India’s main pharmaceutical regulatory body, the CDSCO, recently released
a set of proposed standards that will require contract research organizations
(CROs) to present additional materials and paperwork when applying to import
a large volume of drugs for clinical trials. The Rule 33 (from the 1945 Drugs
and Cosmetics Regulations) that is currently in place allows small quantities
of drugs to be imported into India for test or examination with a Form 11 license.
However, the term “small quantities,” has until now, been taken
very loosely and the actual quantity that is allowed for imports is unclear.
The CDSCO receives many applications from CROs, importers, and drug manufacturers
to import relatively large quantities of APIs and drug formulations.
The proposed guidelines state that in order to import large quantities of drugs
for clinical trial use, applicants will have to submit (1) additional documents
explaining what the materials will be used for, including the details of the
clinical study; (2) documents that demonstrate compliance with regulations from
the drug licensing body where study is to be recorded; and (3) a document from
overseas group stating the specific tasks for the drugs.
The guidelines, if implemented, will apply to drugs that are for human use,
classified as narcotics or psychotropic substances, and that are bulk or formulated.
They will not apply to imports of the following: veterinary medicine, biologics,
medical devices, or diagnostic kits.