The Ministry of Commerce has claimed that India had demonstrated its keenness to meet international requirements for exports of pharmaceutical products yet again by taking timely action for complying with the new procedural requirements of the European Union (EU) for import of Active Pharmaceutical Ingredients (APIs) into the EU.
The Ministry also hoped that the pharma industry would be able to meet the regulatory requirements within the given time frame.
“The Department of Commerce has been seized of this issue right from the beginning since EU is an important market for the pharma industry. Various EU industry members have been expressing their concern about the ability of India to comply with the new procedure by the deadline of 2nd July 2013. However, Government of India is optimistic,” said an official release here today.
European Union issued a new Directive/2011/62/EC dated 8th June 2011 amending earlier Directive 2001/83/EC. The stated objective of this Directive is to lay down a community code relating to medicinal products for human use and to ensure that the defective products do not reach consumers. The Directive lays down a system of control over the entire supply chain for pharmaceuticals. It controls manufacture and import to marketing, wholesale and retail distribution. The said directive will be operational July 2, 2013.
The new legislation requires a ‘written confirmation’ by a competent authority nominated by the Government of India that the API has been manufactured in accordance with EU-GMP standards and that the Manufacturing Facility where the API was manufactured is subject to control and enforcement of GMP standards and is equivalent to those in the EU countries.
“To comply with the above requirements, the Department of Health & Family Welfare officially declared the Central Drugs Standard Control Organization (CDSCO) on 12.11.2012. It was also decided that a protocol for the procedure to be complied by the India API Exporters would be laid down by the CDSCO which has been done,” the release said.
Salient features of the guidelines are that application for issue of “written confirmation” for APIs for medicinal products for human use is to be made by the exporter in prescribed format and after satisfying the completeness of documents submitted, inspection shall be conducted and after satisfactory outcome thereof, formal written confirmation shall be issued.