Pharmexcil calls on India exporters to express concerns on proposed US Drug Safety Enhancement Act

India’s Pharmaceutical Export Promotion Council (Pharmexcil) has asked the country’s exporters to share their comments and apprehensions on the proposed US legislation, titled Drug Safety Enhancement Act, 2011, which is proposed as a draft and put forward in the US Senate for approval as an amendment to the Federal Food, Drug and Cosmetic Act, reports the Indian PharmaBiz news wire.

The objective of the bill is to improve the safety of drugs by vesting, enacting law at every stage of manufacture, approval process and in the supply chain. Under the Bill, it is mandatory to register establishments involved in manufacture, preparation, propagation, compounding or processing of an excipient as per Title 1, Section 101 (b), notes PharmaBiz. In addition to active ingredients, inactive ingredients are considered to meet the objective of Drug supply quality and safety as per Title 1, Section 102.

The terms of the legislation require management to be responsible for effective quality system in providing resources so as to ensure cGMP, quality, risk management, supply chain management, maintenance of records and inspection. For importation or exportation, good importer practices are proposed where in dealing with registration, documentation.