The Central Drugs Standard Control Organization (CDSCO) of India’s Ministry of Health and Family Welfare has issued draft guidelines on the clinical trial and data submission requirements that drug makers must meet before new drugs can be manufactured, marketed or imported into India. Comments are requested by August 24, 2011. While the guidelines would not, apparently, apply to biologicals and vaccines, they would be applicable to active pharmaceutical ingredients.
According to CDSCO, the guidelines are intended to assist the industry in submitting “the required documents in a more realistic manner, which in turn will also help [agency reviewers] to review such application in a systematic manner. It is apparent that this structured application with comprehensive and rational contents will help the CDSCO to review and take necessary actions in a better way and would also ease the preparation of electronic submissions, which may happen in the near future at CDSCO.” See BNA Life Sciences Law & Industry Report, August 12, 2011.