The Pharmaceutical Export Promotion Council (Pharmexcil) has asked the exporters in the country to share their comments and apprehensions on the proposed Bill in USA titled ‘Drug Safety Enhancement Act, 2011’ which is proposed as draft and put forward in US Senate for approval as amendment to Federal Food, Drug and Cosmetic Act (D&C Act).

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. The Pharmexcil has invited comments from the drug manufacturers all over the county on the Bill to share any apprehension pertaining to future trade barriers and other legal implications that may hinder the prospects of trade between the two countries.

As per 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). 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.

Under the Bill, as examined by our Council, management is 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.

Pertaining to Registration of Customs brokers, they are included in addition to importer as per Section 303. Further the proposed bill says, a certification by authorities is mandatory for export from United States.

For inspecting foreign facilities, the draft has a provision of dedicated under Section 306. It is also proposed to have a unique identification number for establishments, importers, customs brokers, principal place of business along with the registration of the person under Title IV, Section 401.

To avoid misbranding, the amendment makes mandatory to disclose website of manufacture, country of origin of each active pharmaceutical ingredient, place of manufacture of finished product under Title IV, Section 402.

Under Title IV, section 405, the draft bill has proposed protection clauses for Whistle blowers. This provision enables protection especially for employees who refuse to violate, or who disclose violation of this act.