India’s Central Drugs Standard Control Organisation (CDSCO) called for tighter rules on the import of larger quantities of drugs for use in clinical trials in July 2009. The proposal by the CDSCO asks for additional documentation and evidence when contract research organisations (CROs) or other companies apply to import 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” with a Form 11 licence. However, this does not state specifically what is considered to be a ‘small’ amount, and so more rules are necessary to control it. The new rules would apply to any quantities of drugs, bulk or formulated.
Further reading - An in-depth analysis of the Indian pharmaceutical market is available from Espicom: The Pharmaceutical Market: India (published June 2009)