India’s Central Drug Standard Control Organisation (CDSCO) wants CROs and trial sponsors to justify and document the increasingly large quantities of drugs and APIs they import for clinical trials.
Under Rule 33 of current drugs guidelines contract research organisations (CRO) in India are permitted to import “small quantities” of candidate drugs for assessment in clinical trials via the Form-11 licensing process.
However, in a document posted on its website late last week, the CDSCO said that, increasingly, CROs and drugmakers are asking to import larger quantities of active pharmaceutical ingredients.
Arvind Kukrety, assistant drugs controller, said that while the term “small quantity” is not defined under current rules “[the] importation of apparently large quantities of drugs should be justified with test parameters, batch sizes [and] no of batches.”
As a result, the CDSCO has asked that, when submitting import applications, CROs provide manufacturing and trial parameters explaining why they want to bring “appreciably large quantities” of an API into the country.
The organisation also wants trials sponsors to provide “intend letters” detailing how the compound will be used, covering everything from stability studies and formulation development to the production of pilot and scale-up batches.
The guidelines also require that CROs seeking to import narcotic or psychotropic APIs should justify the quantities they wish to bring in to the National Drug Regulatory Authority (NDRA) and the Central Bureau of Narcotics (CBN).
The CDCSCO also said that more and more Form-11 applications are being filed for finished dosage forms for use in bioequivalence studies.
It explained that: “Since bioequivalence studies are considered as special studies on new drugs…such applications for [a] Form-11 should accompany NOCs/ approval of the same.”
The CDSCO’s document can be found here .
China’s express customs scheme
Regulation of CRO imports is becoming a key topic for the industry. In China, Asia’s other clinical research hub, authorities introduced an pilot “express customs scheme” last month to cut the time it takes to bring a candidate drug into the country.
As the battle between Indian and Chinese CRO hots up it will be interesting to see how authorities in the respective countries will balance the need to regulate the industry with the desire not to damage competitiveness.