, any imports of “reasonably large” volumes of drugs for clinical trials will need to be justified with additional documentation explaining how the materials are to be used, with details of study parameters and batch manufacturing plans.

Applicants will have to show compliance with official regulatory documents and/or guidelines published by the drug licensing authority of the country where the study data need to be filed. Also required is a letter from the applicant’s overseas partner setting out the specific job assignments for the claimed quantities of drugs.

The new rules would apply to any quantities of drugs, whether bulk or formulated, that are listed as narcotics or psychotropic substances under the Narcotic Drugs and Psychotropic Substances Act, 1985, in addition to the necessary approvals from other competent authorities such as the Central Bureau of Narcotics.

The proposed guideline only covers systemic drugs for human use and does not apply to imports of diagnostic kits, veterinary medicines, medical devices or biologics.

According to the CDSCO, the rationale behind the guideline is to facilitate drug R&D/contract research and to “boost the scientific and technological activities in this knowledge-based industry”.