The Government of India has 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. APIs are commonly referred to as bulk drugs in the pharmaceutical industry and are used in the making of formulations (medicines).

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 from 2nd July 2013.

The changes broadly being introduced now vis-a-vis existing regulations, are as below:

Current Regulation:   Exporter of Active Pharmaceutical Ingredients (APIs) to EU countries should either have a Certificate of Suitability (COS) issued by EU Authority of a Drug Master File (DMF) filed with respective Regulatory Authorities of the respective Member State. Also a Qualified Person (QP) of the company in EU intending to use the API has to certify that the API is manufactured under Good Manufacturing Practice (GMP) prescribed in International Conference for Harmonisation (ICH) guideline Q7A.

New Legislation:- The new legislation coming into force from 02.07.2013 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 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 that its pharma industry would be able to meet regulatory requirements within the given time frame.

Following are the salient features of the guidelines laid down by the CDSCO, which is also hosted on their website:

• Application for issue of “written confirmation” for APIs for medicinal products for human use is to be made by the exporter in prescribed format.
• After satisfying the completeness of documents submitted, inspection shall be conducted and after satisfactory outcome thereof, formal written confirmation shall be issued.
• Non-compliances noticed after inspection shall be communicated to the EU as per their requirement.
• A time frame of 45 days has been prescribed for disposal of satisfactory applications and the written confirmation shall be valid for the three years.
• Detailed forms have been laid down for purposes prescribed under various Articles of the EU Directives by the CDSCO – running into nearly 70 pages.

In due course of time, online application filing and tracking system would be evolved to bring in sufficient expediency and transparency in the system. This landmark achievement underlines the seriousness the Government of India towards pharma exports. Compliance by pharma industry with the EU directive is expected to have a very positive impact on the companies as many of them aspiring to export to the developed countries shall in the process upgrade their plants to WHO GMP standards.

The detailed guidelines laid down by CDSCO and also approvals granted for various exporters are available at http://www.cdsco.nic.in/.

DS/RK

(Release ID :96149)

Written confirmation requirement for API imports enforces EU GMP compliance through national authority confirmation and mandatory inspections. Exporters of Active Pharmaceutical Ingredients must obtain a written confirmation from a nominated national authority that the API and its manufacturing facility comply with EU GMP and are subject to equivalent GMP control and enforcement. The authority will require a prescribed application, document completeness checks, inspection where appropriate, and will communicate any non compliance to the EU. Satisfactory applications are processed within an administrative timetable and issued confirmations carry a defined multi year validity.